Posted by Michael Wonder on 20 Aug 2017
Gilead receives approval in Canada for Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for re-treatment of certain patients with chronic hepatitis C virus infection
17 August 2017 - VOSEVI is the first once daily, single tablet hepatitis C virus (HCV) regimen for re-treatment, and completes Gilead's portfolio of sofosbuvir-based HCV direct-acting anti-viral treatments.
Gilead Canada today announced that Health Canada has granted a Notice of Compliance for Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a pan-genotypic single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor.
The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of Vosevi in direct-acting anti-viral experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
