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FDA Approves Groundbreaking Twice-Yearly HIV Prevention Shot
The U.S. Food and Drug Administration (FDA) has approved a groundbreaking new injectable drug, Yeztugo (lenacapavir), to prevent HIV in at-risk adults and adolescents. This first-of-its-kind shot, developed by Gilead Sciences, is administered twice a year and marks a significant advancement in HIV prevention.
Gilead’s chairman and CEO, Daniel O’Day, hailed the FDA approval as a “historic day” in the fight against HIV. The company highlighted the drug’s “remarkable outcomes” in clinical trials, suggesting it could revolutionize HIV prevention.
Last year, large-scale trials demonstrated Yeztugo’s near-perfect effectiveness, surpassing the performance of daily oral medications like Gilead’s own Truvada. The scientific journal Science even recognized lenacapavir as its 2024 “Breakthrough of the Year.”
Yeztugo’s unique mechanism of action sets it apart from other antivirals. While most target a single stage of viral replication, lenacapavir inhibits HIV at multiple stages of its life cycle. Before starting treatment, individuals must test negative for HIV-1.
The most common side effects reported during trials included injection site reactions, headaches, and nausea.