Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an emergency IND program in the United States

Jaime E. Hernandez, Raghavendra Adiga, Robert Armstrong, Jose Bazan, Hector Bonilla, John Bradley, Robin Dretler, Michael G. Ison, Julie E. Mangino, Stacene Maroushek, Avinash K. Shetty, Anna Wald, Christine Ziebold, Jenna Elder, Alan S. Hollister, William Sheridan

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Abstract

(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.

Original languageEnglish
Pages (from-to)695-706
Number of pages12
JournalClinical Infectious Diseases
Volume52
Issue number6
DOIs
Publication statusPublished - 15-03-2011
Externally publishedYes

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Human Influenza
Emergencies
Investigational Drugs
Viral Pneumonia
Oseltamivir
Drug Approval
peramivir
Drug and Narcotic Control
Research Ethics Committees
Neuraminidase
Pandemics
United States Food and Drug Administration
Artificial Respiration
Respiratory Insufficiency
Hospitalization
Survival Rate
Demography
Infection

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)
  • Infectious Diseases

Cite this

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. In: Clinical Infectious Diseases. 2011 ; Vol. 52, No. 6. pp. 695-706.
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abstract = "(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.",
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Hernandez, JE, Adiga, R, Armstrong, R, Bazan, J, Bonilla, H, Bradley, J, Dretler, R, Ison, MG, Mangino, JE, Maroushek, S, Shetty, AK, Wald, A, Ziebold, C, Elder, J, Hollister, AS & Sheridan, W 2011, 'Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an emergency IND program in the United States', Clinical Infectious Diseases, vol. 52, no. 6, pp. 695-706. https://doi.org/10.1093/cid/cir001

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.

In: Clinical Infectious Diseases, Vol. 52, No. 6, 15.03.2011, p. 695-706.

Research output: Contribution to journalArticle

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T1 - Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an emergency IND program in the United States

AU - Hernandez, Jaime E.

AU - Adiga, Raghavendra

AU - Armstrong, Robert

AU - Bazan, Jose

AU - Bonilla, Hector

AU - Bradley, John

AU - Dretler, Robin

AU - Ison, Michael G.

AU - Mangino, Julie E.

AU - Maroushek, Stacene

AU - Shetty, Avinash K.

AU - Wald, Anna

AU - Ziebold, Christine

AU - Elder, Jenna

AU - Hollister, Alan S.

AU - Sheridan, William

PY - 2011/3/15

Y1 - 2011/3/15

N2 - (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.

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