July 18, 2017
The U.S. Food and Drug Administration (FDA) approved VOSEVI (sofosbuvir, velpatasvir, and voxilaprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have:
• Genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
• Genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.
The approved recommended dosage of VOSEVI is one tablet (sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg) taken orally once daily with food for 12 weeks. Use of VOSEVI is contraindicated with rifampin.