FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization 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 authorized 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 authorized 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.
“DAA-based therapies have transformed our ability to treat hepatitis C. However, until now we have had limited options for patients who have failed to achieve cure with these regimens,” said Professor Michael Manns, Director of the Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. “Vosevi has demonstrated high cure rates across a range of DAA-experienced patients, with a simple 12-week single tablet regimen. Availability of Vosevi will have a significant impact for this group of patients, offering them the opportunity to be cured of this disease.”