The U.S. Food and Drug Administration has approved a groundbreaking twice-yearly injection called Yeztugo (lenacapavir) for HIV prevention, developed by Gilead Sciences. This marks the first and only HIV prevention option administered just two times a year, offering a powerful new tool to combat the HIV epidemic.
A Game-Changer for HIV Prevention
Yeztugo, previously used to treat certain HIV infections, has shown remarkable results in preventing HIV. Clinical trials, including the PURPOSE 1 and PURPOSE 2 studies, demonstrated that lenacapavir reduced HIV infection risk by up to 96%, with one trial showing 100% efficacy in women. This outperforms existing pre-exposure prophylaxis (PrEP) options like daily Truvada pills or bimonthly Apretude injections.
Dr. Jared Baeten, Gilead’s senior vice president of clinical development, emphasized the drug’s convenience: “Lenacapavir allows people to receive a discreet injection twice a year, making HIV prevention simpler and more private.”
Overcoming Barriers
Unlike daily pills, which can cause side effects like upset stomach or be forgotten, Yeztugo’s twice-yearly schedule addresses adherence challenges and reduces stigma. Dr. Carlos del Rio from Emory University noted, “This could transform PrEP uptake by removing barriers like frequent dosing and stigma, especially for those on daily oral PrEP.”
Ian Haddock, a participant in the PURPOSE 2 trial and founder of the Normal Anomaly Initiative, shared his experience: “As someone who faced stigma growing up, being part of this trial felt like a full-circle moment. The injections were easy, with only minor irritation at the injection site.”
A Step Toward Ending HIV
The PURPOSE 2 trial, involving diverse groups including cisgender men, transgender individuals, and nonbinary people, showed lenacapavir was 89% more effective than Truvada, with only two infections among 2,180 participants. The drug was well-tolerated, with injection-site reactions being the most common side effect.
Gilead’s CEO, Daniel O’Day, called this a “milestone moment” in the fight against HIV, highlighting 17 years of research to deliver a prevention option with unmatched efficacy and convenience.
Availability and Pricing
Gilead expects Yeztugo to be available for prescription within days, though insurance coverage may take up to two months. The list price for lenacapavir as a prevention tool is yet to be announced but will differ from its cost for HIV treatment, which can reach $45,000 per year without insurance. Studies suggest mass production could lower costs to as little as $40-$93 annually with generic competition.
A Critical Time for HIV Prevention
This approval comes amid concerns over proposed budget cuts to HIV programs under the Trump administration, which could reduce funding by over $1.5 billion. Carl Schmid of the HIV+Hepatitis Policy Institute warned, “Cutting HIV prevention now would increase infections and costs in the future. We urge Congress to protect these vital programs.”
With about 1.2 million people living with HIV in the U.S. and 32,000 new cases annually, innovations like Yeztugo offer hope for a future without HIV. As Dr. Baeten said, “We want the next generation to see HIV as something they can end in their lifetime.”