Background:
Pregnant people are at 3X higher risk of HIV per coital act than nonpregnant people. MTN-042/DELIVER was a phase 3b study of Dapivirine Vaginal Ring (DVR) and oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) to assess safety, adherence, and acceptability when used during pregnancy (NCT03965923). The results of the first two cohorts of women enrolled during the 3rd trimester have been reported. The results from the 3rd cohort of women initiating product during the 2nd trimester of pregnancy are reported here.
Methods:
Healthy, HIV uninfected, 18–40-year-old pregnant people from South Africa, Uganda, Zimbabwe and Malawi were enrolled and randomised 4:1 to monthly DVR or daily TDF/FTC between 12 0/7 and 29 6/7 weeks gestation. Product use continued until delivery or 41 6/7 weeks’ gestation. Pregnancy outcomes, complications and congenital anomalies reported at the time of delivery were summarized using descriptive statistics. Local background rates from a separate systematic chart review (> 10,000 deliveries) at the participating health centres (MTN-042B) provided a comparator.
Results:
251 participants were enrolled with 202 randomized to DVR and 49 to TDF/FTC. The cohort had a mean age of 25.4 years and gestational age of 23.3 weeks. Of 248 available pregnancy outcomes, there were two stillbirths and one miscarriage. Most deliveries were at term (96%), 4% were preterm and pregnancy complications were uncommon (Table 1). Preterm premature rupture of membranes occurred in three (1%) cases in the DVR arm. Eleven (4%) of the 245 infant participants had congenital anomalies none of which was related to study product with umbilical hernias most frequent (7/11). No HIV infections occurred in these 251 women.
Conclusions:
Adverse pregnancy outcomes related to DVR and TDF/FTC use were uncommon in the second trimester of pregnancy, with rates similar to the communities where the study was conducted. 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.
