Monday, 25 May 2026
FDA approves breakthrough HIV drug that nearly stops transmission
The Food and Drug Administration (FDA) has approved a groundbreaking new HIV-prevention drug, according to an announcement from Gilead Sciences on Wednesday. In clinical studies, the medication—administered as a single injection every six months—virtually halted HIV transmission among participants.
Named lenacapavir, this innovative medication has sparked considerable excitement among HIV prevention advocates, who hope it will help quicken the slow progress of reducing HIV cases in the United States, NBC News reported.
“This is the most significant opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of the nonprofit HIV advocacy organization AVAC.
Unlike current daily oral HIV-prevention drugs, lenacapavir is given by healthcare professionals in clinical settings and, experts say, offers superior effectiveness by overcoming the difficulties many high-risk individuals face in maintaining a daily pill routine.
Gilead’s chairman and CEO, Daniel O’Day, stated Wednesday that lenacapavir holds the promise to “end the HIV epidemic once and for all.”
The FDA approved lenacapavir following exceptional results from extensive clinical trials conducted by Gilead. Participants at risk for HIV were randomly assigned either twice-yearly injections of lenacapavir or daily doses of Truvada, an established pill-based pre-exposure prophylaxis (PrEP). Among gay and bisexual men and transgender people, those who received lenacapavir showed an 89% lower rate of HIV infection compared to those taking Truvada and a 96% lower rate than what Gilead projected would occur without any form of PrEP.
In a separate trial involving cisgender women in sub-Saharan Africa, none of the participants receiving lenacapavir contracted HIV.
Lenacapavir represents the first medication in a new class of antiretrovirals designed to block HIV from entering and replicating within targeted immune cells. Initially approved in 2022 under the brand name Sunleca for use with other therapies against highly drug-resistant HIV strains, lenacapavir now marks a major step forward in the fight against the virus.