Gilead Sciences has revealed the preliminary results of the PURPOSE 2 study, a phase 3 clinical trial evaluating the efficacy of lenacapavir in HIV prevention. The data shows that administration of this drug twice a year reduced HIV infections by 96%, with only 2 incident cases among 2,180 participants. This research was conducted in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States.
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The independent Data Monitoring Committee (DMC) confirmed that the trial met its key efficacy criteria, demonstrating the superiority of lenacapavir against HIV and daily treatment with Truvada, which is used for pre-exposure prophylaxis (PrEP). Following these results, the DMC recommended that Gilead discontinue the blinded phase of the study and offer the drug to all participants.
"With such remarkable results in two phase 3 studies, lenacapavir has demonstrated the potential to transform HIV prevention," said Daniel O'Day, president and chief executive officer of Gilead. The company plans to submit regulatory documentation by the end of 2024, with hopes of launching the medication in 2025.
This is the second clinical trial supporting the efficacy of lenacapavir. In June 2024, the PURPOSE 1 study, focused on cisgender women in sub-Saharan Africa, also demonstrated significant efficacy. The combined results of both studies will be key in the global regulatory approval process.
Gilead has also announced its commitment to facilitating access to the drug in low- and middle-income countries. The company stated that it is negotiating voluntary licenses to allow the production of low-cost versions of lenacapavir, with the goal of reaching populations with the greatest need.
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