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Baloxavir Marboxil: The First Cap-Dependent Endonuclease Inhibitor for the Treatment of Influenza.
Ann Pharmacother. 2019 07; 53(7):754-759.AP

Abstract

OBJECTIVE

To review the pharmacology, pharmacokinetics, clinical trials, and clinical implications of baloxavir marboxil.

DATA SOURCES

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.

STUDY SELECTION AND DATA EXTRACTION

All clinical trials were included.

DATA SYNTHESIS

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.

CONCLUSION

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.

Links

Publisher Full Text

Authors+Show Affiliations

Yang T
1 University of Texas at Tyler Ben and Maytee Fisch College of Pharmacy, Tyler, TX, USA.

MeSH

Antiviral AgentsClinical Trials as TopicDibenzothiepinsDrug Resistance, ViralEndonucleasesHumansInfluenza, HumanMorpholinesOxazinesPractice Guidelines as TopicPyridinesPyridonesThiepinsTriazines

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

30674196

Citation

Yang, Tianrui. "Baloxavir Marboxil: the First Cap-Dependent Endonuclease Inhibitor for the Treatment of Influenza." The Annals of Pharmacotherapy, vol. 53, no. 7, 2019, pp. 754-759.
Yang T. Baloxavir Marboxil: The First Cap-Dependent Endonuclease Inhibitor for the Treatment of Influenza. Ann Pharmacother. 2019;53(7):754-759.
Yang, T. (2019). Baloxavir Marboxil: The First Cap-Dependent Endonuclease Inhibitor for the Treatment of Influenza. The Annals of Pharmacotherapy, 53(7), 754-759. https://doi.org/10.1177/1060028019826565
Yang T. Baloxavir Marboxil: the First Cap-Dependent Endonuclease Inhibitor for the Treatment of Influenza. Ann Pharmacother. 2019;53(7):754-759. PubMed PMID: 30674196.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Baloxavir Marboxil: The First Cap-Dependent Endonuclease Inhibitor for the Treatment of Influenza. A1 - Yang,Tianrui, Y1 - 2019/01/23/ PY - 2019/1/25/pubmed PY - 2020/4/15/medline PY - 2019/1/25/entrez KW - antiviral KW - baloxavir KW - baloxavir marboxil KW - cap-dependent endonuclease inhibitor KW - influenza SP - 754 EP - 759 JF - The Annals of pharmacotherapy JO - Ann Pharmacother VL - 53 IS - 7 N2 - OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical trials, and clinical implications of baloxavir marboxil. DATA SOURCES: 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. STUDY SELECTION AND DATA EXTRACTION: All clinical trials were included. DATA SYNTHESIS: 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. CONCLUSION: 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. SN - 1542-6270 UR - https://www.unboundmedicine.com/medline/citation/30674196/Baloxavir_Marboxil:_The_First_Cap_Dependent_Endonuclease_Inhibitor_for_the_Treatment_of_Influenza_ L2 - https://journals.sagepub.com/doi/10.1177/1060028019826565?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -