Twice-yearly Injectable PrEP Approved by FDA

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TargetHIV

In the latest advance in PrEP options to prevent HIV infection, FDA has approved a twice-yearly injectable called lenacapavir (marketed as Yeztugo). According to the maker, Gilead, "≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative." 

Read more about lenacapavir in the Gilead June 18, 2025 announcement and see the FDA label.

LAI Options for PrEP and HIV Treatment

Long-acting injectable (LAI) options exist for both PrEP and HIV treatment. Corresponding dosing options have advanced rapidly in recent years, from monthly to bimonthly for LAI PrEP and LAI treatment. Daily pill taking is the regimen used by the vast majority of those on PrEP and HIV treatment.

Access our resources on PrEP and long-acting injectables, developed prior to approval of lenacapavir. See also the Accelerating Implementation of Long-Acting Injectables project that is examining optimal delivery approaches for use of LAI in HIV treatment. 

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