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AIDS:
doi: 10.1097/QAD.0000000000000313
Epidemiology and Social: Concise Communication

Pre-exposure prophylaxis does not affect the fertility of HIV-1-uninfected men

Were, Edwin O.a; Heffron, Reneeb; Mugo, Nelly R.b,c,d,e; Celum, Connieb,f,g; Mujugira, Andrewb,g; Bukusi, Elizabeth A.b,c,h; Baeten, Jared M.b,f,g; for the Partners PrEP Study Team

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Abstract

Background: There is a paucity of data on the effect of antiretroviral medications on male fertility. Couples affected by HIV-1 often have fertility intentions, and antiretroviral medications, as both treatment of HIV-1-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons, are part of peri-conception risk reduction.

Methods: Within a randomized, placebo-controlled trial of daily oral tenofovir disoproxil fumarate (TDF) and combination emtricitabine (FTC)/TDF PrEP for HIV-1 prevention conducted among heterosexual HIV-1-serodiscordant couples, we assessed the impact of TDF and FTC/TDF use on male fertility, measured as incident pregnancy in female partners of men assigned to PrEP vs. placebo.

Results: Of the 2962 HIV-1-uninfected men partners, 986 were randomized to TDF, 1013 to FTC/TDF, and 963 to placebo. The overall pregnancy incidence in their HIV-1-infected female partners was 12.9 per 100 person-years and did not differ significantly across the study arms (13.2 TDF, 12.4 FTC/TDF, 13.2 placebo). The frequency of live births, pregnancy losses, and gestational age at birth or loss was also statistically similar in the three randomization groups.

Conclusion: TDF and FTC/TDF, when used as PrEP by HIV-1-uninfected men, did not adversely affect male fertility or pregnancy outcomes.

© 2014 Lippincott Williams & Wilkins, Inc.

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