Posted by Michael Wonder on 31 Jul 2017
European Commission grants marketing authorisation for Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for the treatment of all genotypes of chronic hepatitis C
28 July 2017 - European Commission also extends marketing authorisation for Harvoni (sofosbuvir/ledipasvir), enabling first direct-acting anti-viral regimen for adolescent hepatitis C patients.
Gilead today announced that the European Commission has granted marketing authorisation for Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a once-daily single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.
Vosevi was authorised as a 12-week treatment regimen for patients with any genotype of chronic HCV infection, without cirrhosis or with compensated cirrhosis, who have previously failed therapy with a direct-acting antiviral (DAA)-containing regimen. A 12-week regimen was also authorised for use in DAA-naïve patients with compensated cirrhosis infected with any HCV genotype, with an option to shorten therapy to 8 weeks for those infected with genotype 3. For DAA-naïve patients without cirrhosis, the recommended treatment duration is 8 weeks.
