TY - JOUR
T1 - Isavuconazole for treatment of rare invasive fungal diseases
AU - Cornely, Oliver A.
AU - Mullane, Kathleen M.
AU - Ostrosky-Zeichner, Luis
AU - Maher, Rochelle M.
AU - Croos-Dabrera, Rodney
AU - Lu, Qiaoyang
AU - Lademacher, Christopher
AU - Perfect, John R.
AU - Oren, Ilana
AU - Schmitt-Hoffmann, Anne Hortense
AU - Giladi, Michael
AU - Marty, Francisco M.
AU - Rahav, Galia
N1 - Publisher Copyright:
© 2018 The Authors. Mycoses Published by Blackwell Verlag GmbH.
PY - 2018/8
Y1 - 2018/8
N2 - Data regarding treatment of rare invasive fungal diseases (IFDs) are scarce. We documented the efficacy and safety of isavuconazole for treatment of uncommonly diagnosed IFDs. VITAL was a single-arm, international, open-label study evaluating the efficacy and safety of isavuconazole (200 mg orally or intravenously every 8 hours for 48 hours, then once daily). The primary outcome was overall response at Day 42; key secondary outcomes were overall responses at Day 84 and end of treatment (EOT), mortality at Days 42 and 84, and safety. This analysis includes patients with IFD caused by rare or unidentified pathogens. Twenty-six patients with IFDs caused by rare moulds (n = 17), non-Candida yeasts (n = 2), or unidentified moulds (n = 7) were enrolled (median treatment duration [range], 114.5 [1-496]) days. Overall treatment success was observed in 11/26 (42.3%), 10/26 (38.5%), and 15/26 (57.7%) patients at Days 42, 84, and EOT, respectively. All-cause mortality rates were 2/26 patients (7.7%) at Day 42 and 4/26 patients (15.4%) at Day 84; another two patients died after Day 84. All patients had ≥1 treatment-emergent adverse event (TEAE); 15 patients (57.7%) had serious TEAEs, and TEAEs led to discontinuation of isavuconazole in four patients (15.4%). Isavuconazole may be efficacious for treatment of a range of rare IFDs.
AB - Data regarding treatment of rare invasive fungal diseases (IFDs) are scarce. We documented the efficacy and safety of isavuconazole for treatment of uncommonly diagnosed IFDs. VITAL was a single-arm, international, open-label study evaluating the efficacy and safety of isavuconazole (200 mg orally or intravenously every 8 hours for 48 hours, then once daily). The primary outcome was overall response at Day 42; key secondary outcomes were overall responses at Day 84 and end of treatment (EOT), mortality at Days 42 and 84, and safety. This analysis includes patients with IFD caused by rare or unidentified pathogens. Twenty-six patients with IFDs caused by rare moulds (n = 17), non-Candida yeasts (n = 2), or unidentified moulds (n = 7) were enrolled (median treatment duration [range], 114.5 [1-496]) days. Overall treatment success was observed in 11/26 (42.3%), 10/26 (38.5%), and 15/26 (57.7%) patients at Days 42, 84, and EOT, respectively. All-cause mortality rates were 2/26 patients (7.7%) at Day 42 and 4/26 patients (15.4%) at Day 84; another two patients died after Day 84. All patients had ≥1 treatment-emergent adverse event (TEAE); 15 patients (57.7%) had serious TEAEs, and TEAEs led to discontinuation of isavuconazole in four patients (15.4%). Isavuconazole may be efficacious for treatment of a range of rare IFDs.
KW - VITAL trial
KW - clinical trial
KW - invasive fungal disease
KW - isavuconazole
KW - mould
KW - rare
KW - yeast
UR - http://www.scopus.com/inward/record.url?scp=85049055778&partnerID=8YFLogxK
U2 - 10.1111/myc.12778
DO - 10.1111/myc.12778
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C2 - 29611246
AN - SCOPUS:85049055778
SN - 0933-7407
VL - 61
SP - 518
EP - 533
JO - Mycoses
JF - Mycoses
IS - 8
ER -