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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Main Author: Ke-Wei Zhu
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-08-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2023.1228548/full
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author Ke-Wei Zhu
author_facet Ke-Wei Zhu
author_sort Ke-Wei Zhu
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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 doaj.art-07aab57b507c4d65aa878ba39053b61c2023-08-25T05:14:09ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-08-011410.3389/fphar.2023.12285481228548Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trialsKe-Wei ZhuAzvudine (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.https://www.frontiersin.org/articles/10.3389/fphar.2023.1228548/fullAzvudine (FNC)viral loadsevere acute respiratory syndrome coronavirus 2RNA-dependent RNA polymerasenucleic acid-negative conversion time
spellingShingle Ke-Wei Zhu
Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials
Frontiers in Pharmacology
Azvudine (FNC)
viral load
severe acute respiratory syndrome coronavirus 2
RNA-dependent RNA polymerase
nucleic acid-negative conversion time
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 Azvudine (FNC)
viral load
severe acute respiratory syndrome coronavirus 2
RNA-dependent RNA polymerase
nucleic acid-negative conversion time
url https://www.frontiersin.org/articles/10.3389/fphar.2023.1228548/full
work_keys_str_mv AT keweizhu efficacyandsafetyevaluationofazvudineintheprospectivetreatmentofcovid19basedonfourphaseiiiclinicaltrials