PrEP : HIV Pre-exposure Prophylaxis

1. PrEP: HIV Pre-exposure Prophylaxis Katherine Marx, MS, MPH, FNP-BC June 2014

2. Disclosure I, Katherine Marx, have no relevant financial, professional, or personal relationships to disclose.

3. Objectives • Know current US recommendations for PrEP • Identify candidates for PrEP • Learn about resources for providing PrEP

4. Combination HIV Prevention • Biomedical Interventions • Behavioral Interventions • Structural Interventions

5. Biomedical Interventions • PrEP • Post-exposure prophylaxis • Treatment as prevention • Diagnosis and treatment of sexually transmitted infections • Prevention of mother-to-child transmission of HIV • Contraception to prevent unplanned pregnancy among women with HIV • Voluntary male circumcision • Blood safety • Injection safety • Microbicides

6. PrEP: Pre-exposure Prophylaxis • How does it work? • Uninfected person takes antiretrovirals • May prevent replication of virus & infection • Daily adherence to TDF/FTC

7. NRTI’s and NNRTI’s work here http://www.aidsinfo.nih.gov/education-materials/fact-sheets/19/73/the-hiv-life-cycle

8. PrEP Timeline August 2012 TDF2 Partners PrEP June 2013 Bangkok TDF Study November 2010 iPrEx March 2013 VOICE July 2012 FEM-PrEP June 2013 CDC Interim Guidance: PrEP for IDU July 2012 FDA Approval TDF/FTC PrEP January 2011 CDC Interim Guidance: PrEP for MSM January 2014 NYS AIDS Institute Guidance for PrEP August 2012 CDC Interim Guidance: PrEP for heterosexuals May 2014 US Public Health Service Clinical Practice Guideline for PrEP

9. PrEP Studies: HIV transmission risk lowest when participants took PrEP consistently Adapted from summary of research at http://www.cdc.gov/hiv/prevention/research/prep/

12. PrEP Utilization Female Male Rawlings K, Mera R, Pechonkina A, et al. Status of Truvada for HIV pre-exposure prophylaxis (PrEP) in the United States: an early drug utilization analysis. 53rd ICAAC. September 10-13, 2013. Denver. Abstract H-663a.

13. PrEP: Candidates Substantial risk of acquiring HIV infection • Men who have sex with men (MSM) • HIV-positive sexual partner • Recent bacterial STI • High number of sex partners • History of inconsistent/no condom use • Commercial sex work http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

14. PrEP: Candidates Substantial risk of acquiring HIV infection • Transgender individuals • Engaging in high-risk sexual behaviors www.hivguidelines.org

15. Risk Behavior Assessment for MSM In the past 6 months: • Have you had sex with men, women, or both? • (if men or both sexes) How many men have you had sex with? • How many times did you have receptive anal sex (you were the bottom) with a man who was not wearing a condom? • How many of your male sex partners were HIV-positive? • (if any positive) With these HIV-positive male partners, how many times did you have insertive anal sex (you were the top) without you wearing the condom? • Have you used methamphetamines (such as crystal or speed)? http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

16. PrEP: Candidates Substantial risk of acquiring HIV infection • Heterosexual women and men • HIV-positive sexual partner • Recent bacterial STI • High number of sex partners • History of inconsistent/no condom use • Commercial sex work • High-prevalence area or network http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

17. PrEP: Candidates Substantial risk of acquiring HIV infection • Injection drug users (IDU) • HIV-positive injecting partner • Sharing injection equipment • Recent drug treatment (but currently injecting) http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

18. PrEP vs. nPEP Case #1: 24 year old white MSM who presents 4 hours after unprotected receptive anal sex, for the first time, with his HIV-infected partner.

19. nPEP Non-occupational Post-exposure Prophylaxis • High risk exposure • As soon as possible • 28 day course • Tenofovir/emtricitabine + raltegravir www.hivguidelines.org

20. PrEP vs. nPEP Case #2: 24 year old MSM on nPEP, day 27/28. Struggles with consistent condom use and regularly has unprotected receptive anal intercourse with his HIV-infected partner.

21. PrEP: Clinical Eligibility • Documented negative HIV test • No signs/symptoms of acute HIV infection • Normal renal function • No contraindicated medications • Documented hepatitis B infection & vaccination status http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

22. PrEP: HIV Testing • Are signs/symptoms of acute HIV present now or in prior 4 weeks? • Option 1: retest antibody in one month • Option 2: HIV antibody/antigen assay • Option 3: HIV-1 viral load http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

23. Acute HIV Infection Symptoms • Fever • Fatigue • Myalgia • Skin rash • Headache • Pharyngitis • Cervical Lymphadenopathy • Arthralgia • Night sweats • Diarrhea Daar ES, Pilcher CD, Hecht FM. CurrOpin HIV AIDS. 2008;3(1):10-15.

24. PrEP: Considerations • Age • Reproductive plan • Osteopenia/osteoporosis www.hivguidelines.org

25. PrEP: Risk Reduction Case #3: 32 year old black female seeks pregnancy. She is not infected with HIV. Her partner is HIV-infected and not currently on antiretroviral treatment.

26. Providing PrEP Every visit: Assess adherence Risk reduction counseling Provide condoms Before starting PrEP: • Clinical eligibility • Educate • Side effects • Limitations • Daily adherence • Symptoms of seroconversion • Monitoring schedule • Safety • Criteria for discontinuation • Partner information • Social history: housing, substance use, mental health, domestic violence www.hivguidelines.org

27. Providing PrEP Every visit: Assess adherence Risk reduction counseling Provide condoms After confirmation of clinical eligibility: • Prescribe no more than 90-day supply of PrEP • Truvada 1 tablet PO daily (tenofovir 300mg + emtricitabine 200mg) • Insurance prior approval • Truvada for PrEP Medication Assistance Program http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

28. Providing PrEP Every visit: Assess adherence Risk reduction counseling Provide condoms 3-month visit: • HIV test • Assess for acute infection • Check for side effects • Pregnancy testing • Prescribe 90-day supply of medication http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

29. Providing PrEP Every visit: Assess adherence Risk reduction counseling Provide condoms 6-month • HIV test • STI test • Pregnancy test • Renal function • 90 day prescription 9-month • HIV test • Pregnancy test • 90 day prescription 12-month • HIV test • STI tests • Pregnancy test • Renal function • 90 day prescription • Assess the need to continue PrEP http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

30. Support Adherence Develop trust, avoid judgment • Plan • Monitor • Educate • Identify barriers • Assess for side effects http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

31. Discontinuing PrEP • Positive HIV result • Acute HIV signs or symptoms • Non-adherence • Renal disease • Changed life situation: lower HIV risk http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

32. PrEP: Research • PrEP in the real world • Intermittent dosing • New medications • New formulations

33. PrEP Summary • Effective • FDA approved • Well-tolerated However, • Short-term data only • Daily adherence required • Side effects • Drug resistance in acute infection • Could lead to fewer condoms being used • Cost • Logistics

34. PrEP Resources • CDC: http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf • NYSDOH AI: http://www.hivguidelines.org/ • PrEP Watch/ AVAC: http://www.prepwatch.org/

35. Additional Resources NY/NJ AETC PrEP Webinars • http://nynjaetc.virtualforum.com/pif.asp?Prog_ID=14060902&securitycode=KXbFYh • http://nynjaetc.virtualforum.com/pif.asp?Prog_ID=14052303&securitycode=01r27E • http://nynjaetc.virtualforum.com/pif.asp?Prog_ID=14050908&securitycode=o9k2C2

36. Katherine Marx, MS, MPH, FNP-BC