Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C

This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated with Interferon.

Total 720 subjects are divided into two groups and treated separately according to the HCV genotype（genotype 2,3 and non-genotype 2,3). With 2:1 ratio between experimental group and positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype 2,3 and 504 subjects for non-genotype2,3 will be enrolled. Accordingly, PEG-IFN-SA once weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV genotype 2,3 and the HCV non-genotype 2,3 .

Eligibility Criteria:
Inclusion Criteria:

* Age 18- 65 years
* Body Mass Index (BMI) 18-30
* Chronic hepatitis C , diagnosed according to Chinese guideline of Hepatitis C (year 2004)
* Detectable serum HCV-RNA by quantitative polymerase chain reaction assay and positive anti-HCV antibody
* Female subjects of childbearing age with no history of menopause and negative pregnancy test, both female and male( including their partners ) subjects were required to conduct adequate contraception since screening until the 6 months after treatment
* Volunteered to participate in this study, understood and signed an informed consent

Exclusion Criteria:

* Previous IFN treated patients
* Hepatotoxic drugs was systematically used more than two weeks within past 6 months
* Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids
* Co-infection with HAV, HBV, HEV, EBV, CMV and HIV
* Evidences of hepatic decompensation, including but not limited to serum total bilirubin\> 2 times the upper limit of normal (ULN); serum albumin \<35g/L; prothrombin activity (PTA) \<60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade
* Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP\> l00ng/ml, suspicious liver nodules by imaging examinations
* Liver diseases from causes other than HCV infection, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
* White blood cell count \<3×109/L; Neutrophil count\<1.5×109/L; platelet count\<90×109/L; hemoglobin below the lower limit of normal
* Serum creatinine above the ULN
* Serum creatine kinase\> 3 ULN
* Diabetes mellitus or Poorly controlled Thyroid Diseases
* Poorly controlled hypertension (systolic blood pressure\> 140mmHg, or diastolic blood pressure\> 90 mmHg) with hypertension -related retinal lesions
* Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
* Psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
* Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias)
* Serious blood disorders (all kinds of anemia, hemophilia, etc.)
* Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
* Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
* Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
* Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
* Malignancies
* Function organs transplant
* Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
* Evidence of alcohol or drug abuse (average alcohol consumption male\> 40g / day, female\> 20g / day)
* Pregnant or lactating women
* Usage of prohibition drugs in this study
* Participated in other clinical trials 3 months prior to the screening
* Unwilling to sign the informed consent and adhere to treatment requirements
* Other conditions not suitable for study judged by investigators