Lenacapavir, a twice-a-year injection by Gilead, gains FDA approval as a groundbreaking HIV prevention method with 96% efficacy.
Landmark FDA Decision Expands HIV Prevention Options
In a major public health development, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences’ lenacapavir injection, branded as Yeztugo, for HIV prevention on Wednesday. This biannual injectable marks the first and only HIV prevention option that requires just two doses per year.
Clinical Trials Show Exceptional Protection
The drug’s approval follows robust results from the PURPOSE 1 and 2 trials. Lenacapavir reduced HIV infection risk by 96% in at-risk populations and demonstrated 100% efficacy among women in one study. Compared to existing PrEP methods like daily oral Truvada or bimonthly Apretude shots, Yeztugo offers superior protection with far less frequent dosing.
A Discreet and Empowering Solution
Public health experts say lenacapavir may be a game-changer, especially for communities facing stigma or challenges with daily medication adherence. “A twice-yearly injection could greatly address key barriers like adherence and stigma,” said Dr. Carlos del Rio of Emory University. The injection’s long-acting nature offers privacy, convenience, and continuity for users seeking discreet protection.
Growing HIV Prevention Toolbox
HIV, primarily transmitted through unprotected sex or shared needles, still affects 1.2 million people in the U.S., with 13% unaware of their infection. With the addition of lenacapavir to prevention tools, health professionals hope to accelerate progress toward ending the HIV epidemic, particularly among marginalized and high-risk groups.
Real Stories Show Impact Beyond Data
Ian Haddock, a participant in the PURPOSE 2 trial, shared how the drug helped him avoid the side effects and inconsistency of daily PrEP pills. “I want this next generation to think about HIV as something they can end in their lifetime,” he said. Now the head of a nonprofit tackling HIV stigma, Haddock calls the drug’s approval a deeply personal and cultural milestone.
Pricing and Access Yet to Be Finalized
While the approval is effective immediately, it may take up to two months for providers to administer the first doses based on insurance and coverage processes. Pricing details are still pending. For treatment use, lenacapavir has cost up to $45,000 annually, but researchers estimate it could be produced for under $100 a year with broader licensing and competition.
Approval Comes Amid Budget Cuts
The breakthrough comes at a time when federal HIV funding faces steep proposed cuts under the 2026 budget. Advocacy groups warn that slashing CDC programs would jeopardize the very tools needed to leverage advancements like lenacapavir. “Now is not the time to pull the rug out from under HIV prevention,” said Carl Schmid of the HIV+Hepatitis Policy Institute.
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