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KEY INCLUSION CRITERIA

• Patients must have been previously treated with the following starting doses:
• ≥ 1.5 µg/kg/week PegIFN alfa-2b
• ≥ 180 µg/week PegIFN alfa-2a
  
• Patients will have documented viral nonresponse to past treatment with PegIFN alfa-2a or 2b plus RBV. Viral nonresponse is defined as:
• Less than a 2 log₁₀ reduction in HCV RNA from baseline to any time between 12 and 24 weeks of therapy

or

• Detectable HCV RNA at end-of-treatment (EOT), after completing at least 24 weeks of therapy
  
• Patients of all genotypes and cirrhotics will be considered for enrollment
• Chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA
• Liver biopsy within 3 years of screening, documenting chronic liver disease consistent with chronic HCV

KEY EXCLUSION CRITERIA

• Patients with any history of decompensated liver disease
• Patients who prematurely discontinued, interrupted, or dose reduced prior PegIFN-alfa and RBV therapy, due to noncompliance or safety and/or tolerability issues
• Depression: major depressive episode within 2 years prior to screening
• Patients who have been treated for HCV within 3 months prior to screening
• Use of colony stimulating factor agents within 3 months prior to screening
• Known HIV infection or chronic HBV infection
• History of malignancy within the last 5 years
• History of major organ transplantation, new onset diabetes, unstable thyroid function
• Concurrent therapy with immunosuppressive drugs or cytotoxic agents
• Alcohol or drug abuse within the past year
• Pregnant or lactating women and male partners of women who are pregnant