(73) Efficacy and Safety of Baloxavir in The Treatment of Influenza: A Systematic Review and Meta-Analysis

Saturday, August 27, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 747

Presenting Author(s)

Lara Haidar
– The University of Manitoba, Winnipeg, Manitoba, Canada

Co-Author(s)

Laila Nabil Mahmoud Helmy Aboulatta
– PhD student, University of Manitoba, Winnipeg, Manitoba, Canada
Alekhya Lavu
– The University of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada
Sherif Eltonsy, PhD
– Assistant Professor, University of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada
Rania Azar
– Professor, Faculty of Pharmacy, Lebanese University, Lebanon

Background: Baloxavir marboxil, a cap-dependent endonuclease inhibitor, is a newly approved influenza antiviral medication belonging to the class of polymerase inhibitors. Currently, there is limited evidence on the impact of baloxavir on clinical outcomes in influenza, especially influenza complications.

Objectives: The aim of this systematic review and meta-analysis was to evaluate the efficacy and safety of baloxavir in comparison to placebo or any neuraminidase inhibitor in the treatment of influenza in healthy and at-risk adults and children.

Methods: We searched PubMed, Medline, GoogleScholar, and ClinicalTrials.gov from inception until July 2021. We included published randomized controlled trials that met the following criteria: published in English, compared baloxavir with placebo or any neuraminidase inhibitor, and reported at least one relevant efficacy, virology, or safety outcome. No restrictions were set for patients’ age. Efficacy outcomes included total complications, time to alleviation of symptoms (TTAS), and change from baseline in virus titers at day 2. The primary safety outcome was all adverse events. We used random-effect models to pool the trial results, and statistical heterogeneity was assessed using I2 test.

Results: Out of 307 screened studies, four studies enrolling 2511 patients met our inclusion criteria. Baloxavir did not significantly decrease the likelihood of total complications compared to placebo (RR 0.56; 95% CI 0.21 to 1.53; I2 67%) and oseltamivir (RR 0.94; 95% CI 0.52 to 1.72; I2 21%). Baloxavir significantly reduced TTAS by 26.55 hours (95% CI -33.20 to -19.90; I2 0%) when compared to placebo, however there was no significant difference compared to oseltamivir (-1.14 hours, 95% CI -6.33 to 4.05; I2 0%). The mean decline in virus titer from baseline to day 2 was significantly greater for baloxavir than for placebo (mean difference (MD) -2.43 log10TCID50/ mL; 95% CI of -4.05 to -0.80; I2 98%) and oseltamivir (MD -1.75; 95% CI of -1.96 to -1.54; I2 0%). Baloxavir significantly decreased total adverse events compared to both placebo (RR 0.85, 95% CI 0.74 to 0.97; I2 0%) and oseltamivir (RR 0.87, 95% CI 0.77 to 0.98; I2 0%).

Conclusions: Baloxavir is superior to placebo and as effective as oseltamivir in shortening the duration of influenza symptoms; however, baloxavir did not demonstrate a significant benefit in decreasing complications when compared to both placebo and oseltamivir. Considering its safety profile and convenient single-dose administration, baloxavir can be a preferred choice among clinicians for influenza treatment.