Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)

Inclusion Criteria: Comply with all current Australian Schedule of Pharmaceutical Benefits S100 eligibility criteria. Able to give written informed consent and adhere to study visit schedule. South East Asian ethnicity (except for Caucasian Gt1/1b in comparator arm) i.e. born in Vietnam, Cambodia, Laos, Thailand, Hong Kong, and China or have both parents born in these countries. Genotype 1, 1a, 1b, 6, 6a, 6b, 7, 8, or 9, as classified by INNO-LiPA assay. Hemoglobin >=120 g/L (females), >=130 g/L (males). Platelet count >=100 x 10^9/L. Neutrophil count >=1.5 x 10^9/L. Negative pregnancy test for females. Thyroid stimulating hormone (TSH) within normal limits. Exclusion Criteria: Participation in any other investigational drug program within 30 days of the Screening Visit. Human immunodeficiency virus (HIV) antibody positive or hepatitis B surface antigen (HBsAg) positive. Genotype 2, 3, 4, or 5, as classified by INNO-LiPA assay. Non South East Asian ethnicity (unless recruited to Caucasian GT1 comparator arm). Evidence of liver disease due to other disorders (e.g., hemachromatosis, Wilson's disease). Ongoing drug or alcohol abuse which in the opinion of the investigator would jeopardize the patient's ability to comply with study requirements. Inability to comply with study requirements for other reasons. Decompensated cirrhosis (Ascites, history of encephalopathy or bleeding varices, serum albumin <35 g/L, prothrombin time (PT) prolonged by greater than 3 sec). Present or prior history of severe psychiatric disease requiring hospitalization or medication. History of severe seizure disorder. History of autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, immune thrombocytopenic purpura, systemic lupus erythematosus, or other mixed connective tissue disease, psoriasis, optic neuritis). Poorly controlled thyroid disease. Creatinine clearance <50 mL/min. Severe cardiovascular disease. Hepatocellular cancer. Clinically significant ophthalmologic disorders. Hemoglobinopathies (e.g., thalassemia, sickle-cell anemia). Treatment or recent treatment with immunosuppressive agents (excluding short-term corticosteroid withdrawal), and immunosuppressed transplant recipients scheme.