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Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients
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.
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