(HealthDay News) — Adverse pregnancy outcomes related to use of the dapivirine vaginal ring (DVR) or daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) during the second trimester are uncommon, according to a study presented at the annual Conference on Retroviruses and Opportunistic Infections, held from March 3 to 6 in Denver.
Felix Mhlanga, M.B.Ch.B., from the University of Zimbabwe in Harare, and colleagues presented results from the third cohort of women initiating the DVR product during the second trimester of pregnancy as part of a phase 3b study. The analysis included healthy, HIV-uninfected pregnant women (ages 18 to 40 years) from South Africa, Uganda, Zimbabwe, and Malawi who were randomly assigned (4:1) to monthly DVR (202 participants) or TDF/FTC (49 participants).
The researchers noted two stillbirths and one miscarriage. Most deliveries were at term (96 percent), and pregnancy complications were uncommon. In three cases in the DVR arm, preterm premature rupture of membranes occurred. Overall, 11 infant participants had congenital anomalies (most commonly umbilical hernias), none that related to the study product. No HIV infections occurred in this cohort of women.
“These data, combined with the data from cohorts 1 and 2 and the safety data from women who used the DVR at the time of conception, support using DVR and TDF/FTC as HIV prevention options for pregnant people at risk of HIV,” the authors write.