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Clin Infect Dis. 2012 Jul;55(1):8-15. doi: 10.1093/cid/cis352. Epub 2012 Apr 5.

Peramivir use for treatment of hospitalized patients with influenza A(H1N1)pdm09 under emergency use authorization, October 2009-June 2010.

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1
Regulatory Affairs, Office of the Director, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, Georgia, USA. fkb8@cdc.gov

Abstract

BACKGROUND:

In response to the influenza A(H1N1)pdm09 (pH1N1) pandemic, peramivir, an investigational intravenous neuraminidase inhibitor, was made available for treatment of hospitalized patients with pH1N1 in the United States under an Emergency Use Authorization (EUA). The Centers for Disease Control and Prevention (CDC) implemented a program to manage peramivir distribution to requesting clinicians under EUA. We describe results of the CDC's peramivir program and 3 related surveys.

METHODS:

We analyzed data on peramivir requests made by clinicians to the CDC through an electronic request system. Three surveys were administered to enhance clinician compliance with adverse event reporting, to conduct product accountability, and to collect data on peramivir-treated patients. Descriptive analyses were performed, and 2-source capture-recapture analysis based on the 3 surveys was used to estimate the number of patients who received peramivir through the EUA.

RESULTS:

From 23 October 2009 to 23 June 2010, CDC received 1371 clinician requests for peramivir and delivered 2129 five-day adult treatment course equivalents of peramivir to 563 hospitals. Based on survey responses, at least 1274 patients (median age, 43 years; range, 0-92 years; 49% male) received ≥1 doses of peramivir (median duration, 6 days). Capture-recapture analysis yielded estimates for the potential total number of peramivir recipients ranging from 1185 (95% confidence interval [CI], 1076-1293) to 1490 (95% CI, 1321-1659).

CONCLUSIONS:

Approximately 1274 hospitalized patients received peramivir through EUA program during the pH1N1 pandemic. Further analyses are needed to assess the clinical effectiveness of peramivir treatment of hospitalized patients with pH1N1.

PMID:
22491506
DOI:
10.1093/cid/cis352
[Indexed for MEDLINE]
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