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Baloxavir Marboxil: The First Cap-Dependent Endonuclease Inhibitor for the Treatment of Influenza

tetano

Editor, Senior Moderator
Ann Pharmacother. 2019 Jan 23:1060028019826565. doi: 10.1177/1060028019826565. [Epub ahead of print]
[h=1]Baloxavir Marboxil: The First Cap-Dependent Endonuclease Inhibitor for the Treatment of Influenza.[/h] Yang T[SUP]1[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] To review the pharmacology, pharmacokinetics, clinical trials, and clinical implications of baloxavir marboxil.
[h=4]DATA SOURCES:[/h] A MEDLINE search was conducted using the terms baloxavir, baloxavir marboxil, cap-dependent endonuclease inhibitor, and polymerase acidic endonuclease inhibitor. Additional data were obtained from the prescribing information and relevant guidelines.
[h=4]STUDY SELECTION AND DATA EXTRACTION:[/h] All clinical trials were included.
[h=4]DATA SYNTHESIS:[/h] Baloxavir marboxil exploits a new mechanism of action of inhibiting cap-dependent endonuclease. Baloxavir was shown to be superior compared with placebo and noninferior compared with oseltamivir with regard to the primary end point. Baloxavir was well tolerated in the trials. A second phase III study investigating high-risk patients was completed with positive results. However, the full article is not yet published. Relevance to Patient Care and Clinical Practice: The small amount of literature limits baloxavir's use in certain patient populations. Baloxavir offers advantages such as single-dose regimen, eliminating adherence concerns and lack of cross-resistance, making it an alternative for resistant viruses. Several uncertainties remain. Baloxavir has not been studied in hospitalized patients, patients with symptoms for >48 hours, or in combination with other antiviral agents. Furthermore, resistance to baloxavir can develop after 1 dose. Clinical studies are ongoing to evaluate baloxavir in young pediatric patients, hospitalized patients, and in combination therapy with neuraminidase inhibitors to further elucidate baloxavir's place in therapy.
[h=4]CONCLUSION:[/h] Baloxavir is a new antiviral medication for the treatment of influenza. Given the new mechanism of action, baloxavir may be useful in treating patients with resistant viruses.


[h=4]KEYWORDS:[/h] antiviral; baloxavir; baloxavir marboxil; cap-dependent endonuclease inhibitor; influenza

PMID: 30674196 DOI: 10.1177/1060028019826565







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