Asai Yuki, Kato Hideo, Tawara Isao, Nakano Yuki, Iwamoto Takuya
Department of Pharmacy, Mie University Hospital, Faculty of Medicine, Mie University, Tsu, Mie, Japan.
Department of Pharmacy, Mie University Hospital, Faculty of Medicine, Mie University, Tsu, Mie, Japan.
Clin Ther. 2025 Apr;47(4):330-334. doi: 10.1016/j.clinthera.2025.01.006. Epub 2025 Jan 30.
Despite implementation of therapeutic drug monitoring (TDM) for voriconazole, the incidence of hepatotoxicity remains high. The albumin-bilirubin (ALBI) score may be useful for estimating voriconazole-induced hepatotoxicity. This pilot study aimed to investigate whether the ALBI score could estimate voriconazole-induced hepatotoxicity during TDM implementation.
This single-center, retrospective cohort study included 134 patients. The primary outcome was voriconazole-induced hepatotoxicity. The cutoff value of the ALBI score was determined using a receiver operating characteristic curve. The cumulative risk of hepatotoxicity was evaluated using Kaplan-Meier curve analysis with a log-rank test for the cutoff value and ALBI grade. Moreover, the group of patients with the trough concentration of voriconazole 1-4 μg/mL was also investigated.
The incidence of hepatotoxicity was 13.4% (18/134). The cutoff value of the ALBI score was -1.91 (sensitivity, 0.611; specificity, 0.655; area under the curve, 0.615). The cumulative risk of hepatotoxicity was significantly higher in the ALBI score ≥-1.91 group than in the ALBI score <-1.91 group (P = 0.024) and patients with higher ALBI grades tended to be at higher risk (P = 0.080). The cumulative risk tended to be higher with ALBI ≥-1.91 in the trough concentration 1-4 μg/mL group; however, no significant difference was found (P = 0.134).
The pilot study indicated that the ALBI score ≥-1.91 may be an indicator for voriconazole-induced hepatotoxicity even when TDM is conducted. Because this study was a single-center and small cohort design, further studies should be conducted using a large datasets and translational research.