FDA approves sofosbuvir/velpatasvir/voxilaprevir (Vosevi) second-line DAA HCV treatment in the US in the US
Simon Collins, HIV i-Base
On 18 July 2017, the US FDA approved a fixed dose combination of sofosbuvir/velpatasvir/voxilaprevir (400/100/100) for treatment of DAA-experienced adults with chronic hepatitis C (HCV).
The indication is for adults with genotype 1, 2, 3, 4, 5 or 6 with unsuccessful treatment using an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.
Approval is based on results from the phase 3 POLARIS-1 and POLARIS-4 studies, which used 12 weeks of Vosevi in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
Sofosbuvir/velpatasvir/voxilaprevir is manufactured by Gilead Sciences and marketed with the brandname Vosevi.
Gilead press statement. US Food and Drug Administration approves Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for re-treatment of adults with chronic hepatitis C virus. (18 July 2017).