*Purpose: With great development in immunosuppressive therapy, the long-term outcomes and survival time in patients who received solid organ transplantation have been improved remarkably. The critical drug, tacrolimus (TAC), is one of the major immunosuppressants that compose the post-transplantation therapy. While the relationship has been found between long-term high TAC trough concentration variability (TAC-TCV) and high rejection rate, we want to find out that whether the early time period of tacrolimus trough concentration monitoring can be used as a good indication of early outcomes in pediatric liver transplantation.

*Methods: In total, 716 children that received liver transplantation in our center from 30 June 2006 to 30 June 2017, who were given TAC as the only immunosuppressant and didn’t die within the first 30 days after surgery, were included. The 7-day, 10-day, and 30-day tacrolimus through concentrations were measured to find out the proper time period which might indicate the outcomes in pediatric liver transplantation in clinic. The division of patients into high and low tacrolimus concentration variability was based on the coefficient of variation(CV), in which the high group’s CV were higher than mean CV and the low group’s CV were lower than mean CV.

*Results: Totally, there were 716 children who received liver transplantation in our center. The mean TAC-TC (median,IQR, ng/ml) of different groups is 9.33 (7.22-9.78) for 7-day group, 9.02 (7.57-10.74) for the 10-day and 8.53 (7.23-9.76) for the 30-day. The Coefficient of variation (median,IQR,%) is 34.38 (27.96-43.65) for 7-day group, 34.20 (26.06-45.16) for the 10-day and 35.13 (27.96-43.64) for the 30-day. 175 patients(24%) underwent allograft rejection within 3 months after surgery, 197 patients(28%) within 6 months and 218 (30%) within 1 year. Significant relationship between 10-day TAC-TCV and rejection≤3 months (p-value=0.005), between 30-day TAC-TCV and rejection≤3 months (p-value=0.028). And 7-day TAC-TCV was also associated with infections≤1 year. No significant relationship has been shown among the tacrolimus variability and vascular abnormalities, biliary abnormalities or mortality. In logistic regression analysis, rejection≤3 months (OR:1.721, 95%CI for OR:1.136-2.611, p-value=0.010), 30-Day (OR:0.549, 95%CI for OR: 0.451-0.669, p-value=0.000), 30-day effective TAC-TC proportion ≥20% (OR:2.25, 95%CI for OR:1.344-3.774, p-value=0.002), 7-Day mean TAC trough concentration (OR:1.609 95%CI for OR:1.436-1.803, p-value=0.020) and metabolism disorder (OR:0.313, 95%CI for OR:0.104-0.939, p-value=0.038) were associated with 30-day high TAC-TCV. Patient-Donor CYP3A5 mismatch was associated with rejection ≤3 months.[OR:1.949, 95%CI for OR: 1.195-3.184, p-value=0.008]

*Conclusions: Early tacrolimus trough concentration variability could predict rejections in pediatric liver transplantation

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