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Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials

Azvudine (FNC) is a synthetic nucleoside analog used to treat adult patients living with human immunodeficiency virus-1 (HIV-1) infection with high viral load. After phosphorylation, Azvudine inhibits RNA-dependent RNA polymerase, leading to the discontinuation of RNA chain synthesis in viruses. In...

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Autor principal: Zhu, Ke-Wei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10484631/
https://www.ncbi.nlm.nih.gov/pubmed/37693894
http://dx.doi.org/10.3389/fphar.2023.1228548
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author Zhu, Ke-Wei
author_facet Zhu, Ke-Wei
author_sort Zhu, Ke-Wei
collection PubMed
description Azvudine (FNC) is a synthetic nucleoside analog used to treat adult patients living with human immunodeficiency virus-1 (HIV-1) infection with high viral load. After phosphorylation, Azvudine inhibits RNA-dependent RNA polymerase, leading to the discontinuation of RNA chain synthesis in viruses. In addition, Azvudine is the first dual-target nucleoside oral drug worldwide to simultaneously target reverse transcriptase and viral infectivity factors in the treatment of HIV infection. On 9 August 2022, Azvudine was incorporated into the Guidelines for the Diagnosis and Treatment of Coronavirus Disease 2019 (version ninth) issued by the National Health Commission and the National Administration of Traditional Chinese Medicine. The recommended oral dose of Azvudine for the treatment of moderate coronavirus disease 2019 (COVID-19) is 5 mg once daily, and the duration of Azvudine treatment should not exceed 14 days. Four phase III clinical trials were performed during 2020–2022 to evaluate the efficacy and safety of Azvudine in the treatment of COVID-19. The results revealed that Azvudine could reduce nucleic acid-negative conversion time, viral load, and time to improvement in clinical conditions in patients with moderate COVID-19. In addition, Azvudine exhibited good safety and tolerance. Thereafter, Azvudine was incorporated into the Chinese guidelines and expert consensus for the treatment of COVID-19 and was highly approbated. Furthermore, Azvudine was also included in the Chinese guidelines for HIV infection.
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spelling pubmed-104846312023-09-08 Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials Zhu, Ke-Wei Front Pharmacol Pharmacology Azvudine (FNC) is a synthetic nucleoside analog used to treat adult patients living with human immunodeficiency virus-1 (HIV-1) infection with high viral load. After phosphorylation, Azvudine inhibits RNA-dependent RNA polymerase, leading to the discontinuation of RNA chain synthesis in viruses. In addition, Azvudine is the first dual-target nucleoside oral drug worldwide to simultaneously target reverse transcriptase and viral infectivity factors in the treatment of HIV infection. On 9 August 2022, Azvudine was incorporated into the Guidelines for the Diagnosis and Treatment of Coronavirus Disease 2019 (version ninth) issued by the National Health Commission and the National Administration of Traditional Chinese Medicine. The recommended oral dose of Azvudine for the treatment of moderate coronavirus disease 2019 (COVID-19) is 5 mg once daily, and the duration of Azvudine treatment should not exceed 14 days. Four phase III clinical trials were performed during 2020–2022 to evaluate the efficacy and safety of Azvudine in the treatment of COVID-19. The results revealed that Azvudine could reduce nucleic acid-negative conversion time, viral load, and time to improvement in clinical conditions in patients with moderate COVID-19. In addition, Azvudine exhibited good safety and tolerance. Thereafter, Azvudine was incorporated into the Chinese guidelines and expert consensus for the treatment of COVID-19 and was highly approbated. Furthermore, Azvudine was also included in the Chinese guidelines for HIV infection. Frontiers Media S.A. 2023-08-24 /pmc/articles/PMC10484631/ /pubmed/37693894 http://dx.doi.org/10.3389/fphar.2023.1228548 Text en Copyright © 2023 Zhu. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Zhu, Ke-Wei
Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials
title Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials
title_full Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials
title_fullStr Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials
title_full_unstemmed Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials
title_short Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials
title_sort efficacy and safety evaluation of azvudine in the prospective treatment of covid-19 based on four phase iii clinical trials
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10484631/
https://www.ncbi.nlm.nih.gov/pubmed/37693894
http://dx.doi.org/10.3389/fphar.2023.1228548
work_keys_str_mv AT zhukewei efficacyandsafetyevaluationofazvudineintheprospectivetreatmentofcovid19basedonfourphaseiiiclinicaltrials