Generic name |
sofosbuvir-velpatasvir-voxilaprevir |
---|---|
Strength |
400 mg/100 mg/100 mg |
Form |
tablet |
Special Authority criteria |
---|
For the treatment of direct acting antivirals (DAA) experienced including: NS5A Inhibitor treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype 1, 2, 3, 4 , 5 or 6 infection who meet ALL the following criteria: OR Non-NS5A Inhibitor sofosbuvir-containing regimen treatment-experienced2 adult patients with CHC genotype 1, 2, 3, or 4 infection who meet ALL the following criteria: 1. Fibrosis stage of F0 or greater (Metavir scale or equivalent)
AND 2. Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist, or other prescriber experienced with treating hepatitis C AND 3. Laboratory-confirmed hepatitis C genotype3 1, 2, 3, 4, 5 or 6 AND 4. Laboratory-confirmed quantitative HCV RNA test must be done within the previous 12 months4 at SVR 12 or SVR24 AND 5. Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug |
Treatment regimens for genotype 1, 2, 3, 4, 5 or 6 DAA experienced adult patients with: |
Approval period |
---|---|
NS5A Inhibitor treatment-experienced1 with no cirrhosis or with compensated cirrhosis5 |
12 weeks |
Treatment regimens for genotype 1, 2, 3 or 4 DAA experienced adult patients with: |
Approval period |
Non-NS5A Inhibitor, sofosbuvir-containing regimen treatment-experienced2 with no cirrhosis or with compensated cirrhosis5 |
12 weeks |