Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)

Arms (1)

1. type

   EXPERIMENTAL

   label

   Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir

   description

   Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (\< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day.

   interventionNames

   1. Drug: Pegylated Interferon Alfa 2a
   2. Drug: Ribavirin
   3. Drug: Telaprevir

Primary outcomes (1)

1. measure

   Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant

   timeFrame

   12 weeks post-transplant, up to 48 weeks for overall monitoring

   description

   The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant. Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate.