SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).

Inclusion criteria

• Patients chronically infected with HCV Genotype-1b;
• Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;
• HCV RNA level greater than 10,000 IU/ml at screening;
• Patients with compensated cirrhosis are permitted.

Exclusion criteria

• Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded;
• Screening ECG with clinically significant abnormalities;
• Laboratory results outside of acceptable ranges at screening;
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).