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Gilead Sciences announced that its twice-yearly HIV prevention drug, Lenacapavir, has demonstrated a 96% reduction in HIV infections in its second pivotal Phase 3 trial, PURPOSE 2. The trial included men, transgender women, and non-binary individuals, following a previous trial in cisgender women. Lenacapavir showed superiority to daily Truvada, with only two infections among 2,180 participants, representing 99.9% effectiveness. As a result, Gilead has stopped the blinded phase of the trial and will offer Lenacapavir to all participants. The success of this trial positions Gilead to file for regulatory approval by the end of the year, potentially leading to a 2025 launch. However, there are concerns about the high cost of the drug, which may impact its accessibility. The announcement has boosted Gilead's stock, sending shares higher.
