ISSN 2073–4034
eISSN 2414–9128

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

M.V. Leonova

Interregional public organization Association of Clinical Pharmacologists (Moscow branch), Moscow, Russia
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.

Keywords

baloxavir
endonuclease inhibitor
influenza
virological response
prevention

About the Authors

Marina V. Leonova, Dr. Sci. (Med.), Professor, Corresponding Member of the Russian Academy of Natural Sciences, Member of the Interregional Public Organization of the Association of Clinical Pharmacologists (Moscow Branch), Moscow, Russia; anti23@mail.ru; ORCID: https://orcid.org/0000-0001-8228-1114, eLibrary SPIN: 3281-7884

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