Baloxavir marboxil, favipiravir, or oseltamivir in patients with non-severe symptomatic seasonal influenza…

Randomized trialThe Lancet. Infectious diseases· Jul 2026

Baloxavir marboxil, favipiravir, or oseltamivir in patients with non-severe symptomatic seasonal influenza (AD ASTRA): a phase 2, open-label, adaptive, randomised controlled trial.

Podjanee Jittamala, William H K Schilling, Stije J Leopold … AD ASTRA Collaborative Group

Infectious DiseaseRandomized trialTreatmentQ1IF 7.8

Baloxavir accelerates influenza viral clearance by 86% in non-severe seasonal influenza.

Baloxavir marboxil, favipiravir, or oseltamivir in patients with non-severe symptomatic seasonal influenza (AD ASTRA): a phase 2, open-label, adaptive, randomised controlled trial.

Podjanee Jittamala … AD ASTRA Collaborative Group

The Lancet · Jul 2026

Background

The oral antiviral therapies baloxavir marboxil (hereafter baloxavir), favipiravir, and oseltamivir have not been simultaneously compared for the treatment of seasonal influenza.

Purpose

We aimed to determine their relative efficacies in accelerating viral clearance in patients with symptomatic influenza virus infection at low risk of progression to severe disease.

Methods

Groups were assessed for superiority over the no study drug group (posterior probability >0·9 that the relative increase in viral clearance was ≥20%); if superiority was met, intervention groups were assessed for non-inferiority relative to baloxavir (posterior probability >0·9 that the relative reduction in viral clearance was ≤10%).

n = 944 patients

Results

baloxavir helps the body get rid of the flu virus faster than without medication

baloxavir

86%

favipiravir

66%

oseltamivir

49%

More results

457 (63%) patients in the mITT population were female and 272 (37%) were male.

For all interventions, the posterior probability that the relative increase in viral clearance was 20% or more was 1·0.

More results

Compared with baloxavir, oseltamivir was inferior (20% slower clearance, 95% CrI 6 to 32; posterior probability 0·93 that the relative reduction in viral clearance was <10%); non-inferiority could not be shown for favipiravir (10% slower clearance, 95% CrI -4 to 22; posterior probability 0·55 that the relative reduction in viral clearance was <10%).

“

Conclusion · 1 of 3

Oral baloxavir, favipiravir, and oseltamivir accelerated influenza viral clearance rates in adults with early non-severe seasonal influenza at low risk of progression to severe disease.

Conclusion · 2 of 3

Baloxavir had the greatest in-vivo antiviral efficacy, followed by favipiravir and oseltamivir. These antivirals shortened fever duration but showed no clear effects on time to complete symptom resolution.

Conclusion · 3 of 3

This pharmacometric approach can inform prioritisation of antiviral agents for further study and potential inclusion in pandemic stockpiles.

Baloxavir marboxil, favipiravir, or oseltamivir in patients with non-severe symptomatic seasonal influenza (AD ASTRA): a phase 2, open-label, adaptive, randomised controlled trial.

Baloxavir marboxil, favipiravir, or oseltamivir in patients with non-severe symptomatic seasonal influenza (AD ASTRA): a phase 2, open-label, adaptive, randomised controlled trial.

Related papers