The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Yeztug (lenacapavir), an injectable HIV-1 capsid inhibitor, for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35 kg.
This is the first and only twice-yearly PrEP option available in the United States for individuals who need or prefer this form of prevention.
Data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials show that 99.9% of participants who received Yeztug remained HIV negative, making it functionally akin to a powerful vaccine.
“This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.
“This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV, and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”
FDA Approves Yetzugo Lenacapavir Twice-Yearly HIV Injection
The FDA approved Yeztugo based on results from two major clinical trials conducted by Gilead.
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In the first trial, none of the 2,134 women in sub-Saharan Africa who received Yeztugo got HIV. The injection worked better than the daily PrEP pill called Truvada.
In the second trial, only 2 out of 2,179 people who got Yeztugo got HIV. This means 99.9% of them stayed HIV negative. The trial included men and gender-diverse people from different regions. Yeztugo also worked better than daily Truvada in this group.
In both trials, Yeztugo was more effective than what researchers expected based on normal HIV infection rates. It was also safe and well-tolerated, with no major side effects.
The results from both trials were published in The New England Journal of Medicine. In December 2024, the journal Science named lenacapavir (Yeztugo’s main ingredient) the “Breakthrough of the Year.”
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Safety Information for Yetzugo
Individuals must be tested for HIV-1 infection prior to initiating Yeztugo. Each subsequent injection of Yeztugo will use a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection.
Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed.
Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen.
In October, Gilead made deals with six drug companies to make and sell cheaper versions (generics) of Yeztugo in 120 low- and middle-income countries, once they get government approval.
Since it will take time to start making the drug in those countries, Gilead also made another deal in December with the Global Fund, a health partnership set up by the United Nations, PEPFAR (a U.S. government HIV program), and others. This deal is meant to provide the drug for two million people.
However, budget cuts to PEPFAR during President Donald Trump’s time in office have created uncertainty about whether this plan will continue.
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