Safety and efficacy of four steroid-minimization protocols in liver transplant recipients: 3-year follow-up in a single center

Objective: To evaluate the safety and efficacy of steroid-minimization therapy in liver transplantation (LT) recipients with hepatitis B virus-related diseases in China. Methods: From March 2000 to June 2007, 502 adult LT recipients, mostly with hepatitis B (HBV)-related diseases, were enrolled in our study. Four study groups were setup according to the steroid-minimization protocols: tacrolimus (TAC) with 6 months steroids withdrawal (6M SW), TAC with 3 months SW (3M SW), TAC with 14 days SW (14d SW), and TAC with basiliximab induction and steroids avoidance (Bas SA). All patients were followed up for at least 36 months after LT. Results: There were no significant differences in the overall 3-year survival rates of the patients and graft, and chronic rejection among the four groups (P=0.092, P=0.113 and P=0.684, respectively). There was also no difference in acute rejection within 12 months after LT (P=0.514). The 3-year recurrence rates of HBV infection and hepatocellular carcinoma (HCC) after LT were significantly different among all the groups (lowest in TAC/Bas SA group; P=0.037 and P=0.029, respectively). The overall incidence of infection was significantly higher in the 6M SW group (62.2% vs 56.1% in 3M SW, 30.5% in 14d SW, 20.5% in Bas SA; P<0.01). By the end of the 3-year follow-up, more than 90% of the surviving patients could safely receive TAC monotherapy. Conclusion: Bas SA immunosuppressive protocol can be achieved safely in LT and reduce HBV infection and HCC recurrence and side effects of steroids after LT.