DELIVER: A Safety Study of a Dapivirine Vaginal Ring and Oral PrEP for the Prevention of HIV During Pregnancy

• Published in: Journal of acquired immune deficiency syndromes (1999) Vol. 95; no. 1; p. 65
• Main Authors: Bunge, Katherine, Balkus, Jennifer E, Fairlie, Lee, Mayo, Ashley J, Nakabiito, Clemensia, Mgodi, Nyaradzo, Gadama, Luis, Matrimbira, Moleen, Chappell, Catherine Anne, Piper, Jeanna, Chakhtoura, Nahida, Szydlo, Daniel W, Richardson, Barbra, Hillier, Sharon L
• Format: Journal Article
• Language: English
• Published: United States 01.01.2024
• Subjects: Emtricitabine; Female; Gestational Age; HIV Infections - prevention & control; Humans; Malawi; Pregnancy; Tenofovir - adverse effects; Malawi
• ISSN: 1944-7884
• DOI: 10.1097/QAI.0000000000003312

Pregnancy represents a period of high HIV acquisition risk. Safety data for the monthly dapivirine vaginal ring (DVR) during pregnancy are limited. Here, we report data from the first 2 cohorts of pregnant participants in MTN-042/DELIVER, a phase 3b, randomized, open-label safety trial of DVR and oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). MTN-042 is being conducted in 3 cohorts beginning with later gestational ages when risks of drug exposure are less. Eligible pregnant individuals aged 18-40 years in Malawi, South Africa, Uganda, and Zimbabwe were randomized 2:1 to monthly DVR or daily TDF/FTC. Participants in cohort 1 initiated product use between 36 weeks 0 days (36 0/7 weeks) and 37 6/7 weeks gestation; participants in cohort 2 initiated product use between 30 0/7 and 35 6/7 weeks gestation. All participants continued product use until delivery or 41 6/7 weeks gestation. Pregnancy outcomes and complications were assessed and summarized using descriptive statistics and compared with local background rates obtained through a separate chart review. One-hundred and fifty participants were enrolled into cohort 1 with 101 randomized to DVR and 49 to TDF/FTC. One-hundred and fifty-seven participants were enrolled into cohort 2 with 106 randomized to DVR and 51 to TDF/FTC. In both cohorts, pregnancy complications were rare and similar to local background rates. In this first study of a long-acting HIV prevention agent in pregnancy, adverse pregnancy outcomes and complications were uncommon when DVR and TDF/FTC were used in the third trimester of pregnancy, suggesting a favorable safety profile for both prevention products.