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FDA Approves Gilead’s Lenacapavir for HIV Prevention

By Drooid · · How we work

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Story summary
  • Gilead Sciences received FDA approval for lenacapavir as HIV prevention in June 2025.
  • A 2024 trial of 2,000 South African and Ugandan women recorded zero HIV infections with lenacapavir.
  • The World Health Organization recommended the long-acting injectable as an additional pre-exposure prophylaxis option.
  • Gilead aims to provide lenacapavir for up to three million people through 2028, with generic rollout in 2027.