No Pregnancy Impact with HIV Preexposure Prophylaxis
(HealthDay News) — For HIV-serodiscordant couples, preexposure prophylaxis (PrEP) does not impact pregnancy incidence or outcomes, according to a study published in the July 23/30 issue of the Journal of the American Medical Association, a theme issue on HIV/AIDS. This issue has been released early to coincide with AIDS 2014, the International AIDS Conference, held from July 20–25 in Melbourne, Australia.
Nelly R. Mugo, MBChB, MPH, from the University of Washington in Seattle, and colleagues assessed pregnancy incidence and outcomes in 1,785 HIV-serodiscordant heterosexual couples in which the female partner was HIV uninfected and received active PrEP. The women were randomized to daily oral tenofovir disoproxil fumarate (TDF; 598 women), combination emtricitabine/tenofovir disoproxil fumarate (FTC+TDF; 566 women), or placebo (621 women) through July 2011, and received active PrEP thereafter.
The researchers found that pregnancy incidence was 10.0, 11.9, and 8.8 per 100 person-years among women assigned to placebo, TDF (incidence difference, 1.9; P=0.22 vs. placebo), and FTC+TDF (incidence difference, −1.3; P=0.39 vs. placebo). The occurrence of pregnancy loss was not significantly different for those receiving FTC+TDF or TDF vs. placebo (42.5 and 27.7% vs. 32.3%, respectively; P=0.16 and 0.46, respectively). There were no significant differences in preterm birth, congenital anomalies, and growth throughout the first year of life for infants born to women assigned to PrEP or placebo.
"Among HIV-serodiscordant heterosexual African couples, differences in pregnancy incidence, birth outcomes, and infant growth were not statistically different for women receiving PrEP with TDF alone or combination FTC+TDF compared with placebo at conception," the authors write.
Several authors disclosed financial ties to medical technology and pharmaceutical companies, including Gilead Sciences, which donated study medication.