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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,gfor the Partners PrEP Study Team

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

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.

aDepartment of Reproductive Health, Moi University, Eldoret, Kenya

bDepartment of Global Health, University of Washington, Seattle, Washington, USA

cCentre for Clinical Research

dCentre for Microbiology Research, Kenya Medical Research Institute

eDepartment of Obstetrics and Gynecology, Kenyatta National Hospital, Nairobi, Kenya

fDepartment of Medicine

gDepartment of Epidemiology

hDepartment of Obstetrics and Gynecology, University of Washington, Seattle, Washington, USA.

*Members of the Partners PrEP Study Team are listed in the Acknowledgements section.

Correspondence to Jared Baeten, Department of Global Health, University of Washington, 325 Ninth Ave, Box 359927, Seattle, WA 98104, USA. Tel: +1 206 520 3808; fax: +1 206 520 3831; e-mail:

Received 14 February, 2014

Revised 15 April, 2014

Accepted 16 April, 2014

© 2014 Lippincott Williams & Wilkins, Inc.