Posted on: Fri 20-06-2025

In a major step forward in the fight against HIV, the United States Food and Drug Administration (FDA) has approved a new long-acting antiviral injection developed by pharmaceutical giant Gilead Sciences. The injection, called Yeztugo (generic name: Lenacapavir), is taken just twice a year and has shown remarkable effectiveness in preventing new HIV infections.

This approval marks a significant advancement in HIV prevention. According to reports from CNBC, two major clinical trials conducted in 2024 demonstrated that Yeztugo was nearly 100% effective at stopping new HIV infections when administered every six months. This makes it the most convenient and long-lasting option compared to current HIV prevention methods like daily pills or bimonthly injections.

Gilead’s CEO, Daniel O’Day, highlighted the potential of this innovation to dramatically reduce the spread of HIV. “It’s hard to overstate the importance of this for global public health,” he said. “Yeztugo really will bend the arc of the epidemic as we roll it out around the world.”

The injection’s ease of use could be a game-changer, especially for communities most affected by the virus, such as people of color, gay and bisexual men, and transgender women. In the United States alone, there are still about 700 new HIV cases and 100 related deaths every week, according to Gilead.

Despite the enthusiasm, there are concerns around affordability and accessibility. Yeztugo will be priced at $28,218 per year in the U.S. before insurance—comparable to existing branded pre-exposure prophylaxis (PrEP) options. For instance, Gilead’s daily pills, Truvada and Descovy, each cost about $2,000 a month, and GSK’s injectable PrEP drug, Apretude, costs about $4,000 per dose.

To address affordability concerns, Gilead announced copay assistance programs that could reduce out-of-pocket costs to as little as zero dollars for insured patients. The company also offers a free drug program for uninsured individuals who qualify.

While Yeztugo is newly approved for HIV prevention, the same drug—Lenacapavir—is already in use under the brand name Sunlenca for HIV treatment, with a price tag of more than $42,000 per year.

Advocates like Jeremiah Johnson, Executive Director of PrEP4All, applauded the breakthrough but emphasized that the real impact would depend on how easily people can access the injection, especially in low-income and high-risk communities.

As the world continues to fight the HIV epidemic, Yeztugo offers a new level of hope. With proper distribution, funding, and global cooperation, experts believe this innovative injection could play a vital role in ending new HIV infections and saving millions of lives.

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