Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
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.
Inclusion Criteria:

 -  Willing and able to provide written informed consent

 -  Chronic HCV infection (≥ 6 months) ;

 -  Positive HCV antibody

 -  Serum HCV RNA of ≥ 1 × 104 IU/mL

 -  Hepatitis C virus GT1

 -  Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or
 host-targeting antivirals for HCV

 -  The liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂
 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not
 obtained a liver biopsy or Fibroscan in the last 1 years will have a study related
 Fibroscan performed in order to confirm the diagnosis

 -  Others as specified in the detailed protocol

 Exclusion Criteria:

 -  Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for
 liver cirrhosis patients

 -  Presence or history of non-hepatitis C chronic liver disease, including but not
 limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous
 hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease,
 alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and
 porphyria cutanea tarda causing liver pathology or requiring phlebotomy

 -  Patients with a history of liver cell cancer, screening before or screening suspected
 hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules,
 or AFP > 50 ng/mL

 -  Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody
 or HIV antibody at screening

 -  Others as specified in the detailed protocol