Clinical efficacy and safety of baloxavir marboxil in the treatment of influenza: A systematic review and meta-analysis of randomized controlled trials

J Microbiol Immunol Infect. 2021 Oct;54(5):865-875. doi: 10.1016/j.jmii.2021.04.002. Epub 2021 Apr 29.

Abstract

Purpose: The aim of this meta-analysis is to compare the clinical efficacy and safety of baloxavir with other anti-influenza agents or placebo in the treatment of influenza.

Methods: PubMed, Embase, Web of Science, Google Scholar, Scopus, CINAHL, Cochrane databases and clinical registration were searched from inception until February 15 2021 for relevant randomized controlled trials (RCTs). Only phase 3 RCTs evaluating the usefulness of baloxavir in the treatment of influenza were included.

Results: Three RCTs enrolling 3771 patients (baloxavir group, n = 1451; oseltamivir group, n = 1288; placebo group, n = 1032) were included. Compared with oseltamivir, baloxavir had an insignificantly shorter time to the alleviation of symptoms (mean difference [MD], -1.29 h; 95% CI, -6.80 to 4.21; I2 = 0%). In contrast, baloxavir had a significantly shorter time to the alleviation of symptoms than placebo (MD, -26.32 h; 95% CI, -33.78 to -18.86; I2 = 0%). Baloxavir was associated with a significant decline in influenza virus titers and viral RNA load compared to oseltamivir and placebo. Baloxavir was associated with a lower risk of any adverse events than oseltamivir (OR, 0.82; 95% CI, 0.69-0.98; I2 = 0%) and placebo (OR, 0.79; 95% CI, 0.66-0.96; I2 = 0%).

Conclusions: The findings of this meta-analysis suggested that baloxavir is superior to placebo in the treatment of influenza in both clinical outcome and virological response. Moreover, baloxavir was found to have a better virological response than oseltamivir and to be as effective as oseltamivir clinically. Compared with oseltamivir and placebo, baloxavir appears to be a relatively safe anti-influenza agent.

Keywords: Baloxavir; Influenza; Oseltamivir.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Adolescent
  • Adult
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Child
  • Dibenzothiepins / therapeutic use*
  • Female
  • Humans
  • Influenza, Human / drug therapy*
  • Influenza, Human / virology
  • Male
  • Middle Aged
  • Morpholines / therapeutic use*
  • Oseltamivir / therapeutic use
  • Pyridones / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Triazines / therapeutic use*
  • Viral Load / drug effects
  • Young Adult

Substances

  • Antiviral Agents
  • Dibenzothiepins
  • Morpholines
  • Pyridones
  • Triazines
  • Oseltamivir
  • baloxavir