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Long-acting neuraminidase inhibitor laninamivir octanoate (CS-8958) versus oseltamivir as treatment for children with influenza virus infection.

Abstract

We conducted a double-blind, randomized controlled trial to compare a long-acting neuraminidase inhibitor, laninamivir octanoate, with oseltamivir. Eligible patients were children 9 years of age and under who had febrile influenza symptoms of no more than 36-h duration. Patients were randomized to 1 of 3 treatment groups: a group given 40 mg laninamivir (40-mg group), a group given 20 mg laninamivir (20-mg group), and an oseltamivir group. Laninamivir octanoate was administered as a single inhalation. Oseltamivir (2 mg/kg of body weight) was administered orally twice daily for 5 days. The primary end point was the time to alleviation of influenza illness. The primary analysis included 184 patients (61, 61, and 62 in the 40-mg group, 20-mg group, and oseltamivir group, respectively). Laninamivir octanoate markedly reduced the median time to illness alleviation in comparison with oseltamivir in patients infected with oseltamivir-resistant influenza A (H1N1) virus, and the reductions were 60.9 h for the 40-mg group and 66.2 h for the 20-mg group. On the other hand, there were no significant differences in the times to alleviation of illness between the laninamivir groups and oseltamivir group for patients with influenza A (H3N2) or B virus infection. Laninamivir octanoate was well tolerated. The most common adverse events were gastrointestinal events. Laninamivir octanoate was an effective and well-tolerated treatment for children with oseltamivir-resistant influenza A (H1N1) virus infection. Further study will be needed to confirm clinical efficacy against influenza A (H3N2) or B virus infection. Its ease of administration is noteworthy, because a single inhalation is required during the course of illness.

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  • Authors+Show Affiliations

    ,

    Keiyu Hospital, Department of Pediatrics, Nishi-ku, Yokohama, Kanagawa, Japan. sugaya-n@za2.so-net.ne.jp

    Source

    Antimicrobial agents and chemotherapy 54:6 2010 Jun pg 2575-82

    MeSH

    Administration, Inhalation
    Administration, Oral
    Antiviral Agents
    Child
    Child, Preschool
    Dose-Response Relationship, Drug
    Double-Blind Method
    Drug Administration Schedule
    Enzyme Inhibitors
    Female
    Humans
    Influenza A Virus, H1N1 Subtype
    Influenza A Virus, H3N2 Subtype
    Influenza B virus
    Influenza, Human
    Male
    Neuraminidase
    Oseltamivir
    Treatment Outcome
    Virus Shedding
    Zanamivir

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    20368393

    Citation

    Sugaya, Norio, and Yasuo Ohashi. "Long-acting Neuraminidase Inhibitor Laninamivir Octanoate (CS-8958) Versus Oseltamivir as Treatment for Children With Influenza Virus Infection." Antimicrobial Agents and Chemotherapy, vol. 54, no. 6, 2010, pp. 2575-82.
    Sugaya N, Ohashi Y. Long-acting neuraminidase inhibitor laninamivir octanoate (CS-8958) versus oseltamivir as treatment for children with influenza virus infection. Antimicrob Agents Chemother. 2010;54(6):2575-82.
    Sugaya, N., & Ohashi, Y. (2010). Long-acting neuraminidase inhibitor laninamivir octanoate (CS-8958) versus oseltamivir as treatment for children with influenza virus infection. Antimicrobial Agents and Chemotherapy, 54(6), pp. 2575-82. doi:10.1128/AAC.01755-09.
    Sugaya N, Ohashi Y. Long-acting Neuraminidase Inhibitor Laninamivir Octanoate (CS-8958) Versus Oseltamivir as Treatment for Children With Influenza Virus Infection. Antimicrob Agents Chemother. 2010;54(6):2575-82. PubMed PMID: 20368393.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Long-acting neuraminidase inhibitor laninamivir octanoate (CS-8958) versus oseltamivir as treatment for children with influenza virus infection. AU - Sugaya,Norio, AU - Ohashi,Yasuo, Y1 - 2010/04/05/ PY - 2010/4/7/entrez PY - 2010/4/7/pubmed PY - 2010/9/15/medline SP - 2575 EP - 82 JF - Antimicrobial agents and chemotherapy JO - Antimicrob. Agents Chemother. VL - 54 IS - 6 N2 - We conducted a double-blind, randomized controlled trial to compare a long-acting neuraminidase inhibitor, laninamivir octanoate, with oseltamivir. Eligible patients were children 9 years of age and under who had febrile influenza symptoms of no more than 36-h duration. Patients were randomized to 1 of 3 treatment groups: a group given 40 mg laninamivir (40-mg group), a group given 20 mg laninamivir (20-mg group), and an oseltamivir group. Laninamivir octanoate was administered as a single inhalation. Oseltamivir (2 mg/kg of body weight) was administered orally twice daily for 5 days. The primary end point was the time to alleviation of influenza illness. The primary analysis included 184 patients (61, 61, and 62 in the 40-mg group, 20-mg group, and oseltamivir group, respectively). Laninamivir octanoate markedly reduced the median time to illness alleviation in comparison with oseltamivir in patients infected with oseltamivir-resistant influenza A (H1N1) virus, and the reductions were 60.9 h for the 40-mg group and 66.2 h for the 20-mg group. On the other hand, there were no significant differences in the times to alleviation of illness between the laninamivir groups and oseltamivir group for patients with influenza A (H3N2) or B virus infection. Laninamivir octanoate was well tolerated. The most common adverse events were gastrointestinal events. Laninamivir octanoate was an effective and well-tolerated treatment for children with oseltamivir-resistant influenza A (H1N1) virus infection. Further study will be needed to confirm clinical efficacy against influenza A (H3N2) or B virus infection. Its ease of administration is noteworthy, because a single inhalation is required during the course of illness. SN - 1098-6596 UR - https://www.unboundmedicine.com/medline/citation/20368393/Long_acting_neuraminidase_inhibitor_laninamivir_octanoate__CS_8958__versus_oseltamivir_as_treatment_for_children_with_influenza_virus_infection_ L2 - http://aac.asm.org/cgi/pmidlookup?view=long&pmid=20368393 DB - PRIME DP - Unbound Medicine ER -