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FDA Approves Six-Month HIV Prevention Injection After Zero-Infection Trials

Gilead plans a rapid US rollout with global distribution set to proceed despite President Trump’s proposed funding cuts

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Overview

  • Clinical trials in South Africa and Uganda found zero new HIV infections among participants receiving the twice-yearly injection compared with a 2 percent infection rate in daily oral PrEP users.
  • Yeztugo (lenacapavir) inhibits HIV at multiple stages of its lifecycle and shows no cross-resistance with existing antiviral classes.
  • The long-acting injection, named Discovery of the Year 2024 by Science, addresses adherence challenges posed by daily HIV-prevention pills.
  • Gilead has committed to a fast US launch and partnerships for wider distribution in high-prevalence regions, including sub-Saharan Africa and developing countries.
  • President Trump’s proposed federal funding cuts to HIV prevention programs could jeopardize rollout and research support critical to curbing the epidemic.