Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients

Exclusion Criteria

• •Previous treatment with interferon and / or Ribavirin - based therapy for chronic hepatitis C
• •Co-infection with HBV or HIV
• •Chronic alcohol abuse (daily consumption \> 20 g/day)
• •Autoimmune or metabolic liver disease liver disease
• •Active drug-induced hepatitis or HAV
• •Decompensated liver disease (Child-Pugh classification B or C) including a past history of decompensation
• •Variceal bleeding
• •Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitis or hypertension
• •Neoplastic disease
• •Patients with a value of alpha-fetoprotein \>100 ng/mL will be excluded from the study until imaging studies confirm the absence of HCC. Presence of HCC, as determined by other means will also exclude the patient from histological sampling.
• •Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (40 g/L) (as may be seen with ribavirin therapy) would not be well-tolerated
• •History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
• •Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
• •Current pregnancy, ongoing breast feeding or unwilling to have contraception
• •Bleeding or clotting diatheses
• •Recent history of renal allograft rejection (\< 6 months)
• •Inability or unwillingness to provide informed consent or abide by the requirements of the study.
• •History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
• •History of organ transplantation, other than kidney, with an existing functional graft.
• •Patients requiring dialysis or in whom dialysis is impending.