FDA announcements and press releases

Gilead's $GILD Twice-Yearly Lenacapavir Shows 96% Reduction in HIV Infections in Phase 3 Trial

Sep 12, 2024, 12:43 PM

Gilead Sciences ($GILD) has announced that its twice-yearly HIV prevention drug, Lenacapavir, has shown a 96% reduction in HIV infections in its second pivotal Phase 3 trial. The trial demonstrated the drug's superiority over the daily Truvada regimen. As a result of these positive interim results, Gilead has stopped the blinded phase of the trial and will offer Lenacapavir to all participants in an open-label phase. The trial, known as PURPOSE 2, met its key endpoints, showing significant efficacy in reducing HIV infections compared to the background HIV incidence. Notably, 99.9% of participants in the Lenacapavir group did not acquire HIV, with only 2 cases reported among 2,180 participants. Gilead's antiviral HIV prevention shot has demonstrated 96% efficacy.