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A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

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Trial Profile

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2026

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At a glance

Most Recent Events

  • 21 Jul 2026 According to a Gilead Sciences media release, data from the trial will be presented at the 26th International AIDS Conference (AIDS 2026) taking place in Rio de Janeiro, Brazil, from July 26-31.
  • 21 Jul 2026 Results presented in the Gilead Sciences Media Release
  • 15 Jun 2026 According to a Gilead Sciences media release, company announced the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Yeztugo (lenacapavir) 300-mg tablet for the prevention of HIV as pre-exposure prophylaxis (PrEP). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027.

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