The Food and Drug Administration on Wednesday approved Gilead’s twice-yearly antiviral injection for stopping HIV — a milestone that the corporate and a few experts say could help bring the world closer to ending the decadeslong epidemic brought on by the virus.
However the launch of the injectable drug, which will probably 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 able to virtually eliminating latest HIV infections when taken every six months. That is a less frequent dosage than for all existing HIV prevention medications, including every day pills from Gilead and one other injection, from GSK, taken every other month.
That makes Yeztugo a worthwhile and much more convenient tool for addressing an epidemic that led to around 1.3 million latest infections and contributed to the deaths of 630,000 people globally in 2023, in keeping with the World Health Organization.
The U.S. alone sees 700 latest 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’ve 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.”
However the magnitude of its impact can even rely on how easy it’s to get, said Jeremiah Johnson, executive director of PrEP4All, a corporation focused on expanding access to HIV prevention medications.
Pricing, access, efficacy
Lenacapavir, the generic name of Yeztugo, has an annual list price of $28,218 within the U.S. before insurance, a Gilead spokesperson said in an email. That’s according to existing branded medications approved for a similar use: pre-exposure prophylaxis, or PrEP, which reduces the chance of getting HIV.
A month’s supply of Truvada and Descovy, Gilead’s every day pills for PreP, are each around $2,000 without insurance, which amounts to around $24,000 per 12 months. One dose of GSK’s Apretude, which is taken once monthly for the primary two months after which once every other month thereafter, costs roughly $4,000 before insurance.
“We’re 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 may be broad insurance coverage for existing prevention options.
The corporate said it has a copay savings program for eligible insured patients which will 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 without spending a dime.
Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a price tag of greater than $42,200 per 12 months. One evaluation in 2024 found that the drug might be made for as little as $26 to $40 a 12 months.
Mizuho analysts have estimated that lenacapavir could reach peak sales of around $4 billion globally for each HIV prevention and treatment.
O’Day said the corporate can be committed to supplying the drug for that use globally because the virus “knows no boundaries.” Gilead in October granted licenses to 6 generic manufacturers to provide and sell lower-cost versions of the injection in 120 low- and lower-middle-income countries.
Gilead also promised to provide doses for as much as 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 shape of every day pills, but infections have climbed or remained roughly flat in lots of areas. Pills might be difficult for many individuals to take consistently for several reasons, including inconvenience and stigma around HIV and PrEP in lots of communities, particularly outside the demographic of white men who’ve sex with men.
Black Americans account for 39% of latest HIV diagnoses but only 14% of PrEP users, while Hispanic people represent 31% of latest diagnoses but just 18% of PrEP users, in keeping with 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 in terms of HIV prevention,” Johanna Mercier, Gilead’s chief industrial officer, said in an interview. “Getting a twice-a-year injection really gives you that privacy that individuals have been on the lookout for.”
She said Gilead goals to be certain that more people, especially those not currently using PrEP, are aware of that convenience advantage and the efficacy of the corporate’s injection.
In a single late-stage trial, 99.9% of patients who took Gilead’s injection didn’t contract an infection. There have been only two cases amongst greater than 2,000 patients, effectively reducing the chance of HIV infection by 96% and proving 89% simpler than Gilead’s every day pill Truvada. The study enrolled cisgender men, transgender women, transgender men and gender nonbinary individuals who’ve sex with partners assigned male at birth.
One other trial, on greater than 5,000 cisgender women, found that not one of the roughly 2,000 participants who received Gilead’s injection contracted an HIV infection, demonstrating 100% efficacy.
Proposed federal funding cuts pose a threat
Within the U.S., ensuring access to underserved populations can even require broad insurance coverage. Most PrEP users are under industrial plans, in keeping with the HIV+Hepatitis Policy Institute. However the federal Medicaid program can be crucial to reaching lower-income communities.
Medicaid is the biggest source of insurance coverage for individuals who have the virus within the U.S., covering an estimated 40% of nonelderly adults who’ve HIV, in keeping with health policy research organization KFF. That makes Republicans’ proposed funding cuts to Medicaid an enormous potential threat to HIV treatment and prevention access.
Mercier said that, as of now, Gilead believes that Medicaid will proceed to cover HIV services and support.
“There are pretty incredible programs on the market, not only Medicaid and other government programs, that actually have safety nets to make sure that that individuals who need or want access, each for HIV treatment and prevention, are arrange,” 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 instance, the White House’s proposed budget for fiscal 12 months 2026 includes deep cuts to several HIV prevention programs, particularly those which might be run through the CDC.
While some funding streams are continuing, Johnson said they’re doing so “in a way that will completely destabilize all the field of HIV prevention.”
He said if Congress doesn’t beat back on the White House’s proposed cuts, people currently taking PrEP “could begin to slip off” and HIV infections could rise in lots of communities.
