Peramivir Use for Treatment of Hospitalized Patients with Influenza A(H1N1)pdm09 under Emergency Use Authorization, October 2009 - June 2010.
Clin Infect Dis. 2012 Apr 5;
Authors: Yu Y, Garg S, Yu PA, Kim HJ, Patel A, Merlin T, Redd S, Uyeki TM
Abstract
BackgroundIn 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 U.S. under 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 CDC's peramivir program and three related surveys.MethodsWe analyzed data on peramivir requests made by clinicians to 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 two-source capture-recapture analysis, based upon the three surveys, was used to estimate the number of patients who received peramivir through the EUA.ResultsDuring October 23, 2009 to June 23, 2010, CDC received 1,371 clinician requests for peramivir and delivered 2,129 five-day adult treatment course equivalents of peramivir to 563 hospitals. Based on survey responses, at least 1,274 patients (median age 43 years, range 0-92 years, 49% male) received one or more doses of peramivir (median duration 6 days). Capture-recapture analysis yielded estimates for the potential total number of peramivir recipients ranging from 1,185 (95% CI: 1,076-1,293) to 1,490 (95% CI: 1,321-1,659).ConclusionsApproximately 1,274 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 [PubMed - as supplied by publisher]