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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
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Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct

Robert J Fontana1, Paul B Watkins, Herbert L Bonkovsky

  • 1Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan 48109-0362, USA. rfontana@med.umich.edu

Drug Safety
|January 10, 2009
PubMed
Abstract

Insights

The Drug-Induced Liver Injury Network (DILIN) established a prospective registry to study risk factors and outcomes of drug-induced liver injury (DILI). This network aims to improve understanding of DILI causes and progression.

Area of Science:

  • Hepatology
  • Clinical Pharmacology
  • Toxicology

Background:

  • Drug-induced liver injury (DILI) is an increasingly significant adverse drug reaction.
  • Understanding DILI is crucial for the medical community, pharmaceutical industry, and regulatory bodies.

Purpose of the Study:

  • Establish the Drug-Induced Liver Injury Network (DILIN) for DILI research.
  • Create a prospective patient registry to investigate host risk factors (clinical, genetic, environmental, immunological).
  • Develop standardized nomenclature, terminology, and causality assessment tools for DILI.

Main Methods:

  • Initiated a prospective DILI study across five clinical sites and a data coordinating center in September 2004.
  • Enrolled eligible patients meeting specific laboratory or histological criteria within 6 months of DILI onset, excluding other causes of liver injury.
  • Included patients with HIV, hepatitis B/C, abnormal baseline liver biochemistries, or liver injury from herbal products; control patients to be recruited.

Main Results:

  • Conducted extensive reviews of laboratory, pathology, and imaging studies for enrolled subjects.
  • Followed eligible subjects for 2 years to define the natural history of chronic DILI.
  • Assessed causality and severity of DILI using a panel of three hepatologists; 367 subjects enrolled in the first 3 years.

Conclusions:

  • DILIN is a US-based multicenter network enhancing DILI knowledge.
  • The network is achieving enrollment targets and building a data and sample repository for future DILI pathogenesis and outcome studies.

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