Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

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