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Clinical Experience in Adults and Children Treated with Intravenous Peramivir for 2009 Influenza A (H1N1) Under an Emergency IND Program in the United States
(See the editorial commentary by Jain et al, on pages 707–709.) Background. Peramivir, an investigational intravenous neuraminidase inhibitor in Phase 3 trials for hospitalized patients, was made available during the 2009 H1N1 influenza pandemic under the Emergency Investigational New Drug (eIND) re...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049340/ https://www.ncbi.nlm.nih.gov/pubmed/21367722 http://dx.doi.org/10.1093/cid/cir001 |
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author | Hernandez, Jaime E. Adiga, Raghavendra Armstrong, Robert Bazan, Jose Bonilla, Hector Bradley, John Dretler, Robin Ison, Michael G. Mangino, Julie E. Maroushek, Stacene Shetty, Avinash K. Wald, Anna Ziebold, Christine Elder, Jenna Hollister, Alan S. Sheridan, William |
author_facet | Hernandez, Jaime E. Adiga, Raghavendra Armstrong, Robert Bazan, Jose Bonilla, Hector Bradley, John Dretler, Robin Ison, Michael G. Mangino, Julie E. Maroushek, Stacene Shetty, Avinash K. Wald, Anna Ziebold, Christine Elder, Jenna Hollister, Alan S. Sheridan, William |
author_sort | Hernandez, Jaime E. |
collection | PubMed |
description | (See the editorial commentary by Jain et al, on pages 707–709.) Background. Peramivir, an investigational intravenous neuraminidase inhibitor in Phase 3 trials for hospitalized patients, was made available during the 2009 H1N1 influenza pandemic under the Emergency Investigational New Drug (eIND) regulations. We describe the clinical characteristics and outcomes of all patients for whom peramivir was requested under the eIND. Methods. After obtaining eIND approval from the Food and Drug Administration and local institutional review board approval, clinicians caring for hospitalized patients with influenza administered intravenous peramivir and collected information on demographic characteristics, clinical characteristics, and outcomes. Results. From April through October 2009, peramivir was requested for 42 patients and administered to 20 adults and 11 children. At hospitalization, all patients had rapidly progressing, radiographically confirmed viral pneumonia with respiratory failure, and all but 1 patient required mechanical ventilation. In most patients, including 1 person with documented oseltamivir-resistant infection, the illness had progressed despite oseltamivir treatment. Peramivir was administered for 1–14 days (median duration, 10 days). The 14-day, 28-day, and 56-day survival rates were 76.7%, 66.7%, and 59.0%, respectively. Peramivir was generally well tolerated. Conclusions. Intravenous peramivir was well tolerated and was associated with recovery in most patients hospitalized with severe 2009 H1N1 influenza viral pneumonia and treated under an eIND. |
format | Text |
id | pubmed-3049340 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-30493402011-03-15 Clinical Experience in Adults and Children Treated with Intravenous Peramivir for 2009 Influenza A (H1N1) Under an Emergency IND Program in the United States Hernandez, Jaime E. Adiga, Raghavendra Armstrong, Robert Bazan, Jose Bonilla, Hector Bradley, John Dretler, Robin Ison, Michael G. Mangino, Julie E. Maroushek, Stacene Shetty, Avinash K. Wald, Anna Ziebold, Christine Elder, Jenna Hollister, Alan S. Sheridan, William Clin Infect Dis Articles and Commentaries (See the editorial commentary by Jain et al, on pages 707–709.) Background. Peramivir, an investigational intravenous neuraminidase inhibitor in Phase 3 trials for hospitalized patients, was made available during the 2009 H1N1 influenza pandemic under the Emergency Investigational New Drug (eIND) regulations. We describe the clinical characteristics and outcomes of all patients for whom peramivir was requested under the eIND. Methods. After obtaining eIND approval from the Food and Drug Administration and local institutional review board approval, clinicians caring for hospitalized patients with influenza administered intravenous peramivir and collected information on demographic characteristics, clinical characteristics, and outcomes. Results. From April through October 2009, peramivir was requested for 42 patients and administered to 20 adults and 11 children. At hospitalization, all patients had rapidly progressing, radiographically confirmed viral pneumonia with respiratory failure, and all but 1 patient required mechanical ventilation. In most patients, including 1 person with documented oseltamivir-resistant infection, the illness had progressed despite oseltamivir treatment. Peramivir was administered for 1–14 days (median duration, 10 days). The 14-day, 28-day, and 56-day survival rates were 76.7%, 66.7%, and 59.0%, respectively. Peramivir was generally well tolerated. Conclusions. Intravenous peramivir was well tolerated and was associated with recovery in most patients hospitalized with severe 2009 H1N1 influenza viral pneumonia and treated under an eIND. Oxford University Press 2011-03-15 /pmc/articles/PMC3049340/ /pubmed/21367722 http://dx.doi.org/10.1093/cid/cir001 Text en © The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail:journals.permissions@oup.com. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.5/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Articles and Commentaries Hernandez, Jaime E. Adiga, Raghavendra Armstrong, Robert Bazan, Jose Bonilla, Hector Bradley, John Dretler, Robin Ison, Michael G. Mangino, Julie E. Maroushek, Stacene Shetty, Avinash K. Wald, Anna Ziebold, Christine Elder, Jenna Hollister, Alan S. Sheridan, William Clinical Experience in Adults and Children Treated with Intravenous Peramivir for 2009 Influenza A (H1N1) Under an Emergency IND Program in the United States |
title | Clinical Experience in Adults and Children Treated with Intravenous Peramivir for 2009 Influenza A (H1N1) Under an Emergency IND Program in the United States |
title_full | Clinical Experience in Adults and Children Treated with Intravenous Peramivir for 2009 Influenza A (H1N1) Under an Emergency IND Program in the United States |
title_fullStr | Clinical Experience in Adults and Children Treated with Intravenous Peramivir for 2009 Influenza A (H1N1) Under an Emergency IND Program in the United States |
title_full_unstemmed | Clinical Experience in Adults and Children Treated with Intravenous Peramivir for 2009 Influenza A (H1N1) Under an Emergency IND Program in the United States |
title_short | Clinical Experience in Adults and Children Treated with Intravenous Peramivir for 2009 Influenza A (H1N1) Under an Emergency IND Program in the United States |
title_sort | clinical experience in adults and children treated with intravenous peramivir for 2009 influenza a (h1n1) under an emergency ind program in the united states |
topic | Articles and Commentaries |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049340/ https://www.ncbi.nlm.nih.gov/pubmed/21367722 http://dx.doi.org/10.1093/cid/cir001 |
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