Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)

Inclusion Criteria:

• Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules.
• Males and non-pregnant females and aged >= 18 years, subjects who are over 65 years of age must be in generally good health and must be discussed with and approved by the principal investigator prior to entry.
• The laboratory evaluation within 6 months prior to entering the Pilot Treatment Program must meet the following criteria:
• Hemoglobin values of >= 12 g/dL for females and >= 13 g/dL for males
• Neutrophil count >= 1.5 X10^9/L
• Platelets count >= 100 x 10^9/L
• Total bilirubin < 1.5 mg/dL
• Serum creatinine within normal limits
• Positive serum HCV-RNA (>= 50 IU (100 copy numbers)/mL)
• Anti-HCV positive
• Available HCV genotype 1
• Liver biopsy performed within 12 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (METAVIR system >=F1).
• Compensated liver disease with the following hematological, biochemical, and serologic criteria at the screening visit:
• Hemoglobin values of >= 9 g/dL
• Neutrophil count >= 0.75 x 10^9/L
• Platelets count >= 50 x 10^9/L
• Prothrombin time (PT) prolong <= 3 sec, International Normalized Ratio (INR) <= 1.2
• Total bilirubin <= 3 mg/dL
• Within normal limits (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met).
• Anti-Human Immunodeficiency Virus (HIV) negative.
• Alpha-fetoprotein (AFP) value within normal limits obtained within 12 months prior to entry. Results above the upper limit of normal but <= 50 ng/mL require both of the following:
• AFP value <= 50 ng/mL obtained within 9 months prior to entry in the study or during the Screening period, and Ultrasound obtained within 9 months prior to entry or in the screening period in the study for evidence of not having hepatocellular carcinoma.
• A urine pregnancy test obtained prior to the initiation of pilot treatment must be negative. Female subjects must not be breast feeding.
• Reconfirmation that sexually-active subjects are practicing acceptable methods of contraception during screening period.
• Complete 24 weeks treatment of the Pilot Treatment Program with Peg-Intron + Ribavirin.
• Must be never treated with interferon for HCV infected hepatitis (treatment naïve) before the Pilot Treatment Program.
• The total amount of Peg-Intron and Ribavirin received during the pilot treatment program must achieve more than 80% of the recommended dosage.

Exclusion Criteria:

• Women who are pregnant or nursing.
• Have decompensated cirrhosis.
• History of severe psychiatric disease, especially depression.
• Concurrent malignancies (including hepatocellular carcinoma).
• Unstable or significant cardiovascular diseases. Subjects with (ECG) showing clinically significant abnormalities.
• Prolonged exposure to known hepatotoxins such as alcohol or drugs.
• History of thyroid disease poorly controlled on prescribed medication.
• Poorly controlled diabetes mellitus.
• Has suspected or confirmed significant hepatic disease from an etiology other than HCV.
• Patients co-infected with hepatitis B and /or human immunodeficiency virus (HIV).
• Severe renal disease or myeloid dysfunction.
• History of organ transplantation other than cornea and hair transplant.
• Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
• Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol.
• Allergy to interferon.