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Incidence and risk factors of anti-tuberculosis drug induced liver injury (DILI): Large cohort study involving 4652 Chinese adult tuberculosis patients

Hu, Ting; Hu, Yaoren; Wang, Guangming; Zhu, Yuying; Aithal, Guruprasad P.; Cai, Ting; Wang, Hongxia; Liang, Lili; Yang, Shiqing; Jin, Susu; Du, Jingyuan; Yan, Huadong; Jiang, Fanrong

Incidence and risk factors of anti-tuberculosis drug induced liver injury (DILI): Large cohort study involving 4652 Chinese adult tuberculosis patients Thumbnail


Authors

Ting Hu

Yaoren Hu

Guangming Wang

Yuying Zhu

Ting Cai

Hongxia Wang

Lili Liang

Shiqing Yang

Susu Jin

Jingyuan Du

Huadong Yan

Fanrong Jiang



Abstract

Background and Aims: Anti-tuberculosis drugs remain as an important cause of drug-induced liver injury (DILI) worldwide. Adverse drug reactions reduce the effectiveness of treatment. We aimed to determine the incidence and risk factors associated with anti-tuberculosis DILI (ATDILI). Methods: Using established criteria and causality assessment methods, risk factors for ATDILI were identified in a contemporary cohort and validated in another cohort prospectively. Independent determinants of ATDILI were identified using Cox regression analysis. Results: In the derivation cohort (n=3155), 170 (5.4%) developed ATDILI of which 27 (15.9%) developed jaundice; 9(5.3%) developed acute liver failure (ALF) and 3 died. Among HBsAg positive patients, 11/27 (40.7%) of ATDILI developed after 3months of starting treatment. In addition, of 218 (6.9%) who developed raised alanine transferase (ALT) levels ≥3 times upper limit normal, 193 (88.5%) resolved and 25 (11.4%) progressed to DILI. Age (HR=1.014, 95% CI: 1.005-1.023), baseline ALT (HR=1.014, 95% CI: 1.003-1.024), haemoglobin (HR=1.011, 95% CI: 1.002-1.020) and HBsAg positivity (HR=1.516, 95% CI: 1.004-2.290) were independent risk factors for DILI. In the second cohort (n=1497) of which 85 (5.7%) developed ATDILI. Age (HR=1.029, 95% CI: 1.003-1.056), baseline AST (HR=1.036, 95% CI: 1.010-1.062), previous TB treatment (HR=3.894, 95% CI: 1.304-11.625) and active drinking (HR=3.624, 95% CI: 1.147-11.454) were risk factors for developing jaundice. Conclusion: Elevation of ALT of ≥3×ULN during anti-TB treatment resolves in the vast majority without developing serious consequences. In two cohorts involving 4652 patients, incidence of ALF and death because of ATDILI are low. Age, baseline ALT, haemoglobin and HBsAg positivity are risk factors for the development of DILI and these inform monitoring and management of these patients.

Citation

Hu, T., Hu, Y., Wang, G., Zhu, Y., Aithal, G. P., Cai, T., …Jiang, F. (2021). Incidence and risk factors of anti-tuberculosis drug induced liver injury (DILI): Large cohort study involving 4652 Chinese adult tuberculosis patients. Liver International, 41(7), 1565-1575. https://doi.org/10.1111/liv.14896

Journal Article Type Article
Acceptance Date Mar 27, 2021
Online Publication Date Apr 18, 2021
Publication Date Jul 1, 2021
Deposit Date Mar 30, 2021
Publicly Available Date Apr 19, 2022
Journal Liver International
Print ISSN 1478-3223
Electronic ISSN 1478-3231
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 41
Issue 7
Pages 1565-1575
DOI https://doi.org/10.1111/liv.14896
Keywords Tuberculosis, Drug induced liver injury, anti-tuberculosis drug, incidence, risk factor
Public URL https://nottingham-repository.worktribe.com/output/5423363
Publisher URL https://onlinelibrary.wiley.com/doi/full/10.1111/liv.14896

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