The FDA Approved An HIV Prevention Drug That Is 100% Effective

The United States Food and Drug Administration approved lenacapavir, sold under the brand name Yeztugo, as the first HIV prevention drug offering approximately 100 percent protection against the virus with just two injections per year, a milestone that HIV researchers and public health officials described as one of the most significant developments in the 44-year history of the epidemic. Developed by Gilead Sciences, lenacapavir belongs to a class called capsid inhibitors, which work by blocking the protein shell that houses HIV's genetic material and allows the virus to enter and replicate inside host cells. In clinical trials, the drug prevented every single HIV infection among participants who received it, compared to ongoing transmission in comparison groups. The journal Science named lenacapavir its Breakthrough Invention of the Year in 2024. Daniel O'Day, Chairman and CEO of Gilead Sciences, called it one of the most important scientific breakthroughs of our time and said it offers a very real opportunity to help end the HIV epidemic. In 2022, a version of the drug was already approved under the name Sunlenca to treat existing HIV infection. Yeztugo is the prevention version, and its twice-yearly dosing is designed to address one of the primary reasons existing daily oral PrEP medications fail in practice: adherence.

Gilead has taken an unusually generous approach to access for a drug of this profile. The company signed royalty-free licensing agreements with six generic manufacturers to produce affordable versions of the drug for distribution in 120 high-incidence, resource-limited countries that are primarily low- and lower-middle-income nations. It also partnered with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply enough doses to reach up to two million people over three years at no profit to Gilead. Regulatory applications have been filed in Australia, Brazil, Canada, South Africa, and Switzerland, with additional filings in progress for Argentina, Mexico, and Peru. In the United States, uninsured individuals may be able to access the drug at no cost through Gilead's Advancing Access medication assistance program. Carlos del Rio of Emory University School of Medicine said a twice-yearly injection could greatly address barriers like adherence and stigma that lead many people who need PrEP to stop taking daily oral versions. Peter Sands, Executive Director of the Global Fund, called it not just a scientific breakthrough but a game-changer, noting the ambition to reach two million people but only if the world steps up with the resources required to make that possible.

Source:https://refractor.io/infectious-diseases/hiv-prevention-fda-lenacapavir/