treatment strategies: what’s right for you jamar’s … · job number: prez-0000-p4369 suffi x:...
TRANSCRIPT
PO
SIT
IVE
LY
AW
AR
E.C
OM
JULY + AUGUST 2012
GETTING PrEP’d:ARE YOU READY?LEATHER, PORN,AND KINK.PLAYING IT SAFETREATMENT STRATEGIES:WHAT’S RIGHT FOR YOU
JAMAR’SVOICEFollowing his run on TV’s “The Voice,” Jamar Rogers takes to the stage again —to share his story of life with HIV
Job Number: PREZ-0000-P4369 Suffi x: PA
Colors: Cyan, Magenta, Yellow, Black
Fonts: Helvetica Neue (107 Extra Black Condensed, 47 Light Condensed, 77 Bold Condensed, 47 Light Condensed Oblique, 37 Thin Condensed; Type 1), Helvetica (Bold, Bold Condensed; Type 1), Optima (Extra Black; Type 1)
Images: P4348C13_R0_Background.eps (300 ppi; CMYK), P4348C01SC_R3_Prezista4588.psd (300 ppi; CMYK), Camera_Icon_black.eps, PREZISTA_dt_4C_Wht_R.eps
Date: 6-8-2012 1:15 PM
File Name: p4369_R4_sprd_Prezista_PA.indd
Media: Magazines – 2012
Bleed: 16.5” x 11”
Trim: 15.75” x 10.5”
Safety: 15” x 9.5”
Gutter: 0.5”
Folds: Half
7.875”
Scale: 1 in. = 1 in.
Output%: 76%
Color Sp: Page Spread – Bleed 4/C
Notes: Headline: Is the Prezista Experience
Right for You?
Bill all costs to p4369.
TM: Jamie Shaw
PA: Laura Sherry
Ret: Greg Olsen
QC: Justin O’Brien
PR: Pat Owens
PP: Leslie Burns
Brand: Prezista
AD: Kelly Mayo
CW: Brian Fox
GCD: Michelle Tucker
AE: S. Fuge / L. Schuermann
AB: Lindsay Tyler
Vend: None
Client: Janssen Pharmaceuticals
ABOUT PREZISTA®
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodefi ciency virus) medicines known as protease inhibitors.
PREZISTA® is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.
• The use of other medicines active against HIV in combination with PREZISTA®/ritonavir (Norvir®) may increase your ability to fi ght HIV. Your healthcare professional will work with you to fi nd the right combination of HIV medicines
• It is important that you remain under the care of your healthcare professional during treatment with PREZISTA®
PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.®
Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you.
IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about PREZISTA®?
• PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?”
• PREZISTA® may cause liver problems. Some people taking PREZISTA,® together with Norvir® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare professional should do blood tests before and during your combination treatment with PREZISTA.® If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems
• Tell your healthcare professional if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite
• PREZISTA® may cause a severe or life-threatening skin reaction or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare professional immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or infl amed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild
Who should not take PREZISTA®?
• Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45,® Embolex,® Migranal®), ergonovine, ergotamine (Cafergot,® Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort (Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor®), simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,®
Rifamate,® Rimactane®), sildenafi l (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™), or telaprevir (Incivek™)
• Before taking PREZISTA,® tell your healthcare professional if you are taking sildenafi l (Viagra,® Revatio®), vardenafi l (Levitra,® Staxyn®), tadalafi l (Cialis,® Adcirca®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), pravastatin (Pravachol®), or colchicine (Colcrys,® Col-Probenecid®). Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms
This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What should I tell my doctor before I take PREZISTA®?
• Before taking PREZISTA,® tell your healthcare professional if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia
• Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding
— The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA® is right for you
— Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk
What are the possible side effects of PREZISTA®?
• High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA®
• Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA.® The cause and long-term health effects of these conditions are not known at this time
• Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fi ght infections that have been hidden
• The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA® or any other medicines without fi rst talking to your healthcare professional
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures.
Please read accompanying Patient Information for PREZISTA® and discuss any questions you have with your doctor.
There is no other person in the world who is exactly like you. And
no HIV treatments are exactly alike, either. That’s why you should
ask your healthcare professional about PREZISTA® (darunavir).
Once-Daily PREZISTA® taken with ritonavir and in combination
with other HIV medications can help lower your viral load
and keep your HIV under control over the long term.
In a clinical study* of almost 4 years (192 weeks), 7 out of 10
adults who had never taken HIV medications before
maintained undetectable† viral loads with PREZISTA®
plus ritonavir and Truvada.®
Find out if the PREZISTA® EXPERIENCE is right for you.
Ask your healthcare professional and learn more
at DiscoverPREZISTA.com
Please read the Important Safety Information and
Patient Information on adjacent pages.
*A randomized open label Phase 3 trial comparing PREZISTA®/ritonavir 800/100 mg once daily (n=343) vs. Kaletra®/ritonavir 800/200 mg/day (n=346).
†Undetectable was defi ned as a viral load of less than 50 copies per mL. Registered trademarks are the property of their respective owners.
Snap a quick pic of our logo to show your doctor and get the conversation started.
© Janssen Therapeutics, Division of Janssen Products, LP 2012 06/12 28PRZ1203628
PRZD
TC02
88R8
IS THE PREZISTA® EXPERIENCE RIGHT FOR YOU?
S:15”
S:9
.5”
T:15.75”
T:1
0.5
”
B:16.5”
B:1
1”
F:7.875”
FS:7.25”
F:7.875”
FS:7.25”
Job Number: PREZ-0000-P4369 Suffi x: PA
Colors: Cyan, Magenta, Yellow, Black
Fonts: Helvetica Neue (107 Extra Black Condensed, 47 Light Condensed, 77 Bold Condensed, 47 Light Condensed Oblique, 37 Thin Condensed; Type 1), Helvetica (Bold, Bold Condensed; Type 1), Optima (Extra Black; Type 1)
Images: P4348C13_R0_Background.eps (300 ppi; CMYK), P4348C01SC_R3_Prezista4588.psd (300 ppi; CMYK), Camera_Icon_black.eps, PREZISTA_dt_4C_Wht_R.eps
Date: 6-8-2012 1:15 PM
File Name: p4369_R4_sprd_Prezista_PA.indd
Media: Magazines – 2012
Bleed: 16.5” x 11”
Trim: 15.75” x 10.5”
Safety: 15” x 9.5”
Gutter: 0.5”
Folds: Half
7.875”
Scale: 1 in. = 1 in.
Output%: 76%
Color Sp: Page Spread – Bleed 4/C
Notes: Headline: Is the Prezista Experience
Right for You?
Bill all costs to p4369.
TM: Jamie Shaw
PA: Laura Sherry
Ret: Greg Olsen
QC: Justin O’Brien
PR: Pat Owens
PP: Leslie Burns
Brand: Prezista
AD: Kelly Mayo
CW: Brian Fox
GCD: Michelle Tucker
AE: S. Fuge / L. Schuermann
AB: Lindsay Tyler
Vend: None
Client: Janssen Pharmaceuticals
ABOUT PREZISTA®
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodefi ciency virus) medicines known as protease inhibitors.
PREZISTA® is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.
• The use of other medicines active against HIV in combination with PREZISTA®/ritonavir (Norvir®) may increase your ability to fi ght HIV. Your healthcare professional will work with you to fi nd the right combination of HIV medicines
• It is important that you remain under the care of your healthcare professional during treatment with PREZISTA®
PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.®
Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you.
IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about PREZISTA®?
• PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?”
• PREZISTA® may cause liver problems. Some people taking PREZISTA,® together with Norvir® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare professional should do blood tests before and during your combination treatment with PREZISTA.® If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems
• Tell your healthcare professional if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite
• PREZISTA® may cause a severe or life-threatening skin reaction or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare professional immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or infl amed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild
Who should not take PREZISTA®?
• Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45,® Embolex,® Migranal®), ergonovine, ergotamine (Cafergot,® Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort (Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor®), simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,®
Rifamate,® Rimactane®), sildenafi l (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™), or telaprevir (Incivek™)
• Before taking PREZISTA,® tell your healthcare professional if you are taking sildenafi l (Viagra,® Revatio®), vardenafi l (Levitra,® Staxyn®), tadalafi l (Cialis,® Adcirca®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), pravastatin (Pravachol®), or colchicine (Colcrys,® Col-Probenecid®). Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms
This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What should I tell my doctor before I take PREZISTA®?
• Before taking PREZISTA,® tell your healthcare professional if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia
• Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding
— The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA® is right for you
— Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk
What are the possible side effects of PREZISTA®?
• High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA®
• Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA.® The cause and long-term health effects of these conditions are not known at this time
• Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fi ght infections that have been hidden
• The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA® or any other medicines without fi rst talking to your healthcare professional
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures.
Please read accompanying Patient Information for PREZISTA® and discuss any questions you have with your doctor.
There is no other person in the world who is exactly like you. And
no HIV treatments are exactly alike, either. That’s why you should
ask your healthcare professional about PREZISTA® (darunavir).
Once-Daily PREZISTA® taken with ritonavir and in combination
with other HIV medications can help lower your viral load
and keep your HIV under control over the long term.
In a clinical study* of almost 4 years (192 weeks), 7 out of 10
adults who had never taken HIV medications before
maintained undetectable† viral loads with PREZISTA®
plus ritonavir and Truvada.®
Find out if the PREZISTA® EXPERIENCE is right for you.
Ask your healthcare professional and learn more
at DiscoverPREZISTA.com
Please read the Important Safety Information and
Patient Information on adjacent pages.
*A randomized open label Phase 3 trial comparing PREZISTA®/ritonavir 800/100 mg once daily (n=343) vs. Kaletra®/ritonavir 800/200 mg/day (n=346).
†Undetectable was defi ned as a viral load of less than 50 copies per mL. Registered trademarks are the property of their respective owners.
Snap a quick pic of our logo to show your doctor and get the conversation started.
© Janssen Therapeutics, Division of Janssen Products, LP 2012 06/12 28PRZ1203628
PRZD
TC02
88R8
IS THE PREZISTA® EXPERIENCE RIGHT FOR YOU?
S:15”S:9
.5”
T:15.75”T:1
0.5
”
B:16.5”B
:11”
F:7.875”
FS:7.25”
F:7.875”
FS:7.25”
Job Number: PREZ-0000-P4369 Suffix: PA
Colors: Black
Fonts: None
Images: Prezista Patient 7x9.5.pdf, Prezista Patient 7x9.5_pg2.pdf
Date: 6-8-2012 1:15 PM
File Name: p4369_R4_sprd_Prezista_PA.indd
Media: Magazines – 2012
Bleed: 16.5” x 11”
Trim: 15.75” x 10.5”
Safety: 15” x 9.5”
Gutter: 0.5”
Folds: Half
7.875”
Scale: 1 in. = 1 in.
Output%: 76%
Color Sp: Page Spread – Bleed 4/C
Notes: Headline: Is the Prezista Experience
Right for You?
Bill all costs to p4369.
TM: Jamie Shaw
PA: Laura Sherry
Ret: Greg Olsen
QC: Justin O’Brien
PR: Pat Owens
PP: Leslie Burns
Brand: Prezista
AD: Kelly Mayo
CW: Brian Fox
GCD: Michelle Tucker
AE: S. Fuge / L. Schuermann
AB: Lindsay Tyler
Vend: None
Client: Janssen Pharmaceuticals
PREZISTA (pre-ZIS-ta)(darunavir)
Oral SuspensionPREZISTA (pre-ZIS-ta)
(darunavir)Tablets
Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.Also read the Patient Information leaflet for NORVIR® (ritonavir).What is the most important information I should know about PREZISTA?• PREZISTA can interact with other medicines and cause serious
side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section “Who should not take PREZISTA?”
• PREZISTA may cause liver problems. Some people taking PREZISTA in combination with NORVIR® (ritonavir) have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems.
• Tellyourhealthcareproviderifyouhaveanyofthebelowsignsandsymptoms of liver problems.
• Dark(teacolored)urine • yellowingofyourskinorwhitesofyoureyes • palecoloredstools(bowelmovements) • nausea • vomiting • painortendernessonyourrightsidebelowyourribs • lossofappetitePREZISTA may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below:• fever• tiredness• muscleorjointpain• blistersorskinlesions• mouthsoresorulcers• redorinflamedeyes,like“pinkeye”(conjunctivitis)Rash occurred more often in patients taking PREZISTA and raltegravir together than with either drug separately, but was generally mild.See “What are the possible side effects of PREZISTA?” for more information about side effects.What is PREZISTA?PREZISTA is a prescription anti-HIV medicine used with ritonavir and other anti-HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a proteaseinhibitor.HIVisthevirusthatcausesAIDS(AcquiredImmuneDeficiencySyndrome).When used with other HIV medicines, PREZISTA may help to reduce the amount of HIV in your blood (called “viral load”). PREZISTA mayalsohelptoincreasethenumberofwhitebloodcellscalledCD4(T)cellwhich help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system.This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).PREZISTAdoesnotcureHIVinfectionorAIDSandyoumaycontinuetoexperience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.Avoid doing things that can spread HIV-1 infection.• Donotshareneedlesorotherinjectionequipment.• Donotsharepersonal itemsthatcanhavebloodorbody fluidson
them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.Who should not take PREZISTA?DonottakePREZISTAwith any of the following medicines:• alfuzosin (Uroxatral®)• dihydroergotamine(D.H.E.45®, Embolex®, Migranal®), ergonovine,
ergotamine (Cafergot®, Ergomar®) methylergonovine• cisapride• pimozide (Orap®)• oral midazolam, triazolam (Halcion®)• the herbal supplement St. John’s Wort (Hypericum perforatum)• the cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®,
Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®)• rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®)• sildenafil (Revatio®) only when used for the treatment of pulmonary
arterial hypertension. Serious problems can happen if you take any of these medicines with PREZISTA.What should I tell my doctor before I take PREZISTA?PREZISTA may not be right for you. Before taking PREZISTA, tell your healthcare provider if you:• haveliverproblems,includinghepatitisBorhepatitisC• areallergictosulfamedicines• havehighbloodsugar(diabetes)• havehemophilia• are pregnant or planning to become pregnant. It is not known if
PREZISTA will harm your unborn baby. Pregnancy Registry: You and your healthcare provider will need to
decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is follow the health of you and your baby.
• are breastfeedingor plan to breastfeed.Donot breastfeed. We do not know if PREZISTA can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using PREZISTA and certain other medicines may affect each other causing serious side effects. PREZISTA may affect the way other medicines work and other medicines may affect how PREZISTA works.Especially tell your healthcare provider if you take:• medicinetotreatHIV• estrogen-based contraceptives (birth control). PREZISTA might
reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom.
• medicine for your heart such as bepridil, lidocaine (XylocaineViscous®), quinidine (Nuedexta®), amiodarone (Pacerone®, Cardarone®), digoxin (Lanoxin®), flecainide (Tambocor®), propafenone (Rythmol®)
• warfarin(Coumadin®, Jantoven®)• medicineforseizuressuchascarbamazepine(Carbatrol®, Equetro®,
Tegretol®, Epitol®),phenobarbital,phenytoin(Dilantin®, Phenytek®)• medicine for depression such as trazadone and desipramine
(Norpramin®)• clarithromycin(Prevpac®, Biaxin®)• medicine for fungal infections such as ketoconazole (Nizoral®),
itraconazole (Sporanox®, Onmel®), voriconazole (VFend®)• colchicine(Colcrys®, Col-Probenecid®)• rifabutin(Mycobutin®)• medicineusedtotreatbloodpressure,aheartattack,heart failure,
or to lower pressure in the eye such as metoprolol (Lopressor®, Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®, Combigan®)
• midazolamadministeredbyinjection• medicine for heart disease such as felodipine (Plendil®), nifedipine
(Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®)
IMPORTANT PATIENT INFORMATION
• steroids such as dexamethasone, fluticasone (Advair Diskus®, Veramyst®, Flovent®, Flonase®)
• bosentan(Tracleer®)• medicine to treat chronic hepatitis C such as boceprevir
(VictrelisTM), telaprevir (IncivekTM)• medicine for cholesterol such as pravastatin (Pravachol®),
atorvastatin (Lipitor®), rosuvastatin (Crestor®)• medicine to prevent organ transplant failure such as cyclosporine
(Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®)
• salmeterol(Advair®, Serevent®)• medicinefornarcoticwithdrawalsuchasmethadone(Methadose®,
Dolophine Hydrochloride), buprenorphine (Butrans®, Buprenex®, Subutex®), buprenorphine/naloxone (Suboxone®)
• medicine to treat schizophrenia such as risperidone (Risperdal®), thioridazine
• medicine to treat erectile dysfunction or pulmonary hypertensionsuch as sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®)
• medicine to treat anxiety, depression or panic disorder such assertraline (Zoloft®), paroxetine (Paxil®)
This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor or pharmacistwhen youget a newmedicine.Donot start anynew medicines while you are taking PREZISTA without first talking with your healthcare provider.How should I take PREZISTA?• TakePREZISTAeverydayexactlyasprescribedbyyourhealthcare
provider. • Youmusttakeritonavir(NORVIR®) at the same time as PREZISTA. • Do not change your dose of PREZISTA or stop treatment without
talking to your healthcare provider first.• TakePREZISTAandritonavir(NORVIR®) with food.• SwallowPREZISTAtabletswholewithadrink. Ifyouhavedifficulty
swallowing PREZISTA tablets, PREZISTA oral suspension is also available. Your health care provider will help determine whether PREZISTA tablets or oral suspension is right for you.
• PREZISTA oral suspension should be given with the supplied oraldosing syringe. Shake the suspension well before each usage.
• IfyoutaketoomuchPREZISTA,callyourhealthcareproviderorgoto the nearest hospital emergency room right away.
What should I do if I miss a dose?People who take PREZISTA one time a day:• If you miss a dose of PREZISTA by less than 12 hours, take your
missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.
• IfyoumissadoseofPREZISTAbymorethan12hours,waitandthentake the next dose of PREZISTA at your regularly scheduled time.
People who take PREZISTA two times a day• If you miss a dose of PREZISTA by less than 6 hours, take your
missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.
• IfyoumissadoseofPREZISTAbymorethan6hours,waitandthentake the next dose of PREZISTA at your regularly scheduled time.
IfadoseofPREZISTA isskipped,donotdouble thenextdose.Donottake more or less than your prescribed dose of PREZISTA at any one time.What are the possible side effects of PREZISTA?PREZISTA can cause side effects including:• See“What is the most important information I should know about
PREZISTA?”• Diabetesandhighbloodsugar (hyperglycemia).Some people who
take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA.
• Changes in body fat. These changes can happen in people who take anti retroviral therapy. The changes may include an increased amountof fat in theupperbackandneck (“buffalohump”),breast,and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV medicine.
• Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA.
The most common side effects of PREZISTA include:• diarrhea • headache• nausea • abdominalpain• rash • vomitingTell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all of the possible side effects of PREZISTA. For more information, ask your health care provider.Call your doctor for medical advice about side effects. You may report sideeffectstotheFDAat1-800-FDA-1088.How should I store PREZISTA?• Store PREZISTA oral suspension and tablets at room temperature
[77°F(25°C)].• DonotrefrigerateorfreezePREZISTAoralsuspension.• KeepPREZISTAawayfromhighheat.• PREZISTAoralsuspensionshouldbestoredintheoriginalcontainer.Keep PREZISTA and all medicines out of the reach of children.General information about PREZISTAMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for acondition for which it was not prescribed. Do not give PREZISTA toother people even if they have the same condition you have. It may harm them.This leaflet summarizes the most important information about PREZISTA. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PREZISTA that is written for health professionals. Formoreinformation,call1-800-526-7736.What are the ingredients in PREZISTA?Active ingredient: darunavirInactive ingredients:PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloricacid(forpHadjustment),purifiedwater.PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY®White (polyethylene glycol 3350, polyvinylalcohol-partially hydrolyzed, talc, titanium dioxide).PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® Orange (FD&C Yellow No. 6, polyethyleneglycol3350,polyvinylalcohol-partiallyhydrolyzed,talc,titaniumdioxide).ThisPatient Informationhasbeenapprovedby theU.SFoodandDrugAdministration.Manufactured by:PREZISTA Oral SuspensionJanssen Pharmaceutica, N.V.Beerse, BelgiumPREZISTA TabletsJanssenOrthoLLC,Gurabo,PR00778Manufactured for:JanssenTherapeutics,DivisionofJanssenProducts,LP,TitusvilleNJ08560NORVIR® is a registered trademark of its respective owner.PREZISTA® is a registered trademark of Janssen Pharmaceuticals©JanssenPharmaceuticals,Inc.2006Revised:May2012
IMPORTANT PATIENT INFORMATION
S:15”
S:9
.5”
T:15.75”
T:1
0.5
”
B:16.5”
B:1
1”
F:7.875”
FS:7.25”
F:7.875”
FS:7.25”
Job Number: PREZ-0000-P4369 Suffix: PA
Colors: Black
Fonts: None
Images: Prezista Patient 7x9.5.pdf, Prezista Patient 7x9.5_pg2.pdf
Date: 6-8-2012 1:15 PM
File Name: p4369_R4_sprd_Prezista_PA.indd
Media: Magazines – 2012
Bleed: 16.5” x 11”
Trim: 15.75” x 10.5”
Safety: 15” x 9.5”
Gutter: 0.5”
Folds: Half
7.875”
Scale: 1 in. = 1 in.
Output%: 76%
Color Sp: Page Spread – Bleed 4/C
Notes: Headline: Is the Prezista Experience
Right for You?
Bill all costs to p4369.
TM: Jamie Shaw
PA: Laura Sherry
Ret: Greg Olsen
QC: Justin O’Brien
PR: Pat Owens
PP: Leslie Burns
Brand: Prezista
AD: Kelly Mayo
CW: Brian Fox
GCD: Michelle Tucker
AE: S. Fuge / L. Schuermann
AB: Lindsay Tyler
Vend: None
Client: Janssen Pharmaceuticals
PREZISTA (pre-ZIS-ta)(darunavir)
Oral SuspensionPREZISTA (pre-ZIS-ta)
(darunavir)Tablets
Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.Also read the Patient Information leaflet for NORVIR® (ritonavir).What is the most important information I should know about PREZISTA?• PREZISTA can interact with other medicines and cause serious
side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section “Who should not take PREZISTA?”
• PREZISTA may cause liver problems. Some people taking PREZISTA in combination with NORVIR® (ritonavir) have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems.
• Tellyourhealthcareproviderifyouhaveanyofthebelowsignsandsymptoms of liver problems.
• Dark(teacolored)urine • yellowingofyourskinorwhitesofyoureyes • palecoloredstools(bowelmovements) • nausea • vomiting • painortendernessonyourrightsidebelowyourribs • lossofappetitePREZISTA may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below:• fever• tiredness• muscleorjointpain• blistersorskinlesions• mouthsoresorulcers• redorinflamedeyes,like“pinkeye”(conjunctivitis)Rash occurred more often in patients taking PREZISTA and raltegravir together than with either drug separately, but was generally mild.See “What are the possible side effects of PREZISTA?” for more information about side effects.What is PREZISTA?PREZISTA is a prescription anti-HIV medicine used with ritonavir and other anti-HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a proteaseinhibitor.HIVisthevirusthatcausesAIDS(AcquiredImmuneDeficiencySyndrome).When used with other HIV medicines, PREZISTA may help to reduce the amount of HIV in your blood (called “viral load”). PREZISTA mayalsohelptoincreasethenumberofwhitebloodcellscalledCD4(T)cellwhich help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system.This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).PREZISTAdoesnotcureHIVinfectionorAIDSandyoumaycontinuetoexperience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.Avoid doing things that can spread HIV-1 infection.• Donotshareneedlesorotherinjectionequipment.• Donotsharepersonal itemsthatcanhavebloodorbody fluidson
them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.Who should not take PREZISTA?DonottakePREZISTAwith any of the following medicines:• alfuzosin (Uroxatral®)• dihydroergotamine(D.H.E.45®, Embolex®, Migranal®), ergonovine,
ergotamine (Cafergot®, Ergomar®) methylergonovine• cisapride• pimozide (Orap®)• oral midazolam, triazolam (Halcion®)• the herbal supplement St. John’s Wort (Hypericum perforatum)• the cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®,
Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®)• rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®)• sildenafil (Revatio®) only when used for the treatment of pulmonary
arterial hypertension. Serious problems can happen if you take any of these medicines with PREZISTA.What should I tell my doctor before I take PREZISTA?PREZISTA may not be right for you. Before taking PREZISTA, tell your healthcare provider if you:• haveliverproblems,includinghepatitisBorhepatitisC• areallergictosulfamedicines• havehighbloodsugar(diabetes)• havehemophilia• are pregnant or planning to become pregnant. It is not known if
PREZISTA will harm your unborn baby. Pregnancy Registry: You and your healthcare provider will need to
decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is follow the health of you and your baby.
• are breastfeedingor plan to breastfeed.Donot breastfeed. We do not know if PREZISTA can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using PREZISTA and certain other medicines may affect each other causing serious side effects. PREZISTA may affect the way other medicines work and other medicines may affect how PREZISTA works.Especially tell your healthcare provider if you take:• medicinetotreatHIV• estrogen-based contraceptives (birth control). PREZISTA might
reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom.
• medicine for your heart such as bepridil, lidocaine (XylocaineViscous®), quinidine (Nuedexta®), amiodarone (Pacerone®, Cardarone®), digoxin (Lanoxin®), flecainide (Tambocor®), propafenone (Rythmol®)
• warfarin(Coumadin®, Jantoven®)• medicineforseizuressuchascarbamazepine(Carbatrol®, Equetro®,
Tegretol®, Epitol®),phenobarbital,phenytoin(Dilantin®, Phenytek®)• medicine for depression such as trazadone and desipramine
(Norpramin®)• clarithromycin(Prevpac®, Biaxin®)• medicine for fungal infections such as ketoconazole (Nizoral®),
itraconazole (Sporanox®, Onmel®), voriconazole (VFend®)• colchicine(Colcrys®, Col-Probenecid®)• rifabutin(Mycobutin®)• medicineusedtotreatbloodpressure,aheartattack,heart failure,
or to lower pressure in the eye such as metoprolol (Lopressor®, Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®, Combigan®)
• midazolamadministeredbyinjection• medicine for heart disease such as felodipine (Plendil®), nifedipine
(Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®)
IMPORTANT PATIENT INFORMATION
• steroids such as dexamethasone, fluticasone (Advair Diskus®, Veramyst®, Flovent®, Flonase®)
• bosentan(Tracleer®)• medicine to treat chronic hepatitis C such as boceprevir
(VictrelisTM), telaprevir (IncivekTM)• medicine for cholesterol such as pravastatin (Pravachol®),
atorvastatin (Lipitor®), rosuvastatin (Crestor®)• medicine to prevent organ transplant failure such as cyclosporine
(Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®)
• salmeterol(Advair®, Serevent®)• medicinefornarcoticwithdrawalsuchasmethadone(Methadose®,
Dolophine Hydrochloride), buprenorphine (Butrans®, Buprenex®, Subutex®), buprenorphine/naloxone (Suboxone®)
• medicine to treat schizophrenia such as risperidone (Risperdal®), thioridazine
• medicine to treat erectile dysfunction or pulmonary hypertensionsuch as sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®)
• medicine to treat anxiety, depression or panic disorder such assertraline (Zoloft®), paroxetine (Paxil®)
This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor or pharmacistwhen youget a newmedicine.Donot start anynew medicines while you are taking PREZISTA without first talking with your healthcare provider.How should I take PREZISTA?• TakePREZISTAeverydayexactlyasprescribedbyyourhealthcare
provider. • Youmusttakeritonavir(NORVIR®) at the same time as PREZISTA. • Do not change your dose of PREZISTA or stop treatment without
talking to your healthcare provider first.• TakePREZISTAandritonavir(NORVIR®) with food.• SwallowPREZISTAtabletswholewithadrink. Ifyouhavedifficulty
swallowing PREZISTA tablets, PREZISTA oral suspension is also available. Your health care provider will help determine whether PREZISTA tablets or oral suspension is right for you.
• PREZISTA oral suspension should be given with the supplied oraldosing syringe. Shake the suspension well before each usage.
• IfyoutaketoomuchPREZISTA,callyourhealthcareproviderorgoto the nearest hospital emergency room right away.
What should I do if I miss a dose?People who take PREZISTA one time a day:• If you miss a dose of PREZISTA by less than 12 hours, take your
missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.
• IfyoumissadoseofPREZISTAbymorethan12hours,waitandthentake the next dose of PREZISTA at your regularly scheduled time.
People who take PREZISTA two times a day• If you miss a dose of PREZISTA by less than 6 hours, take your
missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.
• IfyoumissadoseofPREZISTAbymorethan6hours,waitandthentake the next dose of PREZISTA at your regularly scheduled time.
IfadoseofPREZISTA isskipped,donotdouble thenextdose.Donottake more or less than your prescribed dose of PREZISTA at any one time.What are the possible side effects of PREZISTA?PREZISTA can cause side effects including:• See“What is the most important information I should know about
PREZISTA?”• Diabetesandhighbloodsugar (hyperglycemia).Some people who
take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA.
• Changes in body fat. These changes can happen in people who take anti retroviral therapy. The changes may include an increased amountof fat in theupperbackandneck (“buffalohump”),breast,and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV medicine.
• Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA.
The most common side effects of PREZISTA include:• diarrhea • headache• nausea • abdominalpain• rash • vomitingTell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all of the possible side effects of PREZISTA. For more information, ask your health care provider.Call your doctor for medical advice about side effects. You may report sideeffectstotheFDAat1-800-FDA-1088.How should I store PREZISTA?• Store PREZISTA oral suspension and tablets at room temperature
[77°F(25°C)].• DonotrefrigerateorfreezePREZISTAoralsuspension.• KeepPREZISTAawayfromhighheat.• PREZISTAoralsuspensionshouldbestoredintheoriginalcontainer.Keep PREZISTA and all medicines out of the reach of children.General information about PREZISTAMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for acondition for which it was not prescribed. Do not give PREZISTA toother people even if they have the same condition you have. It may harm them.This leaflet summarizes the most important information about PREZISTA. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PREZISTA that is written for health professionals. Formoreinformation,call1-800-526-7736.What are the ingredients in PREZISTA?Active ingredient: darunavirInactive ingredients:PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloricacid(forpHadjustment),purifiedwater.PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY®White (polyethylene glycol 3350, polyvinylalcohol-partially hydrolyzed, talc, titanium dioxide).PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® Orange (FD&C Yellow No. 6, polyethyleneglycol3350,polyvinylalcohol-partiallyhydrolyzed,talc,titaniumdioxide).ThisPatient Informationhasbeenapprovedby theU.SFoodandDrugAdministration.Manufactured by:PREZISTA Oral SuspensionJanssen Pharmaceutica, N.V.Beerse, BelgiumPREZISTA TabletsJanssenOrthoLLC,Gurabo,PR00778Manufactured for:JanssenTherapeutics,DivisionofJanssenProducts,LP,TitusvilleNJ08560NORVIR® is a registered trademark of its respective owner.PREZISTA® is a registered trademark of Janssen Pharmaceuticals©JanssenPharmaceuticals,Inc.2006Revised:May2012
IMPORTANT PATIENT INFORMATION
S:15”S:9
.5”
T:15.75”T:1
0.5
”B:16.5”
B:1
1”
F:7.875”
FS:7.25”
F:7.875”
FS:7.25”
4 JULY+AUGUST 2012 POSITIVELYAWARE.COM
JULY+AUGUST 2012V O L U M E 2 4 N U M B E R 5
ON THE COVER AND ON THIS PAGEJAMAR ROGERS PHOTOGRAPHED BY MATTHEW GARSTECK. MAKEUP: JACKIE MGIDO. JAMAR ROGERS’ ASSISTANT: MICHELLE ROGERS. JAMAR ROGERS’ MANAGER: SALLY COLÓN. STYLIST: KENZIE CROSLEY. CLOTHING PROVIDED BY KITSON IN BEVERLY HILLS, CA.
D E PA R T M E N T S
6 IN BOX
6 READERS’ POLL
7 EDITOR’S NOTE WishHIVaway.
13 BRIEFLY HepatitisCtreatmentwithoutinterferon.
Activistsissuereportoncureresearch.TrendingonTwitter.
23 CULTURE CLUB Rememberingwherewe’vebeen.
44 ASK THE HIV SPECIALIST Howsafeissafe?
45 SALIENT RAMBLINGS “It‘ssostrangethewaythingsturn.”
C O V E R S T O R Y
24 Jamar’s voice AfterhisrunonTV’s“TheVoice,”JamarRogers
takestothestageformorethansinging.
F E AT U R E S
19 Treatment strategies Astherapiesimprove,howtochoosewhat’s
rightforyou.
34 PrEP’ing Areyouready?Doctorsandadvocatesgear
uptobringTruvadaPrEPtothosewhoareatgreatestriskofinfection.
39 Leather, porn, and kink They’reactuallysaferthanyoumightthink.
DIGITAL EDITIONREAD THE PRINT VERSION OF POSITIVELY AWARE ON YOUR COMPUTER OR TABLET.
http://issuu.com/positivelyaware
5537 N. BROADWAY ST.
CHICAGO, IL 60640
phone: (773) 989–9400
fax: (773) 989–9494
email: [email protected]
www.positivelyaware.com
EDITOR-IN-CHIEF Jeff BerryASSOCIATE EDITOR Enid VázquezCOPY EDITOR Sue SaltmarshPROOFREADER Jason LancasterWEB MASTER Joshua ThorneCREATIVE DIRECTOR Rick Guasco
CONTRIBUTING WRITERS
Keith R. Green, Liz Highleyman,Sal Iacopelli, Laura Jones,Jim Pickett, Matt Sharp
PHOTOGRAPHERS
Chris Knight, Joshua Thorne
CONTRIBUTING PHOTOGRAPHER
Matthew Garsteck
MEDICAL ADVISORS
Daniel S. Berger, MDGary Bucher, MDMichael Cristofano, PAJoel Gallant, MDSwarup Mehta, PharmD
ADVERTISING INQUIRIES
Lorraine [email protected]
DISTRIBUTION MANAGER
Bradley P [email protected]
POSITIVELY AWAREIS PUBLISHED BY
EXCLUSIVELY ON
www.positivelyaware.comJamar in fullListentotheaudioorreadthefullinterviewwithJamarRogers.www.positivelyaware.com/jamar
What’s next?HowtheSupremeCourt’srulingwillaffecthealthcare.www.positivelyaware.com/2012/12_05/aca.shtml
FOLLOW USON FACEBOOK AND ON TWITTER (@POSAWARE)
WE READ YOU COMMENT ON OUR ARTICLES ATPOSITIVELYAWARE.COM
© 2012. POSITIVELY AWARE (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. POSITIVELY AWARE is a registered trademark of TPAN. All rights reserved. Circulation: 100,000. For reprint permission, contact Sue Saltmarsh. Six issues mailed bulk rate for $30 donation; mailed free to those living with HIV or those unable to contribute.
We accept contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number.
Although POSITIVELY AWARE takes great care to ensure the accuracy of all the information that it presents, POSITIVELY AWARE staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in POSITIVELY AWARE are not necessarily those of staff or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in POSITIVELY AWARE do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician.
A model, photographer, or author’s HIV status should not be assumed based on their appearance in POSITIVELY AWARE, association with TPAN, or contributions to this journal.
Distribution of POSITIVELY AWARE is supported in part through an unrestricted grant from ViiV Healthcare.
POSITIVELYAWARE.COM JULY+AUGUST 2012 5
IN BOX JOIN THE CONVERSATION: [email protected] AND @POSAWARE
YOUR COMMENTS:
“Testasrequested—andprovideeduca-tion.Makecondomsandlubeavailablesothatwhensexhappens,it’slowerrisk.”
“AsatransgenderwomanwhowasinprisonandinfectedwithHIV,Ifeelitshouldbeofferedtoallinmates.”
“Testingpositiveinjailorprisonhasanegativeimpactonaperson’slife,soinmatesshouldbeabletochoose.Testingshouldbeofferedonlywhereimmediateaccesstoqualitycareandtreatmentisavailable.”
“Wetestuponintake,thenin120daysandagainuponrelease.Mandatorytestingshouldbedoneinallcorrection-alfacilities.Thatwaywecangetthemintotreatmentandtrytokeepthemintreatmentwhenreleased.”
THIS ISSUE’S POLL QUESTION:
Before you tested HIV-positive,did you think you were at risk?n Non Didn’t even think about itn Yes, but low riskn Yes, but didn’t caren Yes, practiced safer sex
CAST YOUR VOTE AT
POSITIVELYAWARE.COM
Idon’tknowwhyhisideasgetmeallchokedup.Maybethereisatraceofpro-vider’sguilt.Iusedtoworry24hoursaday,whenIwaspracticing.IwonderedifImadetherightdecisions,weretheguidelinesmakingtherightcall,weretheavailableregimensaone-size-fits-all.Thereweresomanychoices,Ihavecometosee,thatcouldhavebeenbetter.Letmephraseitdifferently.Therearesomanyaspectsoftreatmentthathavegottenbetter!Oneofthoseistheimprovedsideeffectprofiles.Also,initiatingtreatmentearly…inthegoodway.Notthe“hitithard;hititearly”way.MaybeIjustgetmovedbyhearingthatthereisanothervoiceouttherefightingthesamefight,andlookingatthesameideas,likeswitchingasanoption.LikeJeffsaid,whenweknowbetter,wedobetter.
Ithasbeenajourney.ThankstoJeffforsharinghis.ThankstoPAforbeingapartofmine.
—Name withheld by request
TheresponsefromDr.BickintheMay+June“AsktheSpecialist”columnwasnotaccu-rate.ThewriteraskedaboutherbrothergettingtreatmentforHIVwhileinprisonandDr.Bicksaidhehasarighttoit.
Actually,whileyoumayhavethatright,youdonotnecessarilygettreatmentwheninjail.Ihadtoservetwoweeksinjail.BeforeIwentin,thejudgewasinformedof
myillnessandIhandedallmymedsoveraftersentencing.Iwenttojail,mymedswereshelved,andIwasgivennoaccesstothem.BeforeenteringjailmyT-cellcountwasstableandIwashealthy.Afterleaving,myT-cellswerebelow200,Ihadlostalotofweight,andIhadAIDS.Sopleasedon’tmisinformpeopleaboutrightsthatarenotgiven,evenbythejudges.
IwillneverbefreeoftheangerIhaveforthesepeople.
—KSVIA THE INTERNET
I JUST OPENED THE 2012 PA DRUG GUIDE AND CURLED UPforacover-to-coverread.Ididn’tgetpasttheeditor’snote.Likealways,Jeff’sopensharingwasmoving,andcausedmetopause.Noonetalkssobluntlyaboutswitching,theshiftingparadigmsoftreatment,and/oraging.Nooneelselaysitallouttherewithhon-esty,conviction,andgentleness.
CorrectionIntheMay+Juneissue,inthearticleaboutThe Normal Heart,theexecu-tiveproduceratArenaStagewasreferredtoasEdgarObie.HisnameisactuallyEdgarDobie.
Also,thisproductionisactuallynotthefirstregionalone,butratherthefirstD.C.-areaprofessionalproduction.
Thephotocaptionshouldread“JimParsonsandLeePaceinthe2011BroadwayproductionofThe Normal Heart.”
WeapologizefortheerrorsandthankArenaStageforbringingthemtoourattention.
READERS’ POLLIN THE MAY+JUNE ISSUE, WE ASKED READERS
What do you think is the best way to provide HIV testing in prisons?
DO THE WRITE THING. POSITIVELY AWAREtreatsallcommunications(letters,e-mail,etc.)asletterstotheeditorunlessotherwiseinstructed.Wereservetherighttoeditforlength,style,orclarity.Unlessyoutellusnotto,wewilluseyournameandcity.
WE READ YOU.SHARE YOUR COMMENTS ABOUT OUR ARTICLES ATPOSITIVELYAWARE.COM
POSITIVELY AWARE5537 N. BROADWAY ST.CHICAGO, IL [email protected]
Sharing and educatingNOT SURE
2%IF REQUESTED
8%
OPT-OUT
36%MANDATORY
54%
6 JULY+AUGUST 2012 POSITIVELYAWARE.COM
PH
OT
O: C
HR
IS K
NIG
HT
POSITIVELYAWARE.COM JULY+AUGUST 2012 7
We need to stop wishing HIV away, and it has to begin with us.We need to start by speaking and owning our own truth, if only in the mirror.
Wish Me AwayisthenameofasongbycountrymusicsingerChelyWright,andisalsothetitleofherrecentlyreleaseddocumentaryfilm,whichchroniclesherstrugglescomingoutasalesbiantoherfans,thecountrymusicindustry,andtheworldatlarge.It’satouching,sometimessad,oftenintense,andultimatelyempoweringfilmthattellshertruth,asshehaslivedit,inthehopesthatitmighthelpotherswhomayalsobestruggling.
Duringthefilm’sopening,Chelystatesthatsheisjusttryingtoliveherownlifeopenlyandhonestly,becausenotdoingsoisnearlykillingher.Sheknewfromaveryearlyagethatshewasdifferent,thatshewasgay,andfordecadesshesworetoherselfthatshewouldtakethatsecrettohergrave.Yearsago,Imadeasimilarvowtomyself—thatIwouldtaketothegravemyownsecretthatIhadbeensexuallyabusedasachildbymyfather.
IhavenodoubtthatasimilarconvictionexistsforcountlessotherswhenitcomestotheirHIVstatus.Weliveinfear—fearoflosingourjobs,ourfamily,ourfriends,ourverysafety.SowewishHIVaway.Wetakeourpillsinhiding,sootherswon’taskquestions.Ifthereisablooddriveattheoffice,wecallinsick,ratherthanhavetoexplainwhywecan’tdonate.Wedrivehourstovisitadoctororclinicinanothertown,ratherthanberecognizedat“thatclinic”athome.WewishHIVaway.
I’msureweallhavethatonefriendwhohasneverbeentested,andrefusesto,becausetheywouldjustrathernotknow.TheywishHIVawaybypretendingitdoesn’tevenexist.Thereisthefamilywhohidesthecauseofdeathoftheirsonordaughterbysayingtheydiedofcancer.ThechurchthatpreachesthatAIDSisGod’spunishmentforbeinggay.Thelegislatorswhoslashbudgetsandfundinganddenylifesavingmedica-tionstopeoplewithHIV.TheyallwishHIVaway,and
sweepitundertherug,erroneouslybelievingitcan’thappentothem,attachingshameandstigmatosim-plyhavingavirus.
WeneedtostopwishingHIVaway,andithastobeginwithus.Iknowforsomeofusthefearoflosingourjobs,andhenceourhealthinsur-ance,isaveryreal,palpablefear.Butweneedtostartbyspeakingandowningourowntruth,ifonlyinthemirror.Inthisissue,JamarRogersspeaksveryopenlyandhonestlyabouthisownstruggles,andthepowerofspeakinghisowntruthregardinghisHIVstatus.However,therearesomeofuswhocontinuetohide,orliveindenial,becauseit’smorecomfortable,orit’seasier,orweareafraidoftheunknown.Butitmightbethatwecouldhavearealimpactbycomingoutaboutourstatus,ifonlytoourselves.HIVisnothingtobeashamedof.TheonlystigmaattachedtoHIVisthatwhichweallow.Ithasnopowertodictateouractions,ourfeelings,orourbeliefs,otherthanthepowerthatwechoosetoletithaveoverus.
Let’sstopthefantasy.Let’sstoppretendingthatHIVcanbewishedaway.Untilthereisacure,HIVisunfortu-natelyheretostay.Justlikethatuninvitedguestattheparty,itcaneitherbeshunned,merelytolerated,oritcanbeembraced.
Remember,youarethehost,andit’syourparty—whathappensisuptoyou.Soshineyourlightbrightly,holdyourheaduphigh,don’tbeashamed,andrefusetoliveinfear.It’sonlywhenwefinallydecidetoembraceandrejoiceinourowntruth,thatwecanbegintoseethetruthandlightinothers.Andbyjoin-ingtogether,wecreateaforceandalightsobright,sostrong,thatitspresenceisundeniableanditcannotbeextinguishedorignored.
Takecareofyourself,andeachother.
TRUTHISAFUNNYTHING.ITHASAWAYOFSNEAKINGuponyouwhenyouleastexpectit,likeaguestwhoshowsupataparty,uninvited.
Wish HIV away
EDITOR’S NOTEJEFF BERRY@PAEDITOR ON TWITTER
This page intentionally left blank.➤
This page intentionally left blank.➤
This page intentionally left blank.➤
This page intentionally left blank.➤
CHICAGO CULTURAL CENTER OCTOBER 4, 2012
5:30–8:30 PM
TICKETS AVAILABLEAT WWW.TPAN.COM
SPONSORED BY
Join us as TPAN commemoratesa quarter-century of serviceto Chicago’s HIV community.
A DAYWITH HIV
Take your best shot against HIV.
Positive or negative, we’re all affected by HIV. Join us in the effort to change minds and open hearts by sharing the stories and faces of people living with HIV, their loved ones, and their friends. On September 21, wherever you are, take a photo of a moment of your day that shows how you live with HIV, and help to defeat HIV stigma and discrimination. Photos will appear in our online gallery, and selected images in the November+December issue of PA. Get in the picture!
FOR DETAILS, GO TO
www.ADayWithHIV.com
It’s time for a Plan B.It’s time that the HIV/AIDS community joined all other people living with illness and injury. It’s time we refused to settle for less than single-payer, universal healthcare for all.
25 years ago, ACT UP taught us how to change the status quo. We need to remember. Join us on the National Mall. Show up. Speak out. Make history.
www.duh4all.org
PH
OT
O: JO
SH
UA
TH
OR
NE
POSITIVELYAWARE.COM JULY+AUGUST 2012 13
BRIEFLYENID VÁZQUEZ
HIV patients often drop out of care
Another homeHIV testAnotherFDAadvisorycommitteerecom-mended that the agency approve the OraQuick In-Home HIV Test.Unlikeotherover-the-counterHIVtestsavailablefromHomeAccess,inwhichpeoplemailinsamplesonaswabandgettheirresultsoverthephone,theOraQuicktestresultswouldbeavailablein20minutesandcanbereadrightathome,aswithhomepreg-nancytests.Anoralswabisused.
HIV prevention pill recommended
The Quad goes before the FDALiving with Henryisthetitleofa new Canadian musical that explores present day issues of living with HIVsuchasstigma,disclosure,andinterpersonalrela-tionships.ThemusicalwillbepremieringinNewYorkCitythissummerfromJuly23–29aspartoftheNewYorkMusicalTheatreFestival.
“Ithasbecomeapparentthattherearefew,ifany,theatricalproductionsthatdiscussHIVinthe‘now’context,”sayswriteranddirectorChristopherWilson,whoishimselfHIV-positive.“Living With HenryisacontemporarytheatricalviewofHIV/AIDS,framingitasachronicillnessratherthanadeathsentence.”
Formoreinformationgotowww.LivingWithHenry.com;Living With Henryticketsare$25andcanbepurchasedonlineatwww.nymf.orgorbycalling(212)352-3101.—JEFF BERRY
HIV the musical: Living with Henry
Onlyone in five HIV patients maintained a high level of medical carebasedonthreecriteria,accordingtoananalysisof12clinicsintheU.S.Thestudy,publishedintheApril23editionofJournal of Acquired Immune Deficiency Syndrome(JAIDS),wasbasedonthemedicalrecordsofmorethan22,000peoplereceivingcarebetween2001and2009.Inlookingatthethreecriteria—establishmentofcare(afollow-upappointmentsixormoremonthsafterfirstengagingwithcare);retentionincare(twoormorefollow-upappointmentsatleast90daysapartineachyearofcare);andlosstofollow-up(novisitformorethantwelvemonthswithoutreturn)—theresearchersfoundthat:21.7% ofthesepatientsneverestablishedHIVcareaftertheirfirstvisit;57.4%didnotmeetretentioncriteria;and34.9%werelosttofollow-up.20.4%ofpatientsestablishedandretainedcareunderthedefinitionsofthestudy.
“Foroptimalclinicalbenefit,HIV-infectedpatientsshouldreceiveperiodicoutpatientcareindefinitely,”theresearch-ersstated.“ThesedatahighlighttheneedtoimproveestablishmentandretentioninHIVcare.”
AnadvisorycommitteeoftheFDArec-ommended that the agency approve the use of the HIV medication Truvada for HIV-negative people to prevent infec-tionwiththevirus(seestoryonpage34).TheFDAwasscheduledtoconsiderthenewindicationforTruvadainSeptember,asPOSITIVELY AWAREwenttopress.
Anactualindicationforpreventiononthedruglabelwouldmakeiteasierformedicalproviderstoprescribeitandinsurerstopayforit.
Ryan Kelly (left) and Dale Miller star in Living with Henry.
AnFDAadvisorycommitteevoted13–1torecommend that the FDA approve a new once-daily HIV drug known as the Quad.TheFDAusuallyfollowstherecommenda-tionsofitsadvisorycommitteeandisscheduledtoconsiderapprovaloftheQuadbyAugust27.Ifapproved,itbecomesthethirdsingle-tabletHIVregimenonthemarket,alongwithAtriplaandComplera.
Asitsnicknameimplies,theQuadismadeupoffourdifferentmedications.Thesearethenewintegraseinhibitorelvitegravir(brandnamenotyetavailable),plusVireadandEmtriva(tenofovirandemtricitabine—availablebothseparatelyaswellastogetherunderthebrandnameTruvada),andcobicistat.ThisfourthdrugisnotanHIVmedica-tion,butaboosteragenttoimprovethebioavailabilityofelvitegravir.Currently,Norvir(ritonavir)istheonlysuchboosteragentavailable.ElvitegravirwouldjointheonlyHIVintegraseinhibitorcurrentlyonthemarket,Isentress.
FormoreinformationontheQuad,gotowww.positivelyaware.com/quad.
14 JULY+AUGUST 2012 POSITIVELYAWARE.COM
BRIEFLYENID VÁZQUEZ
Activists issue report on HIV cure researchActivistsfromtheAIDSTreatmentActivistsCoalition(ATAC),ProjectInform(inSanFrancisco),andtheTreatmentActionGroup(TAG,inNewYorkCity)issuedareport summarizing the talks presented at the Community HIV Cure Workshop,whichtookplaceinMarchinSeattlebeforeCROI.ThereportreceivedfundingsupportfromBionorPharma,GileadSciences,andMerck.
“AcureforHIVwillbeessentialtoendingtheAIDSpandemic,butsciencethatisfocuseddirectlyonacureisstillinearlystagesandwilllikelyrequirethesup-portofmultiplestakeholderstoproceedatthefastestpace,”thereportbegins.“Amongrecentsignsofprogress,researchershavecontributednewinsightsintowhereandwhyHIVpersistsdespitepotentARVtherapy.”Readthe10-pagereportatwww.positivelyaware.com.
Treatment for hep C without interferonBoehringerIngelheim(BI)issuedapressreleaseon12-weekdatawithtwoinves-tigationalcompoundsforthetreatmentofhepatitisC,BI201335andBI207127.AlthoughnotyetstudiedinpeoplewithHIV,it’sa beginning for a new treatment option that can be expected to help people co-infected with HIV and hepa-titis C(HCV)inthefuture.Thetwodrugswereusedtogether,alongwithribavirin,butimportantly,withoutinterferon,adrugthatisverydifficulttotolerate,butiscurrentlypartofeveryhepCtreatmentregimen.
“EliminatinginterferonfromHCVtreatmentisanurgentneed,”saidStefanZeuzem,MD.HeisChiefoftheDepartmentofMedicineandProfessorofMedicineattheJohannWolfgangGoetheUniversityHospitalinFrankfurt,Germany,andleadinvestigatorofthestudy.
Theplannedinterimresultsshowedthat68%ofstudyparticipantsachievedasustainedviralresponse(SVR)againsttheirhepC.SVRat12weekshasbeenindependentlycorrelatedtoSVRatweek24,whichisconsideredacure.Theparticipants(lessthan100ofthem)hadgenotype1,themostdifficulttypeofhepCtotreat.TheresultswerepresentedattheEuropeanAssociationoftheStudyoftheLiver(EASL)conference,heldinBarcelonainApril.
Breast milk antibodies help neutralize HIVAntibodiesthathelptostopHIVfromreplicatinghavebeenfoundinbreastmilk.ResearchersatDukeUniversityMedicalCenterisolatedtheantibodiesfromimmunecells,calledBcells,inthebreastmilkofinfectedmothersinMalawi.HIV-1canbetransmittedfrommothertochildviabreastfeeding,butonlyonein10HIV-positivenursingmothersisknowntopassthevirustotheirinfants.ResearchshowedthattheB cells in breast milk can generate neutralizing antibodies that may inhibit the virus.
Thediscoveryofthetwoantibodiesinbreastmilkmayalsohelpresearcherswithnewinvestigationsintoadult-to-adulttransmission,aswellastomother-to-childtransmission.
“Thisisimportantworkthatseekstounderstandwhatavaccinemustdotoprotectbabiesfrommucosaltransmis-sionduringbreastfeeding,”saidBartonHaynes,MD,co-authoranddirectoroftheCenterforHIV/AIDSVaccineImmunology(CHAVI),aswellasdirectoroftheDukeHumanVaccineInstitute(DHVI).“TheantibodiesisolatedarethefirstHIVantibodiesisolatedfrombreastmilkthatreactwiththeHIV-1envelope,anditisimportanttounderstandhowtheyworktoattackHIV-1.”
TheCentersforDiseaseControlandPrevention(CDC)recommendagainstbreastfeedingifamotherhasHIV-1,becausebabyformulaisasafealternativeforU.S.-borninfants.TheWorldHealthOrganization,however,encouragesHIV-positivenursingmothersinresource-poorregionstobreastfeedwhilemotherand/orbabytakeantiretroviraldrugstopre-venttheinfectionintheinfant.Withoutthenutrientsandimmunefactorsinmothers’milk,manymorebabieswoulddiefromotherdiseases.
ThestudywaspublishedMay18inPLoS One.
—SUE SALTMARSH
Clue found to Ziagen and Epzicom hypersensitivityAccordingtoapressreleasefromtheFDAissuedinMay,“Ateamofresearch-ersledbytheU.S.FoodandDrugAdministrationhasdiscovereda new mechanism for identifying and under-standing drug-related autoimmune reactions.
“InanarticlepublishedinthejournalAIDS,theteamdescribesthatincertainat-riskpatients,theanti-HIVdrugZiagen(abacavir)causestheimmunesystemto‘see’apatient’sownhealthytissuesandproteinsasaforeigninvader.Theaffectissimilartowhathappenswhentheimmunesystemrecognizesaviralorbacterialproteinduringaninfection.”
Theagencysaidthe“latestdiscoverywilladvancetheFDA’sabilitytoapprovetherapiesthatarepersonalizedforsafety.”
Ziagenisalsofoundinthetwo-drugcombinationpillEpzicom.Bothmedica-tionscancauseallergicreactionsthatcanbeseriousandevenfatal,buttheriskhasbeenvirtuallyeliminatedbyaneasyandinexpensivetestforthegeneHLA-B*5701,whichmakespeoplesusceptibletothereaction.
ZiagenandEpzicomareratherrarelyusedintheU.S.,withcompetitorTruvadaprobablybeingthenumberonesellingHIVdruginthecountry.
E-NEWS | SIGN UP FOR THE WEEKLY EMAIL NEWSLETTER OF POSITIVELY AWARE. GO TO POSITIVELYAWARE.COM
POSITIVELYAWARE.COM JULY+AUGUST 2012 15
COMPILED FROM THE WEEKLY E-NEWS
Nickelodeon seeks positive youthMalloryKydd,fromNick News with Linda Ellerbee,islookingforyouth ages 11-17 to share their stories of living with HIV foradocumentarytobeairedonWorldAIDSDay,December1.
“Weareprimarilylookingforstoriesthathavealotofdepth.Forexample,therecentnewspieceaboutthe13-year-oldboywhohadhisadmissionrejectedataprivateschoolinPennsylvania,”saidKyddinanemailsenttoAIDSserviceorganizations.
AnyoneinterestedshouldcontactKyddatMallory@LDP.comor1-212-463-0029.
Justice Dept. settles HIV bias lawsuitsTheJusticeDepartmenthasreachedtwo settlements resolving claims that health care providers refused to serve people with HIVinviolationoftheAmericanswithDisabilitiesAct(ADA).
ThefirstcomplaintwasfiledbyamanwithHIVwhowenttotheMercyMedicalGroupMidtownClinicinSacramentoandwasincorrectlytoldbythepodiatristseeinghimthatsurgerywasnotanoptionbecauseoftheriskofthesurgeoncontractingHIVfromhim.
ThesecondcomplaintwasfiledbyamanwithHIVwhowenttotheKnoxvilleChiropracticClinicNorthforchiropractictreatmentfollowinganautomobileaccident,whereadoctordeterminedthatheneeded24appointmentstotreathisinjuries.However,hewasinformedonhisthirdvisitthatthecliniccouldnottreatpeople“likehim.” TheJusticeDepartmentdeterminedthattheKnoxvilleChiropracticCentershadablanketpolicyofrefusingtreatmenttopeoplewithHIVinviolationoftheADA.
“Itiscriticalthatpeoplewithdisabilities,includingHIV,notbedeniedequalaccesstogoodsandservices,especiallytohealthcareservices. TheCivilRightsDivisiontakesdis-criminationbasedonunfoundedfearsandstereotypesaboutHIVveryseriously,”saidThomasE.Perez,AssistantAttorneyGeneralfortheCivilRightsDivision.
Thesettlementagreementsrequiretheentitiestodevelopandimplementanon-dis-criminationpolicyandtotrainstaffontherequirementsoftheADA. Inaddition,MercyMedicalGroupandCHWMedicalFoundationarerequiredtopay$60,000tothecom-plainantand$25,000asacivilpenalty,andKnoxvilleChiropracticCentersisrequiredtopay$10,000asacivilpenalty.
AnnouncementofthesettlementswasmadeinMay.
SixHIV/AIDSactivistsareurgingTwittererstouse the hashtags #HIV, #AIDS, or #IAC during the International AIDS Conference,beingheldJuly22–27inWashington,D.C.Thesuggestionwillhelpto“trend”HIV/AIDSonTwitter,meaningthatinsteadofKimKardashianbeingoneofthemosttalkedabouttopicsonTwitter,itcouldbeHIVandAIDSatthetopofthelistinstead.
“Together,throughthiscampaign,we(theglobalcommunity)can,wemust,make#HIVand#AIDSatrend.Thisisahugeopportunitytobringmuch-neededawarenesstotheHIV/AIDSglobalepidemic.Toachievesuccess,wemustallmakeaconsciousefforttotweetourlittlefingersoff!”writesactivistKevinMaloneyinarecentblogonTheBody.com.“#HIV:Let’sTrenduntiltheEndwillredefinehowHIV,AIDS,andhepatitisC(alongwithothersexuallytransmittedinfections)aware-ness,prevention,outreach,activism,andmuchmoreareputintoactioninareasthatareindesperateneedofsupport.”
Toparticipate,RSVPonthecam-paign’sFacebookeventpage,andclickon“going,”orgototwitter.com/hashtaghiv.
Combivir, Viramune go genericTheFDAhasapprovedgenericformulationsoftheHIVmedi-cationsViramune(nevirapine)andCombivir,acombinationofEpivir(lamivudine)andRetrovir(zidovudineorAZT).TheapprovalsmeanthatthesegenericformulationscanbemarketedintheUnitedStates.Theavailability of these generics could be problematic forHIVtreatment,sinceinanefforttosavemoney,peoplecouldbeforcedtoswitchtothecheapergenericsfromother,moretolerableantiretrovirals.AcomprehensivelistoftheapprovedgenericHIVtherapeuticdrugproductsisavailableontheFDA’sHIVwebsite.
Isentress drug label updateInMay,theFDAapprovedofalabelingupdateforIsentress,anHIVintegraseinhibitor.
Thethree-yeardata(156weeks,fromaplannedfive-yearstudy)showedthat76% of participants given Isentress had reached the goal ofviralloadlessthan50copies/mL,comparedto68%oftheSustivagroup.Moreover,theaverageCD4+T-cellincreaseseenwithIsentresswas281comparedto241forSustiva.Thisstudylookedat600peopletakingHIVtreatmentforthefirsttime,agroupthatisexpectedtoachievethebestresultswiththerapy.
Trending HIV/AIDS on Twitter
Call 1-866-350-9232Need help paying for ISENTRESS?
INDICATIONSISENTRESS (raltegravir) is a prescription HIV-1 medicine used with other HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
The use of other medicines active against HIV-1 in combination with ISENTRESS may increase your ability to fight HIV.
ISENTRESS does not cure HIV Infections or AIDS. Patients must stay on continuous HIV therapy to control infection and decrease HIV-related illnesses.
IMPORTANT RISK INFORMATIONSevere, potentially life-threatening, and fatal skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing.
Sometimes allergic reactions can affect body organs, like the liver. Contact your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of the skin or whites of the eyes, dark or tea-colored urine, pale-colored stools/bowel movements, nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV medicine.
People taking ISENTRESS may still develop infections or other conditions associated with HIV infections.
The most common side effects of ISENTRESS include: headache, trouble sleeping, nausea, and tiredness. Less common side effects include: weakness, stomach pain, dizziness, depression, and suicidal thoughts and actions.
Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.INFC-1038369-0000 05/12
Sustiva is a registered trademark of Bristol-Myers Squibb Brands mentioned are the trademarks of their respective owners.
Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to kidney problems.
Rash occurred more often in patients taking ISENTRESS and darunavir/ritonavir (Prezista) together, than with either drug separately, but was generally mild.
Tell your doctor about all your medical conditions, including if you are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your unborn baby. Also tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby.
Tell your doctor about all the medicines you take, including prescription medicines like rifampin (a medicine used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please read the Patient Information on the adjacent page for more detailed information.
Model
You are special, unique, and different from anyone else. And so is your path to managing HIV. When you’re ready to start HIV therapy, talk to your doctor about a medication
that may fit your needs and lifestyle. In a clinical study lasting 156 weeks, patients being treated with HIV medication for the first time who took ISENTRESS (raltegravir) plus Truvada:
Had a low rate of side effects— The most common side effects of moderate to severe intensity (that interfered with
or kept patients from performing daily activities) were insomnia (4%), headache (4%), nausea (3%), and tiredness (2%)
At week 144, cholesterol was measured and patients who took ISENTRESS plus Truvada experienced less effect on LDL cholesterol (“bad” cholesterol):— Cholesterol increased an average of 7 mg/dL with ISENTRESS plus Truvada
versus 22 mg/dL with Sustiva plus Truvada— When they began the study, the average LDL cholesterol of patients on
ISENTRESS plus Truvada was 97 mg/dL versus 92 mg/dL for those on Sustiva plus Truvada
Ask your doctor about ISENTRESS. Not sure where to start? Visit isentress.com/questions
I am ambitious.I am driven.I am a business owner.I am HIV positive.
Call 1-866-350-9232Need help paying for ISENTRESS?
INDICATIONSISENTRESS (raltegravir) is a prescription HIV-1 medicine used with other HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
The use of other medicines active against HIV-1 in combination with ISENTRESS may increase your ability to fight HIV.
ISENTRESS does not cure HIV Infections or AIDS. Patients must stay on continuous HIV therapy to control infection and decrease HIV-related illnesses.
IMPORTANT RISK INFORMATIONSevere, potentially life-threatening, and fatal skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing.
Sometimes allergic reactions can affect body organs, like the liver. Contact your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of the skin or whites of the eyes, dark or tea-colored urine, pale-colored stools/bowel movements, nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV medicine.
People taking ISENTRESS may still develop infections or other conditions associated with HIV infections.
The most common side effects of ISENTRESS include: headache, trouble sleeping, nausea, and tiredness. Less common side effects include: weakness, stomach pain, dizziness, depression, and suicidal thoughts and actions.
Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.INFC-1038369-0000 05/12
Sustiva is a registered trademark of Bristol-Myers Squibb Brands mentioned are the trademarks of their respective owners.
Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to kidney problems.
Rash occurred more often in patients taking ISENTRESS and darunavir/ritonavir (Prezista) together, than with either drug separately, but was generally mild.
Tell your doctor about all your medical conditions, including if you are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your unborn baby. Also tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby.
Tell your doctor about all the medicines you take, including prescription medicines like rifampin (a medicine used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please read the Patient Information on the adjacent page for more detailed information.
Model
You are special, unique, and different from anyone else. And so is your path to managing HIV. When you’re ready to start HIV therapy, talk to your doctor about a medication
that may fit your needs and lifestyle. In a clinical study lasting 156 weeks, patients being treated with HIV medication for the first time who took ISENTRESS (raltegravir) plus Truvada:
Had a low rate of side effects— The most common side effects of moderate to severe intensity (that interfered with
or kept patients from performing daily activities) were insomnia (4%), headache (4%), nausea (3%), and tiredness (2%)
At week 144, cholesterol was measured and patients who took ISENTRESS plus Truvada experienced less effect on LDL cholesterol (“bad” cholesterol):— Cholesterol increased an average of 7 mg/dL with ISENTRESS plus Truvada
versus 22 mg/dL with Sustiva plus Truvada— When they began the study, the average LDL cholesterol of patients on
ISENTRESS plus Truvada was 97 mg/dL versus 92 mg/dL for those on Sustiva plus Truvada
Ask your doctor about ISENTRESS. Not sure where to start? Visit isentress.com/questions
I am ambitious.I am driven.I am a business owner.I am HIV positive.
Read this Patient Information before you start taking ISENTRESS and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is ISENTRESS?ISENTRESS is a prescription HIV medicine used with other HIV medicines to treat adults and children 2 years of age and older with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
When used with other HIV medicines, ISENTRESS may reduce the amount of HIV in your blood (called “viral load”). ISENTRESS may also help to increase the number of CD4 (T) cells in your blood which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).
It is not known if ISENTRESS is safe and effective in children under 2 years of age.
ISENTRESS does not cure HIV infection or AIDS. People taking ISENTRESS may still develop infections or other conditions associated with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.
Patients must stay on continuous HIV therapy to control infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others: • Do not share needles or other injection equipment. • Do not share personal items that can have blood or body fluids on them,
like toothbrushes and razor blades. • Do not have any kind of sex without protection. Always practice safe sex by using
a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Ask your doctor if you have any questions on how to prevent passing HIV to other people.
What should I tell my doctor before taking ISENTRESS?Before taking ISENTRESS, tell your doctor if you: • haveliverproblems. • have phenylketonuria (PKU). ISENTRESS Chewable Tablets contain phenylalanine
as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU.
• haveanyothermedicalconditions. • are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm
your unborn baby. Pregnancy Registry: You and your doctor will need to decide if taking ISENTRESS is right for you. If you take ISENTRESS while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is to follow the health of you and your baby.
• are breastfeeding or plan to breastfeed. - Do not breastfeed if you are taking ISENTRESS. You should not breastfeed if
you have HIV because of the risk of passing HIV to your baby. - Talk with your doctor about the best way to feed your baby.
Tell your doctor about all the medicines you take, including: prescription and non-prescription medicines, vitamins, and herbal supplements. Taking ISENTRESS and certain other medicines may affect each other causing serious side effects. ISENTRESS may affect the way other medicines work and other medicines may affect how ISENTRESS works.
Especially tell your doctor if you take: • rifampin(Rifadin,Rifamate,Rifater,Rimactane),amedicinecommonlyused
to treat tuberculosis.
Ask your doctor or pharmacist if you are not sure whether any of your medicines are included in the list above.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Do not start any new medicines while you are taking ISENTRESS without first talking with your doctor.
How should I take ISENTRESS? • Take ISENTRESS exactly as prescribed by your doctor. • YoushouldstayunderthecareofyourdoctorwhiletakingISENTRESS. • Do not change your dose of ISENTRESS, switch between the film-coated tablet and the
chewable tablet or stop your treatment without talking with your doctor first. • TakeISENTRESSbymouth,withorwithoutfood. • IfyourchildistakingISENTRESS,yourchild’sdoctorwilldecidetherightdosebased
onyourchild’sageandweight. • ISENTRESSChewableTabletsmaybechewedorswallowedwhole. • ISENTRESSFilm-CoatedTabletsmustbeswallowedwhole. • Ifyoumissadose,takeitassoonasyouremember.Ifyoudonotrememberuntilit
is time for your next dose, skip the missed dose and go back to your regular schedule. Do not double your next dose or take more than your prescribed dose.
• If you take too much ISENTRESS, call your doctor or go to the nearest emergency room right away.
• DonotrunoutofISENTRESS.GetyourISENTRESSrefilledfromyourdoctororpharmacybefore you run out.
What are the possible side effects of ISENTRESS?
ISENTRESS can cause serious side effects including: • Serious skin reactions and allergic reactions. Severe, potentially life-threatening
and fatal skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away:
° fever ° muscle or joint aches ° redness or swelling of the eyes ° generally ill feeling ° blisters or sores in mouth ° swelling of the mouth or face ° extreme tiredness ° blisters or peeling of the skin ° problems breathing
Patient InformationISENTRESS® (eye sen tris) (raltegravir) Film-Coated TabletsISENTRESS® (eye sen tris) (raltegravir) Chewable Tablets
Sometimes allergic reactions can affect body organs, like the liver. Contact your doctor right away if you have any of the following signs or symptoms of liver problems:
° yellowing of the skin or whites of the eyes ° dark or tea colored urine ° pale colored stools/bowel movements ° nausea/vomiting ° loss of appetite ° pain, aching or tenderness on the right side below the ribs
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV medicine.
• Phenylketonuria (PKU). ISENTRESS Chewable Tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU.
The most common side effects of ISENTRESS include: • headache • nausea • troublesleeping • tirednessLess common side effects include: • weakness • depression • stomachpain • suicidalthoughtsandactions • dizziness
Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to kidney problems.
Rash occurred more often in patients taking ISENTRESS and darunavir/ritonavir together than with either drug separately, but was generally mild.
Tell your doctor if you have any side effect that bothers you or that does not go away.
ThesearenotallthepossiblesideeffectsofISENTRESS.Formoreinformation,askyourdoctor or pharmacist.
Callyourdoctorformedicaladviceaboutsideeffects.YoumayreportsideeffectstoFDA at1-800-FDA-1088.
How should I store ISENTRESS?Film-CoatedTablets:• StoreISENTRESSFilm-CoatedTabletsatroomtemperature
between68°Fto77°F(20°Cto25°C).
Chewable Tablets:• StoreISENTRESSChewableTabletsatroomtemperature
between68°Fto77°F(20°Cto25°C).• Store ISENTRESS Chewable Tablets in the original package with the bottle tightly closed.• Keepthedryingagent(desiccant)inthebottletoprotectfrommoisture.
Keep ISENTRESS and all medicines out of the reach of children.
General information about ISENTRESS
Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information Leaflets. Do not use ISENTRESS for a condition for which it was not prescribed. Do not give ISENTRESS to other people, even if they have the same symptoms you have. It may harm them.
This leaflet gives you the most important information about ISENTRESS. If you would like to know more, talk with your doctor. You can ask your doctor or pharmacist for information about ISENTRESS that is written for health professionals.
Formoreinformationgotowww.ISENTRESS.comorcall1-800-622-4477.
What are the ingredients in ISENTRESS?
ISENTRESS Film-Coated Tablets:
Active ingredient: raltegravirInactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasicanhydrous,hypromellose2208,poloxamer407(contains0.01%butylatedhydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate.The film coating contains:polyvinylalcohol,titaniumdioxide,polyethyleneglycol3350,talc,red iron oxide and black iron oxide.
ISENTRESS Chewable Tablets:Active ingredient: raltegravirInactive ingredients: hydroxypropyl cellulose, sucralose, saccharin sodium, sodium citrate dihydrate, mannitol, red iron oxide (100 mg tablet only), yellow iron oxide, monoammonium glycyrrhizinate,sorbitol,fructose,naturalandartificialflavors(orange,banana,andmaskingthat contains aspartame), crospovidone, magnesium stearate, sodium stearyl fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose2910/6cP,PEG400.
ThisPatientInformationhasbeenapprovedbytheU.S.FoodandDrugAdministration.
Distributed by:
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA
Revised April 2012 USPPI-T-05181204R018Copyright©2007,2009,2011MerckSharp&DohmeCorp.,asubsidiaryofMerck & Co., Inc. All rights reserved. INFC-1038369-000005/12
U.S.PatentNos.US7,169,780
POSITIVELYAWARE.COM JULY+AUGUST 2012 19
TREATMENT STRATEGY HISTORYStrategiesforthetreatmentofHIV/AIDShaveevolvedsincetheintroductionofAZT
(Retrovir)inthelate1980s.AZTalonewasafailure.Atmost,itextendedlifebyonlyafewmonths.DualtherapywithAZTand
didanosine(ddI)orlamivudine(3TC),orstavudine(d4T)andddIor3TCwasbetter,succeedinginathirdofthosetreated;theothertwo-thirdsdied.Realprogresscamein1996,withthedevelopmentofpotenttriple-drugtherapies.Inthatbanneryear,themantrabecame“hitearlyandhithard.”
Buthittingearlyandhittinghardhaditsdrawbacks.Someofthesideeffects—especiallytheso-called“Crixivanbelly,”buffalohump,wastingoffacialandlimbfat,and“AZTbutt”—weresoalarmingthat
HIV TREATMENTSTRATEGIES
BEFORETHEMID-1990S,HIVINFECTIONWASADEATHSENTENCE.
Andalmostworsethantheprognosisitselfwasthediseasecourse:suffocationfrompneumonia,blindness,dementia,hideouspurpleskinlesionsengulfinglimbsand
internalorgans,andincurablecancers,tonameafew.NodiseasethatIcanthinkofisasmercilessandmean-spiritedasHIV/AIDS.
As therapies improve, how to choose what’s right for you
BY ROSS SLOTTEN, MD, MPH
ILL
US
TR
AT
ION
© M
ICH
AE
L P
OW
ER
S
20 JULY+AUGUST 2012 POSITIVELYAWARE.COM
patientsandtheiradvocatesaskedwhytherapycouldnotbedelayeduntilabso-lutelynecessary.ThoseofuswhotreatedpeoplewithHIVreluctantlyagreed.Asaresult,untilrecently,mostHIV-infectedindividualsweren’tofferedtreatmentuntiltheirCD4countsapproached250.Nowthatwehavesimplerregimenswithfewerdisturbingsideeffects,thereareonceagainwhispersof“hitearly,hithard.”
WHAT TO DOYou’renewlydiagnosedwithHIVinfectionandtoldthatyourCD4countis510andyourviralloadis7,000.Whatshouldyoudo?
TheprospectoftreatmentstillterrifiesmanypeoplewithHIV,sometimesmorethantheinfectionitself.Forsomeofusover40,thedisfigurementofbodyshapechangeshasbeenadisturbingexperi-ence,whetherforourselvesorourfriends,partners,orrelativeswhotookearlyHIVtherapies.It’struethatthosepeoplewouldnotbealivetodaywithoutthosetherapies,buttheemotionalandphysicalcosthasbeenhigh.Evenchangingtonewerregi-mensdoesn’treversethedisfigurement.Unfortunately,despiteextensiveresearch,thecauseremainsamysteryandthere’snoeffectivesolutioninsight.Today,wecanassurepeoplethatiftheynevertakeAZTord4T,they’reunlikelytodeveloptheso-calledlipodystrophysyndrome.Ihaven’tseenanewcaseinmorethanadecade.
Moreover,nooneknowswhatkindofsideeffectsmightoccuraftertakingantiretroviraltherapyfor30to40yearsormore.Yes,that’showlongmostpeoplewillbetakingthesemedications,sincethetreatmentofHIVissosuccessfulthatmany,ifnotmostpeopleinthedevelopedworldcanexpecttolivenormallifespans,aslongastheydon’tstoptheirtherapy,ever.Andacureisunlikelysoon;maybenonewilleverbefound.Avaccine,ifonecanbedeveloped,willpreventdisease,
butit’sunlikelytohelpthosealreadyinfected.Therearepotentialsideeffectsofanti-HIVmedications—cardiovasculardisease,osteoporosis,kidneyandliverdisease,evencancers.Butlet’sputthisdiseaseinperspective:UntreatedHIVinfectionisfatalinmorethan95%ofthoseinfected.Onlyrabiesismorelethal.NocurrentHIVtherapywilleverapproachthatkindofmortalityrate.Thefearoflong-termeffects,thoughunderstandable,isnotareasontoavoidtreatment.
THE GUIDELINESNowthatweagreethatthemajorityofpeoplewithHIVinfectionshouldbetreat-edatsomepoint,thequestionis,whenshouldwestarttherapy?Sincetheearlypartofthelastdecade,apanelofexpertsundertheauspicesoftheDepartmentofHealthandHumanServiceshasissuedaseriesofguidelinesfortheuseofantiret-roviralagentsinHIV-1infectedadultsandadolescents.Theseguidelinesarebasedonthelatestscientificevidenceandtheexpertopinionsofthepaneliststhem-selveswhenthatevidenceisscanty.
Theprimarygoaloftreatment,ofcourse,istoreducethemorbidityandmortalityofHIVinfection.MorbiditymeansthedevelopmentofdiseasesthatarebothdirectlyandindirectlyrelatedtotheAIDSvirus.Diseasessuchaspneu-mocystispneumonia,cytomegaloviralretinitis,cryptococcalmeningitis,andcryptosporidialdiarrheaaredirectconse-quencesofadvancingdisease,whentheimmunesystemissoseverelyimpairedthatusuallyharmlessorganismscausedreadfulillness.IndirectconsequencesarerelatedtoT-cellactivation,CD4celldepletion,andinflammation,allofwhichincreasetherisksforheartattacks,cognitiveimpairment(dementia),andeverytypeofcancer.Thepanelrecom-mendsantiretroviraltherapyforallpeople,regardlessofCD4count,who
arepregnant,haveahistoryofanAIDS-definingillness,haveHIV-relatedkidneydisease,orareco-infectedwithhepatitisB.Inallfourconditions,randomized,con-trolledstudieshaveprovenbeyonddoubtthatthebenefitsoftherapyfaroutweighthenegatives.Randomized,controlledtrialshavealsoproventhattreatmentisbeneficialforthoseindividualswithCD4countsoflessthan350butwhodonothaveanAIDS-definingillnessandappearperfectlyhealthy.
Non-randomizedorobservationaltrialsalsosupporttheinitiationoftherapyinpeoplewithCD4countsbetween350and500.Suchtrialsareconsideredlesssci-entificallyrigorous,sincetheysometimeslackacontrolarmandarenotrandom-ized,potentiallyintroducingbiasintotheresults.Onestudy,HIV-CAUSAL,acollab-orativestudybetweenU.S.andEuropeansites,includedsome8,300antiretroviral-naïve(thatis,untreated)patientswithinitialCD4countsover500whothenexperienceddropsbelow500cells.Thoseindividualswhosetreatmentwasdelayeduntiltheircountsdroppedbelow350hadahigherriskofanAIDS-definingillnessordeaththanthosewhostartedtreatmentwhentheircountsweregreaterthan350butlessthan500.AnotherstudyfromEurope,Australia,andCanada,calledCASCADE,showedsimilaroutcomes.Asaresult,theexpertpanelrecommendsther-apyforpatientswithCD4countsbetween350and500.
Theevidenceisweakerfortheinitia-tionoftherapyinpeoplewithCD4countsgreaterthan500,inpartbecauseitmaytakeadecadeormoretoknowaboutthebenefits(orharms)ofearlytreat-ment.Becausetrialsareongoing,arenotrandomizedorcontrolled,orareobserva-tionalonly,thepanel’srecommendationfortreatmentismoderate,ratherthanstrong.Nevertheless,manyoftheexpertswouldoffertreatmenttothoseintheearli-estphasesofHIVinfection.Thismakessense—fornoothertreatableinfectiousdiseasedoweopttodelaytherapy.Ifyouhadsyphilis,youwouldn’twaitsixmonths
NO ONE KNOWS WHAT KIND OF SIDE EFFECTS MIGHT OCCUR AFTER TAKING ANTIRETROVIRAL THERAPY FOR 30 TO 40 YEARS OR MORE... [BUT] THE FEAR OF LONG-TERM EFFECTS, THOUGH UNDERSTANDABLE, IS NOT A REASON TO AVOID TREATMENT.
POSITIVELYAWARE.COM JULY+AUGUST 2012 21
togetashotofpenicillin.You’dtreatitatthetimeofdiagnosis.
Thispastyear,thepaneladdedasec-ondarygoalofantiretroviraltherapy:pub-lichealthconsiderations.Althoughstudieslongagodemonstratedthattreatingpreg-nantwomenpreventedperinataltransmis-sionofHIV,itwasnotuntilrecentlythatstudiesshowedasimilarbenefitinsero-discordantcouples.Inamulti-continentaltrialof1,700HIV-discordantheterosexualcouples,halfoftheHIV-infectedpartnerswererandomizedtoreceiveantiretroviraltreatmentimmediately,theotherhalfdelayedtherapyuntiltheirCD4countsdroppedto250.Allwerecounseledaboutsafesexpractices.Inthedelayedarm,therewere28newinfections;intheimme-diatetreatmentarm,onlyoneinfection.Therewasthereforea96%reductioninrateoftransmissionfromtheHIV-positivepartnertotheuninfectedone.ThepanelnowrecommendsthattheHIV-positivepartnerinasero-discordantcouple,straightorgay,betreated,regardlessofCD4countorviralload.OnecanmakeacaseforadvisingthetreatmentofanyHIV-positivepersonwhohasmultiplesexpart-ners,someofwhommaybeHIV-negative.
WHICH WILL IT BE?Oncewe’vedecidedwhentotreat,weneedtoknowwhattreatmenttoinitiate.Asof2012,thereare30FDAapprovedantiretroviralagentsinsixdifferentclasses:nucleosidereversetranscriptaseinhibitors(NRTIs),non-nucleosidereversetranscriptaseinhibitors(NNRTIs),prote-aseinhibitors(PIs),fusioninhibitors(FIs)CCR5antagonists,andintegraseinhibitors(INSTIs).Thedecisionofwhichcombina-tionofdrugstouseisbasedonatleastninefactors:
n Thepresenceofcardiovasculardis-ease,chemicaldependency,liverorkidneydisease,psychiatricillness,ortuberculosis
n Potentialadverseeffectsn Potentialinteractionswithother
medications
n Thepresenceofresistancetoone(ormore)antiretroviralagent
n Genderandpre-treatmentCD4countifconsideringViramune(nevirapine)
n ThepresenceofHLA-B*5701ifcon-sideringZiagen(abacavir)ortheco-formulationEpzicom
n Co-receptortropismifconsideringSelzentry(maraviroc)
n Patientadherenceissuesn Pillburden
Assumingthatnoneofthoseninefac-torsisaconcern,thepanelrecommendsoneoffourregimensbasedontheresultsofrandomized,controlledtrials:
n Atripla(efavirenz/tenofovir/emtricitabine)
n BoostedReyataz(atazanavir+ritonavir)andTruvada(tenofovir/emtricitabine)
n BoostedPrezista(darunavir+ritonavir)andTruvada
n Isentress(raltegravir)andTruvada
That’srelativelyeasy.Butwhatifoneormoreofthoseninefactorsareconcerns?
THE OLDER CROWDIt’sbeyondthescopeofthisarticletoexamineeverypossiblereasonforpre-scribingalternativeregimenstothoserecommendedabove.Theexpertpaneladdressesinpainstakingdetailtheprosandconsofvariousdrugcombinationsinavarietyofsettings.However,forthefirsttimetheguidelinesacknowledgearealityoftheHIV/AIDSepidemicintheUnitedStatesandotherdevelopedcountries:MorethanathirdofpeoplelivingwithHIV/AIDSareolderthan50.Inanotherdecade,thatnumberwillbemorethanhalfofallcases.Mosttrialsfocusonyoungerpatients.Dataforolderpatients,espe-ciallythoseinthe60-to80-year-oldagegroup,arelimited.Inpharmaceuticaltrials,
drugdeveloperscontrolforanumberofvariables,likegenderandrace,buttheydon’twantpeopleintheirtrialswhotakemedicationsthatmayinterferewiththedrugthey’retesting.Theirgoalistogettheirparticulardrugtomarket.Diabetics,orpeopleonbloodthinners,orthosewithkidneyandliverdisease—inshort,manyelderlyindividuals—maybeexcludedfromastudybecausetheirtreatmentsordiseasestatesmaymuddytheoutcomeofthestudy.
Second,thepanelistsrightlyurgehealthcareproviderstotakeagoodsexualhistory.Toooften,weforgetthatolderpeoplearesexuallyactive.Infact,70%ofmenandmorethan50%ofwomenovertheageof60arestillhavingsex.Manyoftheseseniorsdon’tviewthem-selvesathighriskforHIVinfection.Post-menopausalvaginaldryness,thefailureofheterosexualcouplestouseacondombecausepregnancyisnolongeranissue,andtheavailabilityofdrugsforerectiledysfunctionallincreasetheriskofsexuallytransmitteddiseases.
Andthird,forthoseindividualsover50whoaretakingantiretroviralagents,it’sessentialtomonitorbone,kidney,cardiovascular,metabolic,andliverhealth.Thisistrueforyoungerpatientstoo,butco-morbidconditionsand“polypharma-cy”—thatis,takingmedicationsforotherdiseasesaswellasHIV—aremorecommonintheover-50group.
THE COSTWhat’salsonewisthatthepanelhascom-piledalistoftheAverageWholesalePrice(AWP)ofindividualantiretroviralagentsandco-formulationslikeAtripla,Complera,Truvada,andEpzicom.I’mnotsurewhatpurposethisservesexcepttosatisfyourcuriosity.EveryoneknowsthattreatingHIViscrazyexpensive.ThewholesalemonthlycostofAtriplais$2,080.97;thewholesalemonthlycostofPrezista,Norvir,
TOO OFTEN, WE FORGET THAT OLDER PEOPLE ARE SEXUALLY ACTIVE. IN FACT, 70% OF MEN AND MORE THAN 50% OF WOMEN OVER THE AGE OF 60 ARE STILL HAVING SEX.
22 JULY+AUGUST 2012 POSITIVELYAWARE.COM
andTruvadais$2,930.25.ThedifferencebetweengenericlamivudineandthebrandEpivirisonly$48permonth.Mostpeopledon’tpayfortheirmedicationsanyway,althoughsomehavesubstantialco-pays,especiallythoseonmultipledrugregimens.I’mnotawarethatinsurershavebotheredtolookattreatmentguidelinestodeterminewhatco-payshouldbechargedtoapatient.Inmyexperience,thecoststopatientsaregoingup,notdown.Butasmoreantiretroviralagentsgogeneric,perhapsthoseco-payswillgodown.
FINDING THE ANSWERLet’sreturntotheproblemofwhatanewlydiagnosedpersonshoulddo.IagreewithmanyontheexpertpanelthatmostpeoplewithHIVshouldbetreated,nomatterwhattheirCD4countis.I’veseentoomanypeopledietofeelotherwise.I’malsoconcernedabouttransmissiontoanuninfectedsexualpartner.AlthoughthisimaginaryindividualhasanormalCD4countandnotaterriblyhighviralload,he’snotanelitecontroller(thatis,hedoesn’thaveanundetectableviralloadwithouttreatment)andhe’sunlikelytobealong-termnon-progressor(generally,someonewithanaverageviralloadlessthan2,000copies).
Afterdoingaresistanceprofile(geno-type)anddeterminingthatthisindividualdidnothaveunderlyingresistancetooneormoremedicationsinourarmament,Iwouldmostlikelyofferasingletreatmentregimen(Atripla)ratherthanamulti-drugregimen.That’sapersonalpreferencebecauseofconcernsaboutcompliance,notbecauseIfeelthattheotherregimensareinferior.
Ifthisindividualwereafemaleofchild-bearingage,orwaspregnantortryingtoconceive,aregimencontainingSustiva(efavirenz)shouldbeavoided,especiallyinthefirsttrimesterwhentoxiceffectsonthefetusaregreatest.Ingeneral,a
proteaseinhibitor-basedregimenhasbeenprovensafer.AZT,nolongerapreferredagentformostpeople,mayevenbeconsideredasoneofthecomponentsoftherapybecauseofitsprovenefficacyinpreventingmother-to-childtransmission.
Atripla(andpossiblyComplera,thoughCompleraisnewandstillconsideredanalternativetothepreferredregimens)couldbeagoodchoiceforanelderlypatientonmultiplemedications.Drug-druginteractionsarefewerthaninthoseonboostedproteaseinhibitorregimens.However,ifthatindividualsufferedfromunderlyingkidneydisease,IwouldnotrecommendAtriplaorComplerasincetheybothcontaintenofovir,whichcanexacerbatekidneydisease.Inthatcase,ImightrecommendSustivaandEpzicom(abacavirandlamivudine).Abacavir,however,mustbeusedwithcaution,espe-ciallyinindividualswithaknownriskofcardiovasculardisease,andatestmustbeperformedtoruleoutpotentialhypersen-sitivity(severeallergy)tothatdrug.Ah,thecomplexitiesoftreatingHIV!Havingsomanychoices—andtakingsomanythingsintoconsideration—canmakeone’sheadspin.
Onceapersonbeginsanantiretroviralregimen,heorsheneedstobemonitoredperiodically.Thetreatmentgoalisviralsuppressiontolevelsoflessthan75or20copies/milliliterofblood,dependingontheassayusedformonitoring.Itmaytakeupto16weeksforvirallevelstofallbelowdetectability,butdramaticdropsinviralloadaregenerallyseenwithintwotofourweeksofstartingtherapy.Accordingtotheexpertguidelines,avirallevelshouldbemeasurednolaterthaneightweeksafterbeginningtreatmenttopreventfurtherresistancetomedicationsiftheresponsetotreatmentissuboptimal.Thereafter,itshouldbemeasuredeverythreetofourmonths.Apersonisconsid-eredtohavefailedantiretroviraltherapyifhisorhervirallevelispersistentlygreater
than200copies.Occasionally,afterbeingontherapyforyears,apersonmightexperiencea“blip”—thatis,arareinstanceinwhichthevirusisdetectable,usuallyatverylowlevels(between76and199cop-ies).It’snotnecessarytochangetherapyortrytoperformresistancetestingwhenablipoccurs.Thevastmajorityofthetime,virallevelswillbeundetectableatthenextmonitoringvisit.
Ingeneral,apoorCD4responsetotherapyisnotareasontochangeregi-mens.Thoseindividualswhobegintreat-mentwhentheirCD4countsareverylow(under200cells)sometimesdonothaveasrobustaresponsetotherapyasthosewithhigherCD4countsattheinitiationoftherapy.Theviralloadisthebestmeasureoftreatmentsuccess.ThemainconcernaboutCD4countsremainingunder200istheriskofopportunisticinfections,likepneumocystispneumonia,soit’sneces-sarytocontinueprophylaxis(prevention)againsttheseinfectionsuntilcountsrisetosaferlevels.
CONCLUSIONToconclude,althoughHIVisnotcur-able,it’streatable.Andmorethanthat,ifstartedearly,thetreatmentisusuallywelltoleratedandhasfewersideeffects,especiallythenewerregimensdevelopedinthepastdecade.Selectingtheoptimaltreatmentmaybetricky,dependingontheunderlyinghealthoftheHIV-positiveperson.Elderlypatients,pregnantwomen,peoplewithahistoryofsubstanceabuse,andthosealsoinfectedwithhepatitisBorC,ortuberculosispresentgreatchallengestoclinicians.Butnounderlyingdiseasestate,exceptthediagnosisofaterminalill-ness,shouldpreventsomeonefrombeingtreated.Treatmentmeansalongerlifeandbetterqualityoflife,perhapsanormallifespan.Notreatment,whentreatmentiswarranted,meanscertaindeath.
ROSS SLOTTEN, MD, MPH,isafamilyprac-titionerinprivatepracticeinChicago.HehastreatedpeoplewithHIVfor29years.
SELECTING THE OPTIMAL TREATMENT MAY BE TRICKY, BUT NO UNDERLYING DISEASE STATE, EXCEPT THE DIAGNOSIS OF A TERMINAL ILLNESS, SHOULD PREVENT SOMEONE FROM BEING TREATED.
POSITIVELYAWARE.COM JULY+AUGUST 2012 23
PH
OT
O: R
ICK
GE
RH
AR
TE
R
Remembering where we’ve been
RECENTLY A PRESS RELEASE
cameacrossmydeskpromot-ingthedocumentaryfilmWe Were Here,whichIhadwant-
edtoseeforsometime.IsatdownonaFridayafternoontoviewthefilmathome,alone.IreallyhadnopreconceivednotionsaboutthefilmotherthanthatitwasabouttheearlydaysoftheAIDSepidemicinSanFrancisco.Iwaswoefullyunpreparedfortheexperienceofthenext90minutes,andtheeffectandholdthefilmwouldhaveovermeforthenextfewweeks.
Accordingtothepressrelease,“We Were HererevisitsthebeginningoftheAIDScrisisinAmericathroughtheeyesoffiveindividualswholivedinSanFranciscopriortotheepidemic.Fromtheirdifferentvantagepointsascaregivers,activists,researchers,friendsandloversoftheafflicted,andpeoplewithAIDSthemselves,theintervieweessharestorieswhicharenotonlyintenselypersonal,butilluminatethemuchlargerthemesofthatera:thepoliticalandsexualcomplexities,
theterribleemotionaltoll,andtheroleofwomen—particularlylesbians—incaringandfightingfortheirgaybrothers.”
Themovietakesyoubacktoaspe-cifictimeandplaceinhistory,anddoesitextremelywell.IremembermyveryfirstvisittoSanFrancisco,in1983—Iwasstillquiteyoung(24)andyetsomehowseeminglyoblivioustothehorroranddevastationthattheepidemichadalreadyinflictedupontheinhabitantsofthegaymecca.AsPaulBonebergstatesinthefilm,it’sestimatedthatby1977,10%ofthegaymeninSanFranciscowerealreadyinfected.Bythetimethefirstcaseswereseenin1981,20%wereinfected,andbythetimetheyhadatestforHIV(in1985),50%wereinfected.
ThisprogressionoftheepidemicintheCitybytheBayasdepictedinthefilmis,inthewordsofArmisteadMaupin,“absolute-lyelectrifying.”DirectorDavidWeissman,wholivedinSanFranciscoatthetime,saysthatthemoviereflectshisownper-sonalexperienceandview,throughthe
juxtapositionofnormalcyandinsanity.“Itwasveryimportantthatthestorybetoldbysomeonewhohadlivedthroughit,”saysWeismanninabonusfeatureontheDVD,“ratherthanbetoldbysomeonewhowaslearningaboutitfromtheoutside.”
Thefilm’seditorandco-directorBillWeber,wholivedinNewYorkandthenmovedtoSanFranciscointhe1980s,notedthedifferencesbetweenactivistsinNewYork,whoworetheirblackACTUPt-shirts,andthoseinSanFrancisco,someofwhomwouldbealittlemoredaringintheiroutfits.Herecountsaninstancewhencopsdonnedrubbergloveswhilearrestingactivistsduringaprotest,andtheactivistschanted,“Yourglovesdon’tmatchyourshoes,you’llseeitonthenews!”
Itwasimportant,saythedirectors,thatthestorybetoldinawaythatwasnottooheavy-handedoroverwhelming,sotherearemomentsofhumorandperiodsinthefilmwhenyouareintentionallygivenabreakfromtheemotionalrollercoaster.Butintheend,themovieisupliftingandinspirationalandabeautifultributetoabygoneera.Ihighlyrecommenditnotonlytothosewholivedthroughthatperiod,butalsoforanyonewantingtolearnmoreaboutwhatitwasreallylike,havingonlyheardaboutitthroughfriends’storiesornewsclippings.
SaysWeiss,“I’mhopingthatitempow-ersthoseofuswhohavelivedthroughittorealizethatwehavebecomericher,morebeautifulpeoplebecauseofwhatwelivedthrough…andnotfeelanyshameorhesitationinsharingthatpartofourselves.Thatwecanbementors,andteachers,andexamples…”
“Andthatwe’resexy,too,”saysWeber,withachuckle.
WE WERE HEREisnowavailableonDVDinstores,atwww.amazon.com,andforrentorpurchasethroughtheiTunesStore.
CULTURE CLUB
An award-winning documentary looks back at the arrival and impact of AIDS in San Francisco
BY JEFF BERRY
ButRogers’storydoesn’tendthere,andhehasabitofadifferenttakeonthefinaloutcomeofthecompetition.Hisjourneyoffacingadversity,overcomingdespair,andfindingredemptionandheal-ing,isonethatwillresonatewithmany,andcaninspireusall.
I’ve been following you and the show. You sharing your experience and coming
out as HIV-positive was very emo-tional for me, and I’m sure
a lot of
others watching the show, too.
Firstofall,Jeff,hatsofftoyou,brother.It’sjustcrazyhowtheworldis
changing.Myexperienceontheshowhasgivenmefaiththatsocietyisinagoodplacerightnow,whereweallcanreceivethisasastory,andmaybeinourlifetime,stigmaandprejudicewillgoaway,onceandforall.
Absolutely. I agree. So, tell us about yourself. You grew up in Oklahoma, right?
I’mfromallovertheplace,Idon’t
reallyhaveahometown.NewYorkisthetenthstatethatI’velivedininmylifetimebecausemyparentsmovedaroundalot.Iwasraisedinavery,verystrictChristianhouse-hold,andwhenIturned17,
Icompletelyrebelled.Ihadhadenoughofmyparents’rules,andIstarteddab-blingindrugs,Iendeduprunningawayfromhomeattheageof17andwasbasicallystrungoutfromtheagesof18–23oncrystalmeth—wasjustpartyingallthetime,allIeverreallywantedtodowasparty.OnceIdecidedtoactuallygetoffofmeth,acoupleofmonthslaterIfoundoutIwasHIV-positive.
I’vebeenoffofmethfor
sevenyearsthismonth,soIfoundoutIwaspositiveabout6½yearsago.Igotreally,reallysick.Ihadlike
After his standout performance on TV’s “The Voice,” Jamar Rogers takes to the stage again—to share his story of life with HIVI N T E R V I E W BY J E F F B E R RY | P H OTO G R A P H Y BY M AT T H E W G A R S T E C K
INTHISYEAR’SSECONDSEASONOFNBC’SHITREALITYTALENTSHOW“TheVoice,”wewereintroducedtothevibrantandeffusiveJamarRogers,whosecoverofBonJovi’s“It’sMyLife”wasnamedBestPerformanceonTheVoicebyRolling Stonemagazine,whichcalledhisperformance“simplyelectrifying.”
PAspokewithRogersjustafewweeksafterhelostouttoJulietSimmsinthesemi-finalsandwaseliminated.
JAMAR’S VOI CE
24 JULY+AUGUST 2012 POSITIVELYAWARE.COM
fiveT-cells,andIhadKaposi’s
sarcoma,pneu-monia,andthrushin
mymouth.IhadbeengettingsickwhileIwasusingmeth,andIjustthoughtthatthemethdidn’tagreewithmybody.Icontinuedget-tingsickafterIstoppedusingmethandIwenttotheemergency
room.WhenthedoctorfirstcameinandtoldmethatIwaspositive,Idon’tknowwhatothers’experiencesare,Ijustknowthatatthatmoment,Ifeltthebiggestpeacewashoverme.Ican’tbelievehowateaseandpeacefulIfelt.Iwasactuallyverycalm,andIsuddenly
felt,I’mgoingtobealright,I’mgoingtobeokay,I’mgoingtogetthroughthis.
ContractingHIVwasalife-changer,obviously,butitwassortofbetterformebecauseIsettleddown.Ibegantolearnsomuchaboutmyself,andmyowndefen-sivebehavior,andstartedseeking
counseling,andmyrelationshipwithGodflourished.IbegantoseeGodas
apartner,asalovingFather,andnotassomeonewhowaswaitingformetoscrewup.ThatchangedmywholeperspectiveonhowIviewedmyself.
I’mnolongermarriednow,butthegirlIwasmarriedtothenhelpedsavemylife.Shewenttoallmydoctor’sappointmentswithme,didalloftheresearchforme,andwhenIfirststartedtakingAtripla,shetookcareofmeforthosefirstcoupleofweekswhenIwasallwoozy.BythegraceofGod,I’vebeenundetectableforfiveyears,andI’mveryhealthy.
WhenImovedtoNewYorktopursuemusicfull-timeaboutthreeyearsago,IwasnotcomfortablesharingmyHIVstatus.
JAMAR’S VOI CE
MAKEUP: JACKIE MGIDO. JAMAR ROGERS’ ASSISTANT: MICHELLE ROGERS. JAMAR ROGERS’ MANAGER: SALLY COLÓN.
STYLIST: KENZIE CROSLEY. CLOTHING PROVIDED BY KITSON IN BEVERLY HILLS.
POSITIVELYAWARE.COM JULY+AUGUST 2012 25
26 JULY+AUGUST 2012 POSITIVELYAWARE.COM
Myclosefamilyandfriendsknew,butthatwasjustahandfulofpeople.Istillcarriedsomuchstigmaandshame,andsomuchembarrassment.Iwasveryopenandcan-didaboutmydruguseinthepast[includ-ingduringauditionsforseasonseightandnineofAmericanIdol],butIdidn’tfeelthatIwasreadytodiscussmyHIVstatus.Overthecourseof[TheVoice]audition,Iknewitwastimetotalkaboutthis,fortworeasons.One,becauseIdecidedawhileagotoliveforsomethinggreaterthanmyself—mejustbeingfamousforthesakeofbeingfamouswasn’tenough.Iwantedtomakeanimpactontheworld,andIwantedtoreallyhelppeople.Two,IthoughtthatmaybeIcouldusethisasawaytochangepeople’sminds,tomaybeshowpeoplethatHIVcomesinallshapes,sizes,colors,creeds,races,andmaybeifIputamodern,humanfaceonit,itwouldn’tbethisthingthatwewhisperedabout,thatmaybewecouldtalkaboutitoutloud.
Honestly,Jeff,I’msogladthatIdidit.I’msogladthatIovercamethefearthatIhad,becauseIcan’tevenbegintotellyouthenumberofmessagesIreceivedfrompeoplesayingI’mthefirstpersonthey’veevertoldtheywereHIV-positive.AndbecauseIwasabletosharemystory,theynowfeelempoweredtotelltheirfamiliesortheirlovedones.Ijustfeellike,nomat-terwhatplaceIgotontheshow,Iwon.Idefinitelywon,becauseIovercamesomuchfear,andIreallythinkIwasonthepathofchangingpeople’sminds.
You do talk very openly about your crys-tal meth addiction, so how did you get sober, and at what point did you realize, or start to think, that maybe you had a decent shot at life again?
ItwasaseriesofeventsthatmademerealizeIwasjustdonewithmeth.Foronething,Iwasjustgettingmoreandmoredepressedandsuicidal.Itwasonlyamat-teroftimebeforeIwasjustnotgoingtobehereanymore,Ireallybelievethat.Two,noneofmyfriendswouldletmestay
withthemanymorebecauseIwasstealingfromthem,sothatwaspartofmy“rockbottom.”Andthree,Iwasengagedatthetime,andeventhoughshewaspregnant[withanotherman’s]child,weagreedtoraisethebabytogetherasourown.Thedayofthedelivery,Iwentintothebath-roomandshotupandIgotreallyhigh,IrememberIwassogeekedthatIcouldn’tcutthebaby’scord,andthatwaskindofmya-hamoment.Irememberthinking,howareyougoingtotakecareofthischildwhenyoucan’tevencutthecord,youcan’teventakecareofyourself?
TheverynextdayIsaidtomyfiancéeatthetime,let’sgetoutofAtlanta,Ireallywanttomakeachange,andshewasreallyhappy,shehadbeensosupportiveofme.SowemovedtoMilwaukeewheremymomwas,andIdidn’tknowanyonethere,andIdidn’tknowhowtogetanymeth,andthatwasthebeginningofmyrecovery.ItwasafewmonthsafterI
madethatdecisionthatIfoundoutIwasHIV-positive.Iknowsomepeoplemighthavegonebackwards,butifanything,itjustkindofencouragedmetokeepdoingwhatIwasdoinginmyrecovery,becauseIwantedtolivemorethanever,andifmethwasgoingtokillme,thenobviouslyIneededtocutthatoutofmylife.
During auditions your mom said that she saw you through life’s darkest hour, but now you’re a shining example to others. How much does that mean to you, having that kind of support from your family?
Itmeanssomuch,becausewhenIranaway,myrelationshipwithmymomreallysuffered,andfortwoyearswhileIwasoutthere,shehadnoideawhereIwas.Christmaseswentby,andshedidn’tgetaphonecallfromme.Thetruemiracleofmyrecoveryisthereconciliationofmeandmymom.Peoplelookatusandtheythink,oh,
Idecidedawhileagotolive for something greaterthanmyself...Iwantedtomakeanimpactontheworld,andIwantedtoreallyhelppeople.
POSITIVELYAWARE.COM JULY+AUGUST 2012 27
youguysaresoclose,buttheydon’tknowthatwe’vegonetohellandbacktogether.MymomwasthefirstpersonIcalledwhenIfoundoutIwaspositive,sothatrightthereshowsthatwedefinitelyrepairedwhatwehadbroken.It’sabeautifulthing,it’saveryaffirmingpatontheback.
I want to talk a little bit about “The Voice” and that experience. You were the first person to do the blind auditions on “The Voice” [even though it didn’t appear that way on the show], were you more nervous having to go first, or were you just glad to get it out of the way?
Iwasgladtogetitoutoftheway.Wehadbeenauditioningformonthsbeforethatblindaudition,soIwaslike,I’mreadytodothis.Infact,Iwasactuallyrelievedtobegoingfirst,becausethatmeantIdidn’thavetowaitaround,andgetinmyhead.Iwentoutthere,andIjustfelt
good.Iwasn’treallyevennervous,Iwasmoreexcitedthananything.Youhavetounderstand,Ihadbeenwaiting10yearstoshakeCeeLo[Green’s]hand,andevenifhedidn’tturnaroundforme[andwantmeonhisteam],Iwasgoingtoshakehishand[laughs].Iwassoexcitedtojustlethimknowhowmuchhemeanttome,andhowmuchhisartistrymeanttome,soIwasstoked.
Right after the audition, CeeLo told you to stop and listen to the love, and the audience kind of roared, for a nice long ovation, and you got really emotional. Can you describe that moment, what that meant to you?
Growingup,Iwasjustaweirdkid,youknow?WhenIdidliveinOklahoma,Ididn’tfitinwiththeblackkids,Ididn’tfitinwiththewhitekids.Iwasjustkindofthere,andIwasintowhatpeoplewouldconsideraweirdtypeofmusic,andIalwaysdressedkindofweird.I’veneverreallybeenthepopularguy.IthinkatthatmomentIrealizedthatpeoplelikedme,andIhadgenuinelybeenmyself,therewerenosecrets,everythingwasoutthereintheopen,andpeopledidn’tcare.Theylikedmeinspiteofit,andthatwaswhattouchedme.IhadsuchalowopinionofmyselfforsomanyyearsandI’djustbegunbuildingupmyself-esteemafewyearsago,sotohaveitrewardedinsuchaway,itstillstrikesmeemotionallysome-times.Thatmoment,I’llneverforgetthatmoment,itwasabeautifulthing.
IrespectCeeLoasasongwriter,asarapper,asasinger,Irespecteverythingthathedoes,andtohearhimgivemeaccolades—hell,notevenjusthim,allofthecoaches.IhadChristinaAguilera’sandMaroonFive’sfirstalbums,andtohearthesepeoplethatIlistentotellmethattheythinkI’mgreat,Imean,that’sjustagoodfeeling!That’swhyItellpeopleallthetimethatIwon.Iwonthatshow,asfarasI’mconcerned.Iwoninsomanydiffer-entways…yeah,Iwon[laughs].
CeeLo has been so supportive of you from the start of the show…
Andthathasn’tended,ithasn’tstopped.
On the show you performed “It’s My Life” by Bon Jovi and you’ve said it was the favorite performance of yours from the show. Would you say that the song is kind of an anthem for you, now, or perhaps a reflection of where you are?
Absolutely.It’ssofunny,becauseIwasnotabigfanoftheoriginal.Ihadnevergottenintothewords.WhenCeeLofirstsug-gestedthatIsingit,everyinstinctinsideofmewaslike,hellno,Iamnotsingingthatsong.Togetherwecameupwiththatrenditionthateveryoneheard,andhesaid,Ijustneedyoutolistentothewords.OnceIlistenedtothewords,Iwaslikethissongissoperfect,foreverythingthatIbelievein,everythingthatIstandfor.I’mallaboutnevergivingup,I’mallaboutchasinglife,andsavoringlife,andtastinglife,insteadofjustmerelytoleratinglife.I’maboutlivinglifewithpassion,andI’malsoaboutbeingtheexceptiontotherule,andtellingpeopledon’tletsocietydictateyourpersonality,yourself-esteem,anddefinitelydon’tletyourpastdictatethat.IreallybelievethatsongembodieseverythingthatIfeel.Infact,I’vebeeninvitedtosingalotofplacessincemyelimination,andthat’sthesongthateveryonewantstohear.
HIV stigma is still such a huge barrier to people getting into and staying in care and on treatment. Your courage and openness about your HIV status really serves as a role model to those strug-gling with stigma and denial, but also as an example to others who continue to perpetuate the stigma through their own ignorance and fear. What future role do you see yourself playing to help educate others about HIV?
Ihaveplannedondoingactivismworkforyearsnow.Ireallywasn’tdoinghardcore
activismworkinNewYork,Iwasjustvol-unteeringatafewcommunityorganiza-tions,butIdidhavesomeplansforthingsthatIwantedtodo.NowthatIhavethisplatform,Idefinitelyamattackingitwithpassion.InadditiontojoiningthePOZ Army,I’llbedoingsomestuffinD.C.attheInternationalAIDSConference.
And I’ll be there…
Yay!Ibettergettomeetyoufacetoface!
I would like that!
Ijustrecordedthisamazing[CDC]campaignyesterdaythatIthinkwillbeunveilednationwide[duringtheweekoftheconference],butIdon’tthinkitwouldbenearlyenoughformetojustgoaroundgivingspeeches,eventhoughthatwouldhelp.IthinkIneedtomakemusic.Ithinkthat’llbethebestactivismIcando,byshowing,here’sthisartistthat’srelevanttoday,hismusic’splayedontheradio,Iseehismusicvideos,andnoonecaresthathe’sHIV-positive.IfIcanmakeHIVnormalormainstream,inaway,thenitbeginstochangepeople’sperspective.IbelievethatI’vemadealittleheadway,butthere’sstillsomuchworktogetdone.So,inadditiontothespeeches,andthePublicServiceAnnouncement,mynumberonegoalandfocusistomakethebestmusicpossible,becauseeveryonereceivesmusic.Black,white,old,young,musiccanbeahealer,itcanbeauniter,anditcandefinitelybringpeopletogether.WhatI’mhopingisthatmymusicissogood,thatIwon’tbetheHIVguy,butI’lljustbethisamazingartistwhohappenstohaveHIV.
That’s a great way of looking at it— HIV does not define me, it’s just a part of who I am.
Absolutely,andmymessagetopeoplewhoareHIV-negativeismaybeyoucan’trelatetoeveryangleofmystory,butyou’vedefinitelymadebaddecisionsin
yourlife,andyouprobablyregretsomeofthechoicesyou’vemade.We’renodiffer-ent.I’vemadesomebadchoicesandthisiswhoIamtoday.Mymessageisgetup…getup,andkeeprunning.Itdoesn’tmat-terwhatyou’vebeenthrough,whetheritwasanaddiction,abadrelationship,oraneatingdisorder,whateverhashappened,whetheryouwillinglyputyourselfthere,oryouwerethereunwillingly,thereisatomorrowthat’swaiting,sogetwithit,snapoutofit,we’vegotworktodo.
I’m totally with you there. So you said you’re going to be speaking in D.C., do you know what you’re going to be talking about, and will you be performing as well?
Ithinkthattheywantmetoperform,Ihavenoidea.Usually,wheneverIgivespeeches,Ijustgivemyselfatheme,andIjustgoupthereandwingit,anditalwaysworksforme[laughs].Whatpeopledon’tknowaboutmeisIliketospeakasmuchasIliketosing,especiallyaboutsome-thingI’mextremelypassionateabout.I’mjusthonored,becauselastyearatthistimeIwasjustdoingsomeworkforGod’sLoveWeDeliver,andtryingtostartanAIDSoutreachatmychurch,andnowIgettoactuallyspeaktotheworld…ohman,Igetchillsjustthinkingaboutit,Ithinkit’ssocrazy.
Volunteering is such an important part of the success of many AIDS organizations, POSITIVELY AWARE is published by TPAN in Chicago, and we provide sup-port, education, testing, and referrals to people with HIV or at risk. I started out as a volunteer here 20 years ago, so we all understand how important it is. How did you come to volunteer at God’s Love We Deliver, and how important has giving back been to you?
IwasgoingtothisamazingchurchinNewYork,whichwasreallyintoalotofsocialoutreaches,andIknewthatitwouldkindofbewithinthechurch’smessageif
I need to make music.Ithinkthat’llbethebestactivismIcando.
28 JULY+AUGUST 2012 POSITIVELYAWARE.COM
westartedanHIVoutreach.SoIstarteddoingsomeresearchandvolunteerworkatabunchofagenciesinNewYork,andIreallyclickedwithGod’sLoveWeDeliver,soIjustcontinuedvolunteeringtherethroughoutthesummerandthefall,untilthingson“TheVoice”pickedupforme.Whatitdidformepersonallywasreducemyownstigmaandmyownprejudicethatwasmakingmefeelsoashamedanddirtyaboutmyself.BeforeIknewit,Iwasmeet-ingtheseamazingpeopleandtheywereopeningmyeyestosomanythings,andIwaslearningsomuch,andInowseethehandofGodthroughoutitall.BecauseifIhadn’tbeendoingthatvolunteerwork,Idon’tknowifIwouldhavebeenreadyandwillingtotalkaboutiton“TheVoice.”
SonowIhavesomeplanstostartsomeorganizationsofmyown.Iamallaboutpreventativemeasuresandteachingyoungerpeoplethefactssothatthey’reknowledgeable,butmypassionreallylieswithhelpingpeoplethatarelivingwithHIV.Whatarewedoingwhensomeonehasjustfoundoutthey’repositive?I’maboutdealingwiththepsychologyofthematter—let’streatwhatthisisreallyabout,let’sgetthemsomecounseling,let’shelpthemgettheirGED,somejobtrainingskills.IjustknowtheprogramsthathelpedmewhenIfirstmovedtoNewYork,andIwanttodothat.Thisapproachisfromaholisticstandpoint,andfromaspiritualstandpoint.Let’sseeifwecanequipsomemoresoldierstogooutthere,andgetridofthisstigmaandprejudice.Noonepersoncandoit,it’sgoingtotakealargenumberofusbandingtogether,andsaying,thisiswhatitis,butwe’renotgoingtoliedownanddie.We’regoingtoactuallyshowpeoplethatwe’rehere,andwehavesomethingtolivefor,andwehavesomethingtosay.
It must feel sometimes like you are being pulled in a million different directions,
with a lot of people making so many requests and demands for your time and energies. How do you handle that, and how do pace yourself?
Oh,Iloveit!Youhavetounderstand,I’vemadetheseguardrails,whicharemyownpersonalboundariesthatI’vesetformyself.WhatImeanis,Iknowwhatmyvisionis,andIdon’tlikethetermcelebrity,butI’membracingitifitmeansIcanusemycelebrityforgood.SowhatI’vedoneisdefinewhatcelebritymeanstome.Iftherearerequestsformyappearances,orforinterviews,andithasnothingtodowithwhatfitsinwithmyownpersonalgoalsorboundaries,thenIjustsaynotothosekindsofthings.Ihaveaveryclearandconcisemessagerightnow,andIdon’twanttogetoffmessage.Sono,it’snotdifficultatall—obviouslyI’mgoingtotalktoPOSITIVELY AWARE,becausethatgoesalongwithmymessage[bothlaugh].
Well, that’s good to know! Thanks! So, what’s the one thing about Jamar Rogers that people don’t know, that you’d want them to know?
ThatI’maprettyprolificwriter.Yeah,that’swhyIthinkit’sreallyfunnythatthenightbeforeIgoteliminated,CeeLosaidthatifIweretowriteabookaboutmylife,itwouldbeabestseller.Iactuallyhaveplanstowriteseveralbooks.
So what’s ahead for you?
Besidestheactivismwork,I’mstillinL.A.,andI’vebeeninthestudioalmosteverydayrecording,andI’vebeeninsometalkswithsomepeople,Idon’tknowifI’matlibertytosaywhojustyet.Theshowhashelpedmeinawaythat…ithasbasicallyfast-trackedme,andI’mjustsogratefulforit,Iamsogratefulfor“TheVoice.”
WhatI’mhopingisthatmymusicissogood,Iwon’tbetheHIVguy,butI’ll just be this amazing artist who happens to have HIV.
POSITIVELYAWARE.COM JULY+AUGUST 2012 29
GO TO WWW.POSITIVELYAWARE.COM/JAMARTO LISTEN TO THE AUDIO OR FOR A TRANSCRIPT OF THE COMPLETE 30-MINUTE INTERVIEW.
Learn more at www.COMPLERA.com
COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV medicines before. COMPLERA does not cure HIV or AIDS or help prevent passing HIV to others.
Do not take COMPLERA if you are taking the following medicines:• other HIV medicines (COMPLERA provides a complete treatment for HIV infection.)• the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®,
Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
• the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®)
• a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®)
• more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
• St. John’s wort (Hypericum perforatum)• other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®)• other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®,
Epivir® or Epivir-HBV®, Epzicom®, Trizivir®)• rilpivirine (Edurant™)• adefovir (HEPSERA®)
In addition, also tell your healthcare provider if you take:• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium
carbonate. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA
• a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine (Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these medicines at least 12 hours before or at least 4 hours after you take COMPLERA
• the antibiotic medicines clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, Ery-Tab®, PCE®, Pediazole®, Ilosone®), and troleandomycin (TAO®)
• an antifungal medicine by mouth, including fl uconazole (Difl ucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), posaconazole (Noxafi l®), voriconazole (Vfend®)
• methadone (Dolophine®)
This list of medicines is not complete. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.
INDICATIONCOMPLERA® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA® (emtricitabine), EDURANT™ (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate) combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before.
COMPLERA does not cure HIV and has not been shown to prevent passing HIV to others. It is important to always practice safer sex, use latex or polyurethane condoms to lower the chance of sexual contact with any body fl uids, and to never re-use or share needles. Do not stop taking COMPLERA unless directed by your healthcare provider. See your healthcare provider regularly.
IMPORTANT SAFETY INFORMATIONContact your healthcare provider right away if you get the following side effects or conditions while taking COMPLERA:• Nausea, vomiting, unusual muscle pain, and/or weakness. These may be
signs of a buildup of acid in the blood (lactic acidosis), which is a serious medical condition
• Light-colored stools, dark-colored urine, and/or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly), and fat in the liver (steatosis)
• If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without fi rst talking to your healthcare provider. Your healthcare provider will monitor your condition
COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works, and may cause serious side effects.
Before taking COMPLERA, tell your healthcare provider if you:• have liver problems, including hepatitis B or C virus infection• have kidney problems• have ever had a mental health problem• have bone problems• are pregnant or plan to become pregnant. It is not known if COMPLERA can harm
your unborn child• are breastfeeding; women with HIV should not breast-feed because they can pass
HIV through their milk to the baby
Contact your healthcare provider right away if you experience any of the following serious or common side effects:Serious side effects associated with COMPLERA:• New or worse kidney problems can happen in some people who take COMPLERA.
If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA
• Depression or mood changes can happen in some people who take COMPLERA. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of hurting yourself (suicide) or have tried to hurt yourself
• Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones
• Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effect of these conditions are not known
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fi ght infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine
Common side effects associated with COMPLERA:• trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea,
nausea, rash, tiredness, and depression
Other side effects associated with COMPLERA:• vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles),
and pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Take COMPLERA exactly as your healthcare provider tells you to take it• Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to
help get the right amount of medicine in your body. A protein drink does not replace a meal
• Stay under the care of your healthcare provider during treatment with COMPLERA and see your healthcare provider regularly
Please see Patient Information for COMPLERA on the following pages.
* The co-pay program covers up to $200 per month for 1 year from card activation or until the card expires, up to $2400 in a calendar year. The program is subject to change or cancellation at any time.
Patient model. Pill shown is not actual size.
COMPLERA. A complete HIV treatment in only 1 pill a day.
Ask your healthcare provider if it’s the one for you.
You may be able to save on the co-pay for your COMPLERA prescription with a Gilead HIV Co-pay Assistance Card.
Call 1-877-505-6986 for more information or visit www.COMPLERA.com.*
Save up to
$200per month
oneThe for me
PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5”
PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5”Ad page 1 Ad page 2 Postively Aware Postively Aware
Learn more at www.COMPLERA.com
COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV medicines before. COMPLERA does not cure HIV or AIDS or help prevent passing HIV to others.
Do not take COMPLERA if you are taking the following medicines:• other HIV medicines (COMPLERA provides a complete treatment for HIV infection.)• the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®,
Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
• the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®)
• a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®)
• more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
• St. John’s wort (Hypericum perforatum)• other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®)• other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®,
Epivir® or Epivir-HBV®, Epzicom®, Trizivir®)• rilpivirine (Edurant™)• adefovir (HEPSERA®)
In addition, also tell your healthcare provider if you take:• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium
carbonate. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA
• a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine (Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these medicines at least 12 hours before or at least 4 hours after you take COMPLERA
• the antibiotic medicines clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, Ery-Tab®, PCE®, Pediazole®, Ilosone®), and troleandomycin (TAO®)
• an antifungal medicine by mouth, including fl uconazole (Difl ucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), posaconazole (Noxafi l®), voriconazole (Vfend®)
• methadone (Dolophine®)
This list of medicines is not complete. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.
INDICATIONCOMPLERA® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA® (emtricitabine), EDURANT™ (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate) combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before.
COMPLERA does not cure HIV and has not been shown to prevent passing HIV to others. It is important to always practice safer sex, use latex or polyurethane condoms to lower the chance of sexual contact with any body fl uids, and to never re-use or share needles. Do not stop taking COMPLERA unless directed by your healthcare provider. See your healthcare provider regularly.
IMPORTANT SAFETY INFORMATIONContact your healthcare provider right away if you get the following side effects or conditions while taking COMPLERA:• Nausea, vomiting, unusual muscle pain, and/or weakness. These may be
signs of a buildup of acid in the blood (lactic acidosis), which is a serious medical condition
• Light-colored stools, dark-colored urine, and/or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly), and fat in the liver (steatosis)
• If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without fi rst talking to your healthcare provider. Your healthcare provider will monitor your condition
COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works, and may cause serious side effects.
Before taking COMPLERA, tell your healthcare provider if you:• have liver problems, including hepatitis B or C virus infection• have kidney problems• have ever had a mental health problem• have bone problems• are pregnant or plan to become pregnant. It is not known if COMPLERA can harm
your unborn child• are breastfeeding; women with HIV should not breast-feed because they can pass
HIV through their milk to the baby
Contact your healthcare provider right away if you experience any of the following serious or common side effects:Serious side effects associated with COMPLERA:• New or worse kidney problems can happen in some people who take COMPLERA.
If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA
• Depression or mood changes can happen in some people who take COMPLERA. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of hurting yourself (suicide) or have tried to hurt yourself
• Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones
• Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effect of these conditions are not known
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fi ght infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine
Common side effects associated with COMPLERA:• trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea,
nausea, rash, tiredness, and depression
Other side effects associated with COMPLERA:• vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles),
and pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Take COMPLERA exactly as your healthcare provider tells you to take it• Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to
help get the right amount of medicine in your body. A protein drink does not replace a meal
• Stay under the care of your healthcare provider during treatment with COMPLERA and see your healthcare provider regularly
Please see Patient Information for COMPLERA on the following pages.
* The co-pay program covers up to $200 per month for 1 year from card activation or until the card expires, up to $2400 in a calendar year. The program is subject to change or cancellation at any time.
Patient model. Pill shown is not actual size.
COMPLERA. A complete HIV treatment in only 1 pill a day.
Ask your healthcare provider if it’s the one for you.
You may be able to save on the co-pay for your COMPLERA prescription with a Gilead HIV Co-pay Assistance Card.
Call 1-877-505-6986 for more information or visit www.COMPLERA.com.*
Save up to
$200per month
oneThe for me
PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5”
PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5”Ad page 1 Ad page 2 Postively Aware Postively Aware
FDA-Approved Patient LabelingPatient InformationCOMPLERA® (kom-PLEH-rah)(emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets
Important: Ask your doctor or pharmacist about medicines that should not be taken with COMPLERA. For more information, see the section “What should I tell my healthcare provider before taking COMPLERA?”
Read this Patient Information before you start taking COMPLERA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about COMPLERA?
COMPLERA can cause serious side effects, including:1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death.
Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:• feeling very weak or tired• have unusual (not normal) muscle pain• have trouble breathing• have stomach pain with - nausea (feel sick to your stomach) - vomiting• feel cold, especially in your arms and legs• feel dizzy or lightheaded• have a fast or irregular heartbeat
2. Severe liver problems. Severe liver problems can happen in people who take COMPLERA or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take COMPLERA.
Call your healthcare provider right away if you have any of the following symptoms of liver problems:• your skin or the white part of your eyes turns yellow (jaundice).• dark “tea-colored” urine• light-colored bowel movements (stools)• loss of appetite for several days or longer• nausea• stomach pain
You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking COMPLERA or a similar medicine containing nucleoside analogs for a long time.
3. Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A “flare-up” is when your HBV infection suddenly returns in a worse way than before. COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider.• Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare
provider before your COMPLERA is all gone.• Do not stop taking COMPLERA without first talking to your healthcare provider.• If you stop taking COMPLERA, your healthcare provider will need to check your health
often and do regular blood tests to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking COMPLERA.
What is COMPLERA?COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine that:• is used to treat HIV-1 in adults who have never taken HIV medicines before. HIV is the
virus that causes AIDS (Acquired Immunodeficiency Syndrome).• contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate)
combined in one tablet. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and EDURANT is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI).
It is not known if COMPLERA is safe and effective in children under the age of 18 years.
COMPLERA may help:• Reduce the amount of HIV in your blood. This is called your “viral load”.• Increase the number of white blood cells called CD4+ (T) cells that help fight off
other infections.
Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).
COMPLERA does not cure HIV infections or AIDS.• Always practice safer sex.• Use latex or polyurethane condoms to lower the chance of sexual contact with any
body fluids such as semen, vaginal secretions, or blood.• Never re-use or share needles.
Ask your healthcare provider if you have any questions about how to prevent passing HIV to other people.
Who should not take COMPLERA?• Do not take COMPLERA if your HIV infection has been previously treated with
HIV medicines.• Do not take COMPLERA if you are taking certain other medicines. For more
information about medicines that must not be taken with COMPLERA, see “What should I tell my healthcare provider before taking COMPLERA?”
What should I tell my healthcare provider before taking COMPLERA?
Before you take COMPLERA, tell your healthcare provider if you:• have liver problems, including hepatitis B or C virus infection• have kidney problems• have ever had a mental health problem• have bone problems• are pregnant or plan to become pregnant. It is not known if COMPLERA can harm
your unborn child Pregnancy Registry. There is a pregnancy registry for women who take antiviral
medicines during pregnancy. Its purpose is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
• are breast-feeding or plan to breast-feed. The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their milk to the baby. It is not known if COMPLERA can pass through your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works, and may cause serious side effects. If you take certain medicines with COMPLERA, the amount of COMPLERA in your body may be too low and it may not work to help control your HIV infection. The HIV virus in your body may become resistant to COMPLERA or other HIV medicines that are like it.
Do not take COMPLERA if you also take these medicines:• COMPLERA provides a complete treatment for HIV infection. Do not take other HIV
medicines with COMPLERA.• the anti-seizure medicines carbamazepine (CARBATROL®, EQUETRO®, TEGRETOL®,
TEGRETOL-XR®, TERIL®, EPITOL®), oxcarbazepine (TRILEPTAL®), phenobarbital (LUMINAL®), phenytoin (DILANTIN®, DILANTIN-125®, PHENYTEK®)
• the anti-tuberculosis medicines rifabutin (MYCOBUTIN®), rifampin (RIFATER®, RIFAMATE®, RIMACTANE®, RIFADIN®) and rifapentine (PRIFTIN®)
• a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (NEXIUM®, VIMOVO®), lansoprazole (PREVACID®), omeprazole (PRILOSEC®), pantoprazole sodium (PROTONIX®), rabeprazole (ACIPHEX®)
• more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
• St. John’s wort (Hypericum perforatum)
If you are taking COMPLERA, you should not take:• other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®)• other medicines that contain emtricitabine or lamivudine (EMTRIVA®, COMBIVIR®,
EPIVIR® or EPIVIR-HBV®, EPZICOM®, TRIZIVIR®)• rilpivirine (EDURANT™)• adefovir (HEPSERA®)
Also tell your healthcare provider if you take:• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium
carbonate. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA.
• a histamine-2 blocker medicine, including famotidine (PEPCID®), cimetidine (TAGAMET®), nizatidine (AXID®), or ranitidine hydrochloride (ZANTAC®). Take these medicines at least 12 hours before or at least 4 hours after you take COMPLERA.
• the antibiotic medicines clarithromycin (BIAXIN®), erythromycin (E-MYCIN®, ERYC®, ERY-TAB®, PCE®, PEDIAZOLE®, ILOSONE®), and troleandomycin (TAO®)
• an antifungal medicine by mouth, including fluconazole (DIFLUCAN®), itraconazole (SPORANOX®), ketoconazole (NIZORAL®), posaconazole (NOXAFIL®), voriconazole (VFEND®)
• methadone (DOLOPHINE®)
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider and your pharmacist can tell you if you can take these medicines with COMPLERA. Do not start any new medicines while you are taking COMPLERA without first talking with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that can interact with COMPLERA.
How should I take COMPLERA?• Stay under the care of your healthcare provider during treatment with COMPLERA.• Take COMPLERA exactly as your healthcare provider tells you to take it.• Always take COMPLERA with a meal. Taking COMPLERA with a meal is important
to help get the right amount of medicine in your body. A protein drink does not replace a meal.
• Do not change your dose or stop taking COMPLERA without first talking with your healthcare provider. See your healthcare provider regularly while taking COMPLERA.
• If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take your dose of COMPLERA with a meal as soon as possible. Then, take your next dose of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by more than 12 hours of the time you usually take it, wait and then take the next dose of COMPLERA at the regularly scheduled time.
• Do not take more than your prescribed dose to make up for a missed dose.• When your COMPLERA supply starts to run low, get more from your healthcare provider
or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in your blood may increase if the medicine is stopped for even a short time.
• If you take too much COMPLERA, contact your local poison control center or go to the nearest hospital emergency room right away.
What are the possible side effects of COMPLERA?
COMPLERA may cause the following serious side effects, including:• See “What is the most important information I should know about COMPLERA?”• New or worse kidney problems can happen in some people who take COMPLERA.
If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA.
• Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:
- feeling sad or hopeless - feeling anxious or restless - have thoughts of hurting yourself (suicide) or have tried to hurt yourself• Bone problems can happen in some people who take COMPLERA. Bone problems
include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones.
• Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine.
The most common side effects of COMPLERA include:• trouble sleeping (insomnia)• abnormal dreams• headache• dizziness• diarrhea• nausea• rash• tiredness• depression
Additional common side effects include:• vomiting• stomach pain or discomfort• skin discoloration (small spots or freckles)• pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).
How do I store COMPLERA?• Store COMPLERA at room temperature 77 °F (25 °C).• Keep COMPLERA in its original container and keep the container tightly closed.• Do not use COMPLERA if the seal over the bottle opening is broken or missing.
Keep COMPLERA and all other medicines out of reach of children.
General information about COMPLERA:Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use COMPLERA for a condition for which it was not prescribed. Do not give COMPLERA to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about COMPLERA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COMPLERA that is written for health professionals. For more information, call (1-800-445-3235) or go to www.COMPLERA.com.
What are the ingredients of COMPLERA?Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake.
This Patient Information has been approved by the U.S. Food and Drug Administration Manufactured and distributed by:Gilead Sciences, Inc.Foster City, CA 94404
Issued: August 2011
COMPLERA, the COMPLERA Logo, EMTRIVA, HEPSERA, TRUVADA, VIREAD, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc. or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners.
© 2012 Gilead Sciences, Inc. All rights reserved.
202123-GS-000 02AUG2011 CON12383 3/12
BS page 1 BS page 2 Postively Aware Postively AwarePALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5”
PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5”
FDA-Approved Patient LabelingPatient InformationCOMPLERA® (kom-PLEH-rah)(emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets
Important: Ask your doctor or pharmacist about medicines that should not be taken with COMPLERA. For more information, see the section “What should I tell my healthcare provider before taking COMPLERA?”
Read this Patient Information before you start taking COMPLERA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about COMPLERA?
COMPLERA can cause serious side effects, including:1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death.
Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:• feeling very weak or tired• have unusual (not normal) muscle pain• have trouble breathing• have stomach pain with - nausea (feel sick to your stomach) - vomiting• feel cold, especially in your arms and legs• feel dizzy or lightheaded• have a fast or irregular heartbeat
2. Severe liver problems. Severe liver problems can happen in people who take COMPLERA or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take COMPLERA.
Call your healthcare provider right away if you have any of the following symptoms of liver problems:• your skin or the white part of your eyes turns yellow (jaundice).• dark “tea-colored” urine• light-colored bowel movements (stools)• loss of appetite for several days or longer• nausea• stomach pain
You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking COMPLERA or a similar medicine containing nucleoside analogs for a long time.
3. Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A “flare-up” is when your HBV infection suddenly returns in a worse way than before. COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider.• Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare
provider before your COMPLERA is all gone.• Do not stop taking COMPLERA without first talking to your healthcare provider.• If you stop taking COMPLERA, your healthcare provider will need to check your health
often and do regular blood tests to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking COMPLERA.
What is COMPLERA?COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine that:• is used to treat HIV-1 in adults who have never taken HIV medicines before. HIV is the
virus that causes AIDS (Acquired Immunodeficiency Syndrome).• contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate)
combined in one tablet. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and EDURANT is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI).
It is not known if COMPLERA is safe and effective in children under the age of 18 years.
COMPLERA may help:• Reduce the amount of HIV in your blood. This is called your “viral load”.• Increase the number of white blood cells called CD4+ (T) cells that help fight off
other infections.
Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).
COMPLERA does not cure HIV infections or AIDS.• Always practice safer sex.• Use latex or polyurethane condoms to lower the chance of sexual contact with any
body fluids such as semen, vaginal secretions, or blood.• Never re-use or share needles.
Ask your healthcare provider if you have any questions about how to prevent passing HIV to other people.
Who should not take COMPLERA?• Do not take COMPLERA if your HIV infection has been previously treated with
HIV medicines.• Do not take COMPLERA if you are taking certain other medicines. For more
information about medicines that must not be taken with COMPLERA, see “What should I tell my healthcare provider before taking COMPLERA?”
What should I tell my healthcare provider before taking COMPLERA?
Before you take COMPLERA, tell your healthcare provider if you:• have liver problems, including hepatitis B or C virus infection• have kidney problems• have ever had a mental health problem• have bone problems• are pregnant or plan to become pregnant. It is not known if COMPLERA can harm
your unborn child Pregnancy Registry. There is a pregnancy registry for women who take antiviral
medicines during pregnancy. Its purpose is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
• are breast-feeding or plan to breast-feed. The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their milk to the baby. It is not known if COMPLERA can pass through your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works, and may cause serious side effects. If you take certain medicines with COMPLERA, the amount of COMPLERA in your body may be too low and it may not work to help control your HIV infection. The HIV virus in your body may become resistant to COMPLERA or other HIV medicines that are like it.
Do not take COMPLERA if you also take these medicines:• COMPLERA provides a complete treatment for HIV infection. Do not take other HIV
medicines with COMPLERA.• the anti-seizure medicines carbamazepine (CARBATROL®, EQUETRO®, TEGRETOL®,
TEGRETOL-XR®, TERIL®, EPITOL®), oxcarbazepine (TRILEPTAL®), phenobarbital (LUMINAL®), phenytoin (DILANTIN®, DILANTIN-125®, PHENYTEK®)
• the anti-tuberculosis medicines rifabutin (MYCOBUTIN®), rifampin (RIFATER®, RIFAMATE®, RIMACTANE®, RIFADIN®) and rifapentine (PRIFTIN®)
• a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (NEXIUM®, VIMOVO®), lansoprazole (PREVACID®), omeprazole (PRILOSEC®), pantoprazole sodium (PROTONIX®), rabeprazole (ACIPHEX®)
• more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
• St. John’s wort (Hypericum perforatum)
If you are taking COMPLERA, you should not take:• other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®)• other medicines that contain emtricitabine or lamivudine (EMTRIVA®, COMBIVIR®,
EPIVIR® or EPIVIR-HBV®, EPZICOM®, TRIZIVIR®)• rilpivirine (EDURANT™)• adefovir (HEPSERA®)
Also tell your healthcare provider if you take:• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium
carbonate. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA.
• a histamine-2 blocker medicine, including famotidine (PEPCID®), cimetidine (TAGAMET®), nizatidine (AXID®), or ranitidine hydrochloride (ZANTAC®). Take these medicines at least 12 hours before or at least 4 hours after you take COMPLERA.
• the antibiotic medicines clarithromycin (BIAXIN®), erythromycin (E-MYCIN®, ERYC®, ERY-TAB®, PCE®, PEDIAZOLE®, ILOSONE®), and troleandomycin (TAO®)
• an antifungal medicine by mouth, including fluconazole (DIFLUCAN®), itraconazole (SPORANOX®), ketoconazole (NIZORAL®), posaconazole (NOXAFIL®), voriconazole (VFEND®)
• methadone (DOLOPHINE®)
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider and your pharmacist can tell you if you can take these medicines with COMPLERA. Do not start any new medicines while you are taking COMPLERA without first talking with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that can interact with COMPLERA.
How should I take COMPLERA?• Stay under the care of your healthcare provider during treatment with COMPLERA.• Take COMPLERA exactly as your healthcare provider tells you to take it.• Always take COMPLERA with a meal. Taking COMPLERA with a meal is important
to help get the right amount of medicine in your body. A protein drink does not replace a meal.
• Do not change your dose or stop taking COMPLERA without first talking with your healthcare provider. See your healthcare provider regularly while taking COMPLERA.
• If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take your dose of COMPLERA with a meal as soon as possible. Then, take your next dose of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by more than 12 hours of the time you usually take it, wait and then take the next dose of COMPLERA at the regularly scheduled time.
• Do not take more than your prescribed dose to make up for a missed dose.• When your COMPLERA supply starts to run low, get more from your healthcare provider
or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in your blood may increase if the medicine is stopped for even a short time.
• If you take too much COMPLERA, contact your local poison control center or go to the nearest hospital emergency room right away.
What are the possible side effects of COMPLERA?
COMPLERA may cause the following serious side effects, including:• See “What is the most important information I should know about COMPLERA?”• New or worse kidney problems can happen in some people who take COMPLERA.
If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA.
• Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:
- feeling sad or hopeless - feeling anxious or restless - have thoughts of hurting yourself (suicide) or have tried to hurt yourself• Bone problems can happen in some people who take COMPLERA. Bone problems
include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones.
• Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine.
The most common side effects of COMPLERA include:• trouble sleeping (insomnia)• abnormal dreams• headache• dizziness• diarrhea• nausea• rash• tiredness• depression
Additional common side effects include:• vomiting• stomach pain or discomfort• skin discoloration (small spots or freckles)• pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).
How do I store COMPLERA?• Store COMPLERA at room temperature 77 °F (25 °C).• Keep COMPLERA in its original container and keep the container tightly closed.• Do not use COMPLERA if the seal over the bottle opening is broken or missing.
Keep COMPLERA and all other medicines out of reach of children.
General information about COMPLERA:Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use COMPLERA for a condition for which it was not prescribed. Do not give COMPLERA to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about COMPLERA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COMPLERA that is written for health professionals. For more information, call (1-800-445-3235) or go to www.COMPLERA.com.
What are the ingredients of COMPLERA?Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake.
This Patient Information has been approved by the U.S. Food and Drug Administration Manufactured and distributed by:Gilead Sciences, Inc.Foster City, CA 94404
Issued: August 2011
COMPLERA, the COMPLERA Logo, EMTRIVA, HEPSERA, TRUVADA, VIREAD, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc. or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners.
© 2012 Gilead Sciences, Inc. All rights reserved.
202123-GS-000 02AUG2011 CON12383 3/12
BS page 1 BS page 2 Postively Aware Postively AwarePALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5”
PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5”
34 JULY+AUGUST 2012 POSITIVELYAWARE.COM
InMay,theuseoftheHIVdrugTruvadabyHIV-negativepeopletopreventinfec-tionwiththeviruswasrecommendedforFDAapprovalbytheagency’sAntiviralDrugsAdvisoryCommittee(AVDAC).
“TodayisanexcitingdayforHIVprevention,”saidKennethH.Mayer,MD,MedicalResearchDirectorandCo-ChairofTheFenwayInstituteatFenwayHealthinBoston,abouttherecommendation.“Although[Truvada]forPrEP[pre-expo-sureprophylaxis,orprevention]isnotapanacea,thisapproachcanpreventmanynewinfectionsandcoulddramaticallyimpactHIVtransmissionworldwide.”
Butforallofitspromise,andallofitsadvocates,HIVpreventionwithTruvadahassomeconcernedthatitcouldbeusedincorrectly,creatinganewsetofpoten-tiallyseriousproblems.
ManyalsoworrythatpeopleonPrEPmaystopusingcondomsorincreasetheir
riskinotherways,suchashavingsexwithmorepartners.DoingsomaynegatethegoodthatPrEPcando.
Aswell-intentionedasthesepeoplemaybe,theymaybeoverlookingprob-lemswithcondomsandHIVtreatment,bothofwhichifusedandusedcorrectly,arehighlyeffectiveinpreventingHIVtransmission.YetfewcomeoutagainstcondomsorHIVtherapybecauseoftheirpotentialformisuseandharm.
Evensexwithcondomscanberisky,andthepromiseofpreventionforpartnerswithHIVtreatmentisoftenunfulfilledduetolackofaccess—theCentersforDiseaseControlandPrevention(CDC)estimatesthatonlyoneinthreepeoplewithHIVintheU.S.havecontrolled,or“undetectable,”virus,andfurther,thatoneinfivedon’tevenknowthey’reinfected.PeoplewithHIVmayalsochoosenottobeonantiviraltherapyforanynumberofreasons,andsoremainmoreinfectioustotheirsexualpartnersthaniftheywereontreatment,especiallyintheabsenceofcondoms.Nevermindthatthosewithundetectablevirusintheirbloodmaystillbeinfectious.
AT RISKTheweekthattheadvisorycommitteemadeitsdecision,ayoungmaninChicagostruggledwiththesymptomsofserocon-verting,includingnausea,diarrhea,andnightsweats,afterhavingthreeepisodesofunprotectedsexwithapresumablyHIV-negativemaninanothercity.
ChrishadchattedwiththismanformonthsovertheInternet,butitwasn’tuntilaftertheyhadsexthathetoldChris,“Youknow,therearesomepeopleouttherewhosaythatthey’reHIV-negativebutthey’repositiveandthey’respreadingthevirus.Myex-boyfriendinL.A.isoneofthoseguys.”
“Heevenhadawordforit,‘pozzing.’Ineverheardofthat,”saidChris.
WouldtakingTruvadaeverydayhavehelpedChris,whowasnowinastateofpanic?
“Idefinitelywouldbesomebodywhowouldtakesomethinglikethat,”saidChris.“Itsoundsalmostlikeamiracledrug,especiallyafterallI’vebeenthroughwithmyfriends,watchingsomeofthemgetinfectedandsomeofthemdie.Ithinkthedrugisexciting.”
PrEP’ingAre you ready? Doctors and advocates are gearing up to bring Truvada PrEP to people at greatest risk of infection
BY ENID VÁZQUEZ
LOVEITORHATEIT,IT’S
coming:HIVpreventionwiththeuseofonepill,takenonceaday.
PHOTO: JOSHUA THORNE
POSITIVELYAWARE.COM JULY+AUGUST 2012 35
WHEN SAFER SEX ISN’TWhenMark(nothisrealname)workedinHIVservicesinChicagomorethanadecadeago,heheardfromseveralgaymenthattheywereinfectedwhentheirsexpartnertookhiscondomoffwhiletheywerehavingsex,usuallywithouttheirknowledge.Hebeganspreadingthewordaboutthisdangerinhisoutreachandheardbackfrommanymenwhotoldhim,“That’smystory.”
“Iwouldalwaystellpeopletoreacharoundandfeeltoseethatthecondomwasstillon,”saidMark.“Peoplewereshocked.”Heremembersmostdistinctlyahandsomeyoungmanwhostoodupdur-ingoneofhistalksandtearfullythankedhim.“Hewasangryathisinfector,”saidMark,“butIrememberevenmorehisangerandhurtatfriendswhodidn’tbelievethatthishadhappenedtohim.”
Insomecases,gaymenwhowere“tops,”orinsertiveanalsexpartners,thoughttheywerevirtuallyrisk-free.Butwhiletheywereatlowerriskthanthe“bottom”(receptive)partner,manyofthembecameinfectednonetheless.
He’salsohauntedbytheexperienceof
testingtwoyoungmenwhowereacouple.ThefirstboyfriendtestedHIV-negative,butthesecondonetestedpositive.“Rightinfrontofmeoutinthelobby,hesaid,‘I’mnegative,let’sgohome.’AndtherewasnothingIcoulddoaboutit.TheyhadtosendmehomethatdaybecauseIwasgoingoutofmymind.”
AfterwardshemadeitapointtotellpeopletoasktobeinthesameroomwhentheirpartnergetsanHIVtestresult,andthatit’saredflagifthepersonrefuses.
LikeChrisandmanyothergaymen,MarkstruggledwiththedeceptionpracticedontheInternet.“Idon’tknowhowmanytimesguystoldme,‘OhmyGod,you’rethefirstpersontotellmeyou’repositive’or‘You’rethefirstpersonI’vemetwho’sposi-tive.’No,I’mjustprobablythefirstguywhowashonest.Others[whowereHIV-positive]eitherlieortheydon’tknowthey’repositive.Ifyouputyourlifeandyourcareinsome-oneelse’shandsbasedontheirword,you’reputtingyourselfatrisk.”Evengaymenwhothoughttheywereinsafe,monogamousrelationshipsbecameinfectedbythepart-nertheytrusted,hesaid.
MarksaysthatifPrEPprotectsoneortwopeople,it’sworthit.“I’monthesideofusingalltheoptionswecanget.”
SEXUAL ASSAULTEightyearsago,Vince(nothisrealname)wenthomewithamanhe’djustmet.Theymadeout,butVince,drunk,fellasleep.Hewokeupwiththemaninsidehim.Hefoughtbackandgottheguyoffhim,buttherewasnocondom,whichmystifiedhim,since“theguydidn’tknowme.”Havingalwayspracticedprotectedanalsex,Vinceknowsthatthissexualassaultishowhebecameinfected.
Hehadonlyhadunprotectedsexoneothertime—andhethoughtitwasprotected.“Iknowhehadonacondom,Ihelpedhimputiton.Butheletitcomeoffinsideme.”Vincewonderedwhathap-penedtothecondomwhenhedidn’tseeitaftersex.Thinkingbackonthatnightinabathhouse,hesaysheshouldhaveaskedaboutit.(Thecondomcameoutlaterwhenheusedthebathroom.)VincewaitedsixmonthstotestforHIV(therecommen-dationatthetime)andhewasnegative.Hesayshewaslucky.
Butthatwasthenandthisisnow.
Todayonce-dailypreventionwithTruvadaisanoptionthatcanbeaddedtocondomusewithanoff-labelprescriptionandisalreadyavailable,evenwithoutofficialFDAapproval.
“Iabsolutelywouldhavetakenit,eventhoughIalwaysplayedsafe.Youneverknowwhensomethinglikethatisgoingtohappen.Youdoeverythingyoucantopreventitandthenyoumakeonemistakeanditchangesyourlifeforever.Itsucks,”saidVince.HesayshewouldtakeTruvadaPrEPtodayinaheartbeat,ifhewasstillHIV-negativeandatrisk,knowingwhatheknowsnow.
“Havingbeenthroughthat[first]expe-rience,itwouldhavehelpedwhenIgotinfected,”Vincesaid.
RISK PERCEPTIONRealizingthatyoumaybeatrisk,how-ever,isoneofthehurdlesforPrEPusage.SurveysofpeopleathighriskofbecomingHIV-positivehaverepeatedlyfoundthatmanyreporttheywereatlowornoriskofinfection,butaftertesting,manywereinfactalreadypositive.
ThiswasraisedasoneofthepossiblereasonsforthedisappointingresultsofTruvadaPrEPinwomenintheFEM-PrEPstudy.Thewomenwhobecameinfected(anequalnumberinboththeplacebo—fakepill—andTruvadagroups)hadindicatedthattheywereatlowriskforacquiringHIV.
DidthewomengivenTruvadanottakeitbecauseofthatbelief?Theirbloodworkshowedlittleornoevidenceofthedrugbeingintheirsystem.LargelythankstoPrEPresearch,“riskperception”isnowanimportantconsiderationinprevention.
Yet,thelargePartnersPrEPstudyshowedthatTruvadadidprotectwomenagainstHIV.SodidaCDCstudyinBotswana.
AllofwhichgoestoshowthepotentialvalueofPrEP.Undoubtedly,sexcanbecomplicated,andasthestoriesaboveshow,ofteneasierdonethansaid(ordiscussed).
WHAT YOU DON’T KNOWIronically,Chriscouldhaveusedanothermedicationinterventionthat’slongbeenavailable,calledPEP,forpost-exposureprophylaxis.IfcertainHIVmedicationsaretakenfor28days,beginningwithin
PHOTO: JOSHUA THORNE
36 JULY+AUGUST 2012 POSITIVELYAWARE.COM
72hoursaftersexualexposure,theycanpreventinfectionfromtakingplace.It’ssomethinghedidn’tthinkaboutbecausehewasn’tawareofit.
ResearchershavewrittenaboutthelackofawarenessamonggaymenoftheavailabilityofbothPEPandPrEP.Whenthereisawareness,itsometimesgoesalongwithmisunderstandingordownrightmisinformation.Truvadaisnot,forexam-ple,amorning-afterpillassomebelieve.
IfTruvadaisapprovedforuseinHIV-negativeindividuals,thelackofaware-nessarounditspreventionpowershouldchangedrastically,witheducationbecom-ingpossiblebyitsmanufacturer,clinics,andcommunityorganizations.
TO BE YOUNG“WeseePrEPforyouthnotasalifelongmedicationbutasastopgapmeasure,”saidpsychologistSybilHosek,PhD,of
StrogerHospitalofCookCounty,theChicagositefortheAdolescentTrialsNetwork(ATN)forHIV/AIDSInterventions.
“Weknowthatadolescenceisariskytime,”saidHosek.“There’salotofimpul-sivityandalotofbehaviorchanges—hor-monal,psychological,andemotional—thatputpeopleinvulnerablepositionswhenitcomestoHIV.AndsowefeelthatPrEPmaybeagreatoptionduringthatmatura-tionperiod.”
TheATNpointstoCDCstatisticsshow-ingthatamongadolescentsandyoungadults(ages13to25),theestimatedper-centageofHIVinfectionsresultingfrommale-to-malecontactincreasedfrom57%in2005to68%in2008,whileinfectionsresultingfromheterosexualcontactorinjectiondrugusedecreased.Forblackyouth,however,theincreasewas73%inthattimeperiod.
ATN’sProjectPrEParehastwostudieslookingatPrEPeffectivenessnowthatitsinitialresearchhasshownthatyouthwouldacceptandusePrEP(feasibility).Thesetwostudiesarescheduledtoenroll300youthatthenetwork’s14sitesacrossthecountry,includingChicago.Visitwww.projectpare.net.
LikeotherPrEPresearch,ProjectPrEPareprovidescondomsandcounselingalongwithmedication.
AstotheargumentthatmoneyshouldbeusedfortreatmentofactualHIVinfectionratherthanprevention,Hoseksaidthey’rebothpartofthesamepack-age,withPrEPexpectedtoincreaseHIVtestinglevelsandawarenessofprevi-ouslyunknowninfectionwiththeneedforaccesstotreatment.Moreover,shesaiditwouldhelpproviderstalktotheirpatientsaboutgettingHIV-positivepartnersintocareandtreatment.Likemanyadvocates,shealsopointstothefactthatTruvadaPrEP—especiallyforshort-termuse—costslessthanalifetimeofHIVtherapy.
“Ithinkitwouldhelppeopletoremem-bertheirownyouth,”saidHosek.“It’satimeofexploration.It’satimeofemotionalenergyandrisktaking,ofcognitivedevel-opment.Theirbrainsarematuring.Pleasureoftentakesprecedenceoverplanning.
What you should know before PrEPn You need to test HIV-negative
beforegoingonPrEP(pre-exposureprophylaxisorprevention).
n Thismayrequiremultiple testing(forexample,testingHIV-negativethreemonthsinarow).
n Youmustalsobetested for hepati-tis BbeforegettingTruvada.
n Your kidney functionandserumphosphoruslevels(forevidenceofboneweakness)shouldbemeasured.
n It takes about three doses(threedays)forTruvadatoreachadequatelevelsinyourbodyforprotectionagainstHIV.
n Adherence,ortakingPrEPcorrectlyanddaily,isrequired.
n PrEPmustbemonitored with continued testingforHIVandothersexuallytransmittedinfectionsandreviewofanysideeffectsthatmayoccur.
n Monitoring may be requiredeverythreeorfourmonths.
n Side effect monitoringincludeslaboratorytests(blooddraws)forpotentialkidneytoxicity.
n It’swidelybelievedthatPrEP should include the use of con-domsandbehavioralmodification(findingwaystolessentheriskofinfection).
n Itispossiblethatnot using condoms along with PrEP may allow for the
riskofinfection,possiblynegatingtheeffectsofPrEPaltogether.
n Other serious infections can occurwithoutacondomandareepidemicinthegaycommunity:hepatitisC,syphilis,andgonorrhea.(Rememberthatgonorrheaisalsospreadthroughoralsex.)
n PeoplewhobecomeHIV-positivewhileonTruvadaPrEPrisk the development of drug resistance.Instudies,theonlyriskofdrugresis-tanceseenwasinindividualswhowerealreadypositiveatthetimeofstartingPrEPbutdidn’tknowitorpeoplewhowereinfectedwithanalreadydrug-resistantstrainofHIV.
n Healthcareprovidersmightcon-sider supplementing vitamin D and calciuminPrEPpatients.SomepatientsmayalsobenefitfromDEXAbonescansbeforeandduringtreatment.
n Research continues to investigate the best usesofPrEP,suchasthepossibilityoflessthandailyusageandtheuseofothermedicationsbesidesTruvada.Otherbiologicalpreventionmethodssuchasmicrobi-cidesarealsobeingstudied.
READ THE CDC’S INTERIM GUIDELINES:www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm?s_cid=mm6003a1_w.
Truvada is not a morning-after pill as some believe.
PH
OT
O:
Saying‘justuseacondom’isnotworking.“Notthatcondomsaren’tagreat
option,”shecontinued,“butsomepeoplejustaren’tgoingtousethem.SoIthinkthemoreoptionswehaveforyouth,thebetter.”
TURNING THE TIDEInFebruary,Boston’sFenwayInstituteissueda59-pagereportinwhichitstatedthat,basedoninitialstudyresults,“PrEPcouldbethe‘gamechanger’neededtomoreeffectivelyfightHIV.”Theinstitute,oneoftwoU.S.sitesinvolvediniPrEx,urgedtheFDAtoapproveTruvadaPrEP.ItcontinuestoconductPrEPresearchthroughHPTN069(NEXTPrEP),andisalsoinvolvedinHPTN061(theBROTHERSstudy),amultiple-componentinterventionforblackMSM.
HPTN(HIVPreventionTrialsNetwork)hailedtheTruvadaPrEPdecisionas“amilestoneforHIVprevention”andawebi-narannouncementreferredtoPrEPas“abridgetotheendofAIDS.”
WithflatfundingfortheAIDSDrug
AssistanceProgramandcutstoMedicaidthatarebecomingmorecommoninthestates,moreandmorepeoplemayfindthemselveswithoutaccesstotreatment,letaloneprevention.ThereisfreeaccesstoTruvadaPrEPthroughtheiPrExstudywhichhasexpanded(iPrExOLE)withthreeU.S.sites(Chicago,Boston,andSanFrancisco).Theremayalsobepatientassistanceorco-payassistanceprogramsavailableifPrEPisFDAapproved.
Earlier,inAugustof2011,sixorganiza-tionsfromaroundthecountrydevotedtoHIV/AIDSworkandservices(theAIDSFoundationofChicago,AVAC,theBlackAIDSInstitute,theNationalMinorityAIDSCouncil,ProjectInform,andtheSanFranciscoAIDSFoundation)urgedtheDepartmentofHealth&HumanServices(DHHS)toestablishso-called“demonstra-tionprojects”toexaminePrEPeffective-nessoutintherealworld,especiallyamongthehardest-hitMSMofcolor.Ayearlater,fewdemonstrationprojectsareunderway.
SAN FRANCISCO JOINS MIAMISanFranciscoandMiami,twocitiesthathavetraditionallyhadsomeofthehigh-estratesofHIVinfectioninthecountry,haveteamedupforaPrEPdemonstrationprojectfundedbytheNationalInstitutesofHealth(NIH).
StephanieCohen,MD,MPH,medicaldirectoroftheCityClinicforsexuallytransmittedinfections(STIs)fortheSanFranciscoDepartmentofPublicHealth,saidindividualsaccessingcarefromtheclinicwhoareatriskofHIVinfectionwillbeofferedTruvadaPrEP.Inaddition,theMagnetgaymen’shealthclinicintheCastrowillrefermentotheprogram.
“WearelookingatuptakeinPrEP—who’sinterestedinit,who’snot,andwhy,”saidCohen.“Weplantodevelopmarket-ingandeducationmessagesfromwhatwelearninour,andother,demonstrationprojects.”
Thegoalistoenroll300MSMinSanFranciscoand200inMiami.A
ARE YOU AWARE? GET POSITIVELY AWARE.
❑ 1-year subscription: $30 donation. Six bi-monthly issues every year. Subscriptions are mailed freeof
chargewithintheU.S.tothosewhoareHIV-positive.
❑ Bulk copies (U.S. only): Available free of charge; however, a donation is requested to cover
shipping. No international bulk orders. Minimum order 10 copies, shipped via UPS (No P.O. Box addresses): ______ copies
❑ Back issues: $3 per copy. Enclosed is my payment.
______copies: May+June2012 ______copies: March+April2012(HIVDrugGuide) ______copies: January+February2012 ______copies: November+December2011 ______copies: September+October2011
❑ Sign me up for the E-News, PA’sweeklyemailnewsletter:
EMAIL ADDRESS
❑ Enclosed is my donation of ❑ $25 ❑ $50 ❑ $100 ❑ $250 ❑ $500 ❑ $_______
Your contribution helps providesubscriptionstopeoplewhocan’taffordthem.Alldonationsaretax-deductibletothefullextentallowedbylaw.
Bill to:
CARD NUMBER EXPIRES
NAME ON CARD
SIGNATURE (REQUIRED)
CHARGE MY: ❑ Visa ❑ MasterCard ❑ American Express
TOTAL AMOUNT: $___________Charges will appear on your credit card statement as TPA Network. Test Positive Aware Network (TPAN)isanot-for-profitorganizationdedicatedtoprovidingsupportandinformationtoallpeopleaffectedbyHIV.
Ship to:
NAME
AGENCY (IF APPLICABLE)
ADDRESS
CITY STATE ZIP
PHONE E-MAIL
MAIL TO: POSITIVELY AWARE 5537 N. BROADWAY ST. CHICAGO, IL 60640
PrEP could be the ‘game changer’ needed to more effectively fight HIV.
38 JULY+AUGUST 2012 POSITIVELYAWARE.COM
demonstrationprojectisalsointheworksforNewYorkCity,shesaid.
“Doesitwork?Yes,weknowitdoes,buthowdowegetitoutthere?”saidCohen.
TheCaliforniaHIV/AIDSResearchProgram(CHRP)oftheUniversityofCaliforniaisalsoconductingaPrEPdemonstrationproject,incitiesthrough-outthestate(includingOakland,SanDiego,andLongBeach),focusingonhigh-riskMSMofcolor“wholackresourcesfortestingandcounseling.”TheprogramwillalsolookattheuseofTLC+(testingandlinkagetocareplustreatment)inmenwhobecomeinfected.
“It’sanhistoricmomentinHIVpre-vention,”saidCohen,“andthere’salotofworktobedoneinlearninghowtousethisnewpreventiontool.”
CHICAGOInChicago,HowardBrownHealthCenter(HBHC),whichservestheLGBT(lesbian,gay,bisexual,andtransgender)com-munity,doesnothaveademonstrationprojectperse.Rather,thecenterismakingPrEPpartofitsprimarycareservices.IthascreatedaprotocolforstafftrainingsothateveryonecanbeonthesamepageaboutwhomakesagoodcandidateforPrEP,saidKristinKeglovitz,PA,HBHC’smedicaldirector.Shesaidtheclinic’sPrEPprotocolwillbeamultidisciplinarymodelinvolvingtheservicesofcounselorsinadditiontopre-scribers.HBHChasalreadyprescribedPrEPandevenparticipatedintheiPrExstudy,shesaid.
LastyearsheprescribedPEPtwicetoawomanwithanHIV-positivepartnerbeforetellingthepatientshemightbebetteroffonPrEP.It’sastrategythat’sbackedbyresearchshowingthatpeopletakingmultiplecoursesofPEPoftengoontobecomeinfected,becausetheyareatcontinuingriskforthevirus.
“Asanorganization,andformyselfasaprovider,wedefinitelysupportPrEP,”
saidKeglovitz.“It’sabigmilestoneforprevention.”
Shesaidthestrategyis“obviouslynotforeverybody,”andnotareplace-mentforcondoms.“Preventionmes-sageswillbecrucial,”shesaid.
WHAT NOW?TheFDAadvisorycommitteerecom-mendedthatPrEPbeapprovedforthreespecificriskgroups—menwhohavesexwithmen,HIV-negativepartnersofHIV-positivepeople,andothersathighriskofacquiringHIVthroughsex.Itnotedthat“regularHIVtesting,adherence,andbehavioralcounselingonsafersexprac-tices,includingcondomuse,areessen-tialcomponentsofhealthcaredeliveryaroundPrEP.”
AlladvocatesarebeatingthedrumforusingcondomsalongwithPrEP.WhetherPrEPusersoutintherealworlddoornotremainstobeseen.
Butwithalltheunknownssurround-ingPrEP,thereisperhapsonetruetake-homemessagefromstudiesandadvocatesalike:PrEPdoesn’tworkifyoudon’ttakeit.
SittingontheFDAadvisorycommit-teeandvotingtorecommendTruvadaPrEPforapproval,communityrepre-sentativeDanielRaymondoftheHarmReductionCoalitioninNewYorkCityelo-quentlyremindedeveryonethat,“Thisisthe25thanniversaryoftheAIDSCoalitiontoUnleashPower[ACTUP]andpartofthelegacyofthatmovementisempower-ingpatientsaboutlearningandmasteringthescienceandsharingitwithinourrespectivecommunities.IthinkthatPrEPgivesustheopportunitytodothatalloveragain…justasresponsiblyaswe’vebeentryingtodoforthelast25years.”
Clearly,communityawarenessisascrucialasever.
SPECIAL THANKS TO DR. JOEL
GALLANT ofJohnsHopkinsUniversityforreviewingthisarticleandsidebar.
They’re actually not as risky as you might thinkBY ENID VÁZQUEZ
LEATHER, PORN, AND KINK
WHILEHIVPRE-
ventionintheU.S.focusesonmenwho
havesexwithmen(MSM),it’sclearthatanyonecanpickupHIV.Hence,precautionsaretakenincertaincommunitiesthatrevolvearoundsexualactivity.
ADULT FILMSOnJanuary17,2012,LosAngelesMayorAntonioVillaraigosasignedanordinancestatingthatadultfilmactorsworkingwithinLosAngelesmustwearcondoms.California’soccupationalsafetyandhealth
“It’s an historic moment in HIV prevention and there’s a lot of work to be done in learning
how to use this new prevention tool.”
POSITIVELYAWARE.COM JULY+AUGUST 2012 39
agencyalreadyhasrulesstatingthatpornperformersmustwearcondomsduringfilming.
“Since2004,nobodyhascontractedHIVonset,”saysDianeDuke,executivedirectoroftheFreeSpeechCoalition(FSC),locatedinsouthernCalifornia.FSCoverseeshealthandsafetyservicesfortheadultfilmindustry.Dukesaidthereareapproximately1,000performersfilmingeachyearandthefactis,condom-freepornsellsbest.
“We’vedevelopedabloodworkpatho-genplanthatwebelieveisveryeffectiveinprotectingthehealthoftheperform-ers,”shesaid,“andtheysupportit.”
Beforefilmingbegins,performersmusthaveacertificateofresultsfromarecent(thatweek)PCRRNA(HIVviralload)test,
whichcanfindactualHIVinthebloodwithin9to11daysafterexposure.TheymustalsotestmonthlyforgonorrheaandChlamydia,andyearlyforsyphilis.
TheLosAngelesCountyDepartmentofPublicHealthreportedin2010thatfourcasesofHIVhaveoccurredsince2004inthepornindustryduringproduction.DukepointstoarecentLosAngelesCountyreportlookingatHIVriskfactorsandhowtomanagethem.Notonceinthe162-pagereportdoesitrefertotheindustry.
LEATHERTheleathercommunity,whichfocusesonS/Msexuality,doesnotnecessarilyrevolvearoundsexualintercourse.
GregoryBearAbbott,agayleathermanformorethan20years,says,“Weplay.
Thatdoesn’tmeansomebodygetspen-etrated.Itusuallymeanssomebodygetsmarkedup[whipped,flogged,etc.].”
Hesaidhewas“veryimpressed”withtheevidenceofsafersexhesawinMayattheClevelandLeatherAwarenessWeekend(CLAW).Ontheotherhand,he’sheardthephrase“ifyou’reundetectable,you’reuncatchable.”
“I’msorry,butundetectablemeans50copies[ofHIVpermLofblood].Thatcouldmeantherewerestill49.You’restillatrisk,”hesaid.Hepointstootherinfec-tions,likegonorrheaandsyphilis,thatcanbeacquiredwhennotusingacondomandarerampantinthegaymalecommunity.
Hesaidthere’salsosomeknowledgeofTruvadaPrEP,butmisinformationaroundit,too.HeoverheardoneyoungmanatCLAWsayhehadjustgonethroughallofhiscondoms,“butI’vegotTruvadaupstairs,soI’mokay.”
“Isaidno,no,no,”saidSirBear.“Igavehimmorecondomsandhekissedmeonthecheekandsaid,‘Thankyoufortakingcareofme.’“
KINKLikeleathergroups,communitiesformedaroundsexualkinksdonotnecessarilyinvolvesexualintercourse.
Bruce,presidentofLeatherSINSintheChicagoarea,says,“Thesexualactisonlyabout25%ofwhatwedo.Sexisrarelyapartoffantasyandfetish.”
Intermsofsafety,Brucesays,“Sincewedealinriskallthetimeandsincesafetyissuchanimportantpartofwhatwedo,withallthephysiologicalstuffthatcanhappen,STIs[sexuallytransmittedinfec-tions]are,forsomepeople,justanotherofthemanyrisks.”
Perhapsthegreatestpromotionofsafersexandplaycomesthroughwhatisexplicitlydiscussedduringa“negotiation”beforeengaginginactivity.
“Partofitfocusesonphysicalhealth—anyphysicalconditionorinjurythatcouldbeexacerbated.Sodiscussionofblood-bornepathogenscomeseasilytous,”saidBruce.
SirBearsaidthatintwoyearsoffreeHIVtestingatKinkyKollege,runbyLeatherSINS,nearlyeverypersonattheeventwastested.
NotonewasHIV-positive.
They’re actually not as risky as you might thinkBY ENID VÁZQUEZ
LEATHER, PORN, AND KINKPHOTO © FERRAN TRAITE SOLER
www.egrifta.com
Actual patient living with HIV since 2000
HIV-RELATED EXCESS BELLY FAT.YOU’VE WORKED TO CONTROL YOUR HIV. NOW, TIME TO WORK ON YOUR
Important Risk InformationDo not use EGRIFTA® if you:• Have pituitary gland tumor, pituitary gland surgery, or other problems related to your pituitary gland
• Have active cancer (either newly diagnosed or recurrent) or arereceiving treatment for cancer
• Are allergic to tesamorelin or any of the ingredients in EGRIFTA®, including mannitol or sterile water
• Are pregnant or become pregnant
Before using EGRIFTA®, tell your healthcare provider if you:• Have or have had cancer• Have diabetes• Are breastfeeding or plan to breastfeed• Have kidney or liver problems• Have any other medical condition• Take prescription or non-prescription medicines, vitamins, or herbal supplements
EGRIFTA® may cause serious side effects, including:• Serious allergic reaction. Stop using EGRIFTA® and get emergencyhelp right away if you have any of the following symptoms: rash overyour body, hives, swelling of your face or throat, shortness of breath or trouble breathing, fast heartbeat, feeling of faintness or fainting
• Swelling (fl uid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome)
• Increase in glucose (blood sugar) intolerance and diabetes
• Injection-site reactions, such as redness, itching, pain, irritation, bleeding, rash, and swelling. Change (rotate) your injection site to help lower your risk for injection-site reactions
The most common side effects of EGRIFTA® include:• joint pain • numbness and pricking• pain in legs and arms • nausea• swelling in your legs • vomiting• muscle soreness • rash• tingling • itching
EGRIFTA® will NOT cure HIV or lower your chance of passing HIV to others.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Consumer Brief Summary of EGRIFTA® on following page.
Ask your healthcare provider if EGRIFTA®, the � rst and only FDA-approved medicine for HIV-related excess belly fat, may be right for you. For more information, visit www.egrifta.com or call theAXIS Center at 1-877-714-AXIS (2947).
120127-102148 2/12
Indication:EGRIFTA® is a daily injectable prescription medicine to reduce the excess abdominal fat in HIV-infected patients with lipodystrophy.
Limitations of use:• The impact and safety of EGRIFTA® on cardiovascular health has not been studied• EGRIFTA® is not indicated for weight-loss management • It’s not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications• EGRIFTA® is not recommended to be used in children
In two separate clinical trials of HIV-infected people with lipodystrophy, each lasting 6 months, EGRIFTA® (tesamorelin for injection) reduced HIV-related excess belly fat by an average of 18% in the � rst trial, and 14% in the second trial. This reduction in excess belly fat resulted in an approximate 1-inch reduction in waist size. Individual results may vary. On average, patients on EGRIFTA® did not lose weight.
Like HIV, HIV-related excess belly fat is a chronic condition. In clinical studies:• People who used EGRIFTA® continuously for 1 year maintained their results over this time period • People who stopped taking EGRIFTA® after 6 months had their HIV-related excess belly fat come back
EGRIFTA® is believed to work with your own body to produce natural growth hormone to reduce your excess belly fat.
FILE NAME
DATE
CLIENT
PART #
DESCRIPTION
SPECS
MECH. BUILT TO
PRINTED AT
COLOR INFO
0053_EGR_AD_SPD_PA_May_August_M3.indd03.30.12
Egrifta
Print AdPositively Aware - Spread
Trim: 16 x 10.5”Bleed: 16.5 x 11”Safety: 15 x 9.5”Gutter: 1”Colors: 4C, CMYK
100%
100%
120127-102148
B:11 in
B:16.5 in
T:10.5 in
T:16 in
S:9.5 in
S:15 in
www.egrifta.com
Actual patient living with HIV since 2000
HIV-RELATED EXCESS BELLY FAT.YOU’VE WORKED TO CONTROL YOUR HIV. NOW, TIME TO WORK ON YOUR
Important Risk InformationDo not use EGRIFTA® if you:• Have pituitary gland tumor, pituitary gland surgery, or other problems related to your pituitary gland
• Have active cancer (either newly diagnosed or recurrent) or arereceiving treatment for cancer
• Are allergic to tesamorelin or any of the ingredients in EGRIFTA®, including mannitol or sterile water
• Are pregnant or become pregnant
Before using EGRIFTA®, tell your healthcare provider if you:• Have or have had cancer• Have diabetes• Are breastfeeding or plan to breastfeed• Have kidney or liver problems• Have any other medical condition• Take prescription or non-prescription medicines, vitamins, or herbal supplements
EGRIFTA® may cause serious side effects, including:• Serious allergic reaction. Stop using EGRIFTA® and get emergencyhelp right away if you have any of the following symptoms: rash overyour body, hives, swelling of your face or throat, shortness of breath or trouble breathing, fast heartbeat, feeling of faintness or fainting
• Swelling (fl uid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome)
• Increase in glucose (blood sugar) intolerance and diabetes
• Injection-site reactions, such as redness, itching, pain, irritation, bleeding, rash, and swelling. Change (rotate) your injection site to help lower your risk for injection-site reactions
The most common side effects of EGRIFTA® include:• joint pain • numbness and pricking• pain in legs and arms • nausea• swelling in your legs • vomiting• muscle soreness • rash• tingling • itching
EGRIFTA® will NOT cure HIV or lower your chance of passing HIV to others.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Consumer Brief Summary of EGRIFTA® on following page.
Ask your healthcare provider if EGRIFTA®, the � rst and only FDA-approved medicine for HIV-related excess belly fat, may be right for you. For more information, visit www.egrifta.com or call theAXIS Center at 1-877-714-AXIS (2947).
120127-102148 2/12
Indication:EGRIFTA® is a daily injectable prescription medicine to reduce the excess abdominal fat in HIV-infected patients with lipodystrophy.
Limitations of use:• The impact and safety of EGRIFTA® on cardiovascular health has not been studied• EGRIFTA® is not indicated for weight-loss management • It’s not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications• EGRIFTA® is not recommended to be used in children
In two separate clinical trials of HIV-infected people with lipodystrophy, each lasting 6 months, EGRIFTA® (tesamorelin for injection) reduced HIV-related excess belly fat by an average of 18% in the � rst trial, and 14% in the second trial. This reduction in excess belly fat resulted in an approximate 1-inch reduction in waist size. Individual results may vary. On average, patients on EGRIFTA® did not lose weight.
Like HIV, HIV-related excess belly fat is a chronic condition. In clinical studies:• People who used EGRIFTA® continuously for 1 year maintained their results over this time period • People who stopped taking EGRIFTA® after 6 months had their HIV-related excess belly fat come back
EGRIFTA® is believed to work with your own body to produce natural growth hormone to reduce your excess belly fat.
FILE NAME
DATE
CLIENT
PART #
DESCRIPTION
SPECS
MECH. BUILT TO
PRINTED AT
COLOR INFO
0053_EGR_AD_SPD_PA_May_August_M3.indd03.30.12
Egrifta
Print AdPositively Aware - Spread
Trim: 16 x 10.5”Bleed: 16.5 x 11”Safety: 15 x 9.5”Gutter: 1”Colors: 4C, CMYK
100%
100%
120127-102148
B:11 in
B:16.5 in
T:10.5 in
T:16 in
S:9.5 in
S:15 in
FILE NAME
DATE
CLIENT
PART #
DESCRIPTION
SPECS
MECH. BUILT TO
PRINTED AT
COLOR INFO
0053_EGR_AD_PI_PA_May_August_M1.indd
03.27.12
EMD Serono
Print AdPositively Aware - PI Page
Trim: 8 x 10.5”Safety: 7 x 9.5”
100%
100%
CMYK
EGRIFTA® (eh-GRIF-tuh) (tesamorelin for injection) for subcutaneous use
Read the Patient Information that comes with EGRIFTA® before you start to take it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is EGRIFTA®?• EGRIFTA® is an injectable prescription medicine to reduce the excess in abdominal
fat in HIV-infected patients with lipodystrophy. EGRIFTA® contains a growth hormone-releasing factor (GRF)
• The impact and safety of EGRIFTA® on cardiovascular health has not been studied• EGRIFTA® is not indicated for weight-loss management• It is not known whether taking EGRIFTA® helps improve compliance with
antiretroviral medications• It is not known if EGRIFTA® is safe and effective in children. EGRIFTA® is not
recommended to be used in children
Who should not use EGRIFTA®?Do not use EGRIFTA® if you:• have pituitary gland tumor, pituitary gland surgery, or other problems related to your
pituitary gland• have active cancer (either newly diagnosed or recurrent) or are receiving treatment
for cancer• are allergic to tesamorelin or any of the ingredients in EGRIFTA®. See the end of this
leaflet for a complete list of ingredients in EGRIFTA®
• are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA® and talk with your healthcare provider. See “What should I tell my healthcare provider before using EGRIFTA®?”
What should I tell my healthcare provider before using EGRIFTA®?Before using EGRIFTA®, tell your healthcare provider if you:
• have or have had cancer• have diabetes• are breastfeeding or plan to breastfeed. It is not known if EGRIFTA® passes into your
breast milk. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking EGRIFTA®
• have kidney or liver problems• have any other medical condition
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. EGRIFTA® may affect the way other medicines work, and other medicines may affect how EGRIFTA® works. Know the medicines you take. Keep a list with you to show your healthcare provider and pharmacist when you get a new medicine.
How should I use EGRIFTA®?
• Read the detailed “Instructions for Use” that comes with EGRIFTA® before you start using EGRIFTA®. Your healthcare provider will show you how to inject EGRIFTA®
• Use EGRIFTA® exactly as prescribed by your healthcare provider• Inject EGRIFTA® under the skin (subcutaneously) of your stomach area (abdomen)• Change (rotate) the injection site on your stomach area (abdomen) with each dose.
Do not inject EGRIFTA® into scar tissue, bruises, or your navel• Do not share needles or syringes with other people. Sharing of needles can result in
the transmission of infectious diseases, such as HIV
What are the possible side effects of EGRIFTA®?EGRIFTA® may cause serious side effects including:
• Serious allergic reaction. Some people taking EGRIFTA® may have an allergic reaction. Stop using EGRIFTA® and get emergency help right away if you have any of the following symptoms:– a rash over your body
– hives – swelling of your face or throat – shortness of breath or trouble breathing – fast heartbeat – feeling of faintness or fainting
• Swelling (fluid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome)
• Increase in glucose (blood sugar) intolerance and diabetes. Your healthcare provider will measure your blood sugar periodically
• Injection-site reactions. Change (rotate) your injection site to help lower your risk for injection-site reactions. Call your healthcare provider for medical advice if you have the following symptoms around the area of the injection site:
– redness – itching – pain – irritation
The most common side effects of EGRIFTA® include: – joint pain – pain in legs and arms – swelling in your legs – muscle soreness – tingling, numbness, and pricking
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of EGRIFTA®. For more information, ask your healthcare provider or pharmacist.Call your healthcare provider for medical advice about side effects. To report side effects, contact EMD Serono toll-free at 1-800-283-8088, ext. 5563. You may report side effects to the FDA at 1-800-FDA-1088.
Keep EGRIFTA® and all medicines out of the reach of children.
General information about the safe and effective use of EGRIFTA®:Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EGRIFTA® for a condition for which it was not prescribed.
Do not give EGRIFTA® to other people, even if they have the same symptoms you have. It may harm them.Do not share your EGRIFTA® syringe with another person, even if the needle is changed. Do not share your EGRIFTA® needles with another person.
This Patient Information leaflet summarizes the most important information about EGRIFTA®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about EGRIFTA® that is written for healthcare professionals.
For more information about EGRIFTA®, go to www.EGRIFTA.com or contact the AXIS Center toll-free at 1-877-714-2947.
What are the ingredients in EGRIFTA®?Active ingredient: tesamorelinInactive ingredients: mannitol and Sterile Water for Injection
– bleeding– rash– swelling
– nausea– vomiting– rash– itching
© 2012 EMD Serono, Inc. 120120-161843 2/12 All rights reserved. EGRIFTA® is a registered trademark of Theratechnologies Inc.Distributed by EMD Serono, Inc., Rockland, MA 02370
Consumer Brief Summary for EGRIFTA® (tesamorelin for injection)
T:10.5 in
T:8 in
S:9.5 in
S:7 in
Auditorium Theatre of Roosevelt University, 50 East Congress Parkway, ChicagoFor more information or to purchase tickets call 312.922.5812 or visit danceforlifechicago.comBenefiting: AIDS Foundation of Chicago, the Dancers’ Fund and Chicago Women’s AIDS ProjectPerformances by: Giordano Jazz Dance Chicago, Hubbard Street Dance Chicago, The Joffrey Bal le t , Luna Negra Dance Theater, River North Dance Chicago, Ron de Jesus Dance World Premieres by: Harrison McEldowney and Randy Duncan
Media Sponsors:
BestGayChicago.com, Chicago Magazine, ChicagoPride.com, SeeChicagoDance.com, GRAB Magazine, PINK Magazine, Positively Aware Magazine, Viral PR Agency
Dancer: Lizzie MacKenzie - Photography: Sandro - Design: Rutger Thiellier & Brian Jones
SATURDAY, AUGUST 18, 2012
Presenting Sponsor: Sponsors:
44 JULY+AUGUST 2012 POSITIVELYAWARE.COM
SEARCH
FOR AN HIV
SPECIALIST™
Finding an HIV Specialist™ is easy with AAHIVM’s Referral Link: www.aahivm.org. Enter your ZIP code on the home page, and click on the “Go” button for a list of HIV Specialists™ near you.
undetectable,shouldIgettestedregularly?Goingfortestingfreaksmeout.Ihavenotbeentestedsincethreemonthsafterhisdiagnosis,whichwasthreeyearsago.
A: YOU BRING UP SEVERAL
importantissuesthatshouldbeaddressed.Mutualmasturbationistypicallyanexcellentwaytohave
safesexwithanHIV-positivepartner,asareoraloranalsexwithappropriatelyusedcondoms.Inaddition,thebestwaytopreventHIVtransmission,asshownbytherecentstudyincoupleswhereoneispositiveandtheotherisn’t(sero-discordant),isfortheHIV-positivepartnertohaveanundetectableviralloadonconsistentantiretroviraltherapy.Althoughalmostall(97%)ofthecouplesinthisstudywereheterosexual,itisstillhelpfulinshowinghowdifficultitistotransmitHIVwhentheHIV-positivepartneristakingHIVtherapy.
SoistherestillariskofHIVtransmissionwhenyourpartnerhasanundetectableviralloadonmedications?Theanswerisyes,sinceviralparticleshavestillbeendetectedinthesemenofmenwhohaveanundetect-ableviralloadintheirblood.Thisisbecausethesemenisoneoftheso-called“sanctuarysites”whereHIVcancontinuetoreplicate,sincemanyoftheHIVmedicationsweusetodayarenotabletogetintothesemen.
ThisbringsustoyourfirstquestionregardingtheriskoftransmissionofHIVfromthesemenofapart-nerwithanundetectableviralloadtoyouthroughanopencutinyourhand.Theriskoftransmissionthroughanopencutdependsonthetypeanddepthofyourwound:asuperficialwoundwithascabwouldbeextremelyunlikelytoallowHIVtransmission,while
anopenwoundwithvisiblebleedingorexposeddeepertissuewouldputyouathigherrisk.Sincethisdoesn’tsoundlikeahigh-riskexposure,andyourpartnerhadanundetectableviralload,theriskofinfectioninyourcaseislikelyslimtononeandIdonotthinkthattakinga28-daycourseofpost-exposureprophylaxisiswarranted.Ifthecutwasonthedeeper
sideorifyourpartner’sviralloadmayhavebeendetectable,post-exposureprophylaxismighthavebeenprudent,butitwouldhaveneededtobeadministeredwithin72hoursofexposure.
Asforyoursecondquestion:inmyexperienceasaphysician,patientsoftenreportbeinginmonogamousrelationshipsandthenfindoutlaterthattheirpartnerwasnotbeingasmonogamousastheywere.Inaddi-tion,yourpartnermaybelievethathisviralloadisundetectable,buthemaynotknowifhisviralloadcreptupsincehislastcheck-upseveralmonthsprior(althoughthechanceofthishappeningifheis100%adherenttohisantiretroviraltherapyisextremelylow).Whilethepossibilityofinfidelityisneverfuntoconsid-er,figuringoutyourlevelofriskisonlyasgoodastheinformationyouhave!Therefore,ingeneral,allpartnersofHIV-positiveindividualsshouldbetestedforHIVatleastannually,andthoseathigherriskofacquiringHIV(thosewithmultiplepartners,thosewhoshareneedlesforIVdruguse,thosewhoseHIV-positivepartnershavedetectableviralloads,etc.)shouldbetestedmorefrequently.Thatsaid,mutualmasturbationasthesoleformofsexualactivity,inthesettingofanundetectableviralload,confersalmostnoriskoftransmission.
Insummary,youandyourpartneraretobecom-mendedforyoursafesexpracticesandyourpartner’sexcellentvirologiccontrol.YourriskofhavingacquiredHIVfromtheexposureyoudescribeisvirtuallynonexis-tent,butitneverhurtstogettestedforpeaceofmind,andonaregularbasisasahealthyhabit.Infact,theCDCrecommendsthatalladults,regardlessofrisk,betestedforHIVinallhealthcaresettings.
How safe is safe?
ASK THE HIV SPECIALISTHELEN C. KOENIG, MD, MPH
Q: I AM IN A RELATIONSHIP WITH AN
HIV-positivemanwithanundetectableviralload.Iamnegative.Werefrainfrom
oralandanalsex.LastnightwhilemasturbatingsomeofhissemengotonmyhandandIhadanopencut.Ihavenotbeenabletosleep.
Sinceweareinamonogamousrelationshipandheis
P O S I T I V E LYAWA R E . C O M M AY + J U N E 2 0 1 2 | 45
If we compare ourselves to society’s or someone else’s standard of success, how can we ever feel successful? Really, com-paratively few become extensively rich or hugely famous.
‘It is so strange the way things turn’—PeterGabriel,Don’t Give Up
Ifwecompareourselvestosociety’sorsomeoneelse’sstandardofsuccess,howcanweeverfeelsuc-cessful?Really,comparativelyfewbecomeextensivelyrichorhugelyfamous.Andcertainly,domostofthosewhoarefamousdeservesuchaccolades?SnookieofJerseyShore?TheKardashians?Oh,wherearethedivasofyesteryear,theGaborsistersforexample,whowerefamoussimplybybeingsoenchantinglyfabulous?
ConsiderhowdifferentlivingwithAIDSisfromthoseterrifyingearlydays.IfyouwerediagnosedwithAIDSinthe’80s,yourlifeexpectancydwindledtotwoyears.IprogressedtoAIDSin1995,yetstillwalktheearth.Thataloneisasuccess,butcertainly,itwasnotabattlewonwithoutitschallenges.Beforeyoucanachievesuccess,definewhatsuccessmeanstoyou.Isitalovingpart-ner?Enoughfinancialresourcestoenableyoutotravel?Orisitgettingthroughthedaybeingadherenttoyourmedicationregimen?Yoursuccessesarepersonal.Furthermore,successdoesn’tmatterifitdoesn’tmakeyouhappyorfulfilled.Isthebillionairewhoyearnsforameaningfulrelationshipsuccessful?
WhatofmyfriendPattywhowasateenagemotherandahighschooldropoutwhoraisedherchildbrilliant-lyandwhocurrentlyownsahome,hasagreatcareer,isinastrongmarriageandwhosedaughterrecentlyearnedhermaster’sdegree?
OrmybuddyTim,wholosthiswifeinahorriblecaraccidentnotlongaftertheyweremarried,whohasdealtwiththatloss,andhasopenedhisheartoncemoretolove?
Ormymotherwho,whendiagnosedwithemphy-sema,immediatelyquitsmokingandtwoyearslater,braveseachdaysolidly,armedwithoxygenandabat-teryofmedications.
Theyaresuccesses,all.IwenttohighschoolwithaguynamedJohnGreen.
Hehadgleaminggreeneyeswithflecksofgold,thick,unruly,darkbrowncurlsandwasthesmartest,mostcreativepersonIknew.Wewouldwalkhometogether
afterschoolandIwouldrevelinlisteningtohimspeakofhistoryonanysubject,anddescribemovieplotssowellandinthemost
exactingdetail,IfeltasifIwerethere.Inretrospect,IsuspecthemighthavehadavariationofAsperger’ssyndrome.Brilliant,almostanidiotsavant,withfewsocialskills.Ofcourse,hewasteasedmercilesslyforhisoddnessandhiscreativedreaminess.Hisnickname,muchtohischagrin,was“Ancient Green.”Ifoundittobequiteaptandsomewhatromantic.Johnwashappi-estreadingaboutancientcultures,dreamingofwhatitmusthavebeenliketolivewithinthem,andwritingbeautifulpoetryaboutthem.Iwasdeeplyinaweandlovedhim—notsexually,butrather,spiritually,intellec-tually,andemotionally.
Wedriftedapartafterhighschool.Istruggledthroughself-examination,alcoholism,testingHIV-positive,anddebilitatingillness.Today,Iamgratefultohavegoodhealth,awonderfulhome,supportivefriends,andmanyinmyfamilywhomIholddear.Nottomentionthebestdogintheworld.
About10yearsago,onmywaytothebiketrackalongthelake,Istoppedatatrafficlight.Astreetper-sonstoodnearmewaitingtocross.Hewasfilthy,withmattedhair,wearingatornparka.Hestooddreamilylookingupatthesky.Irecognizedhimbyhiseyes,thosesparklinggreen,flecked-with-goldwonders.ItwasJohn.ItoldhimwhoIwasandaskedifheremem-beredme.Hetorehimselffromhisreverie,lookedatmeandmumbled“Uh,yeah.”Thetrafficlightchangedandhehurriedtocrossthestreet.
Sincethen,Ispothimoccasionally,shufflingalongdreamilyintheparkasItearalongonmybike.Sure,heendedupfilthy,halfcrazy,andhomeless.Butallheeverwantedwastobeleftalonetodreamhisdreams.
Sowhoisthesuccess?IsheoramI?
Success is peace of mind, which is a direct result of self-satisfaction in knowing you made the effort to become the best you are capable of becoming.
— JOHN WOODEN
SALIENT RAMBLINGSSAL IACOPELLI
WE ARE CONDITIONED TO THINK OF “SUCCESS” IN TERMS OFwealth,ofaccumulationofpropertyandobjects,orofextensivepower.Thesearerathereasytoachievewhenbornintoaffluentorinfluentialcircumstances.Whataboutmostoftherestofus?
A MESSAGE FROM YOUR IMMUNE SYSTEM
©2012 Gilead Sciences, Inc. All rights reserved. UN13259 06/12
Starting treatment early may help you live a longer, healthier life. Treatment guidelines issued by the US Department of Health and Human Services (DHHS) recommend
starting HIV medicines for all people with HIV, regardless of their CD4 count. Talk with your healthcare
provider about your treatment options and all the factors you need to consider before starting
HIV medicines. For more information, call toll-free 1-888-447-1728 or visit TREATHIVNOW.COM.