tetano
Editor, Senior Moderator
Antivir Ther. 2014 Dec 3. doi: 10.3851/IMP2922. [Epub ahead of print]
Evaluation of safety and efficacy of intravenous zanamivir in the treatment of hospitalized Japanese patients with influenza: an open-label, single-arm study.
Watanabe A1, Yates PJ, Murayama M, Soutome T, Furukawa H.
Author information
Abstract
BACKGROUND:
Zanamivir is a neuraminidase (NA) inhibitor used for the treatment of influenza. There is an unmet need for a parenteral influenza antiviral therapy to treat hospitalized patients. Therefore the safety and efficacy profile of intravenous zanamivir (IVZ) was examined in Japanese patients with severe influenza.
METHODS:
The primary objective of this study was to evaluate the safety of IVZ in Japanese patients. Clinical outcome and virological data were also assessed as secondary measures. Patients hospitalized with influenza were treated with IVZ 600 mg twice daily for five days.
RESULTS:
Twenty-one subjects received IVZ. Seventeen subjects (81%) were infected with influenza A/H3N2, and three (14%) were infected with influenza B. One subject was not laboratory confirmed influenza positive. Thirteen subjects received the first dose of IVZ within two days of the onset of influenza symptoms, and six subjects had been treated with prior influenza antiviral therapy. Overall adverse events (AEs) and serious adverse events (SAEs) were reported in 13 (62%) and four (19%) subjects, respectively. There were no patterns of AEs or SAEs. Median time to clinical response and time to virologic improvement were approximately 4 days (range, 0.5-22) and 3 days (range, 2-5), respectively.
CONCLUSIONS:
In this study, there were no new significant safety findings or patterns of AEs related to IVZ, and therefore the safety profile was confirmed for a small sample of Japanese hospitalized patients with influenza. In addition, improvements in clinical and virological measures suggestive of the clinical usefulness were also observed.
PMID:
25470818
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25470818
Evaluation of safety and efficacy of intravenous zanamivir in the treatment of hospitalized Japanese patients with influenza: an open-label, single-arm study.
Watanabe A1, Yates PJ, Murayama M, Soutome T, Furukawa H.
Author information
Abstract
BACKGROUND:
Zanamivir is a neuraminidase (NA) inhibitor used for the treatment of influenza. There is an unmet need for a parenteral influenza antiviral therapy to treat hospitalized patients. Therefore the safety and efficacy profile of intravenous zanamivir (IVZ) was examined in Japanese patients with severe influenza.
METHODS:
The primary objective of this study was to evaluate the safety of IVZ in Japanese patients. Clinical outcome and virological data were also assessed as secondary measures. Patients hospitalized with influenza were treated with IVZ 600 mg twice daily for five days.
RESULTS:
Twenty-one subjects received IVZ. Seventeen subjects (81%) were infected with influenza A/H3N2, and three (14%) were infected with influenza B. One subject was not laboratory confirmed influenza positive. Thirteen subjects received the first dose of IVZ within two days of the onset of influenza symptoms, and six subjects had been treated with prior influenza antiviral therapy. Overall adverse events (AEs) and serious adverse events (SAEs) were reported in 13 (62%) and four (19%) subjects, respectively. There were no patterns of AEs or SAEs. Median time to clinical response and time to virologic improvement were approximately 4 days (range, 0.5-22) and 3 days (range, 2-5), respectively.
CONCLUSIONS:
In this study, there were no new significant safety findings or patterns of AEs related to IVZ, and therefore the safety profile was confirmed for a small sample of Japanese hospitalized patients with influenza. In addition, improvements in clinical and virological measures suggestive of the clinical usefulness were also observed.
PMID:
25470818
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25470818