STUDY: HIV injectable drug offers pregnant, lactating mothers 100% protection

What the report says

A sub-study of the PURPOSE 1 Phase 3 clinical trial has found that the twice-yearly injectable HIV prevention drug lenacapavir protected pregnant and breastfeeding women from HIV infection, according to reporting by The Independent Uganda based on a URN special report. The study was presented at the International AIDS Conference and published in The Lancet Medical Journal. It focused on women using the medicine as pre-exposure prophylaxis, or PrEP, and concluded that the injection appears safe in pregnancy.

The article says researchers tracked drug levels in mothers, breast milk and infants, and found exposure was comparable across pregnancy stages and postpartum, with no indication that dose adjustments are needed. It also reports that lenacapavir was detected in breast milk, but infant exposure remained minimal. The trial enrolled 5,345 women aged 16 to 26 in South Africa and Uganda, and 487 participants experienced pregnancies while in the study, producing 512 pregnancy outcomes.

The report notes that women who became pregnant during the trial were kept on their assigned study drug, unlike in some earlier prevention studies. It highlights that most pregnancies recorded in the sub-study occurred in Uganda, and that the findings may help address long-standing evidence gaps for pregnant and postpartum women, who face higher vulnerability to HIV infection.

As broader context, the article links the findings to Uganda’s HIV burden, citing official estimates that women make up a large share of people living with HIV and many new infections each year. Health officials quoted in the piece said a longer-acting prevention option could help improve uptake where daily oral PrEP or condom use is difficult for some groups.