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• W4316081520 abstract "Introduction: The azole antifungal (AA) class of drugs is a rare cause of drug induced liver injury (DILI). AA-DILI most often presents with transient elevations in liver enzymes but has not been well studied or compared to DILI from other agents. The aim of this study is to describe the clinical features and outcomes of patients with AA-DILI in a large prospective registry. Methods: The DILIN Prospective Study enrolls participants with suspected DILI and determines causality and severity by committee consensus. Between 9/2004 and 6/2021, a total of 1726 participants with high confidence (causality score: definite, highly likely, probable) DILI were enrolled. The clinical course and outcomes of 15 consecutive patients with high confidence AA-DILI were reviewed and compared with DILI due to other agents. Results: The implicated agents among the 15 cases of AA-DILI were voriconazole (6), fluconazole (5), and ketoconazole (4). The median age was 47 with 53% females, 71% White, and 21% African American. The median (IQR) latency was 37 days (14,93) and the median ALT at DILI onset was 320 (200,906), alkaline phosphatase 176 (146,361), and total bilirubin 1.2 (.7,3). The most common symptoms were nausea 47%, rash 40%, and abdominal pain 33%. The pattern of liver injury included 47% hepatocellular, 40% mixed, and 13% cholestatic. 4 cases met Hy’s Law. 1 patient was treated with steroids while 2 died from non-liver related causes. No patients received liver transplantation or developed chronic DILI. Compared to liver injury due to all other agents (n=1711), there were no significant differences in age, sex, or race. Comorbidities were similar except for malignancy which was present in 33% of AA-DILI compared to 11% of other DILI cases. While there was no difference in latency, AA-DILI cases had significantly shorter time from earliest sign to drug stop, likely due to patients starting azoles inpatient or having close follow-up. Clinically, AA-DILI cases had significantly lower total bilirubin at DILI onset and was less likely to present with jaundice. The pattern of liver injury and number of patients treated with steroids did not differ significantly. Rates of all death and liver transplant did not differ. During follow up, AA-DILI had significantly lower peak total bilirubin and significantly shorter time to recovery of ALT and AST compared to other agents. Conclusion: AA-DILI is characterized by hepatocellular or mixed injury without jaundice. The course of AA-DILI appears to be relatively benign. Table 1. - Selected characteristics of patients with DILI due to azoles versus other agents Characteristic Azole Cases n=15 Other Agents n=1711 p value Age (years, median, IQR) 46.8 (34.3, 66.3) 51.8 (37.2, 62.7) 0.972 Female 53% 58% 0.710 Caucasian 71% 78% 0.558 Days from primary drug start to DILI onset/latency (median (IQR)) 37 (14, 93) 46 (22, 104) 0.256 Days from earliest sign/symptom to primary drug stop (median (IQR)) 1 (1,1) 6 (1, 16) 0.029 Jaundice at DILI onset 20% 63% < 0.001 Treated with prednisone or corticosteroids 7% 23% 0.214 Total bilirubin at DILI onset (mg/dl, median, IQR) 1.2 (0.7, 3) 4.6 (1.3, 9.1) 0.013 Pattern of liver injury (Cholestatic/Mixed/Hepatocellular) 13%/40%/47% 23%/22%/55% 0.288 Peak total bilirubin (from DILI onset to 6 months) (mg/dl) (median ((IQR)) 1.9 (0.9, 4.5) 9.1 (2.3, 19.4) 0.007 ALT (days from peak to below upper limit of normal) (IU/mL) 34 64 0.009 AST (days from peak to below upper limit of normal) (IU/mL) 28 57 0.005 All death 13% 6.4% 0.254 All liver transplant 0% 3.5% >0.999 Chronic DILI 0% 16.9% 0.236" @default.
• W4316081520 created "2023-01-14" @default.
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• W4316081520 date "2022-10-01" @default.
• W4316081520 modified "2023-10-16" @default.
• W4316081520 title "S1218 Characteristics of Liver Injury Due to Azole Antifungal Drugs in the United States: Results From the Drug Induced Liver Injury Network (DILIN) Prospective Study" @default.
• W4316081520 doi "https://doi.org/10.14309/01.ajg.0000861512.20494.17" @default.
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