Gilead Sciences, Inc. (GILD), Wednesday announced full efficacy and safety results from its pivotal, Phase 3 PURPOSE 1 trial with lenacapavir, the company's twice-yearly injectable HIV-1 capsid inhibitor.
The detailed data from the trial's interim analysis announced in June showed that lenacapavir demonstrated zero infections, 100% efficacy and superiority to background HIV incidence for the investigational use of HIV prevention in cisgender women, i.e., women assigned female at birth.
Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg).
The company now said the new data provide details on the efficacy, safety and tolerability of twice-yearly lenacapavir injections; as well as drug adherence among trial participants; and demographic and behavioral characteristics of trial participants, including pregnant women and adolescents.
The data are being presented at a special late-breaking session at the 25th International AIDS Conference, AIDS 2024, in Munich, Germany.
The results were published in The New England Journal of Medicine.
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