The launch of the injection faces potential threats, including the Trump administration's proposed cuts to federal funding for HIV prevention efforts.

Approval of first twice-yearly HIV pre-exposure prophylaxis was based on results from the Phase III PURPOSE 1 and PURPOSE 2 trials, which show that ≥99.9% of patients treated with Yeztugo remained HIV-negative.

The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. Gilead said the drug will be sold under the brand name Yeztugo.