HIV Prophylaxis: Following Occupational and Non-Occupational Exposure

Nanik (Nayri) HatsakorzianPharm.D./MPH candidate 2014Touro University, College of Pharmacy-CA

Quiz

Patient: Jane DoDOB: 09/09/59

Truvada Take 1 tab PO QD # 30

Refill: 6Doctor: Homer Simpson

DEA: J000999000(415)555-5555

What do you do?• A- call the MD office and ask about the rest of the regimen• B- call the MD office and demand an explanation for the refill

number • C- assume it is for Hep B treatment, so consult the patient

accordingly• D- Just fill as is, and consult the patient on adherence and

possible side effects of the drug• E- have an open communication with the patient during the

consultation• F- Shrug your shoulder and say “This crazy doctor sends weird

rx all the time”

PEP: For Occupational Exposure

Preferred Regimens and duration

• Truvada (TDF: 300 mg and FTC: 200 mg)• 1 tab QD for 4 weeks

• Combivir (ZDV: 300 mg and 3TC: 300 mg)• 1 tab BID for 4 weeks

• Other preferred regimens include:• ZDV: 300 mg BID and Emtricitabine 200 mg QD• TDF: 300 mg QD and Lamivudine 300mg QD (or 150

mg BID)

Preferred Expanded Regimen• Basic regimen plus:• Kaletra 400/100 mg BID

Alternative Expanded Regimen• Basic regimen plus: • Atazanavir (400 or 300 mg) +/- ritonavir OD • Efavirenz 600 mg QD (Combo with Truvada= Atripla)

PEP: Non-Occupational Exposure

Preferred Regimens and Duration• Atripla (TDF/FTC/EFV) for 4 weeks• or Efavirenz with lamivudine and zidovudine

Alternative Regimens and Duration• Atazanavir + lamivudine or emtricitabine + zidovudine or

stavudine or abacavir or didanosine or tenofovir (boosted with TDF)

Pre-Exposure Prophylaxis (PrEP)• On January 2011 and August 2012, FDA approved Truvada

once a day as pre-exposure prophylaxis for HIV prevention in MSM and among heterosexual serodiscordant couples and high risk HIV negative couples, respectively.

• CDC recommends clinicians to provide 90 days supply when initiating PreP, and renewable only after HIV negative test results.

• There has been no adverse effects in infants exposed to Truvada. However, couples using Truvada during attempts to conceive should be warned of possible adverse events.

iPrEX Study

• FDA has approved Truvada once a day as PrEP upon results from iPrEX study• A multinational, randomized, double-blind, placebo-controlled,

phase III clinical trial of daily oral Truvada to prevent acquisition of HIV infection among uninfected but exposed MSM

• iPrEX concluded that once-daily oral FTC–TDF provided a 44% additional protection from HIV among men or transgender women who have sex with men who also received a comprehensive package of prevention services.

• iPrEX also concluded poor adherence with higher risk of infection.

Further studies • TDF2• Phase III, randomized, double-blind, placebo-controlled clinical trial• TDF/FTC once daily, decreased the rate of HIV infection in heterosexual men

by 62.2% when it was administered as part of a comprehensive package of HIV-prevention services.

• FEM-PrEP• Randomized, double-blind, placebo-controlled trial with the primary

objective of assessing effectiveness of TDF–FTC in preventing HIV acquisition and evaluate safety.

• The study was stopped early due to lack of efficacy• Good example of failure due to lack of adherence

• CDC 4370 (Bangkok TDF study) • Phase III, randomized, double-blind, placebo-controlled, HIV pre-exposure

prophylaxis trial of daily oral tenofovir. • Trial results will demonstrate whether or not daily oral tenofovir reduces the

risk of HIV infection among IDUs

Answer• This prescription is written as PrEX. Pharmacist has to consult

accordingly with emphasis on the importance of the adherence

As pharmacists• It is very important to differentiate types of HIV prescriptions

received at the pharmacy. Misunderstanding the purpose of a drug regimen can lead to several complications including:• Unnecessary phone calls to MD office• Unnecessary wait for patient • Confusion caused to the patient by questioning the prescription and

prescriber competency• Wrong and incomplete consultation• Disturbance in communication circle between provider, patient, and

pharmacist• It is also important to recognize the purpose of the prescription

since it alters the content of the consultation. Adherence is a vital part of consultation when it comes to HIV drugs, but it gains extra importance during PEP and PrEP consultations.

References • CDC. MMWR. Antiretroviral Postexposure Prophylaxis After Sexual, Injection-

Drug Use, or Other Nonoccupational Exposure to HIV in the United States. Recommendations from the U.S. Department of Health and Human Services. 2005. Retrieved from http://aidsinfo.nih.gov/contentfiles/NonOccupationalExposureGL.pdf

• CDC. MMWR. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis. 2005. Retrieved fromhttp://aidsinfo.nih.gov/contentfiles/HealthCareOccupExpoGL.pdf

• CDC. MMWR. Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men. 2011. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm

• CDC. MMWR. Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults. 2012. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a2.htm?s_cid=mm6131a2_w#tab2