Evidence map›Paper›PMID 40121139›Full record

Observational studyJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2025

Elexacaftor-tezacaftor-ivacaftor pharmacokinetics with concurrent tacrolimus administration after lung transplant.

J S Guimbellot, Ashritha Chalamalla, Elizabeth Baker, K J Ryan, A Dowell, Saly Abouelenein, L E Bartlett, J Bergeron, G Turner, E P Acosta and 1 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Observational
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

J S GuimbellotDepartment of Pediatrics, Section of Pulmonary and Sleep Medicine, University of Arkansas for Medical Sciences, 1 Children's Way, Little Rock, AR, USA. Electronic address: jguimbellot@uams.edu.
Ashritha ChalamallaDepartment of Pediatrics, Section of Pulmonary and Sleep Medicine, University of Arkansas for Medical Sciences, 1 Children's Way, Little Rock, AR, USA; Gregory Fleming James Cystic Fibrosis Research Center, University of Alabama at Birmingham (UAB), Birmingham, AL, USA.
Elizabeth BakerGregory Fleming James Cystic Fibrosis Research Center, University of Alabama at Birmingham (UAB), Birmingham, AL, USA; Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham (UAB) Heersink School of Medicine, Birmingham, AL, USA; Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham (UAB) Heersink School of Medicine, Birmingham, AL, USA.
K J RyanDivision of Clinical Pharmacology, University of Alabama at Birmingham (UAB) Heersink School of Medicine, Birmingham, AL, USA.
A DowellDivision of Clinical Pharmacology, University of Alabama at Birmingham (UAB) Heersink School of Medicine, Birmingham, AL, USA.
Saly AboueleneinDepartment of Pediatrics, Section of Pulmonary and Sleep Medicine, University of Arkansas for Medical Sciences, 1 Children's Way, Little Rock, AR, USA.
L E BartlettDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, University of Washington, Seattle WA, USA.
J BergeronGregory Fleming James Cystic Fibrosis Research Center, University of Alabama at Birmingham (UAB), Birmingham, AL, USA.
G TurnerDivision of Pulmonary and Critical Care, Department of Medicine, University of California, Los Angeles, CA, USA.
E P AcostaGregory Fleming James Cystic Fibrosis Research Center, University of Alabama at Birmingham (UAB), Birmingham, AL, USA; Division of Clinical Pharmacology, University of Alabama at Birmingham (UAB) Heersink School of Medicine, Birmingham, AL, USA.
K J RamosDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, University of Washington, Seattle WA, USA.

Funding

National Dissemination of I-Corps@NCATS: Accelerating Translation through CommercializationUL1TR003096 · NCATS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GUTIERREZ, ORLANDO M, KIMBERLY, ROBERT P. · 2019 to 2023
$43.6M
UAB CF Research and Translation Core CenterP30DK072482 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Susan Elizabeth Birket · 2007 to 2026
$23.0M
Translational Research Center to Expedite Novel Therapies in Cystic FibrosisP30DK089507 · NIDDK · SEATTLE CHILDREN'S HOSPITAL · PI Christopher Hooper Goss, Lucas R Hoffman · 2010 to 2026
$21.4M
Translational Program in CFTR-Related Airway DiseasesR35HL135816 · NHLBI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI ROWE, STEVEN MARK · 2017 to 2022
$6.3M
Pharmacometric approaches to precision optimization of ivacaftor response in cystic fibrosis patientsK23HL143167 · NHLBI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GUIMBELLOT, JENNIFER S · 2020 to 2024
$839k
NCATS NIH HHS UL1 TR003096NHLBI NIH HHS K23 HL143167NHLBI NIH HHS R35 HL135816NIDDK NIH HHS P30 DK072482NIDDK NIH HHS P30 DK089507
6 · The paper itself

Abstract

backgroundCFTR modulators in post-transplant people with cystic fibrosis (pwCF) are less frequently used due to uncertainty regarding effectiveness and interactions with immunosuppressive agents. Elexacaftor/tezacaftor/ivacaftor (ETI) is a triple combination cystic fibrosis (CF) therapeutic with benefits in multiple organ systems where complications can impact lung transplant (LTx) outcomes, including malnutrition, diabetes, and sinus disease. ETI use in LTx recipients is variable.

methodsWe conducted a pharmacokinetics (PK) study of concentrations of ETI parent compounds and the four major metabolites (M23-ELX, M1-TEZ, M1-IVA, M6-IVA) in a prospective non-randomized observational study, with all transplant participants concomitantly taking tacrolimus for LTx immunosuppression and excluded if taking any other medication with known interactions (e.g., azole antifungals) and compared to a non-transplant group of pwCF. We completed non-compartmental analysis (NCA) for both groups and compared the transplant to non-transplant PK parameters, as well as to published data from the manufacturer for non-transplant pwCF. Area under the curve (AUC), average concentrations (C

resultsTwelve transplant and fourteen non-transplant participants with CF completed the study. There were no significant differences between the mean values for any PK parameters for the transplant and non-transplant groups and no substantial differences in frequency of concentrations outside the therapeutic ranges in the two groups.

conclusionsOur data suggest there are not significant differences in concentrations of ELX, TEZ, IVA, or their major human metabolites in LTx recipients compared to non-transplant pwCF.

Indexed as

AminophenolsBenzodioxolesCystic FibrosisImmunosuppressive AgentsIndolesLung TransplantationPyrazolesPyridinesQuinolonesTacrolimusAdultChloride Channel AgonistsDrug CombinationsFemaleHumansMaleAminophenolsBenzodioxolesChloride Channel AgonistsDrug Combinationselexacaftor, ivacaftor, tezacaftor drug combinationImmunosuppressive AgentsIndolesPyrazolesPyridinesQuinolinesQuinolonesTacrolimustezacaftor, ivacaftor drug combinationCystic FibrosisElexacaftorIvacaftorLung transplantPharmacokineticsTacrolimusTezacaftor

Identifiers

PMID40121139
PMCPMC12829593

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.