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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
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A Prospective Observational Study of Hepatic Dysfunction in Children on Antitubercular Drugs

Anju Mehra1, Pooja Semwal1, Nowneet Kumar Bhat1

  • 1Division of Pediatric Gastroenterology, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.

Indian Journal of Pediatrics
|July 22, 2022
PubMed

Insights

Antitubercular drug-induced liver injury (TB-DILI) affects 12.3% of children on therapy. Higher baseline ALT levels increase TB-DILI risk, but reintroduction of therapy is often tolerated.

Area of Science:

  • Pediatric Hepatology
  • Infectious Diseases
  • Pharmacovigilance

Background:

  • Antitubercular therapy (ATT) is crucial for treating tuberculosis (TB).
  • Drug-induced liver injury (DILI) is a significant concern during ATT, particularly in children.
  • Understanding the incidence and risk factors of TB-DILI is essential for patient safety.

Purpose of the Study:

  • To prospectively assess the frequency, risk factors, and prognosis of antitubercular drug-induced liver injury (TB-DILI) in children.
  • To identify clinical and biochemical predictors of TB-DILI.
  • To evaluate the safety of reintroducing ATT after DILI.

Main Methods:

  • Prospective observational study including children (<18 years) on ATT for TB.
  • Liver function tests (LFTs) monitored at baseline and regular intervals during ATT.
  • Statistical analysis to identify risk factors associated with TB-DILI.

Main Results:

  • 10 out of 81 (12.3%) children developed TB-DILI at a median of 8.5 days after starting ATT.
  • Common symptoms included anorexia and nausea (80%).
  • Higher baseline ALT levels were independently associated with DILI (aOR 2.1, p=0.01).
  • Eight patients tolerated sequential reintroduction of ATT 9-24 days after discontinuation.

Conclusions:

  • TB-DILI occurs in a notable proportion of children receiving ATT.
  • Baseline ALT is a significant predictor of TB-DILI in this pediatric population.
  • ATT can often be safely reintroduced in a sequential manner following DILI.

Keywords:
Antitubercular therapyHepatotoxicityLiver injuryPediatric tuberculosis

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