Antimicrobial stewardship & healthcare epidemiology : ASHE · 2026
Hepatotoxicity in hematologic malignancy and hematopoietic stem cell transplant patients receiving posaconazole or isavuconazole prophylaxis: a single-center cohort study.
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Steele Samantha, Nichols Courtney, Coe Kelci, Tran Nikki
Аннотация
OBJECTIVE: To assess and compare the incidence, timing, and severity of hepatotoxicity associated with prophylactic isavuconazole and posaconazole in patients with hematologic malignancies or a history of hematopoietic stem cell transplant (HSCT).
DESIGN: Retrospective cohort study.
SETTING: Large academic tertiary-care center.
PATIENTS: Hospitalized adult patients with hematologic malignancies or a history of HSCT who received posaconazole or isavuconazole for antifungal prophylaxis between August 2015 and August 2024.
METHODS: The primary outcome was the incidence of hepatotoxicity, defined by elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or bilirubin. Secondary outcomes included time to hepatotoxicity, severity grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0., and causality assessment using the Naranjo Adverse Drug Reaction Probability Scale.
RESULTS: A total of 154 patients were included (100 receiving posaconazole, 54 receiving isavuconazole). Hepatotoxicity occurred in 17% of the isavuconazole group and 7% of the posaconazole group (P = .06), with all events classified as mild. The median time to hepatotoxicity was longer for isavuconazole (96 vs. 15 days, P = .16). Survival analysis showed no significant difference in time to hepatotoxicity between groups (P = .07). Most hepatotoxic events were classified as "possible" according to the Naranjo Scale.
CONCLUSIONS: In this retrospective analysis, no statistically significant difference in hepatotoxicity incidence was observed between isavuconazole and posaconazole for prophylaxis. Larger prospective studies are needed to confirm these findings and further define the hepatic safety profiles of these antifungal agents.
DESIGN: Retrospective cohort study.
SETTING: Large academic tertiary-care center.
PATIENTS: Hospitalized adult patients with hematologic malignancies or a history of HSCT who received posaconazole or isavuconazole for antifungal prophylaxis between August 2015 and August 2024.
METHODS: The primary outcome was the incidence of hepatotoxicity, defined by elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or bilirubin. Secondary outcomes included time to hepatotoxicity, severity grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0., and causality assessment using the Naranjo Adverse Drug Reaction Probability Scale.
RESULTS: A total of 154 patients were included (100 receiving posaconazole, 54 receiving isavuconazole). Hepatotoxicity occurred in 17% of the isavuconazole group and 7% of the posaconazole group (P = .06), with all events classified as mild. The median time to hepatotoxicity was longer for isavuconazole (96 vs. 15 days, P = .16). Survival analysis showed no significant difference in time to hepatotoxicity between groups (P = .07). Most hepatotoxic events were classified as "possible" according to the Naranjo Scale.
CONCLUSIONS: In this retrospective analysis, no statistically significant difference in hepatotoxicity incidence was observed between isavuconazole and posaconazole for prophylaxis. Larger prospective studies are needed to confirm these findings and further define the hepatic safety profiles of these antifungal agents.