peg-intron and rebetol therapy in treatment of naive hepatitis c patients: a comparison of race and genotype on treatment outcome (study p04212)

Conditions: Hepatitis C, Chronic

Summary: 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.


Eligibility criteria:
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.

Keywords: chronic hepatitis c pegylated interferon alfa-2b ribavirin asia