First HIV prevention drug offering 100% protection approved for global use
The U.S. Food and Drug Administration (FDA) has approved Yeztugo, the first-ever HIV prevention drug to offer nearly 100% protection with just two injections per year, reports a Kazinform News Agency correspondent.
“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, Chairman and CEO of Gilead Sciences, which developed the drug. “Yeztugo is one of the most important scientific breakthroughs of our time and offers a real opportunity to help end the HIV epidemic.”
Yeztugo, known generically as lenacapavir, is a capsid inhibitor that disrupts the HIV-1 virus’s ability to replicate by targeting its protein shell. In 2024, the journal Science named it the Breakthrough Invention of the Year.
Previously approved in 2022 under the name Sunlenca for treatment of existing HIV cases, the new formulation is now positioned for preventive use (PrEP), showing up to 99% effectiveness in blocking sexual transmission.
Carlos del Rio, MD, from Emory University, called the biannual injection “a transformative PrEP option,” potentially improving access and adherence while reducing stigma.
Gilead is expanding access by licensing the drug royalty-free to six generic manufacturers for use in 120 low- and middle-income countries. The company has also partnered with the Global Fund to supply doses for up to two million people over three years - at no profit.
“This is not just a scientific breakthrough – it’s a game-changer,” said Peter Sands, Executive Director of the Global Fund. “But we can only succeed if the world steps up with the resources required.”
Earlier, Kazinform News Agency reported that a major milestone had been reached in the global fight against HIV, as the FDA approved the use of lenacapavir for HIV prevention. The drug, administered just twice a year, demonstrated near-complete protection against HIV infection in clinical trials.