Academic literature on the topic 'Baloxavir'

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Journal articles on the topic "Baloxavir"

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Sato, Masatoki, Emi Takashita, Masahiko Katayose, Kenji Nemoto, Nobuko Sakai, Koichi Hashimoto, and Mitsuaki Hosoya. "Detection of Variants With Reduced Baloxavir Marboxil Susceptibility After Treatment of Children With Influenza A During the 2018–2019 Influenza Season." Journal of Infectious Diseases 222, no. 1 (February 8, 2020): 121–25. http://dx.doi.org/10.1093/infdis/jiaa061.

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Abstract During the 2018–2019 influenza seasons, we detected reduced baloxavir marboxil (baloxavir) susceptible variants with I38S or I38T amino acid substitutions on the PA subunit of influenza virus ribonucleic acid polymerase in 7 of 18 baloxavi-treated children and found that virus titer rebounded in some of these children with variants. We also found fever durations to be similar between patients with or without the variants, but the patients with variants shed the virus 3 days longer and took longer to improve clinical symptoms than those without variants. The emergence of these variants should be monitored during future influenza seasons.
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Ando, Yoshinori, Takeshi Noshi, Kenji Sato, Toru Ishibashi, Yuki Yoshida, Takahiro Hasegawa, Motoyasu Onishi, et al. "Pharmacokinetic and pharmacodynamic analysis of baloxavir marboxil, a novel cap-dependent endonuclease inhibitor, in a murine model of influenza virus infection." Journal of Antimicrobial Chemotherapy 76, no. 1 (October 10, 2020): 189–98. http://dx.doi.org/10.1093/jac/dkaa393.

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Abstract Background Baloxavir acid, the active form of the orally available prodrug baloxavir marboxil, is a novel cap-dependent endonuclease inhibitor of influenza virus. Baloxavir marboxil has been shown to rapidly reduce virus titres compared with oseltamivir in clinical studies. Objectives We investigated the relationship between pharmacokinetic (PK) parameters and antiviral activity of baloxavir acid based on virus titre reduction in lungs of infected mice. Methods BALB/c mice infected with a sub-lethal dose of influenza A(H1N1), A(H1N1)pdm09, A(H3N2) or type B virus were treated on day 5 with oral baloxavir marboxil (0.5–50 mg/kg q12h), subcutaneous baloxavir acid (0.25–8 mg/kg/day), oseltamivir phosphate (5 or 50 eq mg/kg q12h) or other antivirals for 1 day. Lung virus titres were assessed 24 h after initial antiviral dosing. PK testing was performed at up to 24 h post-dosing of baloxavir marboxil or baloxavir acid in A/WSN/33-infected mice and the PK/pharmacodynamic (PD) relationship was evaluated for baloxavir acid. Results Oral baloxavir marboxil administration showed dose-dependent virus titre reductions in lungs of mice infected with the different types/subtypes of influenza viruses 24 h post-dosing. Baloxavir marboxil at 15 mg/kg q12h resulted in ≥100-fold and ≥10-fold reductions in influenza A and B virus titres, respectively, compared with oseltamivir phosphate. PK/PD analysis showed that the plasma concentration at the end of the dosing interval (Cτ) or the plasma concentration at 24 h after initial dosing (C24) was the PK parameter predicting the virus titres at 24 h post-dosing of baloxavir acid. Conclusions PK/PD analysis of baloxavir acid based on virus titre reduction in this mouse model could be helpful in predicting and maximizing virological outcomes in clinical settings.
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Taieb, Vanessa, Hidetoshi Ikeoka, Fang-Fang Ma, Katarzyna Borkowska, Samuel Aballea, Keiko Tone, and Nobuo Hirotsu. "A network meta-analysis of the efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors for the treatment of influenza in otherwise healthy patients." Terapevticheskii arkhiv 92, no. 11 (December 26, 2020): 122–31. http://dx.doi.org/10.26442/00403660.2020.11.000870.

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Aim. Baloxavir marboxil (baloxavir) is the first cap-dependent endonuclease inhibitor being studied for the treatment of influenza in single oral dosing regimen. This network meta-analysis (NMA) evaluated the efficacy and safety of baloxavir compared to other antivirals for influenza in otherwise healthy patients. Methods. A systematic literature review was performed on 14 November 2016 in Medline, Embase, CENTRAL, and ICHUSHI to identify randomized controlled trials assessing antivirals for influenza. A NMA including 22 trials was performed to compare the efficacy and safety of baloxavir with other antivirals. Results. The time to alleviation of all symptoms was significantly shorter for baloxavir compared to zanamivir (difference in median time 19.96 h; 95% CrI [3.23, 39.07]). The time to cessation of viral shedding was significantly shorter for baloxavir than zanamivir and oseltamivir (47.00 h; 95% CrI [28.18, 73.86] and 56.03 h [33.74, 87.86], respectively). The mean decline in virus titer from baseline to 24 h was significantly greater for baloxavir than for the other drugs. Other differences in efficacy outcomes were not significant. No significant differences were found between baloxavir and the other antivirals for safety, except total drug-related adverse events where baloxavir demonstrated a decrease compared to oseltamivir and laninamivir. Conclusion. The NMA suggests that baloxavir demonstrated better or similar efficacy results compared to other antivirals with a comparable safety profile. Baloxavir led to a significant decrease in viral titer versus zanamivir, oseltamivir and peramivir and decreased viral shedding versus zanamivir and oseltamivir.
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Baker, Danial E. "Baloxavir Marboxil." Hospital Pharmacy 54, no. 3 (April 1, 2019): 165–69. http://dx.doi.org/10.1177/0018578719841044.

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Each month, subscribers to The Formulary Monograph Service receive 5 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433.
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Shah, Sunish, Dayna McManus, Nika Bejou, Samad Tirmizi, Ginger E. Rouse, Steven M. Lemieux, Diana Gritsenko, and Jeffrey E. Topal. "Clinical outcomes of baloxavir versus oseltamivir in patients hospitalized with influenza A." Journal of Antimicrobial Chemotherapy 75, no. 10 (July 26, 2020): 3015–22. http://dx.doi.org/10.1093/jac/dkaa252.

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Abstract Objectives To date, clinical trials evaluating baloxavir have excluded patients hospitalized with influenza infection and therefore this study sought to evaluate the efficacy of baloxavir in inpatients with influenza A. Methods This study was a multicentre, retrospective chart review of adult patients admitted to the hospital within the Yale New Haven Health System who received oseltamivir or baloxavir for the treatment of influenza A. Patients were screened for inclusion between January 2018 and April 2018 in the oseltamivir group, while patients in the baloxavir group were screened for inclusion between January 2019 and April 2019. Influenza A diagnosis was confirmed by RT–PCR using a nasopharyngeal swab specimen. Results Of the 2392 patients assessed, 790 met the inclusion criteria. There were 359 patients who received baloxavir and 431 patients who received oseltamivir. Patients who received baloxavir were younger compared with those who received oseltamivir [median = 69 (IQR = 57–81) years versus 77 (IQR = 62–86) years; P < 0.001]. Patients who received baloxavir had no significant difference in hospital length of stay [median = 4 (IQR = 3–6) days versus 5 (IQR = 3–6) days; P = 0.45] or 30 day all-cause mortality [12 (3.3%) versus 26 (6%); P = 0.079] compared with those who received oseltamivir. However, patients who received baloxavir had a significantly faster time to hypoxia resolution [median = 51.7 (IQR = 25.3–89.3) h versus 72 (IQR = 37.5–123) h; P < 0.001]. Conclusions The results of this study support the use of baloxavir for the treatment of influenza A in hospitalized patients with the potential benefit of a faster time to resolution of hypoxia.
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ter Horst, Sebastiaan, Yaiza Fernandez-Garcia, Marcella Bassetto, Stephan Günther, Andrea Brancale, Johan Neyts, and Joana Rocha-Pereira. "Enhanced efficacy of endonuclease inhibitor baloxavir acid against orthobunyaviruses when used in combination with ribavirin." Journal of Antimicrobial Chemotherapy 75, no. 11 (August 7, 2020): 3189–93. http://dx.doi.org/10.1093/jac/dkaa337.

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Abstract Objectives Baloxavir acid is an endonuclease inhibitor approved for use against influenza. We evaluated whether this compound also targets the endonuclease domain of orthobunyaviruses and therefore could potentially be used against orthobunyavirus infections. Methods We performed a thermal shift assay and a fluorescence resonance energy transfer (FRET)-based nuclease monitoring assay using the La Crosse virus (LACV) endonuclease and baloxavir acid to prove their interaction and identify an inhibitory effect. Their interaction was further studied in a docking simulation using Glide SP. We show that baloxavir acid inhibits the viral replication of Bunyamwera virus (BUNV)–mCherry in vitro using high-content imaging and virus yield assay. Lastly, we investigated the use of baloxavir acid in combination with ribavirin in vitro by implementing the Zero Interaction Potency response surface model. Results We show that baloxavir acid augments LACV enzyme’s melting temperature with ΔTm 9.5 ± 0.4°C and inhibited substrate cleavage with IC50 0.39 ± 0.03 μM. Moreover, our docking simulation suggests that baloxavir acid is able to establish an efficient binding with the LACV endonuclease. In the cell-based assay, we observed that baloxavir acid and ribavirin inhibited BUNV–mCherry with an EC50 of 0.7 ± 0.2 μM and 26.6 ± 8.9 μM, respectively. When used in combination, we found a maximum synergistic effect of 8.64. Conclusions The influenza endonuclease inhibitor baloxavir acid is able to bind to and interfere with the endonuclease domain of orthobunyaviruses and yields a more potent antiviral effect than ribavirin against BUNV–mCherry. The combination of both compounds results in a more potent antiviral effect, suggesting that these molecules could potentially be combined to treat orthobunyavirus-infected patients.
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Yoshino, Yusuke, Keita Misu, Yoshitaka Wakabayashi, Yasuo Ota, and Takatoshi Kitazawa. "2644. Evaluation of Clinical Course and Heath-Related Quality-of-Life Following Treatment with Oseltamivir, Laninamivir, and Baloxavir Marboxil in Adult Patients with Seasonal Influenza: Prospective Observational Study." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S925. http://dx.doi.org/10.1093/ofid/ofz360.2322.

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Abstract Background Influenza is currently being treated in Japan with 4 types of neuraminidase inhibitors and the cap-dependent endonuclease inhibitor baloxavir marboxil. Among these, baloxavir marboxil is the newest agent and currently available in limited countries, while the clinical efficacy of this drug in the real world remains to be determined. Methods Adult patients with seasonal influenza during the 2018–2019 winter season, who received either oseltamivir (75 mg twice daily for 5 days), laninamivir (40 mg once), or baloxavir marboxil (40 or 80 mg once) at their physician’s discretion in one hospital, were enrolled. The course of the symptoms including fever were surveyed by questionnaire. Health-related quality-of-life (HRQOL) was also examined by using Short Form-8 before and 7 days after admission. The main study endpoints were the time to defervescence and the extent of improvement of HRQOL after treatment initiation. Welch’s t-test and Fisher exact test were used for statistical analysis. Results Forty-two patients (oseltamivir group; n = 12, laninamivir group; n = 16, baloxavir group; n = 14) could be followed up. There were no significant differences in clinical backgrounds of all groups. Although there were no significant differences between the oseltamivir and each other groups with the time of defervescence, the average time to defervescence in the baloxavir group was shorter than that in the oseltamivir group (average ± standard deviation; 1.57 ± 0.76 vs. 2.33 ± 1.23 days, P = 0.0853). There were significant differences between the baloxavir and laninamivir groups (2.50 ± 1.26 days, P = 0.0231). There were no significant differences between each group with respect to the change of HRQOL and the time of clearing of other symptoms. Conclusion Regarding the antipyretic effect, baloxavir marboxil is clinically superior to laninamivir. Although there was no significant difference between the baloxavir group and the oseltamivir group with respect to the time to defervescence, baloxiavir marboxil also might be clinically superior to oseltamivir because baloxavir marboxil has an advantage over oseltamivir with respect to medication adherence. Disclosures All authors: No reported disclosures.
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Kiso, Maki, Seiya Yamayoshi, Yuri Furusawa, Masaki Imai, and Yoshihiro Kawaoka. "Treatment of Highly Pathogenic H7N9 Virus-Infected Mice with Baloxavir Marboxil." Viruses 11, no. 11 (November 15, 2019): 1066. http://dx.doi.org/10.3390/v11111066.

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Viral neuraminidase inhibitors show limited efficacy in mice infected with H7N9 influenza A viruses isolated from humans. Although baloxavir marboxil protected mice from lethal challenge infection with a low pathogenic avian influenza H7N9 virus isolated from a human, its efficacy in mice infected with a recent highly pathogenic version of H7N9 human isolates is unknown. Here, we examined the efficacy of baloxavir marboxil in mice infected with a highly pathogenic human H7N9 virus, A/Guangdong/17SF003/2016. Treatment of infected mice with a single 1.5 mg/kg dose of baloxavir marboxil protected mice from the highly pathogenic human H7N9 virus infection as effectively as oseltamivir treatment at 50 mg/kg twice a day for five days. Daily treatment for five days at 15 or 50 mg/kg of baloxavir marboxil showed superior therapeutic efficacy, largely preventing virus replication in respiratory organs. These results indicate that baloxavir marboxil is a valuable candidate treatment for human patients suffering from highly pathogenic H7N9 virus infection.
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Selvanayagam, Stephen, Amy Kang, and David Ha. "Baloxavir Marboxil: A New Antiviral for Acute Influenza." Journal of Contemporary Pharmacy Practice 66, no. 4 (January 1, 2020): 33–38. http://dx.doi.org/10.37901/jcphp19-00004.

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Baloxavir is a newly approved, single-dose, oral influenza antiviral indicated for acute uncomplicated influenza in patients 12 years and older if symptomatic for less than 48 hours. The purpose of this article is to review currently available literature on the mechanism of action, pharmacokinetics, safety, and clinical and virologic efficacy of baloxavir. Its novel mechanism of action prevents influenza replication by targeting the viral cap-dependent endonuclease enzyme. In clinical trials baloxavir was shown to be superior to placebo and comparable to oseltamivir with regard to time to alleviation of symptoms and viral titer reduction and was well tolerated with minimal adverse effects. Baloxavir is a viable treatment option for acute uncomplicated influenza in certain age groups.
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Seldeslachts, Laura, Cato Jacobs, Birger Tielemans, Eliane Vanhoffelen, Lauren Van der Sloten, Stephanie Humblet-Baron, Lieve Naesens, et al. "Overcome Double Trouble: Baloxavir Marboxil Suppresses Influenza Thereby Mitigating Secondary Invasive Pulmonary Aspergillosis." Journal of Fungi 8, no. 1 (December 21, 2021): 1. http://dx.doi.org/10.3390/jof8010001.

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Influenza-associated pulmonary aspergillosis (IAPA) is a global recognized superinfection in critically ill influenza patients. Baloxavir marboxil, a cap-dependent endonuclease inhibitor, is a newly approved anti-influenza therapeutic. Although the benefits as a treatment for influenza are clear, its efficacy against an influenza-A. fumigatus co-infection has yet to be determined. We investigated the therapeutic effect of baloxavir marboxil in a murine model for IAPA. Immunocompetent mice received intranasal instillation of influenza A followed by orotracheal inoculation with Aspergillus fumigatus 4 days later. Administration of baloxavir marboxil or sham was started at day 0, day 2 or day 4. Mice were monitored daily for overall health status, lung pathology with micro-computed tomography (µCT) and fungal burden with bioluminescence imaging (BLI). In vivo imaging was supplemented with virological, mycological and biochemical endpoint investigations. We observed an improved body weight, survival and viral clearance in baloxavir marboxil treated mice. µCT showed less pulmonary lesions and bronchial dilation after influenza and after Aspergillus co-infection in a treatment-dependent pattern. Furthermore, baloxavir marboxil was associated with effective inhibition of fungal invasion. Hence, our results provide evidence that baloxavir marboxil mitigates severe influenza thereby decreasing the susceptibility to a lethal invasive Aspergillus superinfection.
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Book chapters on the topic "Baloxavir"

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Imai, Masaki, and Yoshihiro Kawaoka. "The New Anti-influenza Drug Baloxavir Marboxil: Can Influenza Viruses with Reduced Susceptibility to Baloxavir Maintain Viral Fitness?" In Respiratory Disease Series: Diagnostic Tools and Disease Managements, 211–19. Singapore: Springer Singapore, 2020. http://dx.doi.org/10.1007/978-981-15-9109-9_21.

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Uehara, Takeki. "How to Use Anti-influenza Drugs: Baloxavir Marboxil." In Respiratory Disease Series: Diagnostic Tools and Disease Managements, 171–79. Singapore: Springer Singapore, 2020. http://dx.doi.org/10.1007/978-981-15-9109-9_17.

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Takashita, Emi. "Viruses Resistant to Oseltamivir or Baloxavir: What Do the Data Reveal About Resistance?" In Respiratory Disease Series: Diagnostic Tools and Disease Managements, 221–29. Singapore: Springer Singapore, 2020. http://dx.doi.org/10.1007/978-981-15-9109-9_22.

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Conference papers on the topic "Baloxavir"

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Cagas, S., S. Gupta, J. Han, M. McIntosh, C. Collins, C. Sun, and K. Kuhlbusch. "Efficacy and Safety of Baloxavir Marboxil for the Treatment of Influenza Virus Infection in Patients with Chronic Lung Disease: A Subgroup Analysis of CAPSTONE-2." In American Thoracic Society 2022 International Conference, May 13-18, 2022 - San Francisco, CA. American Thoracic Society, 2022. http://dx.doi.org/10.1164/ajrccm-conference.2022.205.1_meetingabstracts.a3113.

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