Abstract
Isavuconazole (ISA) is a triazole antifungal agent recommended for treatment of invasive aspergillosis or mucormycosis. The objective of this study was to evaluate ISA levels in a real world setting in a mixed patient cohort including patients with non-malignant diseases and extracorporeal treatments, and to correlate findings with efficacy and safety outcomes. We investigated 33 ISA treatment courses in 32 adult patients with hematological and other underlying diseases and assessed the clinical response, side effects and ISA trough plasma concentrations. ISA treatment led to complete and partial response in 87% of patients and was well tolerated. The median ISA plasma concentration was 3.05 µg/mL (range 1.38–9.1, IQR 1.93–4.35) in patients without renal replacement therapy (RRT) or extracorporeal membrane oxygenation (ECMO) and significantly lower in patients with RRT including cases with additional ECMO or Cytosorb® adsorber therapy (0.88 µg/mL, range 0.57–2.44, IQR 0.71–1.21). After exclusion of values obtained from four patients with ECMO or Cytosorb® adsorber the median concentration was 0.91 µg/mL (range 0.75–2.44, IQR 0.90–1.36) in the RRT group. In addition to previous recommendations we propose to monitor ISA trough plasma concentrations in certain circumstances including RRT, other extracorporeal treatments and obesity.
Highlights
Isavuconazole (ISA) is a triazole antifungal agent recommended for treatment of invasive aspergillosis or mucormycosis [1,2,3]
Patients were eligible for ISA treatment if fulfilling criteria of probable/proven mucormycosis with contraindications to liposomal Amphotericin B, adverse events under lipAmpB treatment, lack of clinical response, or in other probable/proven invasive fungal infections based on antifungal susceptibility testing favoring Isavuconazole over alternative antifungals
The rate of side effects in our study was much lower compared to the SECURE trial where systematic prospective assessment revealed that 96% of patients experienced mostly mild treatment-emergent adverse events [4]
Summary
Isavuconazole (ISA) is a triazole antifungal agent recommended for treatment of invasive aspergillosis or mucormycosis [1,2,3]. The authors concluded that without a clear relationship of ISA drug exposure and outcome or side effects there is no clinical evidence for recommending routine therapeutic drug monitoring (TDM) compared to, e.g., voriconazole or posaconazole [5,6,7]. Another post hoc analysis of the SECURE trial showed that more than 97% of patients had ISA plasma concentrations >1 μg/mL and
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