tetano
Editor, Senior Moderator
Clin Infect Dis. 2014 Aug 12. pii: ciu632. [Epub ahead of print]
Evaluation of Intravenous Peramivir for Treatment of Influenza in Hospitalized Patients.
de Jong MD1, Ison MG2, Monto AS3, Metev H4, Clark C5, O'Neil B6, Elder J7, McCullough A8, Collis P8, Sheridan WP8.
Author information
Abstract
BACKGROUND:
Seasonal influenza causes >200,000 annual hospitalizations in the United States. Current antiviral treatment options are limited to oral or inhaled agents. There is an urgent unmet need for intravenous antiviral treatments.
METHODS:
Patients hospitalized with suspected influenza were randomized to 5-day treatment with intravenous peramivir 600 mg once daily or placebo; all received the institution's standard of care (SOC) treatment. Time to clinical resolution and change in viral shedding in nasopharyngeal specimens were the primary and key secondary endpoints.
RESULTS:
Influenza infection was confirmed in 338 of 405 enrolled patients. At the time of a pre-planned interim analysis the primary efficacy analysis population comprised 121 patients who did not receive a concurrent neuraminidase inhibitor as part of SOC. Median (95% CI) time to clinical resolution was 42.5 (34.0- 57.9) for peramivir versus 49.5 (40.0-61.9) hours for placebo (p=0.973) . A larger treatment effect was observed in patients with history of symptoms <48 hours or admitted to an ICU. Greater reductions in viral shedding determined by TCID50 were observed in patients who received peramivir compared to placebo recipients although this difference was not statistically significant. The incidence and severity of adverse events and laboratory abnormalities were similar between the two treatment groups. The study was terminated for futility following a pre-planned interim analysis.
CONCLUSIONS:
A significant clinical benefit was not demonstrated for peramivir plus SOC compared to placebo plus SOC. Peramivir was generally safe and well tolerated. This study highlights the challenges in designing studies to evaluate influenza antiviral agents in a hospitalized setting.
? The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
PMID:
25115871
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25115871
Evaluation of Intravenous Peramivir for Treatment of Influenza in Hospitalized Patients.
de Jong MD1, Ison MG2, Monto AS3, Metev H4, Clark C5, O'Neil B6, Elder J7, McCullough A8, Collis P8, Sheridan WP8.
Author information
Abstract
BACKGROUND:
Seasonal influenza causes >200,000 annual hospitalizations in the United States. Current antiviral treatment options are limited to oral or inhaled agents. There is an urgent unmet need for intravenous antiviral treatments.
METHODS:
Patients hospitalized with suspected influenza were randomized to 5-day treatment with intravenous peramivir 600 mg once daily or placebo; all received the institution's standard of care (SOC) treatment. Time to clinical resolution and change in viral shedding in nasopharyngeal specimens were the primary and key secondary endpoints.
RESULTS:
Influenza infection was confirmed in 338 of 405 enrolled patients. At the time of a pre-planned interim analysis the primary efficacy analysis population comprised 121 patients who did not receive a concurrent neuraminidase inhibitor as part of SOC. Median (95% CI) time to clinical resolution was 42.5 (34.0- 57.9) for peramivir versus 49.5 (40.0-61.9) hours for placebo (p=0.973) . A larger treatment effect was observed in patients with history of symptoms <48 hours or admitted to an ICU. Greater reductions in viral shedding determined by TCID50 were observed in patients who received peramivir compared to placebo recipients although this difference was not statistically significant. The incidence and severity of adverse events and laboratory abnormalities were similar between the two treatment groups. The study was terminated for futility following a pre-planned interim analysis.
CONCLUSIONS:
A significant clinical benefit was not demonstrated for peramivir plus SOC compared to placebo plus SOC. Peramivir was generally safe and well tolerated. This study highlights the challenges in designing studies to evaluate influenza antiviral agents in a hospitalized setting.
? The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
PMID:
25115871
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25115871