– VOSEVI is the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment, and
Completes Gilead’s Portfolio of Sofosbuvir-Based HCV Direct-Acting Antiviral Treatments –
MISSISSAUGA, ON, Aug. 17, 2017 /CNW/ – Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance for VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a pan-genotypic single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of VOSEVI in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
“HCV treatment has been transformed by effective direct-acting antiviral regimens, allowing health care providers the opportunity to cure many patients. However, for those patients who have failed with prior therapy, there remains an unmet clinical need for an effective and well-tolerated option,” said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Diseases, University of Alberta. “VOSEVI Phase 3 clinical studies have resulted in high cure rates among patients who were not previously cured with several widely-prescribed DAA regimens, providing physicians with an important new therapeutic option that could offer hope for their hardest-to-cure patients.”