Twice a year, a clinic worker gives an injection, and that is all the protection some people at risk of HIV will need. The FDA approved that option on Wednesday, Gilead Sciences said. The drug is Yeztugo, whose generic name is lenacapavir.
“This is a historic day in the fight against HIV,” Gilead chairman and CEO Daniel O’Day said. He suggested the drug could “end the HIV epidemic once and for all.”
What the trials found
Gilead tested Yeztugo against daily Truvada pills, the standard form of pre-exposure prophylaxis, or PrEP. Among gay and bisexual men and transgender people, the Yeztugo group had an 89% lower HIV rate than the Truvada group. Against the rate Gilead estimated would have occurred with no PrEP at all, the drop was 96%.
A second trial enrolled cisgender women in sub-Saharan Africa. No one who got the shots became infected.
Mitchell Warren, executive director of the advocacy group AVAC, called it “the single best opportunity in 44 years of HIV prevention.”
Lenacapavir is the first of a new class of antiretrovirals. It blocks HIV from infecting immune cells and from making new copies of itself. It was first approved in 2022, under the name Sunlenca, to treat highly drug-resistant HIV alongside other medicines. The new approval covers prevention.
The price question
Cost may be the biggest hurdle. Yeztugo lists at $14,109 per injection, or $2,352 per month. A generic version of Truvada can cost as little as $30 a month. Elizabeth Kaplan, a director at Harvard Law School’s Health Law and Policy Clinic, said insurers might decline to cover the shots at first or charge higher copays.
Gilead said it will cover up to $7,200 a year in out-of-pocket costs for insured patients, and its assistance program will supply the drug free to low-income people without insurance. Johanna Mercier, the company’s chief commercial officer, said Gilead has been pressing insurers for coverage and expects it to become widespread.
A Gilead spokesperson said patients should be able to ask providers for the drug within two days. Getting the first injection could take up to two months.
Who it could reach
Daily pills have worked unevenly. Truvada, approved in 2012, and Descovy, approved in 2019, each cut HIV risk by at least 99% when taken daily. Missed doses weaken that protection. Black and Latino gay men face much higher HIV rates than white gay men, yet PrEP use among men of color remains disproportionately low.
Dr. Susanne Doblecki-Lewis, an infectious disease chief at the University of Miami Miller School of Medicine, helped run the lenacapavir trial in gay men. She said the drug could narrow racial disparities if it is “available easily and at low or no cost.” If patients hit “complicated prior authorizations or high copays,” she said, “we could see disparities just get worse.”
Federal budget fights add to the doubt. The Trump administration’s 2026 budget request seeks a $1.5 billion, or 35%, cut to domestic HIV funding, including closing the CDC’s $794 million HIV-prevention division.
Mistr, a PrEP telehealth company, said it plans to offer Yeztugo right away through its storefronts in seven major urban gay neighborhoods.
Sources
- FDA approves Yeztugo: Gilead's new twice-yearly HIV prevention injection | The Jerusalem Post
- FDA approves powerful HIV drug that nearly eliminated spread in clinical trials
