FDA approves twice-yearly HIV shot to prevent infections
By Rebecca Okine
The U.S. Food and Drug Administration (FDA) has approved a new, long-acting injectable drug called Yeztugo, marking a significant advancement in the fight against HIV transmission and a milestone in HIV prevention.
Yeztugo, also known by its generic name lenacapavir, is administered just twice a year, offering a simpler and more reliable alternative to daily HIV-prevention pills like Truvada.
The injectable is being hailed as a game-changer, especially for individuals who struggle with the daily pill regimen required by traditional pre-exposure prophylaxis (PrEP). The drug’s approval follows robust clinical trials conducted by Gilead Sciences, which showed striking results.
Among gay and bisexual men and transgender women who received the shot, HIV transmission dropped by 89 percent compared to those on Truvada. In a separate trial involving cisgender women in sub-Saharan Africa, none of the participants who received Yeztugo contracted the virus, an unprecedented result.
“This is the single best opportunity in 44 years of HIV prevention,” said Mitchell Warren, Executive Director of AVAC, a global HIV prevention advocacy group.
His enthusiasm reflects the potential of Yeztugo to reach populations that have been underserved by current HIV-prevention methods.
Unlike earlier versions of PrEP that must be taken daily, Yeztugo works by preventing HIV from replicating in the body’s immune cells. It belongs to a new class of antiretrovirals that provide long-term protection and could reduce barriers related to adherence, stigma, and access.
Daniel O’Day, CEO of Gilead Sciences, noted in a statement that the drug represents a bold step toward ending the HIV epidemic.
Yeztugo was previously approved in 2022 as Sunlenca for treating drug-resistant HIV strains.
