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

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis c, Renal transplantation, Pegylated interferon Read More

Inclusion Criteria:

• Patients, male and female, aged 18 - 68 years
• Post renal transplant patients exceeding one year
• Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months AND/OR
• Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with lower limit of detection at 50 IU/mL
• Compensated liver disease with the following minimum hematologic and biochemical criteria:
• Hemoglobin > 10 g/dL
• WBC > 3000/mm3 ; granulocyte count > 1,500/mm3
• Platelet count > 75,000/mm3
• Albumin within normal limits
• TFT within normal limits
• ANA < 1:320
• Ultrasound of the liver obtained within the preceding 6 months of study entry
• Liver biopsy prior to entry confirming a histological diagnosis consistent with HCV necroinflammatory score (METAVIR) > 1, and fibrosis score >/= 2.

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.