US FDA approves Gilead's twice-yearly injection for HIV prevention
UNITED STATES, JUN 20 – Clinical trials showed lenacapavir reduced HIV infections by more than 99.9% and offers a convenient twice-yearly dosing option to improve prevention adherence, experts say.
- The FDA approved Yeztugo, the world's first twice-yearly injectable drug to prevent HIV infection, on Wednesday, June 18, 2025.
- The approval comes after clinical trials demonstrated that lenacapavir, the active ingredient in Yeztugo, completely prevented HIV infection with just two doses administered annually.
- Yeztugo offers a more convenient alternative to daily oral PrEP, addressing adherence barriers especially for patients facing stigma or who struggle with daily dosing.
- Kevin Frost of amfAR noted that offering a PrEP injection twice a year instead of a daily pill could significantly improve adherence over time for many individuals, while Carlos del Rio described Yeztugo as a groundbreaking PrEP option with the potential to increase usage and support efforts to end the HIV epidemic.
- Experts and advocates highlight that Yeztugo could significantly reduce new HIV infections if made affordable and accessible, though cost and insurance coverage remain challenges.
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