On July 25, the European Medicines Agency advisory committee endorsed Gilead Sciences’ Lenacapavir, a twice-yearly injection, to prevent HIV in adults and adolescents. The European Commission is expected to grant formal approval later this year. The decision follows the U.S. FDA’s authorization of the HIV-1 capsid inhibitor as pre-exposure prophylaxis on June 18, 2025.
The World Health Organization welcomed the FDA decision on June 19 and released usage guidelines on July 14. The guidelines note that more PrEP options could boost uptake and overall HIV prevention by letting users select preferred methods. Trials also indicate Lenacapavir can produce strong viral suppression even when other treatments have failed.
The FDA approval rests on 2024 data from the PURPOSE 1 and PURPOSE 2 trials, which confirmed safety and efficacy across varied groups. PURPOSE 1, a Phase 3 study, enrolled 5,338 cisgender women and girls aged 16-25 at 25 South African and three Ugandan sites. No infections occurred among 2,134 participants given Lenacapavir, versus 39 infections in the group receiving daily oral Truvada.
PURPOSE 2 involved 3,265 participants across Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States. Two infections were recorded in the Lenacapavir arm and nine in the Truvada arm. Background incidence was 2.37 per 100 person-years.
Lenacapavir costs $28,000 for two doses, far more than generic oral PrEP. Experts note that daily pills require perfect adherence, which is rarely achieved. Long-acting injectables such as Lenacapavir, effective for six months, address adherence gaps. Earlier twice-monthly cabotegravir showed similar benefits but demands more frequent dosing.
