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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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World first • Can replace daily pills
US approves twice-yearly injection for HIV prevention – what you need to know about lenacapavir
Taking a blood sample for an HIV test. Ulrich Doering / Alamy Stock Photo by Andrew Owen, University of Liverpool The US Food and Drug Administration (FDA) has approved lenacapavir, an injectable drug that offers long-lasting protection against HIV infection. Administered once every six months, this new treatment marks a major advancement in expanding prevention options … Continued
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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…
US approves twice-yearly injection for HIV prevention – what you need to know about lenacapavir
The US Food and Drug Administration (FDA) has approved lenacapavir, an injectable drug that offers long-lasting protection against HIV infection. Administered once every six months, this new treatment marks a major advancement in expanding prevention options for people at risk of HIV infection. Most HIV prevention drugs are daily pills (known as PrEP), which many people struggle to take regularly for various reasons, including inconvenience, pri…
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