tetano
Editor, Senior Moderator
Antivir Ther. 2015 Feb 10. doi: 10.3851/IMP2944. [Epub ahead of print]
[h=1]Clinical experience with intravenous zanamivir under an Emergency IND program in the United States (2011-2014).[/h] Chan-Tack KM[SUP]1[/SUP], Kim C, Moruf A, Birnkrant DB.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Since the emergence of 2009 H1N1 virus, IV zanamivir has been authorized as an investigational treatment for patients with serious and life-threatening influenza through an Emergency Investigational New Drug application (EIND). This review encompasses FDA's EIND database from May 2011-June 2014.
[h=4]METHODS:[/h] Retrospective descriptive review of patient clinical data in FDA's IV zanamivir EIND database from May 2011-June 2014.
[h=4]RESULTS:[/h] Of 364 IV zanamivir EIND requests, most patients (83%) were aged 18-64 years; 8 (2%) were pregnant, 29 (8%) were children. 234 patients (64%) had [SUP]3[/SUP]1 co-morbidity reported. The majority (87%) were receiving oseltamivir when IV zanamivir was requested, and 33% had suspected (n=120; no improvement or worsening on oseltamivir) H275Y oseltamivir resistance. Influenza A was reported for 300 patients: confirmed 2009 H1N1 (n=163), suspected 2009 H1N1 (n=8), confirmed H3N2 (n=4), not subtyped (n=125). Influenza B was reported for 25 patients. Many patients (87%) required invasive mechanical ventilation, 23 (6%) received high frequency oscillatory ventilation, and 74 (20%) received extracorporeal membrane oxygenation (ECMO). 289 patients (79%) had ≥1 complication such as renal failure (n=124; 77/124 required dialysis), bacteremia (n=18), shock (n=95), or pneumonia (n=159). Of 134 patients (37%) with available outcome data, 83 died, and 51 survived.
[h=4]CONCLUSIONS:[/h] IV zanamivir EIND authorizations were for treatment of critically ill adult patients with 2009 H1N1, including a substantial number with suspected oseltamivir resistance. Data from prospective, randomized controlled trials are needed and are ongoing to assess the safety and efficacy of IV zanamivir for treatment of hospitalized patients with severe influenza.
PMID: 25667992 [PubMed - as supplied by publisher]
[h=1]Clinical experience with intravenous zanamivir under an Emergency IND program in the United States (2011-2014).[/h] Chan-Tack KM[SUP]1[/SUP], Kim C, Moruf A, Birnkrant DB.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Since the emergence of 2009 H1N1 virus, IV zanamivir has been authorized as an investigational treatment for patients with serious and life-threatening influenza through an Emergency Investigational New Drug application (EIND). This review encompasses FDA's EIND database from May 2011-June 2014.
[h=4]METHODS:[/h] Retrospective descriptive review of patient clinical data in FDA's IV zanamivir EIND database from May 2011-June 2014.
[h=4]RESULTS:[/h] Of 364 IV zanamivir EIND requests, most patients (83%) were aged 18-64 years; 8 (2%) were pregnant, 29 (8%) were children. 234 patients (64%) had [SUP]3[/SUP]1 co-morbidity reported. The majority (87%) were receiving oseltamivir when IV zanamivir was requested, and 33% had suspected (n=120; no improvement or worsening on oseltamivir) H275Y oseltamivir resistance. Influenza A was reported for 300 patients: confirmed 2009 H1N1 (n=163), suspected 2009 H1N1 (n=8), confirmed H3N2 (n=4), not subtyped (n=125). Influenza B was reported for 25 patients. Many patients (87%) required invasive mechanical ventilation, 23 (6%) received high frequency oscillatory ventilation, and 74 (20%) received extracorporeal membrane oxygenation (ECMO). 289 patients (79%) had ≥1 complication such as renal failure (n=124; 77/124 required dialysis), bacteremia (n=18), shock (n=95), or pneumonia (n=159). Of 134 patients (37%) with available outcome data, 83 died, and 51 survived.
[h=4]CONCLUSIONS:[/h] IV zanamivir EIND authorizations were for treatment of critically ill adult patients with 2009 H1N1, including a substantial number with suspected oseltamivir resistance. Data from prospective, randomized controlled trials are needed and are ongoing to assess the safety and efficacy of IV zanamivir for treatment of hospitalized patients with severe influenza.
PMID: 25667992 [PubMed - as supplied by publisher]