Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients

Exclusion Criteria

• •Women with ongoing pregnancy or breast feeding
• •Male partners of women who are pregnant
• •Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
• •History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
• •History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• •Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
• •Absolute neutrophil count (ANC) \<750 cells/mm3 at screening
• •Platelet count \<50,000 cells/mm3 at screening
• •Hb \<10 g/dl at screening
• •Dose modification of Peg-Interferon alpha-2b (PegIntron®) or ribavirin (Rebetol®) during the first 4 weeks of the ongoing therapy
• •Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
• •Less than 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
• •Serum creatinine level \>1.5 times the upper limit of normal at screening
• •History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
• •History of a severe seizure disorder or current anticonvulsant use
• •History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
• •History or any other evidence of autoimmune diseases
• •History or other evidence of chronic pulmonary disease associated with functional limitation
• •History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
• •Evidence of thyroid disease that is poorly controlled on prescribed medications
• •Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
• •History of major organ transplantation with an existing functional graft
• •History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• •History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
• •Patients with evidence for tuberculosis
• •Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
• •Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
• •Limited contractual capability