Risk factors for voriconazole-associated hepatotoxicity in patients with liver dysfunction: a retrospective nested case–control study

IntroductionVoriconazole is widely used to prevent and treat invasive aspergillosis. However, its use is restricted by adverse effects, including acute liver injury (ALI). Patients with hepatic insufficiency are often more susceptible to voriconazole-induced liver injury than those with normal hepat...

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Main Authors: Jing Ren, Xinfeng Cai, Wei Ge, Jinlin Guo, Shan Wang, Qinhui Wang, Linna Liu, Le Yang, Qi Yang
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-08-01
Series:Frontiers in Pharmacology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1625003/full
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author Jing Ren
Xinfeng Cai
Wei Ge
Jinlin Guo
Shan Wang
Qinhui Wang
Linna Liu
Le Yang
Qi Yang
author_facet Jing Ren
Xinfeng Cai
Wei Ge
Jinlin Guo
Shan Wang
Qinhui Wang
Linna Liu
Le Yang
Qi Yang
author_sort Jing Ren
collection DOAJ
description IntroductionVoriconazole is widely used to prevent and treat invasive aspergillosis. However, its use is restricted by adverse effects, including acute liver injury (ALI). Patients with hepatic insufficiency are often more susceptible to voriconazole-induced liver injury than those with normal hepatic function. The aim of this study was to determine the incidence and risk factors of ALI in patients with mild or moderate liver dysfunction during voriconazole treatment.MethodsThis single-center nested case–control study involved adult patients treated with voriconazole for at least 3 days. The Child–Pugh score is now extensively utilized to assess liver damage. The hepatotoxicity of voriconazole was assessed in patients with mild or moderate hepatic insufficiency (Child–Pugh A or B). ALI cases were matched with controls based on age and Child–Pugh score. Basic characteristics were compared between patients who developed ALI and those who did not by performing univariate and multivariate conditional logistic regression analyses. The optimal cutoff condition was determined using a receiver operating characteristic curve.ResultsA total of 140 patients (ALI: n = 44; control: n = 96) were enrolled. The incidence of voriconazole-induced ALI in patients with mild or moderate liver dysfunction was 30.6%. The univariate analysis revealed trough voriconazole plasma concentration (VPC), voriconazole treatment duration, activated partial thromboplastin time, and intensive care unit admission as variables for the final analysis. Voriconazole-induced ALI was independently associated with trough VPC (odds ratio [OR]: 1.592, p = 0.013) and voriconazole treatment duration (OR: 1.057, p = 0.005). Notably, the optimal cutoff for treatment duration was 10 days and the recommended trough VPC threshold was 3.81 mg/L.ConclusionThe incidence of voriconazole-induced ALI was higher in patients with mild or moderate liver dysfunction than in the general population. Trough VPC and voriconazole treatment duration are two independent risk factors of ALI. Therefore, voriconazole should be administered with caution to these patients. A lower target trough VPC (<3.81 mg/L) is recommended to minimize the risk of ALI in patients with mild-to-moderate liver dysfunction.
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spelling doaj-art-1ffa71af07a949e1bf0b450f3f174d2f2025-08-26T05:27:59ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-08-011610.3389/fphar.2025.16250031625003Risk factors for voriconazole-associated hepatotoxicity in patients with liver dysfunction: a retrospective nested case–control studyJing Ren0Xinfeng Cai1Wei Ge2Jinlin Guo3Shan Wang4Qinhui Wang5Linna Liu6Le Yang7Qi Yang8Department of Pharmacy, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Pharmacy, Shanxi Province Cancer Hospital, Taiyuan, Shanxi, ChinaDepartment of Disease Prevention and Control, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Pharmacy, Shanxi Provincial People’s Hospital, Taiyuan, Shanxi, ChinaDepartment of Pharmacy, New York University, Langone Hospital–Long Island, Mineola, NY, United StatesDepartment of Pharmacy, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Pharmacy, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Pharmacy, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Pharmacy, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaIntroductionVoriconazole is widely used to prevent and treat invasive aspergillosis. However, its use is restricted by adverse effects, including acute liver injury (ALI). Patients with hepatic insufficiency are often more susceptible to voriconazole-induced liver injury than those with normal hepatic function. The aim of this study was to determine the incidence and risk factors of ALI in patients with mild or moderate liver dysfunction during voriconazole treatment.MethodsThis single-center nested case–control study involved adult patients treated with voriconazole for at least 3 days. The Child–Pugh score is now extensively utilized to assess liver damage. The hepatotoxicity of voriconazole was assessed in patients with mild or moderate hepatic insufficiency (Child–Pugh A or B). ALI cases were matched with controls based on age and Child–Pugh score. Basic characteristics were compared between patients who developed ALI and those who did not by performing univariate and multivariate conditional logistic regression analyses. The optimal cutoff condition was determined using a receiver operating characteristic curve.ResultsA total of 140 patients (ALI: n = 44; control: n = 96) were enrolled. The incidence of voriconazole-induced ALI in patients with mild or moderate liver dysfunction was 30.6%. The univariate analysis revealed trough voriconazole plasma concentration (VPC), voriconazole treatment duration, activated partial thromboplastin time, and intensive care unit admission as variables for the final analysis. Voriconazole-induced ALI was independently associated with trough VPC (odds ratio [OR]: 1.592, p = 0.013) and voriconazole treatment duration (OR: 1.057, p = 0.005). Notably, the optimal cutoff for treatment duration was 10 days and the recommended trough VPC threshold was 3.81 mg/L.ConclusionThe incidence of voriconazole-induced ALI was higher in patients with mild or moderate liver dysfunction than in the general population. Trough VPC and voriconazole treatment duration are two independent risk factors of ALI. Therefore, voriconazole should be administered with caution to these patients. A lower target trough VPC (<3.81 mg/L) is recommended to minimize the risk of ALI in patients with mild-to-moderate liver dysfunction.https://www.frontiersin.org/articles/10.3389/fphar.2025.1625003/fullvoriconazolehepatotoxicityacute liver injurytherapeutic drug monitoringtrough concentration
spellingShingle Jing Ren
Xinfeng Cai
Wei Ge
Jinlin Guo
Shan Wang
Qinhui Wang
Linna Liu
Le Yang
Qi Yang
Risk factors for voriconazole-associated hepatotoxicity in patients with liver dysfunction: a retrospective nested case–control study
Frontiers in Pharmacology
voriconazole
hepatotoxicity
acute liver injury
therapeutic drug monitoring
trough concentration
title Risk factors for voriconazole-associated hepatotoxicity in patients with liver dysfunction: a retrospective nested case–control study
title_full Risk factors for voriconazole-associated hepatotoxicity in patients with liver dysfunction: a retrospective nested case–control study
title_fullStr Risk factors for voriconazole-associated hepatotoxicity in patients with liver dysfunction: a retrospective nested case–control study
title_full_unstemmed Risk factors for voriconazole-associated hepatotoxicity in patients with liver dysfunction: a retrospective nested case–control study
title_short Risk factors for voriconazole-associated hepatotoxicity in patients with liver dysfunction: a retrospective nested case–control study
title_sort risk factors for voriconazole associated hepatotoxicity in patients with liver dysfunction a retrospective nested case control study
topic voriconazole
hepatotoxicity
acute liver injury
therapeutic drug monitoring
trough concentration
url https://www.frontiersin.org/articles/10.3389/fphar.2025.1625003/full
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