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Development and Validation of a Test to Identify Drugs That Cause Idiosyncratic Drug-Induced Liver Injury

Benesic, Andreas, Rotter, Isabelle, Dragoi, Diana, Weber, Sabine, Buchholtz, Marie-Luise, Gerbes, Alexander L.·2018·Clinical Gastroenterology and Hepatology
DOI 10.1016/j.cgh.2018.04.049
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Abstract

Background & aims Idiosyncratic drug-induced liver injury (iDILI) is one of the most challenging diagnoses in hepatology. It is frequently impossible to identify the agent that has caused iDILI in patients who take multiple medicines. We developed an in vitro method to identify drugs that cause liver injury in patients, based on drug toxicity to monocyte-derived hepatocyte-like (MH) cells from patient blood samples. We then collected data on patients who were re-exposed to drugs found to be toxic in the MH test to validate test performance. Methods We performed a prospective study of patients referred to the University Hospital in Munich, Germany, with acute liver injury believed to be caused by medications (300 patients were enrolled in the study and we present data from 40 patients with iDILI and re-exposure to implicated drugs). We collected data from patients on medical history, laboratory test and imaging results, findings from biopsy analyses, and medications taken. Blood samples were collected from all patients and MH cells were isolated and cultured for 10 days. MH cells were then incubated with drugs to which each patient had been exposed, and toxicity was measured based on release of lactate dehydrogenase. Agents found to be toxic to MH cells were considered as candidates for the cause of liver injury. Patients were followed up for up to 6 months after liver injury and data on drug re-exposures and subsequent liver damage within the following 3 to 24 months were ass…

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  • The MetaHeps® test has shown promise as a confirmatory assay in several studies, but further refinement of methodology and validation is required before implementation in clinical practice.

    “While this test has shown promise as a confirmatory assay in several studies, further refinement of the methodology and validation is required for its implementation in clinical practice.”

    From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [67]

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Metadata

Authors
Benesic, A., Rotter, I., Dragoi, D., Weber, S., Buchholtz, M.-L., & Gerbes, A. L.
ORCID
Benesic, Andreas
Venue
Clinical Gastroenterology and Hepatology
Publisher
Elsevier BV
Published
2018-09
Volume
16
Issue
9
Pages
1488-1494.e5
ISSN
1542-3565
DOI
10.1016/j.cgh.2018.04.049
Cited by
52
References
1
Language
en
Update notices
erratum (2019-04-01)
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)

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