<p>Clinical Efficacy of Baloxavir Marboxil in the Treatment of Seasonal Influenza in Adult Patients: A Prospective Observational Study</p>

Abstract

Baloxavir marboxil, a recently developed antiviral drug, has been used to treat influenza in some countries including Japan. The aim of this study was to determine the clinical efficacy of the drug, which currently remains unclear. Patients and Methods: Overall, 43 adult patients with seasonal influenza who visited the outpatient clinic of Teikyo University Hospital in Tokyo during the winter of 2018-2019 were enrolled. Of them, 14, 13, and 16 were prescribed baloxavir marboxil (40 or 80 mg once), oseltamivir (75 mg twice daily for 5 days), and laninamivir (40 mg once), respectively. A questionnaire was used to collect data about symptoms, and the Medical Outcome Study 8-Items Short Form Health Survey was employed to examine health-related quality-oflife (HRQOL) before and 7 days after admission. The main study endpoints included time to defervescence and the extent of improvement in HRQOL after treatment initiation. The data were analyzed with Welch's t-test and Fisher's exact test using StatFlex version 6. Results: No significant differences in clinical background characteristics were observed among the patients. The mean time to defervescence in the baloxavir group (median [interquartile range]; 1.0 [1.0-2.0] days) was significantly shorter than that in the laninamivir group (2.0 [1.5-3.5] days; p=0.0322). No significant differences in mean time to defervescence, change in HRQOL, and time for resolution of other symptoms were observed between the groups. Conclusion: The results suggest that baloxavir marboxil has a better antipyretic effect than oseltamivir and laninamivir. Moreover, baloxavir marboxil might be clinically more valuable than the other two drugs owing to higher medication adherence among patients.

Estimation of the value of convenience in taking influenza antivirals in Japanese adult patients between baloxavir marboxil and neuraminidase inhibitors using a conjoint analysis

“…In that study, the average ± SD time to the alleviation of the fever was reported to be 1.94 ± 0.09 days for 111 patients prescribed baloxavir (a single dose oral antiviral) and 2.35 ± 0.08 days for those prescribed NAIs (oseltamivir: 74 patients, zanamivir: 24 patients, peramivir: 4 patients, and laninamivir: 77 patients), and the difference was statistically significant (p = 0.002). Shorter time to fever resolution in baloxavir (median [interquartile range]: 1.0 [1.0-2.0] days) than in laninamivir (2.0 [1.5-3.5] days, p = 0.032) was also reported in another observational study including 43 adult patients treated with baloxavir (14 patients), laninamivir (16 patients), or oseltamivir (13 patients) [28]. The median time for baloxavir was also shorter than that for oseltamivir (3.0 [1.0-3.0] days), although the difference was not statistically significant (p = 0.067).…”

Rational design of a deuterium-containing M2-S31N channel blocker UAWJ280 within vivoantiviral efficacy against both oseltamivir sensitive and -resistant influenza A viruses

“…Baloxavir marboxil targets the cap-dependent endonuclease activity of the PA polymerase subunit of influenza viruses and prevents viral mRNA synthesis [ 44 ]. Clinical studies suggest that baloxavir treatment is more effective at reducing the duration of fever and influenza-like symptoms compared to individuals treated with NAIs [ 45 , 46 ]. However, baloxavir marboxil exhibits a low barrier of resistance, with the single PA I38T mutation leading to strains with overall fitness similar to the wild-type strain [ 47 , 48 ].…”

Cap-dependent endonuclease inhibitors for adult patients with influenza: the use of baloxavir marboxil

“…Japanese post-marketing surveillance of 3,094 patients (2,198 patients aged ≥ 12 years) confirmed that BXM rapidly improved clinical symptoms and was safe regardless of age group or virus type [6]. Other Japanese studies have also found that the times to resolution of fever and the improvement of clinical symptoms were faster with BXM than with NAIs [7,8].…”