FDA approves Gilead HIV prevention injection lenacapavir

The Food and Drug Administration on Wednesday approved Gilead’s twice-yearly antiviral injection for preventing HIV — a milestone that the company and some experts say could help bring the world closer to ending the decadeslong epidemic caused by the virus. 

But the launch of the injectable drug, which will be marketed under the name Yeztugo, faces a set of potential threats, including the Trump administration’s proposed cuts to federal funding for HIV prevention efforts. 

In two groundbreaking clinical trials in 2024, Gilead’s injection proved to be capable of virtually eliminating new HIV infections when taken every six months. That’s a less frequent dosage than for all existing HIV prevention medications, including daily pills from Gilead and another injection, from GSK, taken every other month. 

That makes Yeztugo a valuable and far more convenient tool for addressing an epidemic that led to around 1.3 million new infections and contributed to the deaths of 630,000 people globally in 2023, according to the World Health Organization. 

The U.S. alone sees 700 new cases and 100 HIV-related deaths each week, Gilead CEO Daniel O’Day said in an interview ahead of the approval. HIV continues to have a disproportionate impact on people of color, gay and bisexual men, other men who have sex with men and transgender women.

“It’s hard to overstate the importance of this for global public health,” O’Day said, adding that the injection “really will bend the arc of the epidemic as we roll this out across the globe.”

But the magnitude of its impact will also depend on how easy it is to get, said Jeremiah Johnson, executive director of PrEP4All, an organization focused on expanding access to HIV prevention medications. 

Lenacapavir, the generic name of Yeztugo, has an annual list price of $28,218 in the U.S. before insurance, a Gilead spokesperson said in an email. That is in line with existing branded medications approved for the same use: pre-exposure prophylaxis, or PrEP, which reduces the risk of getting HIV. 

A month’s supply of Truvada and Descovy, Gilead’s daily pills for PreP, are both around $2,000 without insurance, which amounts to around $24,000 per year. One dose of GSK’s Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance.

“We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage,” the Gilead spokesperson said, adding that there is broad insurance coverage for existing prevention options.

The company said it has a copay savings program for eligible insured patients that may reduce out-of-pocket payments for Yeztugo to as little as zero dollars. Gilead also has a program for eligible uninsured people to receive the injection for free.

Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a price tag of more than $42,200 per year. One analysis in 2024 found that the drug could be made for as little as $26 to $40 a year.

Mizuho analysts have estimated that lenacapavir could reach peak sales of around $4 billion globally for both HIV prevention and treatment.

O’Day said the company is also committed to supplying the drug for that use globally as the virus “knows no boundaries.” Gilead in October granted licenses to six generic manufacturers to produce and sell lower-cost versions of the injection in 120 low- and lower-middle-income countries.

Gilead also promised to supply doses for up to 2 million people at no profit before those generic versions come to the market, O’Day said. 

PrEP has been available for a decade in the form of daily pills, but infections have climbed or remained roughly flat in many areas. Pills can be difficult for many people to take consistently for several reasons, including inconvenience and stigma around HIV and PrEP in many communities, particularly outside the demographic of white men who have sex with men.

Black Americans account for 39% of new HIV diagnoses but only 14% of PrEP users, while Hispanic people represent 31% of new diagnoses but just 18% of PrEP users, according to AIDSVu, a public resource for HIV surveillance data from Gilead in partnership with Emory University’s Rollins School of Public Health.

“Unfortunately, there’s still enormous amount of stigma and cultural challenges when it comes to HIV prevention,” Johanna Mercier, Gilead’s chief commercial officer, said in an interview. “Getting a twice-a-year injection really gives you that privacy that people have been looking for.”

She said Gilead aims to ensure that more people, especially those not currently using PrEP, are aware of that convenience advantage and the efficacy of the company’s injection.

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