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

9. PrEP Studies: HIV transmission risk lowest when participants took PrEP consistently STUDYOVERALL Reduction in risk of HIV infection Detectable level of medication in the blood Reduction in risk of HIV infection iPrEx44%>90% TDF262%--- Partners PrEP75%90% BTS49%74% Adapted from summary of research at http://www.cdc.gov/hiv/prevention/research/prep/

12. PrEP Utilization 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. Female Male

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. Curr Opin 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 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 Every visit: Assess adherence Risk reduction counseling Provide condoms www.hivguidelines.org

27. Providing PrEP 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 Every visit: Assess adherence Risk reduction counseling Provide condoms http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

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

29. Providing PrEP 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 Every visit: Assess adherence Risk reduction counseling Provide condoms 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/prepguidelines20 14.pdf http://www.cdc.gov/hiv/pdf/prepguidelines20 14.pdf NYSDOH AI: http://www.hivguidelines.org/http://www.hivguidelines.org/ PrEP Watch/ AVAC: http://www.prepwatch.org/ 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=14060902&securitycode=KXbFYh http://nynjaetc.virtualforum.com/pif.asp?Prog _ID=14052303&securitycode=01r27E http://nynjaetc.virtualforum.com/pif.asp?Prog _ID=14052303&securitycode=01r27E http://nynjaetc.virtualforum.com/pif.asp?Prog _ID=14050908&securitycode=o9k2C2 http://nynjaetc.virtualforum.com/pif.asp?Prog _ID=14050908&securitycode=o9k2C2

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