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
• No increased birth defects with
strategy.
tenofovir-emtricitabine among
women in the Antiretroviral
Pregnancy Registry
• No difference in birth outcomes
among women receiving PrEP versus
placebo in the Partners PrEP study
• Modeling suggests PrEP adds little,
assuming ART and other factors are
optimized.
1.
2.
3.
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 TDFFTC 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
Injections 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)
1.
2.
– HIV incidence 3.9 per 100 person-years
– ~55% adherent at week 4; 34% at week 48
Hosek 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?)
1.
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 period
– Continue PrEP for 28 days after the risk period
Daskalakis 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.
Time to maximal tissue tenofovir levels with daily use
Cervicovaginal tissue
Rectal tissue
0
5
10
15
Preexposure prophylaxis for the prevention of HIV infection in the United States – 2014. CDC. Available from:
http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf
20
25
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