efficacy and safety study of peg-ifn-sa and ribavirin to treat chronic hepatitis c

Conditions: Chronic Hepatitis c

Summary: 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

Keywords: interferon ribavirin sustained virological response