Sovaldi + GS 5816 + GS 9857 (sofosbuvir + velpatasvir + voxilaprevir) filed with FDA for chronic hepatitis C virus- Gilead Sciences

Gilead Sciences has submitted a New Drug Application (NDA) to the FDA for an investigational, once-daily single tablet regimen containing Sovaldi + GS 5816 + GS 9857 (sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX)) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.

The NDA for SOF/VEL/VOX is based on data from two Phase III studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the fixed-dose combination in DAA-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A-containing regimen. Of the 445 patients treated with SOF/VEL/VOX, 430 (97 percent) achieved the primary efficacy endpoint of SVR12. The NDA is further supported by two additional Phase III studies (POLARIS-2 and POLARIS-3) in which 611 DAA-na�ve HCV-infected patients received 8 weeks of SOF/VEL/VOX. The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea. These data were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2016.