Benefit‐risk assessment for sofosbuvir/velpatasvir/voxilaprevir based on patient population and hepatitis C virus genotype: U. S. Food and Drug Administration's evaluation
Kimberly Struble, Kirk Chan‐Tack, Karen Qi, Lisa K. Naeger, Debra Birnkrant – 23 October 2017 – On July 18, 2017, the U.S. Food and Drug Administration (FDA) approved sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (Vosevi) fixed‐dose combination (FDC), an interferon‐free, complete regimen for adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child‐Pugh A) who have: