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Baloxavir for influenza: Enrichment obscured lack of effect in North-American adults. Author's reply.

Published:January 02, 2020DOI:https://doi.org/10.1016/j.ejim.2019.12.021
      In response to our comment[

      de Haas, Esther C. et al. Baloxavir for influenza: Enrichment obscured lack of effect in North-American adults. European Journal of Internal Medicine, Volume 62, e8–e9.

      ], Dr Portsmouth and colleagues provide additional information about the results of the CAPSTONE-1 trial [
      • Hayden F.G.
      • Sugaya N.
      • Hirotsu N.
      • et al.
      Baloxavir marboxil for uncomplicated influenza in adults and adolescents.
      ], which we appreciate. In our comment, we underlined that the composition of the study population should have been taken into account when the study results were analysed, interpreted and presented.

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      References

      1. de Haas, Esther C. et al. Baloxavir for influenza: Enrichment obscured lack of effect in North-American adults. European Journal of Internal Medicine, Volume 62, e8–e9.

        • Hayden F.G.
        • Sugaya N.
        • Hirotsu N.
        • et al.
        Baloxavir marboxil for uncomplicated influenza in adults and adolescents.
        N Engl J Med. 2018; 379: 913-923
        • Japanese Pharmaceuticals and Medical Devices Agency
        Review Report Xofluza 10 mg and 20 mg.
        2018 (8 FebruaryAvailable via:)
      2. Genentech USA, Inc. XOFLUZA™ (baloxavir marboxil) [label]. 2018. Available via: www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbl.pdf.

        • Portsmouth S.
        • Kawaguchi K.
        • Uehara T.
        • Hayden F.
        Re Baloxavir for influenza: enrichment obscured lack of effect in North-American adults.
        Eur J Int Med. 2019; (this issue)
        • Ison M.G.
        • Portsmouth S.
        • Yoshida Y.
        • Shishido T.
        • Hayden F.
        • Uehara T.
        LB16: phase 3 trial of Baloxavir marboxil in high-risk influenza patients (CAPSTONE-2 study).
        Open Forum Infect Dis. 2018; 5: S764−5

      Linked Article

      • Baloxavir for influenza: Enrichment obscured lack of effect in North-American adults
        European Journal of Internal MedicineVol. 62
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          The FDA recently approved the use of baloxavir marboxil (baloxavir) in patients aged 12–64 years with uncomplicated influenza [1]. The effectiveness of baloxavir had been tested in one phase III trial named CAPSTONE-1 [2]. It consisted of two subtrials: one subtrial compared baloxavir (40 mg once) with placebo and oseltamivir in adult patients, and the other baloxavir with placebo in adolescent patients (total n = 1436). The trial was performed in Japan, the United States, and Canada. In the reported primary efficacy analysis, baloxavir reduced the time to alleviation of flu symptoms with 26.5 hours compared to placebo.
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