Posaconazole salvage therapy: The Posifi study.


Journal

Mycoses
ISSN: 1439-0507
Titre abrégé: Mycoses
Pays: Germany
ID NLM: 8805008

Informations de publication

Date de publication:
Jun 2019
Historique:
received: 19 11 2018
revised: 12 02 2019
accepted: 01 03 2019
pubmed: 14 3 2019
medline: 10 8 2019
entrez: 14 3 2019
Statut: ppublish

Résumé

Posaconazole (PCZ) is used mainly for the prevention of invasive fungal infection (IFI). A multicentre retrospective, investigational study using a non-randomized, single-arm design carried out in six tertiary hospitals in Spain to evaluate the use of PCZ in different forms of administration in the (non-prophylactic) treatment of IFI. Over an eight-year-period, 67 patients were included in this study. PCZ was administered as salvage therapy (intolerant or refractory to a previous antifungal agent) in 65/67 (97%); of these, it was used against Aspergillosis (68.6%), Zygomycosis (13.4%), other moulds (8.9%) and yeast (10.5%). The median duration of PCZ therapy was 75 days. The oral solution was associated with low serum levels (<0.7 mg/L) in 63% of available patients. Clinical response at 3 and 12 months of PCZ therapy were for aspergillosis: 47.8% and 41.3%; for zygomycosis: 55.5% and 55.5%; and for other mycoses: 69.2% and 69.2%, respectively. Suspension by toxicity was only observed in 6% and 7.5% of patients at 3 and 12 months, respectively, mainly with grade III/IV elevations of liver function test (LFTs). Posaconazole salvage therapy, especially oral tablets, can be an effective alternative option for patients with IFI who cannot tolerate or do not respond to other antifungal therapies.

Sections du résumé

BACKGROUND BACKGROUND
Posaconazole (PCZ) is used mainly for the prevention of invasive fungal infection (IFI).
METHODS METHODS
A multicentre retrospective, investigational study using a non-randomized, single-arm design carried out in six tertiary hospitals in Spain to evaluate the use of PCZ in different forms of administration in the (non-prophylactic) treatment of IFI.
RESULTS RESULTS
Over an eight-year-period, 67 patients were included in this study. PCZ was administered as salvage therapy (intolerant or refractory to a previous antifungal agent) in 65/67 (97%); of these, it was used against Aspergillosis (68.6%), Zygomycosis (13.4%), other moulds (8.9%) and yeast (10.5%). The median duration of PCZ therapy was 75 days. The oral solution was associated with low serum levels (<0.7 mg/L) in 63% of available patients. Clinical response at 3 and 12 months of PCZ therapy were for aspergillosis: 47.8% and 41.3%; for zygomycosis: 55.5% and 55.5%; and for other mycoses: 69.2% and 69.2%, respectively. Suspension by toxicity was only observed in 6% and 7.5% of patients at 3 and 12 months, respectively, mainly with grade III/IV elevations of liver function test (LFTs).
CONCLUSIONS CONCLUSIONS
Posaconazole salvage therapy, especially oral tablets, can be an effective alternative option for patients with IFI who cannot tolerate or do not respond to other antifungal therapies.

Identifiants

pubmed: 30864238
doi: 10.1111/myc.12911
doi:

Substances chimiques

Antifungal Agents 0
Triazoles 0
posaconazole 6TK1G07BHZ

Types de publication

Journal Article Multicenter Study Observational Study

Langues

eng

Pagination

526-533

Subventions

Organisme : Institutional Review Board of Hospital Ramon y Cajal
ID : GEM-POSE-2017-01
Organisme : Plan Nacional de I+D+i 2013-2016
Organisme : Instituto de Salud Carlos III
Organisme : Subdirección General de Redes y Centros de Investigación Cooperativa
Organisme : Ministerio de Ciencia, Innovación y Universidades
Organisme : Spanish Network for Research in Infectious Diseases
ID : REIPI RD16/0016; RD16
Organisme : European Development Regional Fund "A way to achieve Europe", Operative Program Intelligent Growth
ID : 2014-2020

Informations de copyright

© 2019 Blackwell Verlag GmbH.

Auteurs

Jesús Fortun (J)

Infectious Diseases Department, Hospital Ramón y Cajal, IRYCIS (Instituto Ramón y Cajal de Investigación Sanitaria), Universidad de Alcalá, Madrid, Spain.

Francesca Gioia (F)

Infectious Diseases Department, Hospital Ramón y Cajal, IRYCIS (Instituto Ramón y Cajal de Investigación Sanitaria), Universidad de Alcalá, Madrid, Spain.

Celia Cardozo (C)

Infectious Diseases Department, Hospital Clínic, IDIBAPS (Institut d'Investigacions biomèdiques Agust Pi i Sunyer), Universitat de Barcelona, Barcelona, Spain.

Carlota Gudiol (C)

Infectious Diseases Department, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
IDIBELL, Universitat de Barcelona, Barcelona, Spain.

Elena Diago (E)

Pharmacology Department, Hospital Puerta de Hierro-Majadahonda, Madrid, Spain.

Juan José Castón (J)

Infectious Diseases Unit, Hospital Universitario Reina Sofia, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain.

Patricia Muñoz (P)

Clinical Microbiology and Infectious Diseases, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Hospital Gregorio Marañón, Madrid, Spain.
Universidad Complutense de Madrid, Madrid, Spain.

Javier López (J)

Hematology Department, Hospital Ramón y Cajal, IRYCIS (Instituto Ramón y Cajal de Investigación Sanitaria), Universidad de Alcalá, Madrid, Spain.

Pedro Puerta-Alcalde (P)

Infectious Diseases Department, Hospital Clínic, IDIBAPS (Institut d'Investigacions biomèdiques Agust Pi i Sunyer), Universitat de Barcelona, Barcelona, Spain.

Matías Enzenhofer (M)

Infectious Diseases Department, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
IDIBELL, Universitat de Barcelona, Barcelona, Spain.

Antonio Ramos (A)

Pharmacology Department, Hospital Puerta de Hierro-Majadahonda, Madrid, Spain.

Azahara Frutos (A)

Infectious Diseases Unit, Hospital Universitario Reina Sofia, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain.

Marina Machado (M)

Clinical Microbiology and Infectious Diseases, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Hospital Gregorio Marañón, Madrid, Spain.
Universidad Complutense de Madrid, Madrid, Spain.

Carolina Garcia-Vidal (C)

Infectious Diseases Department, Hospital Clínic, IDIBAPS (Institut d'Investigacions biomèdiques Agust Pi i Sunyer), Universitat de Barcelona, Barcelona, Spain.

Rocío Parody (R)

Hematology Department, Institut Català d'Oncologia (ICO), Hospital Duran i Reynals, Hospitalet de Llobregat, Barcelona, Spain.

Pilar Martín-Dávila (P)

Infectious Diseases Department, Hospital Ramón y Cajal, IRYCIS (Instituto Ramón y Cajal de Investigación Sanitaria), Universidad de Alcalá, Madrid, Spain.

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Classifications MeSH