Ethics approval: The study was approved by Institution Ethical Review Board.
Outcome and determinants of mortality in 269 patients with combination anti-tuberculosis drug-induced liver injury
Article first published online: 19 DEC 2012
© 2012 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd
Journal of Gastroenterology and Hepatology
Volume 28, Issue 1, pages 161–167, January 2013
How to Cite
Devarbhavi, H., Singh, R., Patil, M., Sheth, K., Adarsh, C. K. and Balaraju, G. (2013), Outcome and determinants of mortality in 269 patients with combination anti-tuberculosis drug-induced liver injury. Journal of Gastroenterology and Hepatology, 28: 161–167. doi: 10.1111/j.1440-1746.2012.07279.x
Author contributions: HD: Concept and design, acquisition of data, analysis and interpretation of data, statistical analysis, drafting and critical revision of the manuscript, study supervision. MP, KS, CKA: Acquisition of data, study supervision, drafting and critical revision of the manuscript. RS: Interpretation of data, statistical analysis, drafting and critical revision of the manuscript. Final approval of the manuscript: All authors
- Issue published online: 19 DEC 2012
- Article first published online: 19 DEC 2012
- Accepted manuscript online: 28 SEP 2012 08:32AM EST
- Manuscript Accepted: 19 SEP 2012
- liver injury;
Background and Aim
Worldwide anti-tuberculosis (TB) drug-induced liver disease (DILI) is an important cause of hepatotoxicity, and drug-induced acute liver failure (ALF). Reported series on anti-TB DILI are limited by a mix of cases with mild transaminase elevation or adaptation. Our aim was to analyze the clinical features, laboratory characteristics, outcome, and determine predictors of 90-day mortality.
Single center analysis of consecutive cases of anti-TB DILI following combination anti-TB drugs exposure from 1997–2011.
Of the 269 patients, 191 (71%) experienced jaundice and 69 (25.7%) accounted for ALF. The mean age and treatment duration was 41.3 years and 1.9 months, respectively; males constituted 55.7%. DILI occurred throughout the course of treatment; three-quarters occurred within the first 2 months. HIV infection was present in 21 (7.8%). The 90-day mortality was 22.7%. DILI accompanied by jaundice (n = 191), encephalopathy (n = 69) or ascites (n = 69) resulted in mortality in 30%, 69.6% and 50.7%, respectively (P < 0.001). Age, gender, transaminase levels, HIV or hepatitis B surface antigen (HBsAg) status did not influence survival. Treatment duration, encephalopathy, ascites, bilirubin, serum albumin, international normalized ratio (INR), serum creatinine and leukocyte count were associated with mortality (P < 0.001). Multivariate logistic regression model for mortality, incorporating encephalopathy, albumin, bilirubin, INR, and creatinine yielded a C-statistic of 97%.
Anti-TB DILI occurs throughout treatment duration progressing to ALF in a quarter of patients. The overall mortality is 22.7%, which is higher when accompanied by jaundice, ascites or encephalopathy. An anti-TB DILI model, incorporating bilirubin, INR, encephalopathy, serum creatinine and albumin predicted mortality with C-statistic of 97%.