Seven out of every ten people who have started South Africa's new twice-yearly HIV prevention injection are women, and most of them are pregnant or breastfeeding, the country's Department of Health said in a statement on 8 September.
Of the 55,123 people initiated on lenacapavir by 7 September, just over three months after the injection became available nationally, women make up 71%, a group the department says has been prioritised because pregnancy and the postpartum period carry a heightened risk of HIV acquisition.
That skew is not incidental. It reflects a deliberate choice in how the drug was tested and how the rollout was designed.
Why women were built into this from the start
Lenacapavir's lead trial, involving adolescent girls and young women in South Africa and Uganda and published in the New England Journal of Medicine in 2024, was designed to allow participants who became pregnant to remain on study and generate pregnancy and breastfeeding safety data rather than excluding them from follow-up. Zero participants who received lenacapavir in that trial acquired HIV, 100% efficacy, and better protection than the existing daily pill regimen it was tested against.
A second, broader trial that enrolled men, transgender women, transgender men and non-binary people recorded two infections among 2,179 participants who received the injection, a rate 96% lower than the background HIV rate researchers had estimated for that group.
Put together, the trials showed that lenacapavir provides exceptionally high protection across different populations, including the adolescent girls and young women who made up the PURPOSE 1 trial.
The daily pill problem lenacapavir is trying to solve
South Africa already runs one of the largest HIV prevention pill programmes anywhere.
2.04 million people have started daily oral pre-exposure prophylaxis (PrEP) since 2016. But maintaining daily PrEP can be difficult for some people because of pill fatigue, stigma, competing demands and the need for regular access to healthcare. South Africa recorded approximately 150,000 new HIV infections in 2024, according to UNAIDS, with women and girls accounting for 59% of those infections.
Lenacapavir removes the daily requirement entirely: after two oral loading doses on days 1 and 2, a person needs only one follow-up injection every six months to stay protected.
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