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

Zhu, K., Frontiers in Pharmacology, doi:10.3389/fphar.2023.1228548, NCT04425772
Aug 2023  
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Azvudine for COVID-19
39th treatment shown to reduce risk in May 2023
*, now known with p = 0.000076 from 13 studies.
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Review of four phase III clinical trials evaluating the efficacy and safety of azvudine, a nucleoside analog, for the treatment of COVID-19. The trials were conducted in China, Russia, and Brazil on patients with mild to moderate disease. Azvudine significantly reduced viral load, time to negative COVID-19 test conversion, and time to clinical improvement compared to placebo in patients with moderate disease, but showed limited efficacy in mild disease, possibly due to its self-limiting course. Azvudine exhibited good safety and tolerability. Based on these results, azvudine was incorporated into Chinese national guidelines for COVID-19 treatment. However, the trials had small sample sizes and did not evaluate azvudine's ability to prevent severe disease progression or reduce mortality.
Zhu et al., 24 Aug 2023, prospective, placebo-controlled, China, peer-reviewed, 1 author, study period June 2020 - March 2022, trial NCT04425772 (history). Contact:
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Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials
Ke-Wei Zhu, Exequiel Oscar, Jesus Porta, Amgad M Rabie
Frontiers in Pharmacology, doi:10.3389/fphar.2023.1228548
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.
Author contributions K-WZ is the sole author of this paper. Conflict of interest Author K-WZ was employed by Guangzhou Baiyunshan Pharmaceutical Holding Co., Ltd. Baiyunshan Pharmaceutical General Factory. Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. Supplementary material The Supplementary Material for this article can be found online at: full#supplementary-material
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