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# Gilead NDA for HIV Combination Drug
- URL: https://www.fdaweb.com/gilead-nda-for-hiv-combination-drug/
- Published: 2017-06-12T12:00:00.000Z
- Updated: 2026-09-14T22:28:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138902

Gilead Sciences has submitted an NDA for a once-daily single tablet regimen containing bictegravir (50 mg), an investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) for treating HIV-1 infection in adults. The drug product has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens, according to the company. The submission is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority, it says.