%0 Journal Article
%T Baloxavir Marboxil: The First Cap
%A Tianrui Yang
%J Annals of Pharmacotherapy
%@ 1542-6270
%D 2019
%R 10.1177/1060028019826565
%X 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
%K baloxavir
%K baloxavir marboxil
%K antiviral
%K influenza
%K cap-dependent endonuclease inhibitor
%U https://journals.sagepub.com/doi/full/10.1177/1060028019826565