High-dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV

Exclusion Criteria

• •history or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study
• •women with ongoing pregnancy or breast feeding
• •therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \<3 months prior to the first dose of study drug
• •any investigational drug \<6 weeks prior to the first dose of study drug positive test at screening for HBsAg, anti-HIV Ab history or other evidence of bleeding from esophageal varices, ascites, or other conditions consistent with decompensated liver disease (Child-Pugh Grade B or C clinical classification)
• •Signs or symptoms of hepatocellular carcinoma
• •history or other strong evidence of a medical condition associated with chronic liver disease other than HCV (e.g., primary hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures
• •Hb \<7.5 mmol/l in women or \<8.6 mmol/l in men at screening
• •any patient with an increased baseline risk for anaemia (e.g. thalassemia, spherocytosis, etc) or for whom anaemia would be medically problematic neutrophil count \<1500 cells/mm3 or platelet count \<80,000 cells/mm3 at screening
• •serum creatinine level \>1.5 times the upper limit of normal at screening
• •history of severe psychiatric disease, especially depression
• •history of a severe seizure disorder or current anticonvulsant use
• •history of immunologically mediated disease
• •history or other evidence of chronic pulmonary disease associated with functional limitation
• •history of severe allergies
• •history of symptomatic and/or significant cardiovascular disease
• •poorly controlled diabetes mellitus
• •history of major organ transplantation with an existing functional graft
• •hyper- or hypothyroidism
• •evidence of severe retinopathy
• •evidence of drug abuse (including excessive alcohol consumption within one year before study entry