Gilead Sciences, announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir), making it the first and only twice-yearly injectable pre-exposure prophylaxis (PrEP) available in the United States for preventing sexually acquired HIV. Approved for adults and adolescents weighing at least 35 kg, Yeztugo offers a groundbreaking option for people who need or prefer less frequent dosing. In Phase 3 PURPOSE 1 and PURPOSE 2 trials, over 99.9% of participants who received Yeztugo remained HIV-negative.
“This marks a historic milestone in the ongoing fight against HIV,” said Daniel O’Day, Chairman and CEO of Gilead Sciences. “Yeztugo represents one of the most significant scientific advancements in HIV prevention. With just two doses a year and outstanding clinical outcomes, it has the potential to transform HIV prevention efforts and bring us closer to ending the epidemic.”
Although Gilead introduced the first PrEP medication in 2012, uptake remains limited. According to the CDC, in 2022 only 36% of Americans eligible for PrEP received a prescription. Certain populations—including women, Black/African American and Hispanic/Latino individuals, and residents of the U.S. South—continue to experience particularly low uptake due to barriers such as stigma, adherence challenges, and limited awareness. In 2023, more than 100 people were diagnosed with HIV each day in the U.S., highlighting the urgent need for more effective and accessible prevention options.
“Yeztugo could be the breakthrough we’ve been waiting for,” said Dr. Carlos del Rio, Distinguished Professor at Emory University School of Medicine. “A twice-yearly injection could significantly address major barriers like adherence and stigma faced by individuals on daily oral PrEP regimens.”
The FDA’s approval was based on robust data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials. In PURPOSE 1, conducted among cisgender women in sub-Saharan Africa, no HIV infections were reported among 2,134 participants receiving Yeztugo, demonstrating complete prevention compared to daily oral Truvada®. In PURPOSE 2, involving a diverse population of cisgender men and gender-diverse individuals, only two HIV infections occurred among 2,179 Yeztugo recipients, yielding a 99.9% prevention rate. Yeztugo showed superiority over Truvada and was well-tolerated in both trials. These results were published in The New England Journal of Medicine, and Science recognized lenacapavir as its 2024 "Breakthrough of the Year."
Gilead is pursuing broad insurance coverage for Yeztugo and offers financial support programs to minimize patient costs. For uninsured individuals in the U.S., the company’s assistance program will provide free access to eligible patients. Regulatory filings are also underway in multiple countries worldwide, including Australia, Brazil, Canada, South Africa, and throughout Europe.
Currently, lenacapavir for HIV prevention is approved only in the United States.