Long‐Acting Neuraminidase Inhibitor Laninamivir Octanoate versus Oseltamivir for Treatment of Influenza: A Double‐Blind, Randomized, Noninferiority Clinical Trial

Abstract

NCT00803595.

The E119D neuraminidase mutation identified in a multidrug-resistant influenza A(H1N1)pdm09 isolate severely alters viral fitness in vitro and in animal models

“…NAIs target the active center of the influenza neuraminidase (NA) molecule, which is made of 8 functional (R-118, D-151, R-152, R-224, E-276, R-292, R-371, and Y-406; N2 numbering) and 11 framework and EÀ425;N2 numbering) residues that are largely conserved among influenza A and B viruses (Colman et al, 1993). Two NAI compounds (i.e., oseltamivir and zanamivir) have been commercially available worldwide for more than a decade whereas peramivir (Birnkrant and Cox, 2009;Press release, 2014) and laninamivir (Kubo et al, 2010;Watanabe et al, 2010) are licensed in a limited number of countries. As for the adamantanes, the emergence of NAI-resistant viruses is a serious threat that may compromise the clinical utility of these agents.…”

Current Research on Respiratory Viral Infections: XIII International Symposium on Respiratory Viral Infections: Part 1

“…Single doses of laninamivir 20 or 40 mg significantly reduced time to alleviation of illness in this subset by 66.2 and 60.9 h, respectively, and shortened the duration of fever compared with oseltamivir [10]. For unexplained reasons, in a parallel study including 996 adults, no clinical differences were observed between the oseltamivir-and laninamivir-treated patients who had infections with oseltamivirresistant seasonal H1N1 viruses [11]. These studies show that a single-dose inhaled laninamivir treatment was at least comparable to a five day oseltamivir regimen in outpatients.…”

Influenza Virus Shedding in Laninamivir-Treated Children upon Returning to School

“…In 2010, two new NAIs, laninamivir and peramivir, were approved for prevention and treatment of influenza in Japan (Kawai et al 2006;Sugaya and Ohashi 2010;Shobugawa et al 2012;Yates et al 2013;Hata et al 2014). Of special interest is laninamivir octanoate hydrate (laninamivir), a long-acting inhaled drug, that is approved for clinical use in Japan only (Sugaya and Ohashi 2010;Watanabe et al 2010). The clinical efficacy of laninamivir is reported to be similar to that of oseltamivir and zanamivir, although the former has been less frequently studied as it has not been approved in other countries (Sugaya and Ohashi 2010;Watanabe et al 2010;Shobugawa et al 2012;Ikematsu et al 2014aIkematsu et al , b, 2015bKoseki et al 2014).…”

“…Of special interest is laninamivir octanoate hydrate (laninamivir), a long-acting inhaled drug, that is approved for clinical use in Japan only (Sugaya and Ohashi 2010;Watanabe et al 2010). The clinical efficacy of laninamivir is reported to be similar to that of oseltamivir and zanamivir, although the former has been less frequently studied as it has not been approved in other countries (Sugaya and Ohashi 2010;Watanabe et al 2010;Shobugawa et al 2012;Ikematsu et al 2014aIkematsu et al , b, 2015bKoseki et al 2014). NAIs have been shown to significantly shorten the duration of fever in children infected with influenza virus, however, virus shedding could still be detected after defervescence (Sugaya et al 2007;Tamura et al 2011).…”