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. 2011 Mar 15;52(6):695-706.
doi: 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

Jaime E Hernandez  1 , 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; eIND Peramivir Investigators
Collaborators, Affiliations

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 et al. Clin Infect Dis. .

Abstract

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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Figures

Figure 1.
Figure 1.
Cumulative requests received for peramivir from April through 23 October 2009 under the Emergency Investigational New Drug (eIND) regulations.
Figure 2.
Figure 2.
Semi-logarithmic concentration of peramivir over time after the second dose of 10 mg/kg/day in patient 8, an 11-year-old girl who recovered.
Figure 3.
Figure 3.
Semi-logarithmic concentration of peramivir over time after the third dose of 600 mg/day in patient 10, a post-partum woman who recovered.
Figure 4.
Figure 4.
Kaplan-Meier survival curve.
See this image and copyright information in PMC

Comment in

References

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