Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients

Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation

This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.

A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.

Inclusion Criteria:

• Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
• Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.

Exclusion Criteria:

• Recipient of multi-organ transplant
• Recipient of an auxiliary graft
• Patient is receiving ABO incompatible graft
• Patients requiring immunosuppressive treatment
• Patients requiring ongoing corticosteroid therapy.
• Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
• Patient or donor is known to be HIV positive.
• Patient is allergic or intolerant to study medication
• Patient is pregnant or breast-feeding.
• Patient has been previously enrolled in this study