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. PEP: For Mucus Membrane Exposure

6. 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)

7. 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)

8. PEP: Non-Occupational Exposure

9. 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)

10. Recommended laboratory evaluation

11. 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.

12. 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.

13. 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

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

15. 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.

16. 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