Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.

This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for HCV.

Inclusion Criteria:

• Males and females age 18 years and older
• HCV RNA positive by PCR after liver transplantation
• Elevated ALT at any time point after liver transplantation
• Protocol liver biopsy (standard of care) consistent with Stage greater than or equal to 2 of Ishak fibrosis score after liver transplantation
• Able to provide written informed consent
• Willing to practice acceptable birth control during the study period.

Exclusion Criteria:

• Decompensated Cirrhosis
• hemoglobin < 12 g/dl
• WBC < 3,500/cubic mm
• Platelets < 75,000/cubic mm
• Human immunodeficiency virus infection
• Pregnancy
• Positive HbsAg
• History of coronary artery disease, history of seizure disorder, poorly controlled autoimmune conditions, thyroid dysfunction, diabetes mellitus, major psychosis, intolerance to previous interferon-based therapy other than anemia or neutropenia
• History of suicidal ideation or suicidal attempts
• Creatinine > 2.0 mg/dl
• Severe non-hepatic illnesses