PloS one · 2026
Longitudinal changes in laboratory parameters and QTc during isavuconazole therapy in Japanese patients with hematologic malignancies.
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Ohata Koichi, Kobayashi Ryo, Watanabe Daichi, Yamada Yuto, Niwa Takashi, Wada Mio, Ohashi Momoko, Kaneda Yuto, Ikoma Yoshikazu, Matsumoto Takuro, Nakamura Nobuhiko, Nakamura Hiroshi, Kanemura Nobuhiro, Shimizu Masahito, Suzuki Akio
Аннотация
BACKGROUND: Isavuconazole (ISCZ) is an azole antifungal with a low risk of QTc prolongation and no requirement for renal dose adjustment. However, real-world data in Asian patients remain limited.
METHODS: We retrospectively evaluated 45 patients who received ISCZ between April 2023 and March 2025. Laboratory parameters and QTc values (QTcB/QTcF) were extracted from medical records. Longitudinal changes were assessed using linear mixed-effects models. In patients receiving arsenic trioxide (ATO), QTc trajectories were compared among ATO alone, ATO with ISCZ (ATO-ISCZ), and ATO with other antifungals.
RESULTS: Grade ≥2 elevations in AST and ALT occurred in 11.1% and 13.3% of patients, respectively, and were transient. No significant deterioration in laboratory parameters was observed. In the ATO subgroup, QTc values in the ATO-ISCZ group were lower than those in the ATO group from Day 30, with the largest difference at Day 70 (-45.5 ms for QTcB and -42.3 ms for QTcF; both p < 0.001). The ATO-other antifungals group showed similar trends to the ATO group. No clinically significant cardiac events were observed.
CONCLUSIONS: ISCZ showed a favorable safety profile in Japanese patients with hematologic malignancies and may be a safe option during QT-prolonging therapies.
METHODS: We retrospectively evaluated 45 patients who received ISCZ between April 2023 and March 2025. Laboratory parameters and QTc values (QTcB/QTcF) were extracted from medical records. Longitudinal changes were assessed using linear mixed-effects models. In patients receiving arsenic trioxide (ATO), QTc trajectories were compared among ATO alone, ATO with ISCZ (ATO-ISCZ), and ATO with other antifungals.
RESULTS: Grade ≥2 elevations in AST and ALT occurred in 11.1% and 13.3% of patients, respectively, and were transient. No significant deterioration in laboratory parameters was observed. In the ATO subgroup, QTc values in the ATO-ISCZ group were lower than those in the ATO group from Day 30, with the largest difference at Day 70 (-45.5 ms for QTcB and -42.3 ms for QTcF; both p < 0.001). The ATO-other antifungals group showed similar trends to the ATO group. No clinically significant cardiac events were observed.
CONCLUSIONS: ISCZ showed a favorable safety profile in Japanese patients with hematologic malignancies and may be a safe option during QT-prolonging therapies.