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

SEASON South East Asian Study Of Novel Genotypes in Hepatitis C Infection: Pegylated-Interferon and Ribavirin Therapy (PEGATRON REDIPEN Combination Therapy (PEG-Intron® REDIPEN Plus REBETOL®)) in Treatment Naive Patients With Genotypes 1, 6, 7, 8, 9: A Comparison of Race and Genotype on Treatment Outcome.

This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.

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.