Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

University of Florida39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

CyclosporineDRUG

Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.

TacrolimusDRUG

Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter. Immunosuppression was typically tapered to monotherapy (TAC alone) within 4-6 months of transplantation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL

Number of Participants with Undetectable or Less than 100 copies/ml Hepatitis C Viral Level --defined as SVR -Sustained Virologic Response

Time frame: 6 months after completion of interferon based therapy

Data from ClinicalTrials.gov

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