Liver transplant recipients who received everolimus-based immunosuppression with reduced tacrolimus experienced similar results to those treated with standard tacrolimus, while maintaining better renal function, in a study presented at the International Liver Congress in Amsterdam.
In a multicenter, open-label study, researchers randomly assigned 719 de novo liver transplant recipients to receive either 3 ng/mL to 8 ng/mL everolimus (EVR) with 3 ng/mL to 5 ng/mL reduced tacrolimus (rTAC, n=245), 6 ng/mL to 10 ng/mL EVR with TAC withdrawal initiated at 4 months (n=231) or 6 ng/mL to 10 ng/mL EVR with standard TAC (TAC-C, n=243) for 24 months. All patients also received steroids, and began treatment 30 ± 5 days after transplantation.
The composite efficacy failure rate, including incidence of biopsy-proven acute rejection, graft loss or death, was 10.3% in the rTAC group, compared with 12.5% in the TAC-C group (P=.452) at 24 months. The two groups had similar rates of graft and overall survival, while acute rejection occurred significantly less frequently in the rTAC group (6.1% vs. 13.3%; P=.01), with no moderate or severe rejection events occurring, compared with 10 in the TAC-C group.
Investigators noted that renal function was significantly better among rTAC recipients, with an adjusted mean estimated glomerular filtration rate [eGFR] of 6.66 mL/min/1.73 m2 from baseline (P=.0018) in the ITT group and 8.69 mL/min/1.73 m2 among PP participants (P<.0001).
Researchers reported serious adverse events in 56.3% of the rTAC group and 54.1% of the TAC-C group. Discontinuation due to adverse events occurred in 29.8% of rTAC cases and 21.5% of TAC-C participants.
“Immunosuppression with early EVR-facilitated TAC reduction provides comparable overall efficacy and safety vs. standard TAC with superior renal function sustained for 24 months in [liver transplant recipients],” the researchers concluded.
For more information:
Nevens F. #26: Everolimus-Based Immunosuppression Provides Superior Renal Function and Comparable Efficacy Versus Standard Tacrolimus in De Novo Liver Transplant Recipients: 24-Month Results of a Randomized Controlled Trial. Presented at: The International Liver Congress 2013; April 24-28, Amsterdam.