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Clinical features, outcomes, and HLA risk factors associated with nitrofurantoin-induced liver injury
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DOI：10.1016/j.jhep.2022.09.010.png)
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Abstract
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Background & Aims: Nitrofurantoin (NTF) is widely used for the treatment (short-term) and prevention (long-term) of urinary tract infections. We aimed to describe the clinical characteristics, outcomes, and HLA risk factors for NTF-induced liver injury (NTF-DILI) among individuals enrolled in the Drug Induced Liver Injury Network (DILIN).Methods: Seventy-eight individuals with definite, highly likely, or probable NTF-DILI were enrolled into DILIN studies between 2004-2020. HLA alleles were compared between NTF-DILI and three control groups: population (n = 14,001), idiopathic auto -immune hepatitis (n = 231), and non-NTF DILI (n = 661).Results: Liver injury was hepatocellular in 69% and icteric in 55%. AST > ALT was more common in the 44 long-exposure (>-1 year) NTF-DILI cases than in the 18 short (<-7 days) and 16 intermediate (>7 to <365 days) exposure cases (73% vs. 33% vs. 50%, respectively, p = 0.018), as was ANA or SMA positivity (91% vs. 44% vs. 50%, respectively, p <0.001), and corticosteroid use (61% vs. 27% vs. 44%, respectively, p = 0.06). In long-term NTF-DILI, bridging fibrosis, nodularity or cirrhosis, or clinical and imaging evidence for cirrhosis were present in 38%, with massive or sub-massive necrosis in 20%. No one in the short-term exposure group died or underwent transplantation, whereas 7 (12%) patients from the other groups died or underwent trans-plantation. After covariate adjustments, HLA-DRB1*11:04 was significantly more frequent in NTF-DILI compared to population controls (odds ratio [OR] 4.29, p = 1.15 x 10-4), idiopathic autoimmune hepatitis (OR 11.77, p = 7.76 x 10-5), and non-NTF DILI (OR 3.34, p = 0.003).Conclusion: NTF-DILI can result in parenchymal necrosis, bridging fibrosis, cirrhosis, and death or liver transplantation, especially with long-term exposure, and is associated with HLA-DRB1*11:04. To mitigate against serious liver injury associated with NTF, regulators should revise the prescribing information and consider other mitigation strategies.(c) 2022 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Keywords:
DILI
Causality
Chronic DILI
LiverTox
Corticosteroids
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