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