Gilead Submits NDA for Triple Drug Combo for Hep C

Gilead Sciences has submitted an NDA for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for treating direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The submission is based on data from two Phase 3 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, according to the company. Of the 445 patients treated, 430 (97%) achieved the primary efficacy endpoint, it says. The NDA is further supported by two additional Phase 3 studies (POLARIS-2 and POLARIS-3) in which 611 DAA-naïve HCV-infected patients received eight weeks of SOF/VEL/VOX. The most common adverse events seen in trials were headache, fatigue, diarrhea and nausea.