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# Gilead Positive on Twice-Yearly HIV Drug Data
- URL: https://www.fdaweb.com/gilead-positive-on-twice-yearly-hiv-drug-data/
- Published: 2024-09-12T12:00:00.000Z
- Updated: 2026-09-14T14:41:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157766

Gilead Sciences says data from an interim analysis from a second pivotal Phase 3 clinical trial investigating its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, showed that it reduced HIV infections by 96% compared to background HIV incidence. “There were two incident cases among 2,180 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group,” the company says. The therapy also demonstrated superiority to Gilead’s once-daily Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg).

In the analysis by an independent data monitoring committee (DMC) confirmed that the PURPOSE 2 trial met its key efficacy endpoints for pre-exposure prophylaxis, Gilead says, adding that the DMC recommended that the trial’s blinded phase end so patients can be offered open-label lenacapavir.

The company says it will soon begin a series of global regulatory filings to launch the twice-yearly HIV prevention therapy in 2025, if approved.