Predicting Acute Liver Failure in Drug-Induced Liver Injury

Cases of severe drug-induced liver injury (DILI) have been defined as Hy's Law cases, marked by an alanine aminotransferase (ALT) level >3 times the upper limit of normal (ULN) and total bilirubin (Tbili) level >2 times ULN with other potential causes excluded. Although the FDA has used this definition in clinical drug development, it is less specific in predicting acute liver failure (ALF) in patients with severe DILI.

To optimize the definition of Hy's Law and develop an improved model to predict ALF in patients with DILI, researchers used data from 771 patients with DILI (805 episodes) from the validated Spanish DILI Registry. Hy's Law was used in three different ways: Tbili >2xULN and either ALT >3xULN, an R value (ALT xULN/alkaline phos…