Gilead announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of sofosbuvir (SOF) and velpatasvir (VEL) for the treatment of chronic genotype 1–6 hepatitis C virus (HCV) infection.

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The NDA is supported by data from four Phase 3 ASTRAL clinical trials, which evaluated the fixed-dose combination in patients with genotypes 1-6 HCV infection. ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies (n=1,035) achieved the primary endpoint of sustained viral response at 12 weeks (SVR12) following treatment with SOF/VEL (98%). The ASTRAL-4 study, which randomized 267 patients with decompensated cirrhosis to receive SOF/VEL plus ribavirin (RBV) for 12 weeks, SOF/VEL for 12 weeks or SOF/VEL for 24 weeks, achieved an SVR12 rate of 94%, 83%, and 86%, respectively.

The FDA has previously granted SOF/VEL a Breakthrough Therapy designation.

Sofosbuvir, approved as Sovaldi in 2013, is a nucleotide analog polymerase inhibitor and velpatasvir is an investigational pan-genotypic NS5A inhibitor.

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