The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Danoprevir (DNV) 100mg tablet administered orally twice daily
Ritonavir 100mg tablet administered orally twice daily
PegIFN subcutaneous injection at 180 mcg weekly
Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
Time frame: 24 weeks
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Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)