tetano
Editor, Senior Moderator
Clin Infect Dis. (2012) doi: 10.1093/cid/cis352 First published online: April 5, 2012
Peramivir Use for Treatment of Hospitalized Patients with Influenza A(H1N1)pdm09 under Emergency Use Authorization, October 2009 ? June 2010
Yon Yu1,
Shikha Garg2,
Patricia A. Yu1,
Hye-Joo Kim1,
Anita Patel3,
Toby Merlin4,
Stephen Redd5, and
Timothy M. Uyeki2
+ Author Affiliations
1Regulatory Affairs, Office of the Director, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA
2Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA
3Division of Strategic National Stockpile, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention, Atlanta, GA
4Division of Preparedness and Emerging Infections, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA
5Influenza Coordination Unit, Office of the Director, Office of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA
Corresponding Author: Yon Yu, PharmD, 1600 Clifton Road, Mail Stop C-18, Atlanta, GA 30333; email: fkb8@cdc.gov, 404-639-3046 (phone), 404-639-1275 (fax)
Alternate corresponding author: Timothy M. Uyeki, MD, MPH, MPP, 1600 Clifton Road, Mail Stop A-20, Atlanta, GA 30333; email: tmu0@cdc.gov, 404-639-0277 (phone), 404-639-3866 (fax)
Through clinician requests to the Centers for Disease Control and Prevention, approximately 1,274 hospitalized pH1N1 patients received antiviral treatment with intravenous peramivir, an investigational neuraminidase inhibitor, under Emergency Use Authorization during the pH1N1 pandemic.
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 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.
Methods We 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.
Results During 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).
Conclusions Approximately 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.
http://cid.oxfordjournals.org/content/early/2012/04/05/cid.cis352.short?rss=1
Peramivir Use for Treatment of Hospitalized Patients with Influenza A(H1N1)pdm09 under Emergency Use Authorization, October 2009 ? June 2010
Yon Yu1,
Shikha Garg2,
Patricia A. Yu1,
Hye-Joo Kim1,
Anita Patel3,
Toby Merlin4,
Stephen Redd5, and
Timothy M. Uyeki2
+ Author Affiliations
1Regulatory Affairs, Office of the Director, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA
2Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA
3Division of Strategic National Stockpile, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention, Atlanta, GA
4Division of Preparedness and Emerging Infections, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA
5Influenza Coordination Unit, Office of the Director, Office of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA
Corresponding Author: Yon Yu, PharmD, 1600 Clifton Road, Mail Stop C-18, Atlanta, GA 30333; email: fkb8@cdc.gov, 404-639-3046 (phone), 404-639-1275 (fax)
Alternate corresponding author: Timothy M. Uyeki, MD, MPH, MPP, 1600 Clifton Road, Mail Stop A-20, Atlanta, GA 30333; email: tmu0@cdc.gov, 404-639-0277 (phone), 404-639-3866 (fax)
Through clinician requests to the Centers for Disease Control and Prevention, approximately 1,274 hospitalized pH1N1 patients received antiviral treatment with intravenous peramivir, an investigational neuraminidase inhibitor, under Emergency Use Authorization during the pH1N1 pandemic.
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 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.
Methods We 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.
Results During 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).
Conclusions Approximately 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.
http://cid.oxfordjournals.org/content/early/2012/04/05/cid.cis352.short?rss=1