Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Peginterferon alfa-2a; Ribavirin; telaprevir
Intervention description: Patients will be treated with pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week for 12 weeks, followed by pegylated interferon alfa-2a (Pegasys®) and ribavirin for another 36 weeks. Patients will be assessed at periodic intervals for safety and adverse effects. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.; Patients will be given ribavirin 600-1200 mg PO per day for 12 weeks, followed by pegylated interferon alfa-2a (Pegasys®) and ribavirin for another 36 weeks. Patients will be assessed at periodic intervals for safety and adverse effects. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.; Patients will be given telaprevir 750 mg tid (Incivek®) for 12 weeks, followed by pegylated interferon alfa-2a (Pegasys®) and ribavirin for another 36 weeks. Patients will be assessed at periodic intervals for safety and adverse effects. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis C virus; liver transplant recipient

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients > 18 years of age.

          -  Detectable plasma HCV-RNA by qualitative PCR assay.

          -  HCV genotype 1 infection,

          -  Documented recurrent hepatitis C by liver biopsy within the past year.

          -  On cyclosporine or tacrolimus-based immunosuppression

          -  Negative urine pregnancy test before initiating the treatment for women of
             childbearing potential.

          -  Willingness of the patient and all potentially childbearing partners to use a reliable
             form of effective contraception during the study, unless the patient or partner is
             surgically sterile or post-menopausal.

          -  Willingness to undergo provide informed consent and comply with study requirements.

        Exclusion Criteria:

          -  Genotype non-1 HCV infection.

          -  Women who are pregnant or breast-feeding.

          -  Male partners of women who are pregnant.

          -  Evidence of co-infection with HIV or hepatitis B.

          -  History of severe psychiatric disease.

          -  History of immunologically mediated disease (e.g., inflammatory bowel disease, lupus
             erythematosus, rheumatoid arthritis, etc.)

          -  History of clinically significant pulmonary disease.

          -  History of severe cardiac disease.

          -  History of malignancy where risk of recurrence is >20% within 2 years.

          -  History of uncontrolled seizure disorder.

          -  History of poorly controlled thyroid disease.

          -  History of poorly controlled diabetes mellitus.

          -  History of severe retinopathy.

          -  Active gout.

          -  History or evidence of severe medical illness that, in the opinion of the
             investigator, makes the patient unsuitable for pegylated interferon alfa-2a treatment
             (Pegasys®).

          -  Inability or unwillingness to abstain from alcohol throughout the entire study period.