Efficacy And Safety Of Basiliximab Induced Immunosuppress Protocol In Liver Transplantation For Patients With Hepatitis B Virus-related Diseases

Background:The application of immunosuppressants improves short-and long-term survival of liver transplantation, but the long time usage of immunosuppressants brings many complications such as infection and renal injury principally. Basiliximab is an interleukin-2 (IL-2) receptor antagonist which competitively inhibits a critical IL-2 mediating pathway in the cellular immune response. And the usage of basiliximab has been proved to protect renal function after liver transplantation (LT). Currently, most available studies of basiliximab utilization in liver transplantation were conducted in non-hepatitis B patients, though hepatitis B is still considered to be quite prevalent in China.Objective:We aim to evaluate the efficacy and safety of basiliximab in liver transplantation for patients with hepatitis B virus-related diseases.Methods:A total of 268 patients with hepatitis B virus-related diseases undergoing LT were enrolled and divided into two groups according to the usage of basiliximab. Total survival, the survival of high-risk and low-risk patients defined by the post-transplant model for predicting mortality, acute rejection rates, biochemical parameters and other follow-up data were compared between the two groups.Results:Group Bas was composed of 131 patients who received basiliximab treatment, and Group Triple enrolled the other 137 patients who did not. Between the two groups, there was no significant difference in the cumulative survival of patients without hepatocellular carcinoma or in the cumulative survival of patients with hepatocellular carcinoma. For patients with benign end-stage liver diseases, Group Bas had more patients with a high risk of short-and medium-term mortality than Group Triple (22.81% vs.8.85%, p=0.017), but the survival curves of the two groups were not significantly different. The 1-year incidence of acute rejection was lower in Group Bas, although the difference was not significant (8.75% vs.15.33%, p>0.05). In both Group Bas and Group Triple, the level of serum creatinine at 1 week post-transplantation was significantly lower than pre-transplantation (61.00 vs.88.50 μmol/L, p<0.001; 61.50 vs. 74.00 μmol/L, p<0.001; respectively). There was a significant difference in the pre-transplantation serum creatinine between the two groups (88.50 vs.74.00 μmol/L, p=0.005), but the values of serum creatinine decreased to the same level one week (61.00 vs.61.50 μmol/L, p>0.05) and four weeks (61.00 vs.59.00 μmol/L, p>0.05) after transplantation. Significantly fewer recipients in Group Bas experienced hepatitis B relapse than in Group Triple (2/131 vs.13/137, p=0.006).Conclusions:A basiliximab-induced immunosuppressive protocol is a safe regimen that achieves similar survival without increasing the acute rejection rate for LT recipients with hepatitis B virus-related diseases. For patients with benign end-stage liver diseases, this regimen reduces medium-term mortality in high-risk patients. This regimen remarkably improves renal function in the first month after LT and is correlated with a decreased hepatitis B recurrence rate in adult patients after LT.