Might isoniazid plasma exposure be a valuable predictor of drug-related hepatotoxicity risk among adult patients with TB?

To investigate the relationship between isoniazid plasma exposure and the likelihood of elevation of ALT (≥51 IU/L) among adult patients with TB. A retrospective observational study was conducted in patients who underwent periodic monitoring of hepatic function and in whom pharmacokinetic data were...

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Bibliographic Details
Published in:Journal of antimicrobial chemotherapy 2016-05, Vol.71 (5), p.1323-1329
Main Authors: Cojutti, Piergiorgio, Duranti, Silvia, Isola, Miriam, Baraldo, Massimo, Viale, Pierluigi, Bassetti, Matteo, Pea, Federico
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Alanine Transaminase - blood
Antitubercular Agents - adverse effects
Antitubercular Agents - blood
Chemical and Drug Induced Liver Injury - prevention & control
Correlation analysis
Drug dosages
Drug Monitoring - methods
Female
Humans
Isoniazid - adverse effects
Isoniazid - blood
Male
Medical treatment
Middle Aged
Monte Carlo simulation
Plasma
Plasma - chemistry
Retrospective Studies
Risk Assessment
Toxicity
Tuberculosis - drug therapy
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Summary:To investigate the relationship between isoniazid plasma exposure and the likelihood of elevation of ALT (≥51 IU/L) among adult patients with TB. A retrospective observational study was conducted in patients who underwent periodic monitoring of hepatic function and in whom pharmacokinetic data were collected. Monte Carlo simulation was performed with the intent of identifying the probability of achieving an AUC24 greater than the identified threshold of hepatotoxicity with different dosing regimens (2.5, 5.0 and 7.5 mg/kg/day). Forty-one out of 185 evaluable patients (22.2%) had an ALT elevation. A mild correlation between isoniazid AUC0-24 and ALT increase was observed (Spearman's ρ = 0.34, P 
ISSN:0305-7453
1460-2091
DOI:10.1093/jac/dkv490