the challenge of starting haart in corrections ernesto j. lamadrid, md, aahivs florida/caribbean...
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THE CHALLENGE OF THE CHALLENGE OF STARTING HAART IN STARTING HAART IN
CORRECTIONSCORRECTIONS
Ernesto J. Lamadrid, MD, AAHIVS
Florida/Caribbean AETC
August 11, 2007
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Disclosure of Financial Relationships
This speaker has no significant financial relationships with commercial entities to disclose.
This slide set has been peer-reviewed to ensure that there are no conflicts of interest represented in the presentation.
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Adults and children estimated to be living with HIV, 2005
Total: 38.6 (33.4 – 46.0) million
Western & Central Europe
720 000720 000[550 000 – 950 000][550 000 – 950 000]
North Africa & Middle East
440 000440 000[250 000 – 720 000][250 000 – 720 000]Sub-Saharan Africa
24.5 million24.5 million[21.6 – 27.4 million][21.6 – 27.4 million]
Eastern Europe & Central Asia
1.5 million1.5 million [1.0 – 2.3 million][1.0 – 2.3 million]
South & South-East Asia
7.6 million7.6 million[5.1 – 11.7 million][5.1 – 11.7 million]Oceania
78 00078 000[48 000 – 170 000][48 000 – 170 000]
North America1.3 million1.3 million
[770 000 – 2.1 million][770 000 – 2.1 million]
Caribbean330 000330 000
[240 000 – 420 000][240 000 – 420 000]
Latin America1.6 million1.6 million
[1.2 – 2.4 million][1.2 – 2.4 million]
East Asia680 000680 000
[420 000 – 1.1 million][420 000 – 1.1 million]
UNAIDS
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Incarceration and HIV/AIDSIncarceration and HIV/AIDS• Incarcerated in USA
– 1,310,710 in state and federal prison
• Prevalence of HIV
– 2.2% of state prison inmates
– 3.6% of female state prison inmates
– 1997: 20% to 26% of people living with HIV in the USA passed through a correctional facility
• Prevalence of AIDS
– 0.6% of state inmates
– 0.2% of federal inmates
– Overall rate of AIDS among prison inmates 4x that in the general population
Maruschak LM. Bureau of Justice Statistics Bulletin. 2000. NCJ 196023.Hammett TM, et al. Am J Public Health. 2002;92:1789-1794.
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US HIV Data:Prisons and General Population
• State and federal prisons (2004)– HIV prevalence among
the prison population was 4 to 5 times that of the general population
– 1.8% of inmates known to be HIV positive (n=23,046*)
• Males: 1.7% (n=20,668†) • Females: 2.4% (n=2084†)
Maruschak LM. Bur Justice Stat Bull. November 2006.Available at: http://www.ojp.usdoj.gov/bjs/abstract/hivp04.htm.
0
0.5
1
1.5
2
2.5
3HIV Prevalence
Pre
vale
nce
(%
)
All Prisoners(State and Federal)
98 99 00 01 02 03 04
General Population
*Estimated.†Reported. Year
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Identified HIV Infection:Distribution by Jurisdiction (2004)
Maruschak LM. Bur Justice Stat Bull. November 2006.Available at: http://www.ojp.usdoj.gov/bjs/abstract/hivp04.htm.
19.5%New York
(n=4500)
14.1%Florida(n=3250)
10.4%Texas(n=2405)
California (n=1212)
Georgia(n=1109)
45.9%45.9%Other State and Federal PrisonsOther State and Federal Prisons
(n=10,570)(n=10,570)
5.3%
4.8%
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US AIDS Data:Prisons and General Population
• State and federal prisons (2004)– Overall rate of
confirmed AIDS among the prison population was >3 times that of the general population
• Inmates: 0.5%• General population:
0.15%
Maruschak LM. Bur Justice Stat Bull. November 2006.Available at: http://www.ojp.usdoj.gov/bjs/abstract/hivp04.htm.
0
10
20
30
40
50
60
70Confirmed AIDS Cases
Cas
es p
er 1
0,00
0 All Prisoners(State and Federal)
93 94 95 96 97 98 99 00 01 02 03 04
General Population
Year
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Why Care About the Healthof Inmates?
• Those who have been incarcerated– 25% of HIV-infected Americans– 33% of Americans infected with hepatitis C virus
(HCV)– 40% of Americans with active tuberculosis
• Among inmates– Up to 50% have axis 1 or 2 mental disorders– As many as 75% have alcohol and/or other substance
abuse disorders
Hammett TM, et al. Am J Public Health. 2002;92:1789-1794.
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Why Are Correctional Institutions Important Targets for Intervention?
HIV-infected persons are frequently diagnosed HIV-infected persons are frequently diagnosed and initiate antiretroviral therapy in prisonand initiate antiretroviral therapy in prison
Prison68%
Other settingOther setting32%32%
Mostashari F, et al. JAIDS. 1998;18:341-348.
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Virologic and Immunologic Outcomes Among HIV-Infected Recidivists
-0.5
-0.3
-0.1
0.1
0.3
0.5
0.7
0.9
1.1
1.3
1.5
Ch
ang
e (l
og
10 c
op
ies/
mL
)
-0.03
HIV RNA Change
Stephenson BL, et al. Public Health Rep. 2005;120:84:88.
+1.29*
IncarceratedPrisoners
(n=30)
Re-IncarceratedPrisoners
(n=15)
0
100
200
300
400
500
600
CD
4 C
ell C
ou
nt
(cel
ls/m
m3 )
446
CD4 Cell Counts
224
IncarceratedPrisoners
(n=30)
Re-IncarceratedPrisoners
(n=15)
Baseline2.60
Baseline2.91
554*
157†
BaselineEnd of study
*P=0.003†P=0.013
*P=0.018
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Only the Incarcerated Have a Legal Right to Healthcare
• “The public be required to care for the prisoner who cannot by reason of the deprivation of his liberty, care for himself.”– Spicer vs Williams 191 NC 1926
• Deliberate indifference to serious medical needs of the prisoners is a violation of the 8th amendment– Supreme Court 1976
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Comorbid Conditionsin the Incarcerated Population
• Mental illness• Substance abuse• Tuberculosis• STDs• Hepatitis, especially HCV
– 1.3 to 1.4 million inmates are HCV+– Prevalence of HCV in inmates 10x that of US
population– Incarcerated women have a higher rate of HCV than
incarcerated menDeGroot A. HEPP News. April 2001; Baillargeon J, et al. Public Health. 2003;117:43-48.
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Opportunities for HIV Carein Corrections
• Large reservoir of people living with HIV• Structured environment with universal
access to healthcare• Important site for initiating health promotion• Improved health in the community post-
release• Decreased transmission of HIV
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Challenges to HIV Carein Corrections
• Lack of HIV specialists, integrated delivery systems, community standard practices
• Remote locations • Continuity of care • Mistrust and stigma• Language/cultural barriers• Restricted formularies• Confidentiality/privacy
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Considerations for Managementof HIV in Correctional Settings
• Educating patients about HIV, antiretroviral therapy, and adherence
• Initiating treatment– When to start– What regimen to use
• Simplicity, dosing, frequency, side effect profile, drug interactions
• Planning for continuity of care from the outset
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Antiretroviral Therapyin Correctional Settings
• Structured setting• Equal access to care• Availability of ART• Possible DOT
• Court runs• Transfers• Strip searches• Potential breach of
confidentiality• “Unstructured” DOT presence of mental
illness
AdvantagesAdvantages DisadvantagesDisadvantages
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Selection of Antiretroviral Regimens for the Incarcerated
Patient
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Factors to Consider When Selectingan Initial Antiretroviral Regimen
• Viral load and CD4 count• Primary resistance• Potency• Adherence potential• Tolerability/toxicities• Convenience • Future options• Drug interactions• Comorbidities
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Special Considerations for Initiating ART in Correctional Settings
• Adequate length of stay to assess initial tolerability and response
• Availability of therapy at intake• Timely renewal of medications• Organization of medication dispensation• Adequate discharge medications• Linkage to community providers
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Considerations in Talking to Your Patients About Starting ART
• Essential part of the patient-provider relationship– Provide patient with an understanding of
possible side effects– Acknowledge that starting ART can be difficult– Provide a mechanism of support – Explain the importance of adherence and the
potential for developing resistance
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Probability of Survival by CD4 Countand Viral Load Stratification
Viral Load (copies/mL)Viral Load (copies/mL)
Hogg RS, et al. JAMA. 2001;286:2568-2577.
0
20
40
60
80
100
0 6 12 18 240 6 12 18 24
Pro
bab
ility
of
Su
rviv
al (
%)
Pro
bab
ility
of
Su
rviv
al (
%)
CD4 Cell Count (cells/mmCD4 Cell Count (cells/mm33))
Time to Start of ART (Months)
Low: <50 (n=142)Low: <50 (n=142)Intermediate: Intermediate: >>50-199 (n=301)50-199 (n=301)High High >>200 (n=776)200 (n=776)
0
20
40
60
80
100
0 6 12 18 0 6 12 18 2424
Pro
bab
ility
of
Su
rviv
al (
%)
Pro
bab
ility
of
Su
rviv
al (
%)
Time to Start of ART (Months)
Low: <50,000 (n=356)Low: <50,000 (n=356)Intermediate: Intermediate: >>50,000-199,99950,000-199,999High High >>200,000 (n=420)200,000 (n=420)
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Goals of Therapy and Tools to Achieve Goals of Therapy and Tools to Achieve ThemThem
GOALS Maximal and durable
suppression of viral load. Restoration or preservation of
immunologic function. Improvement in quality of life. Reduction of HIV-related
morbidity and mortality.
TOOLS Maximize adherence to the
antiretroviral regimen. Rational sequencing of drugs. Preservation of future
treatment options. Use of drug-resistance testing in
selected clinical
settings.
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Indications for the Initiation of Antiretroviral Therapy in the Chronically HIV-Infected
Patient: April 2007Clinical Category CD4 Cell Count Plasma HIV RNA Recommendation
Symptomatic Any value Any value Treat
Asymptomatic, AIDS
CD4<200 cells/mm3
Any value Treat
Asymptomatic CD4 >200 but <350 cells/mm3
Any value Treatment should generally be offered, but controversy exists.
Asymptomatic CD4 > 350 cells/mm3
>100,000 copies/mL
Some experts recommend initiating therapy.
Asymptomatic CD4 > 350 <100,000 copies/mL
Many experts defer therapy and observe.
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents 4/2007
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The Patient’s First HAARTThe Patient’s First HAART
Start when the patient (not the provider) is emotionally, psychologically and intellectually ready to start.
Explain the natural progression of HIV infection.
Explain the way the ARV’s work against the HIV.
Know the preferences and concerns of the patient.
Introduce the adequate ARV regimens according to her/his needs.
HAART IS NOT AN EMERGENCYHAART IS NOT AN EMERGENCY
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The Doctor’s First HAAARTThe Doctor’s First HAAART
Start with the best regimen for the patient:
Most tolerable.
Best chance for adherence.
Most adequate for the patient’s lifestyle and habits.
The most salvageable.
HAART IS NOT AN EMERGENCYHAART IS NOT AN EMERGENCY
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THE COMBO’S:WHAT TO START WITH?
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PRE-HAART RENAL PRE-HAART RENAL EVALUATIONEVALUATION
Always calculate creatinine clearance when considering ART. Use Caukroft-Gault or MDRD
Renal excretion. Serum creatinine IS NOT an
accurate marker of renal function.
Adjust the dose of Tenofovir if necessary.
DO NOT use Truvada or Atripla if Tenofovir requires dose adjustment.
Creatinine clearance=
(140-age) (Weight-kg)(72) (Serum
creatinine-mg/dL)
If female, multiply by 0.85
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Recommended Regimens forTreatment-Naïve Patients: DHHS 2006
Available at: www.aidsinfo.nih.gov/guidelines April 2007.
Column A Column B
NNRTI PI NRTI
Preferred(alphabetical order)
Efavirenz Atazanavir + Ritonavir
Fosamprenavir+
Ritonavir BID
Lopinavir+Ritonavir BID
Tenofovir/
emtricitabine
Zidovudine/
lamivudine
Alternative(alphabetical order)
Nevirapine Atazanavir unboosted
Fosamprenavir unboosted
Fosamprenavir+
Ritonavir QD
Lopinavir+Ritonavir QD
Abacavir/
lamivudine
Didanosine/ lamivudine
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Tenofovir + Emtricitabine + Efavirenz
AdvantagesOne pill QD
Proven efficacy
Improves adherence
Long term safety
Low incidence of lipoatrophy
No effect on bone density
Thoroughly studied
DisadvantagesNeuropsychiatric side effects: careful in psychiatric patients
Nephrotoxic
Pregnancy category D
Hypertriglyceridemia
1 pill
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Zidovudine + Lamivudine + Efavirenz
AdvantagesProven efficacy
Low pill burden
Thoroughly studied
DisadvantagesBID dosingNeuropsychiatric side effects: careful in psychiatric patientsBone marrow suppression: anemia, fatigue are common side effectsPregnancy category DHypertriglyceridemia
3 pills
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Tenofovir + Emtricitabine + Boosted Atazanavir
AdvantagesQDProven efficacyImproves adherenceLong term safetyLow incidence of lipoatrophyNo effect on bone densitySafe lipid profile
DisadvantagesHyperbilirubinemia/
jaundiceNephrolithiasis, rare. No hydration requirements.
3 pills
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Zidovudine + Lamivudine + Boosted Atazanavir
AdvantagesProven efficacy
Safe lipid profile
DisadvantagesBID dosingHyperbilirubinemia/
jaundiceNephrolithiasis, rare. No hydration requirements.Anemia, fatigueLipoatrophy
4 pills
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Tenofovir +Emtricitabine + Fosamprenavir 700/Ritonavir 100 BID
AdvantagesLow pill burden
Good lipid profile
Low incidence of long-term toxicities
DisadvantagesNephrotoxicity
BID dosing
GI side effects: nausea, vomiting, diarrhea
5 pills
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Zidovudine + Lamivudine + Fosamprenavir 100/Ritonavir 100 BID
Advantages• Low pill burden• Good lipid profile
Disadvantages• Anemia, fatigue• BID dosing• GI side effects
• Lipoatrophy secondary to ZDV6 pills
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Tenofovir +Emtricitabine + Lopinavir /Ritonavir BID
Advantages• Low pill burden• Proven efficacy in early
and advanced disease• Thoroughly
investigated• Sustained viral
suppression in studies over 5 years
Disadvantages• BID dosing• GI side effects• Nephrotoxicity• Hyperlipidemia• Lipodystrophy
5 pills
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Abacavir + Lamivudine
Advantages• QD• Good lipid profile• Low incidence of GI
side effects• Well tolerated
Disadvantages• Close monitoring in
patient with hepatic impairment
• Hypersensitivity reaction: • Fever, rash, malaise, flu-
like symptoms, chest pain in 1-6 weeks of initiating treatment
• Test for HLA-B*5701
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Case #1
• 32 y/o WM MSM, 2 year sentence, multiple disciplinary reports for not following orders.
• HIV infected since 1997, HAART naïve
• No IVDU, no ETOH abuse
• He wants to start ART with the “once a day pill”.
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Case #1 (cont.)
Labs:CBC: WBC=5,200 Hgb=15.2 g/dL Hct=40%Hepatitis Bs Ab (-), HBs Ag (-), HCV Ab (-)Creatinine clearance >60CD4=300 (25%) RNA=132,000Genotype: wild type
Would you recommend HAART?
What regimen would you choose?
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Case #2
• 45 y/o AAM, IVDU, promiscous unprotected sex, 10 year sentence, few DR’s.
• HIV infection diagnosed at reception center• He is unsure of initiating ART due to side
effects. “My friend died on AZT 15 years ago”.
• Asymptomatic• Smoker of 1-2 ppd
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Case #2 (cont.)
Labs:CBC: WBC=3,200 Hgb=13.4 g/dL Hct=32%HBsAb (+), HBsAg (-), HCV Ab (+)Creatinine clearance>60CD4=220 (18%) RNA=278, 000 Lipids: Total cholesterol 346 LDL=220
What’s the next step?
Genotype: NRTI: K103N PI: WT
What regimen would you choose?
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Case #3
• 29 y/o AAF, 3 year sentence for prostitution and drug possession, close management
• HIV infected since 2001 when tested for pregnancy
• She was treated with ZDV/3TC during pregnancy and stopped after delivery
• No IVDU
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Case #3 (cont.)
Labs:CBC: WBC=4,400 Hgb=9.8 g/dL Hct=23%HbsAb (-), HBsAg (+), HCV Ab (-)AST=45 ALT=68Creatinine clearance >60CD4=180 (10%) RNA=98,000
What’s the next step?
Genotype: WT
What regimen would you choose?
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SUMMARYSUMMARY
• Antiretroviral therapy is lifelong treatment• Should aim to select regimens with
– Good tolerability from the start to ensure adherence– Adequate long-term safety profiles to preserve
patients’ quality of life
• ARVs vary in type and degree of toxicities– We still need to be alert for appearance or
progression of long-term toxicities
• New ARVs have helped minimize the trade-off between efficacy and toxicity
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