A retrospective, multi-center, non-interventional cohort study has been going to explore whether artificial intelligence can discriminate Drug-induced liver injury and Autoimmune hepatitis.

A machine learning-based tool will be developed and validated to help clinicians to differentiate between Drug-induced liver injury and Autoimmune hepatitis

Research Objectives:

1. To develop a machine learning-based model from retrospective data.
2. To validate the machine learning-based model from internal dataset and external datasets nationwide.
3. To setup a website or application based on the above model to discriminate Drug-induced liver injury and Autoimmune hepatitis.

Inclusion Criteria:

• Drug-induced liver injury

  1. RUCAM ≥6 and met one of the following biochemical conditions: a.) ALT≥5 ULN, b.) or ALP ≥2 ULN, iii) or ALT≥3 ULN and TBil≥2 ULN.
  2. RUCAM was between 3-5, the medical records were further reviewed by the three authors to determine the eligibility.

• Autoimmune hepatitis

  1. The revised International Autoimmune Hepatitis Group (IAIHG) diagnostic score≥6 points.
  2. Liver biopsy available, which is compatible with typical features of AIH.
  3. If liver biopsy was unavailable, patients who achieved biochemical resolution after sustained immunosuppressive therapy.

Exclusion Criteria:

• Drug-induced liver injury

  1. Hepatotropic viral infection: hepatitis A, B, C, D and E.
  2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
  3. Hypoxic ischemic hepatitis and congestive liver disease.
  4. Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
  5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
  6. Autoimmune hepatitis.
  7. Parasitic infection.
  8. Sepsis.
  9. Previous liver transplantation or bone marrow transplantation.
  10. Pregnancy or lactation.
  11. Genetic and metabolic liver diseases.

• Autoimmune hepatitis

  1. Hepatotropic viral infection: hepatitis A, B, C, D and E.
  2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
  3. Hypoxic ischemic hepatitis and congestive liver disease.
  4. Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
  5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
  6. Drug-induced liver injury.
  7. Parasitic infection.
  8. Sepsis.
  9. Previous liver transplantation or bone marrow transplantation.
  10. Pregnancy or lactation.
  11. Genetic and metabolic liver diseases.

Hospitalized patients with a definite diagnosis of DILI and AIH were recruited from all hospitals between January 2009 to December 2025. This study was approved by the Institutional Ethical Review Board (2022-P2-263-01).