Monthly Vaginal Ring Prevents HIV During Breastfeeding Safely

A monthly vaginal ring containing the antiretroviral drug dapivirine – an HIV prevention method that has been approved in several African countries and recommended by the World Health Organization (WHO) –appears to be safe when used during breastfeeding, suggests results of a study presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2023) in Seattle. The study, which was conducted in Malawi, South Africa, Uganda, and Zimbabwe, found that while the drug could be detected in breastmilk, the absolute levels were very low and the amount of drug ingested by babies even lower, posing no safety concerns.

Dapivirine Vaginal Ring: New Choice for HIV Prevention for Breastfeeding Women

Women need safe and effective methods for HIV prevention they can use at all times of their lives, perhaps especially when they are breastfeeding, which we know to be a time of heightened risk for infection. The risk of acquiring HIV during breastfeeding is estimated to be up to four times higher compared to other periods in life.

The study was designed to provide the kind of information regulatory authorities and national programs would need to consider making the dapivirine ring available to breastfeeding and pregnant women and enable healthcare providers, and women themselves, to make informed choices about whether to use the ring while pregnant or breastfeeding.

Women enrolled in the study were randomly assigned to use either the monthly dapivirine vaginal ring or Truvada® as daily oral PrEP (short for pre-exposure prophylaxis) for three months, with three times as many participants assigned to use the dapivirine ring – 148 women used the dapivirine ring (inserting a new ring each month) and 49 women were assigned to use Truvada as daily oral PrEP.

Both mothers and their babies were followed for an additional two weeks after they stopped using the study product. At different time points during the study, researchers assessed how much drug from each product could be measured in blood samples from the mothers, how much was present in breast milk, and how much could be measured in blood samples from the babies.

Dapivirine Ring Appears Safe for HIV Prevention While Breastfeeding

Most of the information about the safety of Truvada (which contains emtricitabine and tenofovir disoproxil fumarate) during pregnancy and breastfeeding is based on its use for the treatment of HIV in combination with other drugs, with a growing body of evidence finding it safe to use for HIV prevention during pregnancy and breastfeeding as well.

Much less is known about the dapivirine ring’s use during pregnancy and breastfeeding. This is the first study of the dapivirine ring in women who are actively breastfeeding.

The monthly dapivirine vaginal ring received a positive scientific opinion from the European Medicines Agency in July 2020 for its use by cisgender women at high risk for HIV who cannot or choose not to use daily oral PrEP, and in 2021, WHO recommended the ring as an additional prevention option for women.

Countries that have approved the dapivirine ring include Kenya, Rwanda, South Africa, Uganda, and Zimbabwe, among others. In mid-2022, the dapivirine vaginal ring and other IPM assets were transferred to the Population Council, a global non-profit research organization. The final results of this study are anticipated in late 2024 or early 2025. Let us hope for good things to come.



Source-Eurekalert