A recent article in The Lancet HIV describes results of a study on the safety of the dapivirine vaginal ring for preventing HIV in breastfeeding mothers—and consequently protecting their babies, as well. We recently spoke with lead author Dr. Lisa Noguchi, Jhpiego’s Director for Maternal and Newborn Health, about the real-life implications of these findings.
Why is HIV prevention important for breastfeeding mothers and their babies?
The world has made incredible progress in preventing vertical transmission of HIV—meaning from the mother to her child during pregnancy, labor and delivery, or breastfeeding. Unfortunately, progress has slowed recently. In West and Central Africa, for example, vertical HIV transmission elimination programs probably only reach about half of pregnant or breastfeeding women living with HIV.
We know from previous research that pregnancy and the postpartum period are critical times for HIV prevention. The chance of acquiring HIV per sex act is probably as much as four times higher for a postpartum woman compared to times when she is not pregnant. We also know that if a postpartum mother gets an acute HIV infection, the chance of passing it to her breastfeeding baby is higher than if she’d acquired an HIV infection prior to her pregnancy.
So, while oral pre-exposure prophylaxis (PrEP)—HIV-negative individuals taking oral medication to reduce their chance of acquiring HIV—is a safe and effective option for many people including breastfeeding women, we need a range of options, because different strategies work for different people.
What are the current recommendations for breastfeeding?
The World Health Organization (WHO) universally recommends exclusive breastfeeding (i.e., providing only breast milk as their source of nutrition) for infants younger than 6 months, and continued breastfeeding plus appropriate complementary foods until age 2 years or older. That’s how impactful breastfeeding is in terms of its power to save infant lives and protect them from malnutrition, ear infections, respiratory tract infection, asthma, sudden infant death, obesity, type 1 diabetes, and more. But breastfeeding doesn’t just protect babies—it protects mothers, too. Women who breastfeed have a lower risk of high blood pressure, breast cancer, ovarian cancer, diabetes, and more.
For readers who might not be familiar with the dapivirine ring, can you explain what it is?
A dapivirine vaginal ring is a flexible ring, made of silicone elastomer, that contains 25 mg of dapivirine, an antiviral drug. The ring is designed to be inserted in the vagina and replaced monthly. Based on multiple safety and efficacy studies, WHO recommended the ring in 2021 as an additional prevention choice for women at substantial risk of HIV infection.
What did you set out to learn in this study and what did you find?
Our study, which was a randomized trial, aimed to describe the safety of two different HIV prevention products during breastfeeding. Some women in the study used oral PrEP and some used the ring. We also measured medication levels in mothers and infants. The study was carried out at HIV research sites in Malawi, South Africa, Uganda, and Zimbabwe.
We found that the dapivirine ring was very well tolerated and safe for breastfeeding moms and their babies. We observed very few significant side effects or health issues in either the ring or the oral PrEP group. While this wasn’t a trial designed to measure effectiveness, it was reassuring that none of the study participants acquired HIV.
Because of this study, we now know that dapivirine levels in breastfeeding infants are very low and infrequent. This and the safety data underscore that a health worker should be able to prescribe the ring for a breastfeeding mom, because it looks very safe for both her and the baby.
What is the take-home message?
Since breastfeeding has such powerful benefits, no one living where HIV is common should have to choose between breastfeeding and protecting themselves—and their baby—from HIV infection. They need options! Not everyone can take a PrEP pill every day. Now, the dapivirine ring is one more way that breastfeeding moms can help protect themselves from getting HIV—and give their babies all the benefits of breastfeeding.
Safety and drug quantification of the dapivirine vaginal ring and oral pre-exposure prophylaxis in breastfeeding mother–infant pairs (MTN-043): a phase 3B, open-label, randomised trial by Lisa Noguchi, PhD; Maxensia Owor, MMed; Nyaradzo M Mgodi, MMed; Brenda Gati Mirembe, MBChB; Sufia Dadabhai, PhD; Elizea Horne, MBChB; et al. was published in the March 2025 issue of The Lancet. Read the full article here and listen to the podcast episode featuring Dr. Lisa Noguchi.