TOPLINE:

Healthy pregnant women who tested negative for HIV and who started preexposure prophylaxis (PrEP) with either a monthly dapivirine vaginal ring or daily oral tenofovir disoproxil fumarate-emtricitabine in the second trimester and continued until delivery experienced no safety concerns. Both products had favorable acceptability and adherence.

METHODOLOGY:

• Researchers conducted a phase 3b randomized trial to assess the safety and acceptability of and adherence to the dapivirine vaginal ring and oral PrEP with tenofovir disoproxil fumarate-emtricitabine when initiated in the second trimester of pregnancy.
• They randomly assigned 251 healthy pregnant women without HIV infection (mean age, 25.3 years) at 12-29 weeks’ gestation to receive a 25 mg dapivirine vaginal ring inserted monthly (n = 202) or daily oral PrEP (300 mg tenofovir disoproxil fumarate plus 200 mg emtricitabine; n = 49); women used the assigned product until delivery or 41 weeks’ gestation.
• The primary outcome was a composite of all serious adverse events, comprising maternal deaths and grade ≥ 3 adverse events, and pregnancy outcomes; pregnancy outcomes included full-term live birth, premature live birth, and pregnancy loss.
• The follow-up schedule included periodic in-person visits through 36 weeks’ gestation and a postpartum assessment.
• Adherence was assessed through women’s self-reports and biological measures, including the amount of residual dapivirine in returned rings and dried blood spot concentrations of tenofovir diphosphate and emtricitabine triphosphate.

TAKEAWAY:

• The mean duration of product use was 113.3 days for the dapivirine vaginal ring and 110.6 days for oral PrEP. Overall, 11% of the women met the composite primary outcome (12% with the dapivirine ring and 8% with oral PrEP), and none of these events were related to the study products.
• No women acquired HIV infection, and no maternal deaths occurred. Product-related adverse events were mild or moderate in severity.
• Pregnancy outcomes were available for 98% of women, and 99% of these were live births. Among live births, 95% were term and 5% were preterm. In the dapivirine vaginal ring group, two stillbirths and one miscarriage occurred.
• Of the dispensed rings, 99% were returned. Among tested rings, 88% had residual dapivirine consistent with medium or high level of adherence, and 69% of dried blood spot samples in the oral PrEP group showed medium or high level of adherence.

IN PRACTICE:

“These data, combined with the data from cohorts 1 and 2 from MTN-043 and the safety data from women who used the DVR [dapivirine vaginal ring] at the time of conception, and favourable acceptability and adherence findings support the use of DVR and oral PrEP as HIV prevention options for pregnant and breastfeeding women at risk of HIV,” the authors wrote.

SOURCE:

The study was led by Felix G. Mhlanga, MMED, University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe. It was published online on February 10, 2026, in The Lancet HIV.

LIMITATIONS:

The trial relied on a local comparator dataset of women presenting for delivery over an 8-week window at the same sites; as a result, early pregnancy losses were likely missed. Only uncomplicated singleton pregnancies in urban or peri-urban settings were included, limiting generalizability to multiple or complicated pregnancies; the study was also not powered to detect rare pregnancy complications.

DISCLOSURES:

The trial was funded by the National Institute of Allergy and Infectious Diseases, with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health. Several authors reported having relationships with multiple pharmaceutical companies — including advisory payments to their institutions, grants, consulting fees, travel support, and product donations — with some also reporting support from National Institutes of Health to their institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.