Longitudinal changes in laboratory parameters and QTc during isavuconazole therapy in Japanese patients with hematologic malignancies
Koichi Ohata1, Ryo Kobayashi1,2, Daichi Watanabe1
1Department of Pharmacy, Gifu University Hospital, Gifu, Japan.
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.
Insights
Isavuconazole (ISCZ) is a safe antifungal for Japanese patients with hematologic malignancies. It demonstrated a favorable safety profile, even when used with QT-prolonging therapies like arsenic trioxide.
Area of Science:
- Pharmacology
- Clinical Medicine
- Infectious Diseases
Background:
- Isavuconazole (ISCZ) is an azole antifungal known for low QTc prolongation risk and no need for renal dose adjustment.
- Limited real-world data exists for ISCZ in Asian patient populations.
Purpose of the Study:
- To evaluate the safety and efficacy of Isavuconazole (ISCZ) in Japanese patients with hematologic malignancies.
- To assess the impact of ISCZ on QTc interval, particularly when co-administered with arsenic trioxide (ATO).
Main Methods:
- Retrospective evaluation of 45 patients receiving ISCZ between April 2023 and March 2025.
- Analysis of laboratory parameters and QTc values (QTcB/QTcF) using linear mixed-effects models.
- Comparison of QTc trajectories in patients receiving ATO alone, ATO with ISCZ, and ATO with other antifungals.
Main Results:
- Transient, grade ≥2 elevations in AST (11.1%) and ALT (13.3%) were observed, with no significant laboratory deterioration.
- In the ATO subgroup, ISCZ was associated with lower QTc values compared to ATO alone (p < 0.001).
- No clinically significant cardiac events were reported during the study period.
Conclusions:
- Isavuconazole (ISCZ) exhibits a favorable safety profile in Japanese patients with hematologic malignancies.
- ISCZ appears to be a safe therapeutic option, even during concurrent QT-prolonging treatments.
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