An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and
 ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen
 following liver transplantation.
Inclusion Criteria:

 -  Male and female participants 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 pegylated interferon/ribavirin treatment or experienced with pegylated
 interferon/ribavirin 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 greater than (>) 1
 rejection within 12 months

 -  Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5
 milligram per 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 human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA)
 antibody screen or Hepatitis B deoxyribonucleic acid (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 hepatitis C virus (HCV) protease inhibitor