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Lookup NU author(s): Professor Ann DalyORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2026 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license. http://creativecommons.org/licenses/by/4.0/Background: The liver maintains bile acid (BA) homoeostasis; circulating BA levels are used as a biomarker in certain cholestatic conditions. BAs can initiate processes in the pathogenesis of drug-induced liver injury (DILI), an unpredictable occurrence which can lead to liver failure. As such, this study aimed to explore whether changes in plasma BA profiles can serve as useful biomarkers for diagnostic and prognostic purposes in patients presenting with suspected DILI.MethodsIn a prospective, nested case–control observational study, patients presenting with acute liver injury potentially due to DILI were sampled and followed through standard clinical care with severity and outcomes monitored. After review, cases were adjudicated as DILI or nonDILI (alternate causes). Plasma BA levels and profile were quantified and compared to those in healthy volunteers (n = 25).FindingsTotal plasma BA levels in patients with DILI (n = 120) were significantly elevated compared to healthy volunteers; the nonDILI group (n = 49) also displayed marked hypercholanemia. Higher values of total, primary, and conjugated BAs at presentation, were associated with liver injury that was likely to progress in severity. The ratios of primary-to-secondary BAs and (cholic acid + deoxycholic acid) to (chenodeoxycholic acid + lithocholic acid) improved the prognostic value of the model for end-stage liver disease (MELD) score.InterpretationBA profiling could be useful for the early detection of patients where DILI is likely to become more severe and those with outcomes of death or liver transplantation. Further investigation in another independent longitudinal study is needed to validate this biomarker.FundingIMI2 821283; IS-BRC-1215-20003.
Author(s): Monte MJ, Tran TD-B, Grove JI, Li D, Stephens C, Lucena MI, Andrade RJ, Weber S, Gerbes A, Bjornsson ES, Stirnimann G, Bjornsson HK, Daly AK, Evans A, Ramaiah SK, Paciga SA, Lingaya M, Atallah E, Robles-Diaz M, Samodelov SL, Poetz O, Rosenberg W, Ramage J, Fowell A, Griffiths WJH, Cramp ME, Patel J, Elsharkawy AM, Marin JJG, Kullak-Ublick GA, Aithal GP
Publication type: Article
Publication status: Published
Journal: eBioMedicine
Year: 2026
Volume: 126
Print publication date: 01/04/2026
Online publication date: 24/03/2026
Acceptance date: 07/03/2026
Date deposited: 13/04/2026
ISSN (electronic): 2352-3964
Publisher: Elsevier
URL: https://doi.org/10.1016/j.ebiom.2026.106229
DOI: 10.1016/j.ebiom.2026.106229
Data Access Statement: The bile acid levels determined in the study participants are available in Mendeley (https://doi.org/10.17632/sf6w9yyvnj.1). The participant data that support the findings of this study (in deidentified format) are available for medical research purposes on written request to the cor responding author with provision of a data transfer agreement with the source institutions, upon publication
PubMed id: 41880860
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