Please use this identifier to cite or link to this item:
http://hdl.handle.net/11054/1842
Title: | SUBA-itraconazole for primary antifungal prophylaxis after allogeneic hematopoietic cell transplantation. |
Author: | Lindsay, J. Othman, J. Kong, Y. Yip, A. Van Hal, S. Bryant, C. Gibson, J. Kerridge, I. Fay, K. Stevenson, W. Arthur, C. Chen, S. Kong, David C. M. Greenwood, M. Pergam, S. Liu, C. Slavin, M. |
Issue Date: | 2021 |
Publication Title: | Open Forum Infectious Diseases |
Volume: | 8 |
Issue: | 11 |
Abstract: | Background: Itraconazole (ITZ) is an effective agent when used as primary invasive fungal disease (IFD) prophylaxis, but is limited by drug tolerability and variability in serum concentrations. A new formulation, SUBA-itraconazole (for “super bioavailability”; S-ITZ), addresses the limitations of conventional ITZ formulations. Methods: We conducted a retrospective cohort study at 2 Australian centers to evaluate the safety, tolerability, and effectiveness of S-ITZ as primary antifungal prophylaxis in hematopoietic cell transplant (HCT) recipients without grade II–IV acute graft-vs-host disease, from day 1 until approximately day 100 (cohort A) or day 1 until neutrophil engraftment (cohort B). A total of 204 patients and 1410 trough plasma ITZ concentrations were assessed. Results: The incidence of breakthrough proven/probable IFD at day 180 was 1.0% (95% confidence interval [CI], .2%–3.2%), with 1.6% in cohort A and 0% in cohort B, and overall fungal-free survival of proven/probable IFD was 82.9% (95% CI, 76.8%–87.4%). Preengraftment early permanent S-ITZ discontinuation was 3.4% overall, with no significant difference between cohorts. No patients required cessation due to gastrointestinal intolerance attributed to S-ITZ. The geometric mean trough plasma ITZ concentration was 1130ng/mL (interquartile range, 566–1801ng/mL; coefficient of variation, 56.57%) and the median time to achieve therapeutic levels was 10 days. Conclusions: S-ITZ is a safe and well-tolerated oral formulation and is a novel alternative for primary IFD prophylaxis after HCT. |
URI: | http://hdl.handle.net/11054/1842 |
DOI: | https://doi.org/10.1093/ofid/ofab502 |
Internal ID Number: | 01867 |
Health Subject: | ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT (HCT) ANTIFUNGAL PROPHYLAXIS ITRACONAZOLE HCT S-ITZ SUBA ITRACONAZOLE |
Type: | Journal Article Article |
Appears in Collections: | Research Output |
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Open Forum Infectious Disease - uploaded with permission.pdf | Open Forum Infectious Disease - uploaded with permission | 705 kB | Adobe PDF | ![]() View/Open |
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