Systemic antifungal therapy with isavuconazonium sulfate or other agents in adults with invasive mucormycosis or invasive aspergillosis (non‐fumigatus): A multicentre, non‐interventional registry study

• Published in: Mycoses Vol. 65; no. 2; pp. 186 - 198
• Main Authors: Thompson, George R., Garcia‐Diaz, Julia, Miceli, Marisa H., Nguyen, M. Hong, Ostrosky‐Zeichner, Luis, Young, Jo‐Anne H., Fisher, Cynthia E., Clark, Nina M., Greenberg, Richard N., Spec, Andrej, Kovanda, Laura, Croos‐Dabrera, Rodney, Kontoyiannis, Dimitrios P.
• Format: Journal Article
• Language: English
• Published: Germany Wiley Subscription Services, Inc 01.02.2022
• Subjects: Adult; Amphotericin B; Antifungal Agents - adverse effects; Antifungal Agents - therapeutic use; antifungals; Aspergillosis; Aspergillosis - drug therapy; azoles; Humans; invasive aspergillosis; Invasive Fungal Infections - drug therapy; invasive mucormycosis; isavuconazonium sulfate; Mortality; Mucormycosis; Mucormycosis - drug therapy; Nitriles - adverse effects; Nitriles - therapeutic use; non‐fumigatus Aspergillus; Patients; Pyridines - adverse effects; Pyridines - therapeutic use; Registries; Triazoles - adverse effects; Triazoles - therapeutic use; Voriconazole; invasive aspergillosis; invasive mucormycosis; non-fumigatus Aspergillus; antifungals; azoles; isavuconazonium sulfate
• ISSN: 0933-7407; 1439-0507
• DOI: 10.1111/myc.13412

Background Isavuconazole, administered as isavuconazonium sulfate (ISAVUSULF), is a broad‐spectrum triazole agent for the treatment of invasive fungal disease. In phase 3 studies, ISAVUSULF showed comparable efficacy to voriconazole and amphotericin B for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM), respectively. Objectives The objective of this study is to determine all‐cause mortality and safety outcomes among adults with IM and/or IA non‐fumigatus (nf) treated with ISAVUSULF or other antifungal therapies (AFT). Patients and methods This multicentre, non‐interventional registry enrolled patients aged ≥18 years with IM or IA‐nf who received systemic AFT from January 2016 to November 2018. Patients received primary ISAVUSULF, non‐primary ISAVUSULF, or other AFT, as monotherapy or combination therapy. The primary end point was all‐cause mortality at Days 42 and 84; safety outcomes were adverse drug reactions (ADRs) to ISAVUSULF. Results Of 204 patients enrolled, 74 received primary ISAVUSULF, 30 non‐primary ISAVUSULF, and 100 other AFT. All‐cause mortality through Day 42 was numerically lower in the non‐primary ISAVUSULF group than in the primary ISAVUSULF and other AFT groups, for patients with IM (20.0% vs. 33.3% and 41.3%, respectively) or IA‐nf (0% vs. 14.8% and 17.8%, respectively). All‐cause mortality tended to be lower with combination therapy than with monotherapy, except for patients with IM receiving primary ISAVUSULF. Of 111 patients receiving ISAVUSULF, 14 (12.6%) reported ADRs, of whom three (2.7%) developed serious ADRs. There were no drug‐related deaths. Conclusions This study supports the effectiveness and tolerability of ISAVUSULF in clinical practice. Further research is required to confirm the value of ISAVUSULF combination therapy over monotherapy.