Baloxavir is a new antiviral drug for the treatment of influenza recommended by WHO

封面

如何引用文章

全文:

开放存取 开放存取
受限制的访问 ##reader.subscriptionAccessGranted##
受限制的访问 订阅或者付费存取

详细

Currently, there are 3 types of direct-acting antiviral drugs approved for use against influenza: M2 ion channel inhibitors, neuraminidase inhibitors, and RNA polymerase inhibitors (nucleoside RNA polymerase inhibitors and endonuclease inhibitors). The latter group includes baloxavir, approved by the FDA for the treatment and prevention of influenza. Over a 5-year period, a number of studies of various designs have been conducted to study the efficacy of baloxavir in the treatment of influenza in outpatients, as well as in patients at high risk of adverse outcomes, including inpatient treatment. According to the results of two network meta-analyses of studies comparing the efficacy of baloxavir with neuraminidase inhibitors in outpatients with influenza, baloxavir demonstrated a significantly shorter period of time to relief of all influenza symptoms and resolution of fever compared with placebo, but there were no reliable differences with neuraminidase inhibitor drugs. In terms of virological outcomes, baloxavir demonstrated advantages in terms of a significant reduction in the time to cessation of viral shedding and a greater reduction in antibody titers within 24 hours compared with all other neuraminidase inhibitor drugs. In a meta-analysis of studies with hospitalized patients, the use of baloxavir significantly reduced mortality and significantly shortened the period of hospitalization compared with oseltamivir. In a number of studies in children, baloxavir demonstrated good tolerability and efficacy in alleviating influenza symptoms and rapid elimination of the virus, which allowed the FDA to approve the drug in pediatric practice. A study of the prophylactic effect of baloxavir showed its efficacy for post-exposure prophylaxis of influenza, as well as for preventing transmission of infection, which creates the preconditions for a significant reduction in influenza incidence during epidemic seasons. In 2024, WHO recommended the use of baloxavir for patients with non-severe influenza and a high risk of progression to severe disease, which reduces the frequency of hospitalizations, shortens the duration of illness by 1 day and prevents mortality.

全文:

受限制的访问

作者简介

Marina Leonova

Interregional public organization Association of Clinical Pharmacologists (Moscow branch)

编辑信件的主要联系方式.
Email: anti23@mail.ru
ORCID iD: 0000-0001-8228-1114
SPIN 代码: 3281-7884

Dr. Sci. (Med.), Professor, Corresponding Member of the Russian Academy of Natural Sciences, Member of the Interregional Public Organization

俄罗斯联邦, Moscow

参考

  1. World Health Organization. Influenza (Seasonal) Key Facts. 2023. https://www.who.int/news-room/fact-sheets/detail/influenza-seasonal, (accessed 08/07/2024).
  2. Swierczynska M., Mirowska-Guzel D.M., Pindelska E. Antiviral drugs in influenza. Int J Environ ResPublic Health. 2022;19(5):3018. doi: 10.3390/ijerph19053018.
  3. Kumari R., Sharma S.D., Kumar A., et al. Antiviral Approaches against Influenza Virus. Clin. Microbiol Rev. 2023;36(1):e0004022. doi: 10.1128/cmr.00040-22.
  4. Takeda M., Pekosz A., Shuck K., et al. Influenza a virus M2 ion channel activity is essential for efficient replication in tissue culture. J Virol. 2002;76(3):1391–9. doi: 10.1128/jvi.76.3.1391-1399.2002.
  5. Kamali A., Holodniy M. Influenza treatment and prophylaxis with neuraminidase inhibitors: a review. Infect Drug Resist. 2013;6:187–98. doi: 10.2147/IDR.S36601.
  6. Holmes E.C., Hurt A.C., Dobbie Z., et al. Understanding the Impact of Resistance to Influenza Antivirals. Clin Microbiol Rev. 2021;34(2):e00224–20. doi: 10.1128/CMR.00224-20.
  7. Deyde V.M., Xu X., Bright R.A., et al. Surveillance of resistance to adamantanes among influenza A(H3N2) and A(H1N1) viruses isolated worldwide. J Infect Dis. 2007;196(2):249–57. doi: 10.1086/518936.
  8. Garcia V., Aris-Brosou S. Comparative dynamics and distribution of influenza drug resistance acquisition to protein m2 and neuraminidase inhibitors. Mol Biol Evol. 2014;31(2):355–63. doi: 10.1093/molbev/mst204.
  9. Govorkova E.A., Takashita E., Daniels R.S., et al. Global update on the susceptibilities of human influenza viruses to neuraminidase inhibitors and the cap-dependent endonuclease inhibitor baloxavir, 2018–2020. Antiviral Res. 2022;200:105281. doi: 10.1016/j.antiviral.2022.105281.
  10. Palomba E., Castelli V., Renisi G., et al. Antiviral treatments for influenza. Semin Respir. Crit. Care Med. 2021;42(6):859–72. doi: 10.1055/s-0041-1733830.
  11. Clinical practice guidelines for influenza. Geneva: World Health Organization; 2024. https://iris.who.int/bitstream/handle/10665/378872/9789240097759-eng.pdf?sequence=1.
  12. Tejus A., Mathur A.G., Pradhan S., et al. Drug update – baloxavir marboxil: latest entrant into the arena of pharmacotherapy of influenza. Med J Armed Forces India. 2022;78(2):125–30. doi: 10.1016/j.mjafi.2021.09.005.
  13. Abraham G.M., Morton J.B., Saravolatz L.D. Baloxavir: A Novel Antiviral Agent in the Treatment of Influenza. Clin Infect Dis. 2020;71(7):1790–94. doi: 10.1093/cid/ciaa107.
  14. Noshi T., Kitano M., Taniguchi K., et al. In vitro characterization of baloxavir acid, a first-in-class cap-dependent endonuclease inhibitor of the influenza virus polymerase PA subunit. Antiviral Res. 2018;160:109–17. doi: 10.1016/j.antiviral.2018.10.008.
  15. Mishin V.P., Patel M.C., Chesnokov A., et al. Susceptibility of influenza A, B, C, and D viruses to baloxavir. Emerg. Infect. Dis. 2019;25(10):1969–72. doi: 10.3201/eid2510.190607.
  16. Hayden F.G., Sugaya N., Hirotsu N., et al. Baloxavir Marboxil Investigators Group. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Engl J Med. 2018;379(10):913–23. doi: 10.1056/NEJMoa1716197.
  17. Ison M.G., Portsmouth S., Yoshida Y., et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet. Infect Dis. 2020;20(10):1204–14. doi: 10.1016/S1473-3099(20)30004-9.
  18. Kuo Y.C., Lai C.C., Wang Y.H., et al. Clinical efficacy and safety of baloxavir marboxil in the treatment of influenza: A systematic review and meta-analysis of randomized controlled trials. J Microbiol Immunol Infect. 2021;54(5):865–75. doi: 10.1016/j.jmii.2021.04.002.
  19. Taieb V., Ikeoka H., Ma F.F., et al. A network meta-analysis of the efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors for the treatment of influenza in otherwise healthy patients. Curr Med Res Opin. 2019;35(8):1355–64. doi: 10.1080/03007995.2019. 1584505.
  20. Тайеб В., Икеока Х., Ма Ф. и др. Сетевой метаанализ эффективности и безопасности балоксавира марбоксила в сравнении с ингибиторами нейраминидазы при лечении гриппа у пациентов без факторов риска. Терапевтический архив. 2020;92(11):122–31. doi: 10.26442/00403660.2020.11.000870.
  21. Taieb V., Ikeoka H., Wojciechowski P., et al. Efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors in the treatment of influenza virus infection in high-risk and uncomplicated patients - a Bayesian network meta-analysis. Curr Med Res Opin. 2021;37(2):225–44. doi: 10.1080/03007995.2020.1839400.
  22. Shah. S, McManus D., Bejou N., et al. Clinical outcomes of baloxavir versus oseltamivir in patients hospitalized with influenza A. J Antimicrob Chemother. 2020;75(10):3015–22. doi: 10.1093/jac/dkaa252.
  23. Shiraishi C., Kato H., Hagihara M., et al. Comparison of clinical efficacy and safety of baloxavir marboxil versus oseltamivir as the treatment for influenza virus infections: A systematic review and meta-analysis. J Infect Chemother. 2024;30(3):242–9. doi: 10.1016/j.jiac.2023.10.017.
  24. Yokoyama T., Sakaguchi H., Ishibashi T., et al. Baloxavir marboxil 2% granules in Japanese children with influenza: an open-label phase 3 study. Pediatr Infect Dis J. 2020;39(8):706–12. doi: 10.1097/INF.0000000000002748.
  25. Hirotsu N., Sakaguchi H., Sato C., et al. Baloxavir marboxil in Japanese pediatric patients with influenza: safety and clinical and virologic outcomes. Clin Infect Dis. 2020;71(4):971–81. doi: 10.1093/cid/ciz908.
  26. Hirotsu N., Sakaguchi H., Fukao K., et al. Baloxavir safety and clinical and virologic outcomes in influenza virus-infected pediatric patients by age group: age-based pooled analysis of two pediatric studies conducted in Japan. BMC. Pediatr. 2023;23(1):35. doi: 10.1186/s12887-023-03841-5.
  27. Sonoyama T., Sakaguchi H., Koshimichi H, Noshi T, Tsuchiya K, Uehara T. Open-label study of the safety, pharmacokinetics, and effectiveness of a 2 mg/kg dose of baloxavir marboxil 2% granules in children <20 kg with influenza. J Infect Chemother. 2021;27(8):1223–9. doi: 10.1016/j.jiac.2021.05.009.
  28. Baker J., Block S.L., Matharu B., et al. Baloxavir marboxil single-dose treatment in influenza-infected children: a randomized, double-blind, active controlled phase 3sSafety and efficacy trial (miniSTONE-2). Pediatr Infect Dis J. 2020;39(8):700–5. doi: 10.1097/INF.0000000000002747.
  29. Ikematsu H., Hayden F.G., Kawaguchi K., et al. Baloxavir marboxil for prophylaxis against influenza in household contacts. N Engl J Med. 2020;383(4):309–20. doi: 10.1056/NEJMoa1915341.
  30. Komeda T., Takazono T., Hosogaya N., et al. Comparison of household transmission of influenza virus from index patients treated with baloxavir marboxil or neuraminidase inhibitors: a Health Insurance Claims Database Study. Clin Infect Dis. 2021;72(11):e859–67. doi: 10.1093/cid/ciaa1622.
  31. Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses. News release. Roche. September 19, 2024. Accessed September 19, 2024. URL: https://www.roche.com/media/releases/med-cor-2024-09-19. Options-XII-2024-presentation-monto-phase-III-CENTERSTONE-study-of-single-dose.pdf.
  32. Du Z., Nugent C., Galvani A.P., et al. Modeling mitigation of influenza epidemics by baloxavir. Nat Commun. 2020;11(1):2750. doi: 10.1038/s41467-020-16585-y.
  33. Jiang Y., Lin Y.F., Shi S., et al. Effects of baloxavir and oseltamivir antiviral therapy on the transmission of seasonal influenza in China: A mathematical modeling analysis. J Med Virol. 2022;94(11):5425–33. doi: 10.1002/jmv.27969.

补充文件

附件文件
动作
1. JATS XML
下载
2. Fig. 1. Mechanisms of action of direct-acting antiviral drugs against influenza [3]

下载 (329KB)
索引源数据
3. Fig. 2. Results of a meta-analysis comparing clinical and virological outcomes of influenza treatment with baloxavir and neuraminidase inhibitor drugs [20]

下载 (498KB)
索引源数据

版权所有 © Bionika Media, 2025