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Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: Challenges and lessons of the VITAL trial

Invasive fungal disease (IFD) confers a substantial risk for morbidity and mortality to immunocompromised patients. Invasive aspergillosis (IA) is the most common IFD caused by moulds but the prevalence of other rare mould diseases, such as mucormycosis, hyalohyphomycosis and phaeohyphomycosis, may...

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Autores principales: Perfect, John R., Cornely, Oliver A., Heep, Markus, Ostrosky-Zeichner, Luis, Mullane, Kathleen M., Maher, Rochelle, Croos-Dabrera, Rodney, Lademacher, Christopher, Engelhardt, Marc, Chen, Caroline, Marty, Francisco M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6490690/
https://www.ncbi.nlm.nih.gov/pubmed/29570857
http://dx.doi.org/10.1111/myc.12769
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author Perfect, John R.
Cornely, Oliver A.
Heep, Markus
Ostrosky-Zeichner, Luis
Mullane, Kathleen M.
Maher, Rochelle
Croos-Dabrera, Rodney
Lademacher, Christopher
Engelhardt, Marc
Chen, Caroline
Marty, Francisco M.
author_facet Perfect, John R.
Cornely, Oliver A.
Heep, Markus
Ostrosky-Zeichner, Luis
Mullane, Kathleen M.
Maher, Rochelle
Croos-Dabrera, Rodney
Lademacher, Christopher
Engelhardt, Marc
Chen, Caroline
Marty, Francisco M.
author_sort Perfect, John R.
collection PubMed
description Invasive fungal disease (IFD) confers a substantial risk for morbidity and mortality to immunocompromised patients. Invasive aspergillosis (IA) is the most common IFD caused by moulds but the prevalence of other rare mould diseases, such as mucormycosis, hyalohyphomycosis and phaeohyphomycosis, may be increasing. Treatments are available for IA, but evidence to support efficacy and safety of antifungal agents for rare IFDs, or for IFDs in special patient populations, is limited or lacking. The VITAL trial was conducted to assess the efficacy and safety of isavuconazole for the treatment of patients with IA and renal impairment, or with IFDs caused by rare moulds, yeasts or dimorphic fungi. These patients stand to benefit most from a new treatment option but are unlikely to be included in a randomised, controlled trial. In this article, we review the challenges faced in the design and conduct of the VITAL trial. We also review the findings of VITAL, which included evidence of the efficacy and safety of isavuconazole. Finally, we consider the importance of trials such as VITAL to inform therapeutic decision making for clinicians faced with the challenge of treating patients with rare IFDs and as one paradigm of how to determine efficacy and safety of new drugs for rare and resistant infections without a suitable comparator.
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spelling pubmed-64906902019-07-01 Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: Challenges and lessons of the VITAL trial Perfect, John R. Cornely, Oliver A. Heep, Markus Ostrosky-Zeichner, Luis Mullane, Kathleen M. Maher, Rochelle Croos-Dabrera, Rodney Lademacher, Christopher Engelhardt, Marc Chen, Caroline Marty, Francisco M. Mycoses Article Invasive fungal disease (IFD) confers a substantial risk for morbidity and mortality to immunocompromised patients. Invasive aspergillosis (IA) is the most common IFD caused by moulds but the prevalence of other rare mould diseases, such as mucormycosis, hyalohyphomycosis and phaeohyphomycosis, may be increasing. Treatments are available for IA, but evidence to support efficacy and safety of antifungal agents for rare IFDs, or for IFDs in special patient populations, is limited or lacking. The VITAL trial was conducted to assess the efficacy and safety of isavuconazole for the treatment of patients with IA and renal impairment, or with IFDs caused by rare moulds, yeasts or dimorphic fungi. These patients stand to benefit most from a new treatment option but are unlikely to be included in a randomised, controlled trial. In this article, we review the challenges faced in the design and conduct of the VITAL trial. We also review the findings of VITAL, which included evidence of the efficacy and safety of isavuconazole. Finally, we consider the importance of trials such as VITAL to inform therapeutic decision making for clinicians faced with the challenge of treating patients with rare IFDs and as one paradigm of how to determine efficacy and safety of new drugs for rare and resistant infections without a suitable comparator. 2018-04-19 2018-07 /pmc/articles/PMC6490690/ /pubmed/29570857 http://dx.doi.org/10.1111/myc.12769 Text en This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. http://creativecommons.org/licenses/by-nc-nd/4.0/
spellingShingle Article
Perfect, John R.
Cornely, Oliver A.
Heep, Markus
Ostrosky-Zeichner, Luis
Mullane, Kathleen M.
Maher, Rochelle
Croos-Dabrera, Rodney
Lademacher, Christopher
Engelhardt, Marc
Chen, Caroline
Marty, Francisco M.
Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: Challenges and lessons of the VITAL trial
title Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: Challenges and lessons of the VITAL trial
title_full Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: Challenges and lessons of the VITAL trial
title_fullStr Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: Challenges and lessons of the VITAL trial
title_full_unstemmed Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: Challenges and lessons of the VITAL trial
title_short Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: Challenges and lessons of the VITAL trial
title_sort isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: challenges and lessons of the vital trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6490690/
https://www.ncbi.nlm.nih.gov/pubmed/29570857
http://dx.doi.org/10.1111/myc.12769
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