FDA Approves Yeztugo (Lenacapavir), Twice-a-Year Shot for HIV Prevention

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On June 21, 2025

People at risk of contracting HIV through sexual contact have a groundbreaking new option to protect themselves: The U.S. Food and Drug Administration (FDA) approved Yeztugo (lenacapavir), the first and only twice-yearly injectable HIV prevention medication for adults and adolescents who weigh at least 77 pounds. Studies have shown the new drug to be more than 99.9 percent effective at preventing HIV.

Yeztugo offers an alternative to the current regimens available for PrEP (pre-exposure prophylaxis) that people use to prevent HIV, in the form of daily pills or every-other-month injections.

The twice-a-year formulation and the approval are both “really, really exciting,” says

Matthew Hamill, MBChB, PhD, an associate professor of medicine and infectious disease doctor at Johns Hopkins Medicine in Baltimore.

“I speak not only for myself, but also for many of my colleagues in the field. And lots of my patients have been asking me: ‘When can I get the twice yearly injection?’ This approval is completely game-changing,” says Dr. Hamill, who wasn’t involved in the development of Yeztugo.

The Most Effective HIV Prevention Medication to Date

Yeztugo’s approval was based on data from two pivotal phase 3 trials, PURPOSE 1 and PURPOSE 2.

In the PURPOSE 1 trial, which included more than 5,000 cisgender women in sub-Saharan Africa, no participants who received Yeztugo acquired HIV — an impressive 100 percent reduction.

Similarly, in the PURPOSE 2 trial of more than 3,000 men who have sex with men and gender-diverse individuals, only two HIV cases occurred among Yeztugo recipients, translating to a 99.9 percent protection rate.

“I think there’s no question that this is the most effective medication we have to date,” says Hamill.

In Clinical Trials, Yeztugo Was Safe and Had No Significant Side Effects

The medication received Priority Review and was granted Breakthrough Therapy designation by the FDA in 2024, which helps expedite the development of drugs that show substantial improvements over existing treatments.

Yeztugo was generally well tolerated in clinical trials. The most frequently reported side effects were mild to moderate injection site reactions, including nodules (lumps) and localized pain.

Scientists observed no significant or unexpected safety issues.

New Option Could Particularly Help People of Color

The FDA approved the first HIV prevention drug, the daily pill Truvada (also developed by Gilead), in 2012. But the most recent data shows that only about 1 in 3 people in the United States who could benefit from PrEP were prescribed an HIV prevention treatment.

Research suggests that stigma around HIV, low awareness of medication options, and the daily pill burden continue to limit PrEP use, especially among women, Black and Latino Americans, and people living in the Southern United States.

That’s why many people — experts and at-risk individuals — hope Yeztugo will address these barriers.

That includes Ian L. Haddock, a participant in the clinical trials for Yeztugo. Haddock is the founder of the Normal Anomaly Initiative, a nonprofit focused on empowering Black queer communities in the South.

As a Black gay man, Haddock understands many of the challenges of HIV prevention, including the inherent mistrust many Black Americans feel towards the medical community due to past harms.

Additionally, many of the people who could benefit the most from advancements like PrEP aren’t aware of these new opportunities, he says.

“I know that if the community can access this information, it will revolutionize how people approach prevention,” says Haddock.

Globally, Yeztugo Puts Women in Control

Results from the trial in cisgender women are especially notable because historically, trials in women in Africa have yielded disappointing results, says Hamill. That’s been mostly driven by poor adherence to the preventative medications, caused by many complex reasons, he says.

Yeztugo removes those challenges, says Hamill. “It takes away needing to hide your pills from your partner, if you’re worried that your partner might be abusive if he finds out you’re using PrEP. It removes the stigma of carrying medications that people know are part of HIV treatment.”

“I would compare this to injectable contraceptives. Women are in control — no one needs to know, and it gives them more autonomy,” he says.

Will People in the U.S. and Around the World Be Able to Get the New Drug?

Yeztugo will cost $14,109 per injection, or $2,352 per month, per USA Today, which means cost could be a hurdle.

In the United States, Gilead’s access strategy is designed to enable broad availability for people with and without insurance coverage, says a company spokesperson.

“It will be priced in line with existing branded HIV prevention options, and we expect to see high levels of coverage for it,” they say.

For eligible individuals with commercial insurance, there’s a copay savings program that may reduce out-of-pocket costs to as little as zero dollars, says the Gilead spokesperson, and eligible uninsured individuals may be able to get Yeztugo free of charge through Gilead’s Advancing Access Patient Assistance Program.

Whether people around the world will have access to Yeztugo is “the million dollar question,” says Hamill.

This medication has the potential to end the HIV epidemic globally — but pricing will be a big factor in making that a reality, he says.

Through a variety of channels, including providing the drug to some high-incidence countries without seeking profit, the company aims to reach two million people globally over three years, the Gilead spokesperson says.