Gilead Sciences, Inc. announced that the New England Journal of Medicine (NEJM) has published full results from the company’s pivotal Phase 3 PURPOSE 2 trial, which evaluates twice-yearly lenacapavir in experimental HIV prevention use among a wide range of geographically diverse cisgender men and gender-diverse people. The study showed that lenacapavir given twice a year as part of pre-exposure prophylaxis (PrEP) was highly effective in reducing HIV infections, reducing them by 96% compared to baseline incidence. of HIV. There were two incident cases among the 2,179 participants, meaning that 99.9% of participants did not acquire HIV infection in the lenacapavir group.
Lenacapavir administered twice a year as part of PrEP also demonstrated superiority compared to Truvada administered once daily (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) as part of PrEP and was generally well tolerated, with no significant or new safety concerns identified. The high efficacy and tolerability of lenacapavir is consistent with previous results from the PURPOSE 1 trial, which demonstrated no infections and 100% efficacy for investigational use of lenacapavir in PrEP in cisgender women in sub-Saharan Africa. Data from PURPOSE 1 and PURPOSE 2 will serve as the basis for a series of marketing authorization applications for lenacapavir for the prevention of mother-to-child transmission globally, which will begin by the end of the year 2024.
The use of lenacapavir for HIV prevention is experimental, has not been found to be safe or effective, and is not approved anywhere in the world.
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