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• Posted June 20, 2025

FDA Approves First Twice-a-Year HIV Prevention Shot

FRIDAY, June 20, 2025 (HealthDay News) — A new shot to prevent HIV infection has just been approved — and it only needs to be taken twice a year.

On Wednesday, the U.S. Food and Drug Administration (FDA) approved lenacapavir, a long-acting injection that was shown to be nearly 100% effective in clinical trials.

Made by Gilead Sciences and sold under the name Yeztugo, the drug gives people a new way to stay protected from HIV without needing daily pills or frequent injections, The New York Times reported.

“We’re on the precipice of now being able to deliver the greatest prevention option we’ve had in 44 years of this epidemic,” Mitchell Warren, head of the international HIV prevention group AVAC, said.

But there’s a catch: Global health funding is shrinking and many programs that would normally provide the shot in low-income countries are now being cut. That could limit access in the places that need it most.

Lenacapavir is the second long-acting drug approved to prevent HIV. The first, Apretude, is given every two months and is used by about 21,000 Americans. By comparison, nearly 500,000 people take daily pills to prevent HIV.

Experts say a twice-yearly shot could transform HIV prevention — especially for people who struggle to take pills every day or keep up with frequent medical visits.

In a clinical trial, participants who received just two shots a year were almost completely protected from HIV, The Times said.

Gilead says the list price for Yeztugo will be $28,218 per year, though most people are not expected to pay that full amount. Insurance and Medicaid will likely help cover the cost.

For comparison, daily HIV prevention pills can cost as little as $1 per dose when bought as generics. Apretude, the other long-term option, costs about $24,000 per year.

Some people are worried that access to the new shot could still be limited.

“In the U.S., we’re anticipating that history will repeat itself with lenacapavir, with widespread access being thwarted by many of the same pricing and coverage nightmares we saw with the launch of daily oral PrEP and Apretude,” Jeremiah Johnson, executive director of PrEP4All, told The Times.

Cuts to Medicaid and other federal programs could also keep the shot out of reach for many Americans at the highest risk of infection.

Globally, 1.3 million people were newly infected with HIV in 2023, according to the latest estimates. But getting lenacapavir to low- and middle-income countries may take time.

Gilead says it will provide the drug at no-profit pricing for up to 2 million people in low-income countries until local manufacturers are ready to take over in two to three years. The company said last year that it would allow six companies worldwide to make and sell it in 120 low-income nations.

However, many middle-income countries — like Brazil, which sees a high number of new infections — are not yet included in that deal.

“This is a profound barrier to access and means millions of people will be consigned to second-class PrEP that science has shown us does not work for them,” said Asia Russell, executive director of Health Gap, a nonprofit focused on HIV advocacy.

In the United States alone, more than 39,000 people were newly infected with HIV in 2023, The Times reported. 

And each infection resultws in an estimated $1.1 million in lifetime medical costs,  Gilead CEO Daniel O’Day said.

The Trump administration also recently paused funding for PEPFAR, a key global program that supports HIV treatment and prevention. Although some treatment funds were restored, prevention efforts are still unfunded.

“Prevention just feels hugely at risk writ large,” Dr. Linda-Gail Bekker, who led a clinical trial of the drug, said. “If we don’t prevent this epidemic, it will just drag on and on and on.”

More information

The National Institutes of Health has more on HIV prevention.

SOURCE: The New York Times, June 18, 2025