FDA Approves Twice-Yearly HIV Prevention Shot

The U.S. Food and Drug Administration (FDA) has approved a new HIV prevention method — a twice-a-year injection of lenacapavir, branded as Yeztugo, developed by Gilead Sciences. Previously used to treat certain HIV infections, this drug has now been authorized for pre-exposure prophylaxis (PrEP).

Clinical trials showed that lenacapavir offers near-complete protection against HIV infection, outperforming existing PrEP options like daily pills (e.g., Truvada) and bi-monthly injections (e.g., Apretude).

This approval marks Yeztugo as the first and only PrEP injection administered just twice a year, providing a promising alternative for people seeking less frequent dosing. Experts believe this could increase PrEP use and help overcome challenges related to adherence and stigma, especially among those who find daily or frequent dosing difficult.

Dr. Carlos del Rio of Emory University hailed the approval as a major advancement, noting that long-acting options like Yeztugo can be pivotal in efforts to end the HIV epidemic. Gilead’s Dr. Jared Baeten emphasized that by maintaining drug levels in the body, the injection effectively blocks HIV from establishing an infection.

HIV primarily spreads through unprotected sex or shared needles and, if untreated, can lead to AIDS by weakening the immune system.