Combination of Sovaldi + GS 5816 (sofosbuvir + velpatasvir) filed with FDA for genotype 1-6 hepatitis C virus- Gilead Sciences

Gilead Sciences has submitted a New Drug Application (NDA) to the FDA for once-daily fixed-dose combination of Sovaldi + GS 5816 (sofosbuvir (SOF) + velpatasvir (VEL)) for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis.

The NDA for SOF/VEL is supported by data from four Phase III ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98%) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Those who received SOF/VEL plus RBV for 12 weeks achieved an SVR12 rate of 94%, while those who received SOF/VEL for 12 weeks and 24 weeks achieved SVR12 rates of 83% and 86%, respectively.

Patients treated with SOF/VEL for 12 weeks in ASTRAL-1, ASTRAL-2 and ASTRAL-3 had similar adverse events compared with placebo-treated patients in ASTRAL-1. The most common adverse events were headache, fatigue and nausea. The most common adverse events in ASTRAL-4 were fatigue, nausea and headache. Gilead plans to submit a regulatory application for approval of SOF/VEL in the European Union by the end of the year.