Dapivirine vaginal ring for HIV prevention safe to use during breastfeeding

SEATTLE — A monthly dapivirine vaginal ring, used by women as HIV prophylaxis, is safe for breastfeeding babies, according to results of a phase 3b trial presented at the Conference on Retroviruses and Opportunistic Infections 2023.

The dapivirine vaginal ring previously received a positive scientific opinion from the European Medicines Agency in 2020 for use among women at high risk for HIV who cannot or do not want to use daily oral pre-exposure prophylaxis. In addition, in 2021, WHO recommended the monthly dapivirine vaginal ring as an additional HIV prevention option for women.

“In this first evaluation of safety and drug detection of the 25 mg dapivirine vaginal ring during breastfeeding, we observed that the ring appears to be very safe for both mothers and their breastfeeding infants and that extremely low concentrations of dapivirine are transferred to infants via breastmilk,” Jennifer E. Balkus, PhD, MPH, associate professor of epidemiology at the University of Washington School of Public Health, Seattle, told Healio. “The dapivirine vaginal ring is safe for using during breastfeeding and should be made available as an option for breastfeeding individuals interested in utilizing an antiretroviral-based HIV prevention method.”

This phase 3b, open-label study, B-PROTECTED, included 197 breastfeeding women and their 6- to 12-week-old infants in Malawi, South Africa, Uganda and Zimbabwe from September 2020 to November 2021. The women were randomly assigned to use the monthly dapivirine 25 mg vaginal ring (Johnson & Johnson; n = 148) or the daily oral pre-exposure prophylaxis emtricitabine/tenofovir disoproxil fumarate (Truvada; Gilead; n = 49) for 3 months. Researchers followed the mothers and their babies for an addition 2 weeks post-intervention.

Results demonstrated that dapivirine levels in breastmilk were similarly as low as levels observed for emtricitabine/tenofovir disoproxil fumarate with even lower levels of the drug exposed to the infants via breastmilk.

According to Balkus, this favorable safety profile supports updates to WHO and national guidelines to include breastfeeding individuals when recommending the dapivirine vaginal ring as an option for HIV prevention.

“The postpartum period is an exciting and sometimes challenging time for new parents. Research on how to best support lactating individuals in their use of HIV prevention modalities, including the dapivirine vaginal ring, would be beneficial,” Balkus said. “In addition, as countries approve the dapivirine vaginal ring and begin rollout, implementation science research on best approaches to incorporate the dapivirine ring into postnatal care will help to ensure that breastfeeding individuals who desire HIV prevention methods will have efficient access to this safe, effective and easy to use HIV prevention modality.”

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Jennifer E. Balkus, PhD, MPH, can be reached at jbalkus@uw.edu.