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 in creases in serum viral loads. Our aim was to analyze the effect of a r andomized study of two immunosuppressive agents (tacrolimus vs. microe mulsion cyclosporine) on the outcome of HCV patients following orthoto pic liver transplantation. Methods. From December 1995 to September 19 96, 50 adult patients transplanted for HCV cirrhosis were randomly ass igned to receive tacrolimus (Prograf) (group 1, 25 patients) or microe mulsion cyclosporine (Neoral) (group 2, 24 patients). All patients rec eived alpha-interferon after transplantation, and the overall steroid doses were no different between the groups. Serum RNA levels were meas ured by signal amplification of Chiron. Biopsies were taken when trans aminases were greater than 2x base line or when there was an inappropr iate response to alterations in immunosuppression regimens. Results. T here were more episodes of rejection in the Neoral group, but there we re no differences in bacterial and viral infections, nor in the rate o f HCV recurrence between the two groups. There were seven deaths in gr oup 1 and eight in group 2. Overall patient and graft survival rates i n the Prograf and Neoral groups at 18 months were 72 and 68% and 67 an d 64%, respectively. Conclusions. (a) Both immunosuppression regimens had similar HCV recurrence rates; (b) there were no differences in bac terial or opportunistic infections; and (c) patient and graft survival was similar between the two groups.