title: Pre-exposure prophylaxis does not affect the fertility of HIV-1-uninfected men.
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.
  
  
  CONCLUSIONS
  TDF and FTC/TDF, when used as PrEP by HIV-1-uninfected men, did not adversely affect male fertility or pregnancy outcomes.
authors.affiliation: 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.
authors.forename: Edwin O
authors.initials: EO
authors.lastname: Were
authors.forename: Renee
authors.initials: R
authors.lastname: Heffron
authors.forename: Nelly R
authors.initials: NR
authors.lastname: Mugo
authors.forename: Connie
authors.initials: C
authors.lastname: Celum
authors.forename: Andrew
authors.initials: A
authors.lastname: Mujugira
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Bukusi
authors.forename: Jared M
authors.initials: JM
authors.lastname: Baeten
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage / Q000009:adverse effects*; D018890:Chemoprevention / Q000009:adverse effects* / Q000379:methods; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000068679:Emtricitabine; D005260:Female; D005298:Fertility / Q000187:drug effects*; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects; D010919:Placebos / Q000008:administration & dosage; D065129:Pre-Exposure Prophylaxis / Q000379:methods*; D011247:Pregnancy; D000068698:Tenofovir
chemical_list: D044966:Anti-Retroviral Agents; D063065:Organophosphonates; D010919:Placebos; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine