Effects of baloxavir marboxil: A Synthesis of Findings from 15 Studies

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Original Abstract of the Article

Major Research Findings

Research on the effects of baloxavir marboxil suggests its effectiveness against influenza A and B virus infections. In particular, the prophylactic effect of baloxavir marboxil was shown to be superior to oseltamivir in a mouse model. 4 It has also been reported that infectious viral titers decrease rapidly within one day after baloxavir marboxil administration. 2 This rapid reduction in viral titer is a characteristic of baloxavir marboxil. 2 Research on baloxavir marboxil resistance mutations has shown that PA I38T, I38L, or E199D substitutions reduce susceptibility to baloxavir. 7 These substitutions decreased susceptibility to baloxavir by 15.3 to 72.3 times. 7 There have also been some reports of bleeding symptoms associated with the use of baloxavir marboxil. 13 These bleeding symptoms are listed in the package insert as a potential side effect of baloxavir marboxil. 13

Benefits and Risks

Benefit Summary

The benefits of baloxavir marboxil include prophylactic effect against influenza A and B virus infection, rapid reduction of viral titers, and improvement of influenza symptoms. 4 2 In addition, administration of baloxavir marboxil was shown to resolve fever more quickly than oseltamivir. 6 These findings suggest that baloxavir marboxil treatment may be helpful in treating influenza.

Risk Summary

The risks of baloxavir marboxil include reports of bleeding symptoms. 13 Therefore, it is necessary to be aware of bleeding symptoms when using baloxavir marboxil.

Comparison Between Studies

Commonalities

Research on the effects of baloxavir marboxil has a commonality in that they suggest its effectiveness against influenza. 4 2 6 Administration of baloxavir marboxil may contribute to the reduction of influenza virus titers, improvement of influenza symptoms, and shortening of fever duration. These studies suggest the usefulness of baloxavir marboxil in the treatment of influenza.

Differences

The differences between studies mainly concern the research subjects, research design, and evaluation criteria. 4 2 6 For example, the administration method, dosage, and evaluation criteria of baloxavir marboxil may vary depending on the study. Therefore, it is necessary to consider the research design and evaluation criteria when interpreting the results.

Consistency and Contradictions in Results

Research on the effects of baloxavir marboxil has produced results that suggest its effectiveness against influenza. 4 2 6 However, these studies are still small-scale and need to be confirmed in large-scale studies. Also, contradictory results such as reports of bleeding symptoms associated with the use of baloxavir marboxil have been reported. 13 These contradictions need to be addressed in further research.

Cautions Regarding Real-World Applications

Research on the effects of baloxavir marboxil has produced results that suggest its effectiveness against influenza. 4 2 6 However, these studies are still small-scale and need to be confirmed in large-scale studies. Also, contradictory results such as reports of bleeding symptoms associated with the use of baloxavir marboxil have been reported. 13 These contradictions need to be addressed in further research. Baloxavir marboxil should be used under the guidance of a doctor.

Limitations of Current Research

Research on the effects of baloxavir marboxil is still in its early stages. 4 2 6 Further research, including large-scale studies, long-term studies, and studies on side effects, is needed. Research on side effects such as bleeding symptoms associated with the use of baloxavir marboxil is also needed. 13

Future Research Directions

Future research should focus on large-scale studies, long-term studies, and studies on side effects in order to gain a deeper understanding of the effects of baloxavir marboxil. 4 2 6 13 Through these studies, the safety and effectiveness of baloxavir marboxil can be evaluated in more detail.

Conclusion

Research on the effects of baloxavir marboxil has produced results that suggest its effectiveness against influenza. 4 2 6 However, these studies are still in their early stages. Large-scale studies, long-term studies, and studies on side effects are needed in the future. 13 Through these studies, the safety and effectiveness of baloxavir marboxil can be evaluated in more detail. Baloxavir marboxil should be used under the guidance of a doctor.

Literature analysis of 15 papers
Positive Content
14
Neutral Content
0
Negative Content
1
Article Type
3
0
0
0
15
1.

Safety, Tolerability, and Pharmacokinetics of the Novel Anti-influenza Agent Baloxavir Marboxil in Healthy Adults: Phase I Study Findings.

Author: KoshimichiHiroki, IshibashiToru, KawaguchiNao, SatoChisako, KawasakiAkira, WajimaToshihiro

Viral replication suppression

This first-in-human phase I study evaluated the safety, tolerability, and pharmacokinetics of baloxavir marboxil/baloxavir acid in healthy Japanese volunteers. The study showed that baloxavir marboxil was well tolerated and had a favorable pharmacokinetic profile. A separate phase I, crossover study evaluated the food effects of baloxavir marboxil/baloxavir acid.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Carryover effects of baloxavir acid in human nasopharyngeal/pharyngeal swabs on infectious titer testing of influenza virus.

Author: BabaKeiko, OkaRyoko, ShanoShinya, OmotoShinya, NoshiTakeshi, ShishidoTakao, NaitoAkira, KawaguchiKeiko, IshibashiToru, UeharaTakeki

Rapid antiviral effect

This study investigated the potential for carryover effects of baloxavir acid (BXA), the active form of baloxavir marboxil (BXM), on infectious titer testing.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Baloxavir marboxil use for critical human infection of avian influenza A H5N6 virus.

Author: GuanWenda, QuRong, ShenLihan, MaiKailin, PanWeiqi, LinZhengshi, ChenLiping, DongJi, ZhangJiawei, FengPei, WengYunceng, YuMinfei, GuanPeikun, ZhouJinchao, TuChuanmeizi, WuXiao, WangYang, YangChunguang, LingYun, LeSheng, ZhanYangqing, LiYimin, LiuXiaoqing, ZouHeyan, HuangZiqi, ZhouHongxia, WuQiubao, ZhangWenjie, HeJiayang, XuTeng, ZhongNanshan, YangZifeng

Effective treatment

The high fatality rate of human infections with highly pathogenic avian influenza H5N6 virus necessitates the search for effective treatments due to recent outbreaks and ongoing virus reassortment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

7.

Impact of Baloxavir Resistance-Associated Substitutions on Influenza Virus Growth and Drug Susceptibility.

Author: HickersonBrady T, PetrovskayaSvetlana N, DickensheetsHarold, DonnellyRaymond P, InceWilliam L, IlyushinaNatalia A

Influenza treatment
Drug resistance

This study investigated the impact of the proportion of drug-resistant subpopulations on the ability to detect resistance in clinical isolates and the impact of substitutions on viral replication of mixtures containing both drug-sensitive and drug-resistant variants. The findings highlight the potential impact of baloxavir-resistant substitutions on baloxavir susceptibility and other biological properties of influenza virus.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

8.

Baloxavir safety and clinical and virologic outcomes in influenza virus-infected pediatric patients by age group: age-based pooled analysis of two pediatric studies conducted in Japan.

Author: HirotsuNobuo, SakaguchiHiroki, FukaoKeita, KojimaSatoshi, PiedraPedro A, TsuchiyaKenji, UeharaTakeki

Reduced influenza symptoms
Fever recurrence

A post hoc pooled analysis of two open-label studies of 137 Japanese children with influenza found that a single dose of baloxavir marboxil (baloxavir) was safe and effective across all age groups and influenza virus types. Symptom and fever recurrence was more common in children under 6 years old with influenza B. Transient virus titer increase was more common in children under 6 years old.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Pharmacokinetics, safety, and simulated efficacy of an influenza treatment, baloxavir marboxil, in Chinese individuals.

Author: LiuYanmei, RetoutSylvie, DuvalVincent, JiaJingying, ZouYang, WangYijun, CossonValérie, JolivetSébastien, De BuckStefan

Influenza treatment
Safety profile

Baloxavir marboxil is an antiviral medication used to treat influenza. This study evaluated the pharmacokinetics and safety of baloxavir marboxil in healthy Chinese volunteers. The authors found that baloxavir marboxil was well-tolerated and had similar pharmacokinetic parameters to Asian populations in other studies. Simulated efficacy data suggested that Chinese patients could benefit from similar efficacy to Asian patients. The study provides important data for the use of baloxavir marboxil in Chinese patients.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Characterization of the In Vitro and In Vivo Efficacy of Baloxavir Marboxil against H5 Highly Pathogenic Avian Influenza Virus Infection.

Author: TaniguchiKeiichi, AndoYoshinori, KobayashiMasanori, TobaShinsuke, NoboriHaruaki, SanakiTakao, NoshiTakeshi, KawaiMakoto, YoshidaRyu, SatoAkihiko, ShishidoTakao, NaitoAkira, MatsunoKeita, OkamatsuMasatoshi, SakodaYoshihiro, KidaHiroshi

Antiviral efficacy
H5N1 HPAIV treatment

This study investigated the antiviral efficacy of baloxavir acid (BXA) against H5 highly pathogenic avian influenza virus (HPAIV), including recent H5N8 variants. The study found that BXA exhibited similar in vitro activities against H5N1, H5N6, and H5N8 variants and demonstrated potent antiviral efficacy against H5 HPAIV infections in mice.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

12.

Comparison of the incidence of bleeding between baloxavir marboxil and other anti-influenza drugs among outpatients with influenza virus infection: A retrospective cohort study using an employment-based health insurance claims database in Japan.

Author: HaraAzusa, HaraKanae, KomedaTakuji, OguraEriko, MiyazawaShogo, KobayashiChiduru, FujiwaraMasakazu, YoshidaManami, UrushiharaHisashi

Reduced bleeding events
None mentioned

This study compared the incidence of bleeding events in influenza patients treated with baloxavir or other anti-influenza drugs versus untreated patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Association of bleeding symptoms during influenza infection and administered drugs.

Author: SugawaraTamie, OhkusaYasushi, TaniguchiKiyosu, MiyazakiChiaki, KatoYoko, OkabeNobuhiko

bleeding risk

This study elucidated bleeding symptoms among influenza patients and hospitalized patients who were administered anti-influenza drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Exploration of the 2,3-dihydroisoindole pharmacophore for inhibition of the influenza virus PA endonuclease.

Author: RogolinoDominga, NaesensLieve, BartoliJennifer, CarcelliMauro, De LucaLaura, PelosiGiorgio, StokesRyjul W, Van BerwaerRia, VittorioSerena, StevaertAnnelies, CohenSeth M

Influenza virus inhibition

This study explored the 2,3-dihydro-6,7-dihydroxy-1H-isoindol-1-one scaffold as an inhibitor of influenza virus PA endonuclease. The study identified compounds with nanomolar inhibitory activity and highlighted the potential of this scaffold for developing novel PA inhibitors with activity against baloxavir-resistant mutants.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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