Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir) as a pre-exposure prophylaxis (PrEP) to prevent sexually acquired HIV-1. This milestone makes Yeztugo the first and only FDA-approved HIV prevention treatment that requires just two injections per year, offering a long-acting option for adults and adolescents weighing at least 35kg.
The approval is based on compelling data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials. More than 99.9% of participants who received Yeztugo remained HIV negative, including zero infections in the PURPOSE 1 trial among cisgender women in sub-Saharan Africa and only two infections in the PURPOSE 2 trial, which included cisgender men and gender-diverse people. Yeztugo outperformed daily oral Truvada, the current standard, in preventing HIV across diverse populations.
“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, Gilead’s CEO. “Yeztugo represents a scientific breakthrough that could transform HIV prevention and bring us closer to ending the epidemic.”
Despite earlier PrEP options, uptake remains low. According to the CDC, only 36% of eligible individuals in the U.S. were prescribed PrEP in 2022. Barriers such as adherence challenges, stigma, and limited awareness continue to restrict access—especially among women, Black/African American and Hispanic/Latino communities, and those in the Southern U.S.
Experts believe Yeztugo’s twice-yearly dosing could improve persistence and uptake. “A long-acting injectable PrEP like Yeztugo could remove key barriers and be a game-changer,” said Dr. Carlos del Rio, a professor at Emory University. “Many people prefer less frequent dosing.”
Yeztugo was granted FDA approval under Priority Review and received Breakthrough Therapy Designation in October 2024. The drug showed a favorable safety profile, with no new safety concerns reported.
To ensure accessibility, Gilead plans to provide broad insurance coverage and support programs to reduce or eliminate out-of-pocket costs. Uninsured patients may qualify for free access through Gilead’s Advancing Access® program.
Gilead is also pursuing regulatory approval in multiple countries, including in Europe, South America, and Africa, with a focus on fast-tracking access where HIV burden remains high.
Though not a cure for HIV, Yeztugo offers a powerful new option in global HIV prevention efforts.