HIV Prophylaxis: Following Occupational and Non-Occupational Exposure

1. HIV Prophylaxis: Following Occupational and Non-Occupational Exposure Nanik (Nayri) Hatsakorzian Pharm.D./MPH candidate 2014 Touro University, College of Pharmacy-CA

2. Quiz Patient: Jane Do DOB: 09/09/59 Truvada Take 1 tab PO QD # 30 Refill: 6 Doctor: Homer Simpson DEA: J000999000 (415)555-5555

3. 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”

4. PEP: For Occupational Exposure

5. 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)

6. 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)

7. PEP: Non-Occupational Exposure

8. 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 + zidovudineor stavudine or abacavir or didanosine or tenofovir (boosted with TDF)

9. 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.

10. iPrEX Study • FDA has approved Truvada once a day as PrEP upon results from iPrEXstudy • 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.

11. 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

12. Answer • This prescription is written as PrEX. Pharmacist has to consult accordingly with emphasis on the importance of the adherence

13. 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.

14. 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 PostexposureProphylaxis. 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