Do patient characteristics influence efficacy and renal outcomes in liver transplant patients receiving everolimus?

TY - JOUR

T1 - Do patient characteristics influence efficacy and renal outcomes in liver transplant patients receiving everolimus?

AU - De Simone, Paolo

AU - Saliba, Faouzi

AU - Dong, Gaohong

AU - Escrig, Cesar

AU - Fischer, Lutz

N1 - © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

PY - 2016/3

Y1 - 2016/3

N2 - Data from the 24-month randomized, multicenter, open-label H2304 study in 719 de novo liver transplant recipients were analyzed to evaluate the influence of variables potentially affecting immunological or renal response: recipient age, gender, end-stage disease, hepatitis C virus (HCV) status, and Model for End-stage Liver Disease score and estimated glomerular filtration rate (eGFR) at randomization (day 30). Treated BPAR was similar between everolimus with reduced tacrolimus (EVR + Reduced TAC) vs. conventional tacrolimus-based therapy (TAC Control) in all subpopulations, with a trend to lower risk under everolimus with reduced tacrolimus (EVR + Reduced TAC) in patients < 60 yrs and HCV-negative recipients. Risk of graft loss or death was similar in both treatment groups for all subpopulations. The change in eGFR to month 24 showed a benefit for EVR + Reduced TAC vs. TAC Control in all subpopulations other than those with the lowest baseline eGFR (30 to < 55 mL/min/1.73 m(2)), with a significant difference in favor of EVR + Reduced TAC for younger recipients (< 60 yr), female patients, HCV-negative patients and those with baseline eGFR of 55 to < 70 mL/min/1.73 m(2). Everolimus with reduced tacrolimus maintains efficacy to at least two yr after liver transplantation even in patients with risk factors for rejection, with particular renal benefits in specific patient subpopulations.

AB - Data from the 24-month randomized, multicenter, open-label H2304 study in 719 de novo liver transplant recipients were analyzed to evaluate the influence of variables potentially affecting immunological or renal response: recipient age, gender, end-stage disease, hepatitis C virus (HCV) status, and Model for End-stage Liver Disease score and estimated glomerular filtration rate (eGFR) at randomization (day 30). Treated BPAR was similar between everolimus with reduced tacrolimus (EVR + Reduced TAC) vs. conventional tacrolimus-based therapy (TAC Control) in all subpopulations, with a trend to lower risk under everolimus with reduced tacrolimus (EVR + Reduced TAC) in patients < 60 yrs and HCV-negative recipients. Risk of graft loss or death was similar in both treatment groups for all subpopulations. The change in eGFR to month 24 showed a benefit for EVR + Reduced TAC vs. TAC Control in all subpopulations other than those with the lowest baseline eGFR (30 to < 55 mL/min/1.73 m(2)), with a significant difference in favor of EVR + Reduced TAC for younger recipients (< 60 yr), female patients, HCV-negative patients and those with baseline eGFR of 55 to < 70 mL/min/1.73 m(2). Everolimus with reduced tacrolimus maintains efficacy to at least two yr after liver transplantation even in patients with risk factors for rejection, with particular renal benefits in specific patient subpopulations.

KW - End Stage Liver Disease

KW - Everolimus

KW - Female

KW - Follow-Up Studies

KW - Glomerular Filtration Rate

KW - Graft Rejection

KW - Graft Survival

KW - Humans

KW - Immunosuppressive Agents

KW - Kidney Function Tests

KW - Liver Transplantation

KW - Male

KW - Middle Aged

KW - Postoperative Complications

KW - Prognosis

KW - Prospective Studies

KW - Risk Factors

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1111/ctr.12687

DO - 10.1111/ctr.12687

M3 - SCORING: Journal article

C2 - 26717035

VL - 30

SP - 279

EP - 288

JO - CLIN TRANSPLANT

JF - CLIN TRANSPLANT

SN - 0902-0063

IS - 3

ER -