Taking PrEP (pre-exposure prophylaxis) does not negatively impact fertility among HIV-negative men or subsequent pregnancy outcomes among their HIV-positive female partners, suggests a new study published in the journal AIDS.
Limited data are available on the effect of antiretrovirals on sperm health and male fertility, even though PrEP for the HIV-negative partner is common among mixed-status heterosexual couples when trying to get pregnant, according to the researchers.
The study followed 4,747 heterosexual mixed-status couples, where the male was negative and the female was positive, in Kenya and Uganda.
The male partners were randomized to receive once-daily PrEP, either tenofovir (Viread) or tenofovir/emtricitabine (Truvada), or a placebo. The participants were followed monthly, with HIV testing, pill refills and adherence counseling.
The researchers then looked at the incidence of pregnancy among the female partners, comparing the use of PrEP versus placebo.
Overall, there were 583 pregnancies among the female partners, with a pregnancy incidence of 12.9 per 100 person-years, which was similar across all three groups: 13.2 in the tenofovir group, 12.4 in the tenofovir/emtricitabine group and 13.2 in the placebo group.
The frequency of live births, pregnancy losses and gestational age at birth or loss was similar across all three groups.
Among the male participants, adherence was high, with more than 95% of pills estimated to have been taken, based on the amount of unused pills that were returned. Moreover, more than 80% of a randomly selected subset of participants taking PrEP had detectable drug levels in their blood.
All couples were given comprehensive HIV prevention counseling, free condoms and screening and treatment for sexually transmitted infections.
While there were some limitations, including a lack of data on seminal parameters and conception intentions, the authors concluded that tenofovir-based PrEP does not have adverse effects on the fertility of HIV-negative men or the subsequent pregnancy outcome. While the study only included HIV-negative men, the researchers stated that the findings are relevant for HIV-positive men as well, since tenofovir is a part of first-line HIV treatment in many settings.