Large-scale clinical trials in Uganda and South Africa have shown that a novel pre-exposure prophylaxis (PrEP) medication administered twice a year can completely protect young women from HIV infection. The research, led by principal investigator Linda-Gail Bekker, compared the efficacy of two daily pills and an injection of lenacapavir in preventing HIV. The Purpose 1 trial involved 5,000 participants across three sites in Uganda and 25 in South Africa.What is LenacapavirLenacapavir, an inhibitor of the HIV capsid, is administered subcutaneously every six months. The trial, funded by Gilead Sciences, tested the safety and efficacy of lenacapavir against Truvada (F/TDF), a widely used daily PrEP pill, and Descovy (F/TAF), a newer daily pill with superior pharmacokinetics.Segregation of Participants and impactParticipants were randomized in a double-blind manner into three groups: lenacapavir, F/TAF, or F/TDF. The study targeted young women, who are highly vulnerable to HIV in eastern and southern Africa and often find it challenging to adhere to daily PrEP.Remarkably, none of the 2,134 women who received lenacapavir contracted HIV, demonstrating 100% efficacy. In contrast, 1.5% of the women on Truvada and 1.8% on Descovy contracted HIV. Based on these results, an independent data safety monitoring board recommended ending the trials blinded phase and offering participants a choice of PrEP.What do the various studies sayThe study underscores the potential of biannual injections to improve HIV prevention among young women, who may struggle with daily PrEP regimens due to structural and social barriers. Gilead Sciences plans to submit the trial results to regulators in Uganda, South Africa, and the World Health Organization. They also aim to license generic drug production to lower costs, potentially allowing governments to offer this effective prevention method widely. The World Health Organization will also review the data and may provide recommendations.
