The Medication Level Variability Index (MLVI) Predicts Poor Liver Transplant Outcomes: A Prospective Multi-Site Study.
Nonadherence to immunosuppressant medications is a leading cause of poor long-term outcomes in transplant recipients. The Medication Level Variability Index (MLVI) provides a vehicle for transplant outcome risk-stratification through continuous assessment of adherence. The MALT (Medication Adherence in children who had a Liver Transplant) prospective multi-site study evaluated whether MLVI predicts late acute rejection (LAR). Four hundred pediatric (1-17-year-old) liver transplant recipients were enrolled and followed for 2 years. The a-priori hypothesis was that a higher MLVI predicts LAR. Predefined secondary analyses evaluated other outcomes such as liver enzyme levels, and sensitivity analyses compared adolescents to pre-adolescents. In the primary analysis sample of 379 participants, a higher prerejection MLVI predicted LAR (mean prerejection MLVI with LAR: 2.4 [3.6 standard deviation] versus without LAR, 1.6 [1.1]; p = 0.026). Fifty-three percent of the adolescents with MLVI>2 in year 1 had LAR by the end of year 2, as compared with 6% of those with year 1 MLVI≤2. A higher MLVI was significantly associated with all secondary outcomes. MLVI, a marker of medication adherence that uses clinically derived information, predicts LAR in pediatric liver transplant recipients.
Icahn School of Medicine at Mount Sinai, New York, NY.
E
http://orcid.org/0000-0003-2508-3423
E
Shemesh
Cincinnati Children's Hospital Medical Center, Cincinnati, OH.
J C
http://orcid.org/0000-0002-6767-8874
JC
Bucuvalas
The Emmes Corporation, Rockville, MD.
R
R
Anand
Hillman Center for Pediatric Transplantation Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA.
G V
GV
Mazariegos
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.
E M
EM
Alonso
Mattel Children's Hospital at UCLA, Los Angeles, CA.
R S
RS
Venick
Hillman Center for Pediatric Transplantation Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA.
M
M
Reyes-Mugica
Icahn School of Medicine at Mount Sinai, New York, NY.|Department of Psychology, Fordham University, New York, NY.
R A
RA
Annunziato
Texas Children's Hospital, Houston, TX.
B L
BL
Shneider
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D006084:Graft Rejection; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000097:blood; D007223:Infant; D016031:Liver Transplantation; D010349:Patient Compliance; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage / Q000097:blood; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016559:Tacrolimus
biomarker; calcineurin inhibitor; clinical research/practice; clinical trial; compliance/adherence; immunosuppressant; liver allograft function/dysfunction; liver transplantation/hepatology; organ transplantation in general; pediatrics; tacrolimus