Combination Therapy With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After Therapy With Pegylated Interferon and Ribavirin

Exclusion Criteria

• •Women with ongoing pregnancy or breast feeding
• •Previous non-response during treatment (as defined as having detectable HCV RNA ≥ 50 IU/ml at the end of previous treatment) with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks
• •Less than 24 weeks have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period prior to inclusion in this study.
• •Therapy with any systemic anti-viral
• •* anti-neoplastic
• •* immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤ 6 months prior to the first dose of study drug
• •Any investigational drug ≤ 6 weeks prior to the first dose of study drug. HCV genotype 1, 4, 5 or 6 infection
• •Positive test at screening for anti-HAV IgM Ab
• •* HBsAg
• •* anti-HBc IgM Ab
• •* anti-HIV Ab
• •Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• •History or other evidence of decompensated liver disease
• •Neutrophil count \< 1500 cells/mm3 or platelet count \< 75,000 cells/mm3 at screening
• •Serum creatinine level \> 2 mg/dl (\> 124 µmol/L) or creatinine clearance \< 50 ml/minute at screening
• •Severe psychiatric disease, especially depression, as judged by the treating physician
• •History of a severe seizure disorder or current anticonvulsant use
• •History of immunologically mediated disease
• •* severe chronic pulmonary disease associated with functional limitation
• •* severe cardiac disease
• •* major organ transplantation or other evidence of severe illness
• •* malignancy
• •* any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• •Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range)
• •Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or
• •* clinically relevant ophthalmological disorder due to diabetes mellitus or
• •* hypertension
• •Evidence of drug abuse (including excessive alcohol consumption) in accordance with local therapeutic traditions. (Patients receiving Methadone or Subutex therapy may be included in this study.)
• •Inability or unwillingness to provide informed consent or abide by the requirements of the study
• •Male partners of women who are pregnant
• •Hemoglobin \< 11.3 g/dL (\< 7.0 mmol/L) in women or \< 12.9 g/dL (\< 8.0 mmol/L) in men at screening.
• •Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, etc) or for whom anemia would be medically problematic
• •Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated