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FDA Approves Breakthrough HIV Drug, but It Could Be Hard to Access

Learn more about lenacapavir, the most effective HIV treatment and prevention drug, and how its cost could cause a setback.

ByMonica Cull
(Image Credit: Billion Photos/Shutterstock) Billion Photos/Shutterstock

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In 2022, the Food and Drug Administration (FDA), along with other health organizations, approved the drug lenacapavir as a groundbreaking HIV/AIDS treatment. The FDA, as of June 18, 2025, has now approved the drug as an HIV preventive, or HIV pre-exposure prophylaxis (PrEP).

In a 2024 clinical trial, lenacapavir had a 100 percent success rate at preventing HIV transmission with only two injections per year.

“PrEP is one of the most indispensable tools we have for ending the HIV epidemic. Having the option of a twice-annual shot, rather than relying on a daily pill, will make long-term adherence to PrEP much easier for many,” said Kevin Robert Frost, the CEO of the American Foundation for AIDS Research (amfAR) in a press release. “But this remarkable drug will only be as effective as it is accessible and affordable. amfAR calls on Gilead Sciences and the U.S. Government to do everything in ...

  • Monica Cull

    A graduate of UW-Whitewater, Monica Cull wrote for several organizations, including one that focused on bees and the natural world, before coming to Discover Magazine. Her current work also appears on her travel blog and Common State Magazine. Her love of science came from watching PBS shows as a kid with her mom and spending too much time binging Doctor Who.

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