tetano
Editor, Senior Moderator
J Infect Dis. 2013 Aug 27. [Epub ahead of print]
Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, phase II study.
Marty FM, Man CY, van der Horst C, Francois B, Garot D, M?nez R, Thamlikitkul V, Lorente JA, Alvarez-Lerma F, Brealey D, Zhao HH, Weller S, Yates PJ, Peppercorn AF.
Source
Division of Infectious Diseases, Brigham and Women's Hospital, Boston MA 02115, USA.
Abstract
Background. Intravenous zanamivir (IVZ) is a neuraminidase inhibitor suitable for treatment of hospitalized patients with severe influenza.Methods. Patients were treated with IVZ 600 mg twice-daily, adjusted for renal impairment, for up to 10 days. Primary outcomes included adverse events (AEs), and clinical/laboratory parameters. Pharmacokinetics, virus load and disease course were also assessed.Results. One-hundred-thirty patients received IVZ (median=5 days; range=1-11) a median of 4.5 days (range=1-7) after onset of influenza; 83% required intensive care. The most common influenza type/subtype was A/H1N1pdm09 (71%). AEs and serious AEs (SAEs) were reported in 85% and 34% of patients. SAEs included bacterial pulmonary infections (8%), respiratory failure (7%), sepsis/septic shock (5%), and cardiogenic shock (5%). No drug-related trends in safety parameters were identified. Protocol-defined liver events were observed in 13% of patients. The 14- and 28-day all-cause mortality was 13% and 17%. No fatalities were considered zanamivir-related. Pharmacokinetic data showed dose adjustments for renal impairment yielded similar zanamivir exposures. Ninety-three patients, positive at baseline for influenza by quantitative PCR showed a median decrease in virus load of 1.42 log10 copies/mL after 2 days of treatment.Conclusions. Safety, pharmacokinetic and clinical outcome data support further investigation of IV zanamivir.
PMID:
23983212
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23983212
Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, phase II study.
Marty FM, Man CY, van der Horst C, Francois B, Garot D, M?nez R, Thamlikitkul V, Lorente JA, Alvarez-Lerma F, Brealey D, Zhao HH, Weller S, Yates PJ, Peppercorn AF.
Source
Division of Infectious Diseases, Brigham and Women's Hospital, Boston MA 02115, USA.
Abstract
Background. Intravenous zanamivir (IVZ) is a neuraminidase inhibitor suitable for treatment of hospitalized patients with severe influenza.Methods. Patients were treated with IVZ 600 mg twice-daily, adjusted for renal impairment, for up to 10 days. Primary outcomes included adverse events (AEs), and clinical/laboratory parameters. Pharmacokinetics, virus load and disease course were also assessed.Results. One-hundred-thirty patients received IVZ (median=5 days; range=1-11) a median of 4.5 days (range=1-7) after onset of influenza; 83% required intensive care. The most common influenza type/subtype was A/H1N1pdm09 (71%). AEs and serious AEs (SAEs) were reported in 85% and 34% of patients. SAEs included bacterial pulmonary infections (8%), respiratory failure (7%), sepsis/septic shock (5%), and cardiogenic shock (5%). No drug-related trends in safety parameters were identified. Protocol-defined liver events were observed in 13% of patients. The 14- and 28-day all-cause mortality was 13% and 17%. No fatalities were considered zanamivir-related. Pharmacokinetic data showed dose adjustments for renal impairment yielded similar zanamivir exposures. Ninety-three patients, positive at baseline for influenza by quantitative PCR showed a median decrease in virus load of 1.42 log10 copies/mL after 2 days of treatment.Conclusions. Safety, pharmacokinetic and clinical outcome data support further investigation of IV zanamivir.
PMID:
23983212
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23983212