Generic name |
sofosbuvir-velpatasvir (for use with or without ribavirin [RBV]) |
---|---|
Strength |
400 mg/100 mg |
Form |
tablet |
Special Authority criteria |
---|
For the treatment of treatment-naïve or treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype 1, 2, 3, 4, 5, 6 or mixed genotype infection who meet ALL of 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 another prescriber experienced with treating hepatitis C AND 3. Laboratory-confirmed hepatitis C genotype2 1, 2, 3, 4, 5 or 6 AND 4. Laboratory-confirmed quantitative HCV RNA test must be done within the previous 12 months3 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 CHC adult patients who are | Approval period |
---|---|
Treatment-naïve or treatment-experienced1 with no cirrhosis or with compensated cirrhosis4 |
12 weeks |
Treatment-naïve or treatment-experienced1 with decompensated cirrhosis5 |
12 weeks with RBV OR 24 weeks |