Novel formulations (gastro-resistant tablet and intravenous solution) of posaconazole (POS) have been approved in prophylaxis and therapy of invasive fungal diseases (IFDs). The aim of this multicenter non-interventional study was to analyze treatment strategies and clinical effectiveness of these new options.
We set up a web-based registry on the science platform www.ClinicalSurveys.net and members of the Infectious Diseases Working Party of the German Society of Hematology and Medical Oncology (AGIHO) were invited to provide clinical data on patients who received novel POS formulations. Data analysis was split into two groups of patients who received novel POS formulations for antifungal prophylaxis (posaconazole prophylaxis group) and antifungal therapy (posaconazole therapy group), respectively.
One hundred eighty hospitalized patients (151 in the posaconazole prophylaxis group and 29 in the posaconazole therapy group) from six German tertiary care centers treated between 07/2014 – 03/2016 were included into our analysis. Seventy-six patients were female (42%) and median age was 58 years (range: 19 – 77 years). Most patients (n= 111; 62%) had an acute myeloid leukemia as primary underlying disease. In the posaconazole prophylaxis group and posaconazole therapy group, mean POS serum levels at steady-state were 1,154 µg/L (n= 40; 95% CI: 911 – 1,396 µg/L) and 1,097 µg/L (n= 19; 95% CI: 817 – 1,378 µg/L), respectively (P= 0.776). In the posaconazole prophylaxis group, nine (6%) probable/proven fungal breakthroughs were reported. In the posaconazole therapy group, 17 and 12 patients received POS as first line therapy and salvage therapy, respectively. Most frequent indications were possible (n= 9) and probable (n= 7) aspergillosis and proven (n= 7) mucormycosis. The median overall duration of POS therapy was 18 days (IQR: 7 – 23 days). Thirteen patients (45%) had progressive IFD under treatment with novel POS formulations.
Our study demonstrates clinical effectiveness of antifungal prophylaxis with novel POS formulations. In patients treated for possible/probable/proven IFD, the observed tolerability and overall mortality was comparable to previous studies with other antifungals in similar patient population.
S. M. Heimann,
W. J. Heinz, MSD: Grant Investigator and Speaker's Bureau , Research grant and Speaker honorarium .
T. Rachow, None
G. Egerer, None
J. Kessel, None
A. Löhnert, None
J. Vehreschild, MSD: Grant Investigator and Speaker's Bureau , Research grant and Speaker honorarium .