An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients

Inclusion Criteria:

• Male and female subjects between the ages of 18 and 65 years
• History of orthotopic liver transplantation less than 10 years before the Screening visit but no sooner than 6 months before Day 1
• Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months
• Naive to P/R treatment or experienced with P/R prior to transplantation with relapse, partial, or null response

Exclusion Criteria:

• Documented cirrhosis after liver transplantation
• Ascites or hepatic encephalopathy within 6 months before Screening
• Retransplantation for recurrent hepatitis C
• Treatment for hepatitis C post liver transplantation
• History within the past 3 months of: rejection within 3 months or > 1 rejection within 12 months
• Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5 mg/day) is permitted
• History within 3 months of any bacterial infection requiring > 1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush)
• History of post transplant lymphoproliferative disease
• Acceptable laboratory values at Screening as specified in the protocol
• Positive for HIV1/2 EIA antibody screen or Hepatitis B DNA or Hepatitis B surface antigen
• History of hepatocellular carcinoma with high risk of recurrence
• Any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis C
• Autoimmune-mediated disease
• History of acute pancreatitis within 5 years before the Screening visit
• Prior treatment with an HCV protease inhibitor