GY48LS6

Феърфилд
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Балоксавир марбоксил (Baloxavir marboxil)
Международное непатентованное наименование Балоксавир марбоксил (Baloxavir marboxil)
Торговое наименование Xofluza
Производитель, страна Roche Holding, Switzerland
Механизм действия

Baloxavir marboxil is an influenza therapeutic agent, specifically, an enzyme inhibitor targeting the influenza virus' cap-dependent endonuclease activity, one of the activities of the virus polymerase complex. In particular, it inhibits a process known as cap snatching, by which the virus derives short, capped primers from host cell RNA transcripts, which it then uses for polymerase-catalyzed synthesis of its needed viral mRNAs. A polymerase subunit binds to the host pre-mRNAs at their 5′-caps, then the polymerase's endonuclease activity catalyzes its cleavage "after 10–13 nucleotides". As such, its mechanism is distinct from neuraminidase inhibitors such as oseltamivir and zanamivir.

Публикации COVID-19

Masami NakazawaKanae HaraTakuji KomedaEriko Ogura. Safety and Effectiveness of Baloxavir Marboxil for the Treatment of Influenza in Japanese Clinical Practice: A Postmarketing Surveillance of More Than 3000 Patients. J Infect Chemother. 2020 May 11;S1341-321X(20)30140-9. DOI: 10.1016/j.jiac.2020.04.014.

 

Yan LouLin LiuYunqing Qiu. Clinical Outcomes and Plasma Concentrations of Baloxavir Marboxil and Favipiravir in COVID-19 Patients: an Exploratory Randomized, Controlled Trial. May 05, 2020. DOI: 10.1101/2020.04.29.20085761. 

 

Hiroki KoshimichiSylvie Retout, et al. Population Pharmacokinetics and Exposure-Response Relationships of Baloxavir Marboxil in Patients Infected With Influenza at High Risk of Influenza Complications. Antimicrob Agents Chemother2020 Apr 20;AAC.00119-20. DOI: 10.1128/AAC.00119-20.

Клинические исследования
1.
Название протокола Randomized, open-label, controlled trial for evaluating of the efficacy and safety of Baloxavir Marboxil, Favipiravir, and Lopinavir-Ritonavir in the treatment of novel coronavirus pneumonia (COVID-19) patients
Дата начала и окончания КИ April 4, 2020 - June 3, 2020
Название организации, проводящей КИ The First Affiliated Hospital, Zhejiang University School of Medicine
Страны China
Кол-во пациентов 30
2.
Название протокола A randomized controlled trial for the efficacy and safety of Baloxavir Marboxil, Favipiravir tablets in novel coronavirus pneumonia (COVID-19) patients who are still positive on virus detection under the current antiviral therapy
Дата начала и окончания КИ April 4, 2020 - May 31, 2020
Название организации, проводящей КИ The First Hospital Affiliated to Zhejiang University's Medical School
Страны China
Кол-во пациентов 30