The decades-long global fight against HIV may be nearing a turning point following the U.S. Food and Drug Administration’s (FDA) approval of Gilead Sciences’ new HIV prevention injection, a major advancement experts believe could dramatically curb new infections worldwide.
The drug, Yeztugo (generic name: lenacapavir), was approved on Wednesday for twice-yearly use as a pre-exposure prophylaxis (PrEP) treatment, making it the first long-acting HIV prevention shot that only needs to be administered every six months. Existing PrEP options, such as daily pills and GSK’s Apretude injection (taken every two months), require more frequent dosing.
According to CNBC, the approval follows two landmark clinical trials in 2024 in which Yeztugo showed near-total effectiveness in preventing new HIV infections among high-risk individuals when taken as prescribed.
“This really will bend the arc of the epidemic as we roll this out across the globe,” said Daniel O’Day, CEO of Gilead Sciences, ahead of the FDA’s announcement. He described the approval as a critical breakthrough in global public health.
The World Health Organization (WHO) reported approximately 1.3 million new HIV infections and 630,000 HIV-related deaths worldwide in 2023. In the United States alone, an estimated 700 people contract HIV and about 100 die from related causes each week, underscoring the urgency of improved prevention tools.
Yeztugo, O’Day said, could be a “game-changer,” particularly for populations disproportionately affected by HIV, including people of color, gay and bisexual men, other men who have sex with men, and transgender women.
Cost and Access Challenges
Despite its promise, questions remain about access and affordability, especially in the face of potential federal funding cuts for HIV prevention programs proposed under the Trump administration.
Yeztugo’s annual list price is set at $28,218 before insurance, according to Gilead. That pricing is comparable to existing PrEP treatments:
- Gilead’s own daily pills, Truvada and Descovy, cost about $2,000 per month, totaling $24,000 per year.
- GSK’s injectable Apretude, taken monthly for the first two doses and bi-monthly thereafter, costs around $4,000 per dose.
Gilead said it is working to ensure broad insurance coverage for Yeztugo and offers copay assistance that could lower out-of-pocket costs to as little as zero for eligible insured individuals. The company also provides a free drug program for eligible uninsured patients.
“Access will be critical,” said Jeremiah Johnson, Executive Director of PrEP4All, a non-profit focused on equitable access to HIV prevention. “The magnitude of Yeztugo’s impact will depend on how easily people can obtain it.”
Broader Implications
Yeztugo has already been approved under the brand name Sunlenca for HIV treatment, with a list price of over $42,200 annually. Its dual use for both treatment and prevention could expand its global reach as countries look to reduce HIV transmission.
The new FDA approval positions Yeztugo as the most convenient PrEP option available, with dosing just twice a year, potentially improving adherence rates and accessibility for people who struggle with daily or monthly medication routines.
With the drug’s rollout expected to begin soon, health officials, patient advocates, and global stakeholders are closely watching how Yeztugo is integrated into public health programs—especially in underserved and high-risk communities.
If widely adopted, Yeztugo could mark a decisive step toward achieving the long-standing goal of ending the HIV epidemic.
