PrEP Cases Kevin L. Ard, MD, MPH Massachusetts General Hospital - PowerPoint Presentation

PrEP Cases Kevin L. Ard, MD, MPH Massachusetts General Hospital National LGBT Health Education Center

Case 1 A 36 year-old woman and her 39 year-old husband present to discuss conception. He’s HIV infected and virologically suppressed on ART; she’s HIV-negative. They want to conceive a child and do not have access to sperm washing. Would you recommend PrEP for her and condomless sex in this situation?

PrEP may be part of a safe conception strategy. No increased birth defects with tenofovir-emtricitabine among women in the Antiretroviral Pregnancy Registry No difference in birth outcomes among women receiving PrEP versus placebo in the Partners PrEP studyModeling suggests PrEP adds little, assuming ART and other factors are optimized. Antiretroviral pregnancy registry interim report. 2014. Available from: www.apregistry.com/forms/exec-summary.pdf . Mugo NR, et al. Pregnancy incidence and outcomes among women receiving preexposure prophylaxis for HIV prevention: A randomized clinical trial. JAMA. 2014;312(4):362. Hoffman RM, et al. Benefits of PrEP as an adjunctive method of HIV prevention during attempted conception between HIV-uninfected women and HIV-infected male partners. J Infect Dis. 2015;212(10):1534.

Case 2 A 27 year-old man is referred for PrEP. He is sexually active with 1 primary and 2 occasional male partners. Treated for secondary syphilis 3 months ago History includes IgA nephropathy HIV antibody/antigen negative, creatinine is 1.72 (eGFR ~ 40 ) Would you recommend TAF-FTC for PrEP?

There is not yet enough evidence to recommend TAF for PrEP. Animal data are promising. In one human study of TAF, tenofovir concentrations were undetectable in 83% of tissue samples. DISCOVER study assessing TAF-FTC versus TDF-FTC for PrEP in MSM and transgender women Massud I, et al. Chemoprophylaxis with oral FTC/TAF protects macaques from rectal SHIV infection. CROI 2016. Abstract 107. Garrett KL, et al. Concentrations of TFV and TFVdp in female mucosal tissues after a single dose of TAF. CROI 2016. Abstract 102LB.

The future of PrEP I njections of long-acting PrEP (e.g., cabotegravir?) Other oral agents (e.g., TAF, maraviroc?) Rectal microbicides PrEP-impregnated vaginal rings (e.g., dapivirine)

Case 3 A 17-year-old man presents to the clinic after a sexual partner said he had chlamydia. He is sexually active with multiple male partners, rarely using condoms. He asks about PrEP, as many of his friends take it. Would you recommend PrEP for him?

High HIV risk, suboptimal PrEP adherence 15- to 17-year-olds in 6 U.S. cities (ATN 113) HIV incidence 6.4 per 100 person-years 60% adherent at week 4; 28% at week 48 18- to 22-year-olds in 12 U.S. cities (ATN 110) HIV incidence 3.9 per 100 person-years ~55% adherent at week 4; 34% at week 48Hosek S, et al. An HIV pre-exposure prophylaxis (PrEP) demonstration project and safety study for adolescent MSM ages 15-17 in the United States (ATN 113). International AIDS Society. Durban, 2016. Abstract TUAX0104LB.Hosek S, et al. An HIV preexposure prophylaxis demonstration project and safety study for young MSM. J Acquir Immune Defic Syndr. 2017;74(1):21.

Special considerations for PrEP use in adolescents Tenofovir-emtricitabine only licensed for adults Effects on bone mineral density Parental consent Adherence support (monthly visits?) Hosek S, et al. Preventing HIV among adolescents with oral PrEP: observations and challenges in the United States and South Africa. J AIDS. 2016;19(Suppl 6):21107.

Case 4 A 42-year-old transgender woman presents with rectal pain and discharge and is diagnosed with gonorrhea. Multiple male sexual partners with whom she engages in condomless receptive anal sex She uses an estradiol patch and spironolactone and is concerned that PrEP may interact with these drugs. Does PrEP interact with gender-affirming hormonal treatments? What is known about PrEP efficacy for transgender women ?

Does PrEP work in transgender women? No benefit in 339 transgender women in a post-hoc analysis of iPrEX 18% of transgender women had protective drug levels, compared to 36% of MSM. No transgender women who contracted HIV had detectable drug levels at the time of diagnosis. 0 infections occurred in transgender women taking 4 or more doses of PrEP per week.Bottom line: PrEP can work, but adherence is crucial.Deutsch MB, et al. HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial. Lancet HIV. 2015;2:e512.

Case 5 A 35 year-old gay man presents to discuss PrEP. While home in Boston, he is rarely sexually active with other men and always uses condoms. He is vacationing in Spain in one month and anticipates multiple unprotected anal sexual encounters there. He would like to take PrEP for his upcoming vacation and stop after he returns to Boston. What would you recommend?

PrEP and “risk vacations” PrEP effectiveness has not explicitly been assessed in this situation, but… The patient’s situation is not materially different than use of PrEP for conception in serodifferent heterosexual couples. Suggest: Start PrEP 7-28 days prior to the risk period Take PrEP daily during the risk periodContinue PrEP for 28 days after the risk periodDaskalakis D. HIV preexposure prophylaxis in the real world. Top Antivir Med. 2014;22(4):670.

Time to maximal protection may differ by route of HIV exposure . Preexposure prophylaxis for the prevention of HIV infection in the United States – 2014. CDC. Available from: http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf

Summary PrEP is an option to reduce HIV transmission for serodifferent couples wanting to conceive. There are no current options for PrEP for people with renal failure. Consider prescribing PrEP to adolescents at high risk of HIV. PrEP is not known to interact with gender-affirming hormonal therapy. Time to maximal protection, time to continue PrEP after the last exposure