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. 2025 Sep 1;11(9):648.
doi: 10.3390/jof11090648.

Isavuconazole Therapy for Patients with Hematologic Diseases and Hematopoietic Cell Transplantation with and Without Breakthrough Invasive Fungal Infections

Fabián Herrera  1 , Diego Torres  1 , Gustavo Mendez  2 , Noelia Mañez  3 , Rosana Jordán  4 , Adriana Manzur  5 , Myrna Cabral  6 , Manuel Alderete  7 , Natalia García Allende  8 , José Benso  9 , Claudia Salgueira  10 , María Laura Pereyra  11 , Hugo Peretti  12 , Carla Niveyro  2 , Maximiliano Castro  1 , Federico Pollastrelli  4 , Silvina García Rojas  4 , Juan Dapás  6 , Agustina Risso Patrón  8 , Verónica Fernández  9 , Rocío Gago  11 , Javier Afeltra  13 ; Multicenter study on Isavuconazole for Treatment and Prophylaxis of Invasive Fungal Infections in Patients with Hematologic Malignancies and Hematopoietic Cell Transplantation (EMISA)
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Isavuconazole Therapy for Patients with Hematologic Diseases and Hematopoietic Cell Transplantation with and Without Breakthrough Invasive Fungal Infections

Fabián Herrera et al. J Fungi (Basel). .

Abstract

There are no data available on the effectiveness and safety of isavuconazole (ISA) for treating breakthrough invasive fungal infections (bIFIs). A retrospective and prospective cohort study was conducted between January 2020 and March 2025 in 13 centers in Argentina. Hematologic diseases (HD) and hematopoietic cell transplantation (HCT) patients who received ISA for IFI were included and followed for 12 weeks. Patients with proven and probable bIFIs and non-bIFIs were compared. One hundred and sixty-three patients were included. IFIs were classified as proven (13.5%), probable (26.9%) and possible (59.5%). Among 66 proven and probable IFIs, 53% were bIFIs, with aspergillosis and mucormycosis being the most common. Twenty-three (34.8%) patients had acute myelogenous leukemia, and 40.9% had received HCT. Forty-eight (72.7%) patients experienced neutropenia, with a median duration of 26 days (interquartile range [IQR] 16-44). Fluconazole and posaconazole were the most frequently received antifungal prophylaxis. ISA was prescribed as first-line therapy in 31 (46.9%) patients. The other 35 received ISA as a continuation therapy, mainly as a step-down therapy after liposomal amphotericin B. Four (6.1%) patients developed adverse effects, and one discontinued ISA. The 90-day overall clinical response between patients with bIFI vs. non-bIFI was 91.4% vs. 70.9% (p = 0.052). The 90-day overall and IFI-related mortality rates were, respectively, 11.4% vs. 32.3% (p = 0.068) and 5.7% vs. 9.7% (p = 0.659). The study data evidence ISA effectiveness and safety for the treatment of HD and HCT patients with and without bIFIs.

Keywords: breakthrough invasive fungal infections; hematologic diseases; hematopoietic cell transplantation; isavuconazole therapy.

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Conflict of interest statement

F.H. has participated in advisory boards and/or received speaker honoraria and grants from Gilead, Knight Therapeutics, Merck, Sharp & Dohme (MSD), SteinCares, Biomerieux, Rochem Biocare, TEVA, TAKEDA, and Pfizer. D.T. has participated in advisory boards and/or received speaker honoraria from Gilead, Knight Therapeutics, MSD, Pfizer and GlaxoSmithKline. G.M. has participated in advisory boards and/or received speaker honoraria from Knight Therapeutics. R.J. has participated in advisory boards and/or received speaker honoraria from Knight Therapeutics and Pfizer. J.A. has participated in advisory boards and/or received speaker honoraria from Knight Therapeutics, Gilead and Pfizer. All other authors report no potential conflicts of interest.

Figures

Figure 1
Figure 1
Risk factors for IFIs.
Figure 2
Figure 2
Clinical outcomes at 12 weeks in patients with probable and proven non-bIFIs and bIFIs.
See this image and copyright information in PMC

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