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.
