Posted by Michael Wonder on 11 Dec 2016
Gilead submits new drug application to U.S. FDA for the investigational single tablet regimen sofosbuvir/velpatasvir/voxilaprevir
8 December 2016 - If approved, SOF/VEL/VOX would be the first once daily single tablet regimen available as a salvage therapy for patients infected with HCV genotype 1-6 who have failed prior treatment with direct-acting anti-viral regimens including NS5A inhibitors.
Gilead Sciences today announced that it has submitted a new drug application to the U.S. FDA for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting anti-viral experienced chronic hepatitis C virus 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.
