FDA approves Gilead's twice-yearly HIV prevention injection, offering a powerful and convenient new option
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 decades-long epidemic caused by the virus.
But the launch of the injectable drug, lenacapavir, 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 last year, Gilead's injection proved to be capable of virtually eliminating new HIV infections when taken every six months. Patients take it less frequently than all existing HIV prevention medications, including daily pills from Gilead and another injection from GSK received every other month.
That makes lenacapavir 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 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.
Gilead did not immediately share how much the injection will cost under its new use: pre-exposure prophylaxis, or PrEP, which reduces the risk of getting HIV. Mizuho analysts have estimated that lenacapavir could reach peak sales of around $4 billion globally for both HIV prevention and treatment.
In a statement ahead of the approval, Gilead said the pricing of lenacapavir for HIV prevention will be in line with existing branded PrEP options. A month's supply of Truvada and Descovy, Gilead's daily pills for PreP, are both around $2,000 without insurance. 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.
The company is also committed to supplying the drug for that use globally as the virus "knows no boundaries," O'Day said. 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.
"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 efficacy of the company's injection.
In one late-stage trial, 99.9% of patients who took Gilead's injection did not contract an infection. There were only two cases among more than 2,000 patients, effectively reducing the risk of HIV infection by 96% and proving 89% more effective than Gilead's daily pill Truvada. The study enrolled cisgender men, transgender women, transgender men and gender nonbinary individuals who have sex with partners assigned male at birth.
Another trial on cisgender women found that none of the participants who received Gilead's injection contracted an HIV infection, demonstrating 100% efficacy.
In the U.S., ensuring access to underserved populations will also require broad insurance coverage. While most PrEP users are under commercial plans, the federal Medicaid program is also crucial to reaching lower-income communities.
Medicaid is the largest source of insurance coverage for people who have the virus in the U.S., covering an estimated 40% of nonelderly adults with HIV, according to health policy research organization KFF. That makes Republicans' proposed funding cuts to Medicaid a huge potential threat to HIV treatment and prevention access.
Mercier said, as of now, Gilead believes that Medicaid will continue to cover HIV services and support.
"There are pretty incredible programs out there, not only Medicaid and other government programs, that really have safety nets to make sure that people who need or want access, both for HIV treatment and prevention, are set up," she said, also pointing to Gilead's programs for uninsured individuals.
But PrEP4All's Johnson said the "entire foundation for HIV prevention in America is under attack at this moment."
Other proposed federal funding cuts could make it harder to get Gilead's injection into the hands of physicians and patients, Johnson said. For example, the White House's proposed budget for fiscal year 2026 includes deep cuts to several HIV prevention programs, particularly those run through the CDC.
While some funding streams are continuing, Johnson said they are doing so "in a way that would completely destabilize the entire field of HIV prevention."
He said if Congress does not push back on the proposed cuts, people currently taking PrEP "could start to slip off" and HIV infections could rise in many communities.
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