Evidence map›Paper›PMID 42349254›Full record

ArticleEBioMedicine2026

Effectiveness of baloxavir marboxil in nonhuman primates infected with highly pathogenic avian influenza A(H7N9) virus.

Kiyoko Iwatsuki-Horimoto, Masaki Imai, Toru Ishibashi, Shinya Yamada, Maki Kiso, Mutsumi Ito, Atsuhiro Yasuhara, Seiya Yamayoshi, Yoshihiro Kawaoka

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in EBioMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Kiyoko Iwatsuki-HorimotoDivision of Virology, Institute of Medical Science, University of Tokyo, Tokyo, Japan; The University of Tokyo Pandemic Preparedness, Infection and Advanced Research Center (UTOPIA), University of Tokyo, Tokyo, Japan.
Masaki ImaiInternational Virus Infectious Disease Research Center, National Institute of Global Health and Medicine, Japan Institute for Health Security, Tokyo, Japan; Department of Special Pathogens, International Research Center for Infectious Diseases, Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Toru IshibashiClinical Pharmacology & Pharmacokinetics, Medical Science Department, Shionogi & Co., Ltd., Osaka, Japan.
Shinya YamadaDivision of Virology, Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Maki KisoThe University of Tokyo Pandemic Preparedness, Infection and Advanced Research Center (UTOPIA), University of Tokyo, Tokyo, Japan.
Mutsumi ItoDivision of Virology, Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Atsuhiro YasuharaDivision of Virology, Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Seiya YamayoshiDivision of Virology, Institute of Medical Science, University of Tokyo, Tokyo, Japan; The University of Tokyo Pandemic Preparedness, Infection and Advanced Research Center (UTOPIA), University of Tokyo, Tokyo, Japan; International Virus Infectious Disease Research Center, National Institute of Global Health and Medicine, Japan Institute for Health Security, Tokyo, Japan; Department of Special Pathogens, International Research Center for Infectious Diseases, Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Yoshihiro KawaokaDivision of Virology, Institute of Medical Science, University of Tokyo, Tokyo, Japan; The University of Tokyo Pandemic Preparedness, Infection and Advanced Research Center (UTOPIA), University of Tokyo, Tokyo, Japan; International Virus Infectious Disease Research Center, National Institute of Global Health and Medicine, Japan Institute for Health Security, Tokyo, Japan; Department of Pathobiological Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, Madison, WI, USA. Electronic address: yoshihiro.kawaoka@wisc.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHighly pathogenic avian influenza (HPAI) A(H7N9) virus poses a potential public health threat, underscoring the need for effective antiviral options for outbreak preparedness. Baloxavir marboxil (BXM) is a cap-dependent endonuclease inhibitor approved for seasonal influenza, but its in vivo efficacy against HPAI A(H7N9) virus has not been fully evaluated.

methodsWe evaluated the efficacy of BXM in cynomolgus macaques infected with a reverse genetics-generated HPAI A(H7N9) virus. Animals received either low- or high-dose BXM, single-dose oseltamivir, or vehicle at 4 or 48 h post-infection (hpi). BXM administration was designed to mimic human pharmacokinetics. Viral titres, body temperature, body weight, lung pathology, and treatment-emergent viral substitutions were analysed.

findingsEarly treatment (4 hpi) with BXM significantly reduced viral titres in nasal and tracheal swabs, lessened weight loss, and decreased pulmonary inflammation and alveolar damage compared to untreated or oseltamivir-treated animals. Virus pathogenicity was relatively mild; no animals died. Delayed treatment (48 hpi) showed limited benefit. The PA-I38T (83.8%) and PA-E23G (78.6%) substitutions associated with BXM resistance were detected in one animal, and a PA-K34R (85.4%) substitution was detected in another animal. These substitutions reduce BXM susceptibility and were detected at low titres.

interpretationAlthough the dosing regimen used in this study involved repeat dosing to achieve the plasma drug concentrations after a single dose in humans, these findings highlight the importance of early antiviral intervention and support BXM use as a potential countermeasure against HPAI A(H7N9) virus infection, as resistance-associated substitutions remained limited in the macaque model. BXM may be a valuable therapeutic option for HPAI A(H7N9) virus infections.

fundingSupported by the Japan Agency for Medical Research and Development (JP20wm0125002, JP223fa627001) and Shionogi & Co., Ltd.

Indexed as

Antiviral AgentsDibenzothiepinsInfluenza A Virus, H7N9 SubtypeMorpholinesOrthomyxoviridae InfectionsOxazinesPyridinesPyridonesThiepinsTriazinesAnimalsDisease Models, AnimalDrug Resistance, ViralFemaleHumansLungAntiviral AgentsbaloxavirDibenzothiepinsMorpholinesOseltamivirOxazinesPyridinesPyridonesThiepinsTriazinesA(H7N9)Baloxavir marboxilHPAIInfluenza virusNonhuman primate

Identifiers

PMID42349254
PMCPMC13325332

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.