Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation

HCV positive patients undergoing orthotopic liver transplantation

Inclusion Criteria:

• About to undergo a primary liver transplant (including living donor, split liver) and are HCV positive.
• Willing and capable of giving written consent for study participation
• Expected to be capable of study participation for full 24 months post-transplantation.
• Allograft biopsies will be possible
• Expected use of calcineurin inhibitor (Neoral or Tacrolimus) as primary immunosuppression An immunosuppressive regimen consisting of a calcineurin inhibitor (Neoral or Tacrolimus) in combination with Simulect and MYCOPHENOLATE SODIUM

Exclusion Criteria:

• This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
• This is a liver transplant from a non-heart beating donor.
• This is an ABO incompatible transplant.
• Patients with serum creatinine level > 250 umol/L.
• The recipient is seropositive for human immunodeficiency virus (HIV) antibodies.
• Fulminant liver failure is the reason for transplant.
• Patient is participating in other clinical trial involving exploratory drug
• There is a known malignancy, or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma less than 5 cm meeting Milan criteria for transplantation5.
• The patient is being transplanted for hepatic malignancy with greater than 5 known lesions.
• Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.
• A female transplant candidate is pregnant, lactating or of childbearing potential and not practicing an acceptable method of contraception.
• An unlicensed drug or therapy has been administered within one month prior to study entry or if such therapy is to be instituted post-transplantation.