Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

Inclusion Criteria: * 18 to 65 year old patients, male or female, having undergone a LT for end-stage liver disease due to HCV * patients presenting after LT with recurrent HCV infection, documented by presence of HCV RNA in serum, and recurrent hepatitis, diagnosed at histology; the liver biopsy upon which the diagnosis is established must have been performed within the 12 months prior to inclusion; the treatment cannot start within the 6 months following LT * alpha fetoprotein value within normal limits obtained within 3 months before entry visit * stable immunosuppressive regimen, defined as lack of any therapeutic measures aimed at preventing or treating graft rejection during the three months prior to antiviral therapy Exclusion Criteria: * participation in other clinical trial within 30 days of entry into this protocol * patients retransplanted for rejection or for recurrent hepatitis C on the graft * patients with a history of cardiovascular disease including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure are excluded * presence of HBsAg and/or HIV * history of auto-immune disease, including auto-immune hepatitis * alcohol consumption exceeding 40 grams per day * acute rejection episode within the 3 months prior to inclusion, or current histological features possibly related to underlying rejection * hepatocellular carcinoma * unresolved biliary complication * renal insufficiency (serum creatinine levels above 200 micromol/l) * unconjugated bilirubin blood level \> 100 micromol/l * gammaglutamyl transferase \> 20 times the upper limit of normal range * prothrombin time below 60% of control (except in case of oral anti-coagulant therapy) * neutrophil count less than 1,500/mm3 * platelet count less than 90,000/mm3 * hemoglobin below the lower limit of normal of the testing laboratory * other organ or bone marrow transplantation * current neoplasm and/or anti-tumor chemotherapy * current hepatic arterial thrombosis * pregnant or breast feeding women; child bearing potential women without adequate contraception throughout the course of therapy * psychosis or anti-depressant therapy for uncontrolled clinical depression * clinically significant retinal abnormalities * thyroid dysfunction (abnormal TSH value with or without clinical symptoms) * immunosuppressive therapy with OKT3 or any other anti-lymphocyte serum * drug abuse (heroin, cocaine) or substitution therapy during the 12 months prior to inclusion * history of ischemic cardiopathy * interstitial pneumonitis * previous auto-immune hemolysis and all causes of chronic hemolysis