Treatment of Liver Injury with Autoimmune Phenotype Following Drug, Herbal, Dietary Supplement, or Vaccine Exposure

When a patient presents with liver injury that carries features of an autoimmune process — circulating autoantibodies, elevated IgG levels, and/or histological evidence of autoimmunity in the liver — alongside a history of recent exposure to a drug, herbal product, dietary supplement, or vaccine, a specific diagnostic and management pathway applies.

The Clinical Scenario

Drug-induced liver injury (DILI) associated with an autoimmune phenotype — the presence of autoantibodies, high IgG levels, and/or histological evidence of autoimmunity in the liver — should be considered as possible drug-induced autoimmune-like hepatitis (DI-ALH). The history of exposure to a potentially causative agent is the pivotal clinical feature that distinguishes this scenario and shapes the management approach.

Management Approach

The first and most critical step is prompt withdrawal of the suspected causative agent. When hepatitis is severe, liver function is impaired, or liver tests fail to normalise within 30 days of discontinuing the implicated agent, a short course of corticosteroid therapy may be recommended.

The full protocol specifies the complete sequential approach, criteria for each step, and criteria for response assessment →

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References

DOI: 10.1016/j.jhep.2025.03.017

DILI associated with an autoimmune phenotype, i.e. the presence of autoantibodies, high IgG levels and/or histological evidence of autoimmunity in the liver, should be considered as possible DI-ALH (LoE 2, strong recommendation, strong consensus).
In suspected cases of DI-ALH, the potential causative agent should be immediately withdrawn (LoE 2, strong recommendation, strong consensus).
In patients with severe hepatitis or impaired liver function or no improvement of liver tests within 30 days of discontinuation of the implicated agent, a short course of predniso(lo)ne is recommended (LoE 4, strong recommendation, strong consensus).
Predniso(lo)ne at an initial dose of 0.5 mg/kg/day followed by rapid tapering until complete withdrawal within 1-2 months is recommended (LoE 5, strong recommendation, strong consensus).

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