Generic name |
ledipasvir-sofosbuvir |
---|---|
Strength |
90 mg/400 mg |
Form |
tablet |
Special Authority criteria |
|
---|---|
For the treatment of treatment-naïve or treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype 1 infection who meet ALL the following criteria:
|
Treatment regimens for genotype 1 CHC adult patients |
Approval period |
Treatment-naïve with no cirrhosis, who have pre-treatment HCV RNA level < 6 million IU/mL |
8 weeks or 12 weeks4 |
Treatment-naïve with no cirrhosis, who have pre-treatment HCV RNA level ≥ 6 million IU/mL OR Treatment-naïve with compensated cirrhosis5 OR Treatment-experienced1 with no cirrhosis OR Treatment-naïve and treatment-experienced1 HCV/HIV-1 co-infected with no cirrhosis or with compensated cirrhosis |
12 weeks |
Treatment-experienced1 with compensated cirrhosis5 |
24 weeks |
Treatment-naïve and treatment-experienced1 with decompensated cirrhosis6 |
12 weeks with RBV OR 24 weeks |
Treatment-naïve and treatment-experienced1 liver transplant recipients with no cirrhosis or with compensated cirrhosis |
12 weeks with RBV OR 12 weeks |