COMPARISON OF TACROLIMUS WITH MICROEMULSION CYCLOSPORINE AS PRIMARY IMMUNOSUPPRESSION IN HEPATITIS C PATIENTS AFTER LIVER TRANSPLANTATION

Background. Immunosuppression in patients with hepatitis C virus (HCV) following orthotopic liver transplantation can lead to significant increases in serum viral loads. Our aim was to analyze the effect of a randomized study of two immunosuppressive agents (tacrolimus vs. microemulsion cyclosporine) on the outcome of HCV patients following orthotopic liver transplantation. Methods. From December 1995 to September 1996, 50 adult patients transplanted for HCV cirrhosis were randomly assigned to receive tacrolimus (Prograf) (group 1, 25 patients) or microemulsion cyclosporine (Neoral) (group 2, 24 patients). All patients received a-interferon after transplantation, and the overall steroid doses were no different between the groups. Serum RNA levels were measured by signal amplification of Chiron. Biopsies were taken when transaminases were greater than 23 base line or when there was an inappropriate response to alterations in immunosuppression regimens. Results. There were more episodes of rejection in the Neoral group, but there were no differences in bacterial and viral infections, nor in the rate of HCV recurrence between the two groups. There were seven deaths in group 1 and eight in group 2. Overall patient and graft survival rates in the Prograf and Neoral groups at 18 months were 72 and 68% and 67 and 64%, respectively. Conclusions. (a) Both immunosuppression regimens had similar HCV recurrence rates; (b) there were no differences in bacterial or opportunistic infections; and (c) patient and graft survival was similar between the two groups. End-stage liver disease secondary to hepatitis C is the most common indication for orthotopic liver transplantation. Disease recurrence after transplantation is recognized as a major problem because there are no effective antiviral agents; furthermore, immunosuppression accelerates its course by increasing viral replication (1‐5). There are conflicting reports regarding the role of the two most commonly used immunosuppressive agents, cyclosporine (CsA*) and tacrolimus, impacting the course of the hepatitis C virus (HCV) after transplant. In a randomized prospective study, we compared the effects of these two immunosuppressive agents on patients who underwent liver transplantation for hepatitis C. The new microemulsion form of CsA, Neoral, was used.