Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients
Status:
Terminated
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
Patients are being asked to be part of this study because they are a liver transplant
recipient and have the Hepatitis C Virus (HCV). Current routine treatment for HCV for liver
transplant patients includes taking two medications called pegylated interferon alfa-2a
(Pegasys®) and ribavirin. Patients Pegasys and ribavirin are FDA approved for the treatment
of HCV.
This study will evaluate the safety and efficacy of adding a third drug called telaprevir for
the experimental treatment of HCV in liver transplant patients. The combination of Pegasys,
ribavirin and telaprevir is currently FDA approved for the treatment of HCV, but is
specifically not FDA approved for HCV patients who have had a liver transplant. This is
because more information is needed about possible drug interactions between telaprevir and
cyclosporine, or telaprevir and tacrolimus-based immunosuppressive drugs, which are typically
part of routine care for transplant patients.
Studies have shown that the addition of telaprevir greatly increases the efficacy of Pegasys
and ribavirin for the treatment of HCV. However, these studies did not include adequate
information on transplant patients due to the potential drug interactions.
The investigators hope to gather more information about the safety and efficacy of telaprevir
given in combination with Pegasys and ribavirin in the liver transplant patients who have HCV
that is not well controlled with Pegasys and ribavirin alone.