US FDA approves Gilead's twice-yearly injection for HIV prevention
- On June 18, 2025, the U.S. FDA authorized Gilead Sciences' lenacapavir, marketed as Yeztugo, as the first injectable HIV preventive treatment administered twice yearly for adults and adolescents who are vulnerable to sexually transmitted HIV-1 infection.
- This approval follows two Phase 3 clinical trials showing Yeztugo's superior effectiveness over daily oral PrEP drugs like Truvada and Descovy, with no HIV infections in the injection group compared to 2% infections in the pill group.
- Yeztugo works by inhibiting the virus’s capsid through subcutaneous injection twice a year, which could improve adherence and reduce stigma linked to daily oral PrEP, while Gilead sets a U.S. list price of $28,218 annually for the drug.
- Gilead has signed agreements with generic manufacturers to supply low-cost versions to 120 low-income countries and plans to produce shots for 2 million people at no profit until generics arrive, though accessibility concerns and high costs remain key challenges.
- Experts emphasize that Yeztugo could boost global HIV prevention efforts by addressing adherence barriers, but existing health system gaps and funding cuts may limit its impact despite its potential to help end the HIV epidemic.
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FDA Approves First And Only Twice-Yearly PrEP Option
Source: YakubovAlim / Getty It has been a very long journey in the ongoing fight to end the HIV/AIDS epidemic, and now it appears we might be one step closer towards our goal with the FDA approval of Yeztugo. According to a new report by Gilead Sciences, Yeztugo (lenacapavir) will be the first and so far only option that gives people who need or want PrEP the option of injecting only twice a year. READ MORE STORIES FDA Approves First And Only Tw…
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U.S. approves first-ever biannual shot to prevent HIV, but getting it might be hard
WASHINGTON — The U.S. has approved the world’s only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions – although it’s unclear how many in the U.S. and abroad will get access to the powerful new option.
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