Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Genotype 2 Chronic Hepatitis C

Exclusion Criteria

• •being infected with mixed-genotype HCV
• •having previously used any investigational or experimental direct antiviral agents against HCV, including protease, nonstructural (NS) protein 5B polymerase or NS5A inhibitors, before screening
• •having received any interferon-based anti-HCV regimens before screening
• •having been exposed to any systemic potent immunomodulators , such as steroids or thymosin alfa (excluding use of nasal, inhalational, topical steroids and/or others) for more than two (2) weeks within six (6) months before screening, or anticipated to be exposed to these agents during the study period
• •being coinfected with hepatitis B virus (HBV) or human immunodeficient virus (HIV)
• •with evidence of decompensatory liver function, including but not limited to total serum bilirubin (TBIL) above twice (2) of the upper limit of normal (ULN), serum albumin (ALB) below 35 g/L, or prothrombin activity (PTA) below 60%; emergence of ascites, upper gastrointestinal bleeding and/or hepatic encephalopathy; with liver function reserve Child-Pugh class B or C
• •with primary liver cancer confirmed or evidenced by serum alfa-fetoprotein above 100 ng/ml or liver imaging study showing suspected nodules
• •with a previous history of liver disease of other causes, including alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (anti-nuclear antibody\[ANA\] titer above 1:100), Wilson disease or hemochromatosis
• •with serum alaine aminotransferase (ALT) or asparate aminotransferase (AST) above ten (10) times of ULN
• •with white blood cell (WBC) count below 3x10\^9 per liter, neutrophil count below 1.5x10\^9 per liter, platelet count below 50x10\^9 per liter, or hemoglobin below the lower limit of the normal
• •with serum creatinine clearance (CLcr) below 50 ml/min using the Cockcroft-Gault formula
• •with uncontrolled diabetes mellitus (hemoglobin A1c\[HbA1c\] above 7.0%)
• •with psychiatric or neurologic disorders, including previous or family history of psychiatric disorders (especially depression, depressive state, epilepsy or hysteria)
• •with serious cardiovascular disorders, including uncontrolled hypertension (systolic blood pressure at or above 160 mmHg and/or diastolic blood pressure at or above 100 mmHg), heart insufficiency of New York Heart Association class III or above, history of myocardial infarction within six (6) months before screening, history of percutaneous transluminal coronary angioplasty within six (6) months before screening, unstable angina pectoris, or any uncontrolled arrhythmias
• •with serious hematologic disorders (such as anemia, hemophilia and others)
• •with serious kidney diseases (such as chronic kidney disease, kidney insufficiency and others)
• •with serious gastrointestinal disorders (such as peptic ulcer, colitis and others)
• •with serious respirator disorders (such as active pulmonary tuberculosis, lung infection, chronic obstructive pulmonary disease, pulmonary interstitial disease and others)
• •with active or suspected malignant tumors or with a previous history of malignant tumors (excluding skin basal cell carcinoma or cervical carcinoma in situ) within five (5) years before screening
• •with a history of major organ transplantation
• •being known to be severely hypersensitive or allergic to any drugs, especially the testing medications and other constituents
• •with a history of active alcohol or drug abuse
• •being pregnant or lactating
• •being unable to discontinue prohibited medications as defined by the protocol
• •having participated in any other clinical studies within three (3) months before screening
• •being unable or unwilling to provide informed consent or unable to follow the protocol requirements
• •any other conditions of excluding a potential participant at the discretion of the investigators