In this article, Gilead announced that its twice-yearly shot reduced HIV infections by 96% in a second large study. The positive phase-three trial data on lenacapavir paves the way for probable approval by the U.S. Food and Drug Administration for HIV prevention. Gilead’s CEO, Daniel O’Day, stated that with a comprehensive dataset, the company will collaborate urgently with regulatory, government, public health, and community partners to ensure global delivery of twice-yearly lenacapavir for PrEP.
Pre-exposure prophylaxis (PrEP) is a medication used to prevent HIV transmission, as per the Centers for Disease Control and Prevention. Gilead’s shares rose over 1% following the announcement. The company reported that 99.9% of participants who received lenacapavir did not contract HIV, with only two cases among 2,180 individuals. The trial encompassed various gender identities and sexual orientations.
In comparison, there were nine HIV cases among a group of over 1,000 individuals assigned to receive Truvada, Gilead’s older daily pill for prevention and treatment. Gilead stated that lenacapavir was 89% more effective than Truvada in the study. Both lenacapavir and Truvada were well-tolerated by patients without new safety concerns. Gilead plans to present detailed data at an upcoming medical conference.
In a separate late-stage trial involving cisgender women, Gilead reported that lenacapavir was 100% effective at preventing HIV. None of the approximately 2,000 women who received the shot had contracted HIV by the time of an interim analysis in September 2023. Analyst Michael Yee from Jefferies noted that the data on lenacapavir is consistent and solid across both studies and populations. Yee predicted that the trial results would lead to FDA approval and market launch by 2025.
