Oral azvudine for mild‐to‐moderate COVID‐19 in high risk, nonhospitalized adults: Results of a real‐world study

Azvudine is recommended by Chinese health authorities for COVID‐19 treatment but has not been tested in real‐world clinical studies. This study aimed to evaluate the real‐world effectiveness of Azvudine among COVID‐19 nonhospitalized patients. This was a retrospective cohort study, looking at nonhospitalized patients who tested positive for SARS‐CoV‐2. Patients admitted between December 19, 2022 and January 5, 2023 were included. Those who received Azvudine treatment were in the Azvudine group, while those who received supportive treatment were the control group. The primary outcome was the disease progression rate by Day 28. Secondary outcomes were individual disease progression outcomes (death or COVID‐19‐related hospitalization) and duration of fever. The safety outcomes were assessed based on adverse events (AEs) overall, as well as AEs that were considered to be related to the drug. A total of 804 patients with high risk for progression were enrolled in our study. Among them, 317 (39.43%) received treatment with Azvudine. Our study found that Azvudine could reduce the rate of disease progression, as well as rate of COVID‐19‐related hospitalization in patients comparing the control group. Furthermore, if taken within 3 days of the onset of symptoms, it could also shorten the duration of fever. Despite a higher incidence of drug‐related AEs compared to supportive treatment, the majority of these were mild. Azvudine has been found to be effective in reducing the rate of disease progression of COVID‐19, albeit with a slight increase in AEs.

[1]  S. B. de Souza,et al.  Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19 , 2023, Frontiers in Medicine.

[2]  Q. Zhang,et al.  VV116 versus Nirmatrelvir–Ritonavir for Oral Treatment of Covid-19 , 2022, New England Journal of Medicine.

[3]  Bin Yu,et al.  The first Chinese oral anti-COVID-19 drug Azvudine launched , 2022, The Innovation.

[4]  G. Castaldo,et al.  Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study , 2022, medRxiv.

[5]  G. Guyatt,et al.  A living WHO guideline on drugs for covid-19 , 2022, BMJ.

[6]  M. Boccellino,et al.  Advances in the Omicron variant development , 2022, Journal of internal medicine.

[7]  M. Baniecki,et al.  Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19 , 2022, The New England journal of medicine.

[8]  Nan Wang,et al.  Structural and functional characterizations of infectivity and immune evasion of SARS-CoV-2 Omicron , 2022, Cell.

[9]  L. Bekker,et al.  Effectiveness of BNT162b2 Vaccine against Omicron Variant in South Africa , 2021, The New England journal of medicine.

[10]  E. Callaway Omicron likely to weaken COVID vaccine protection , 2021, Nature.

[11]  Bin Liu,et al.  Azvudine is a thymus-homing anti-SARS-CoV-2 drug effective in treating COVID-19 patients , 2021, Signal Transduction and Targeted Therapy.

[12]  T. Burki Omicron variant and booster COVID-19 vaccines , 2021, The Lancet Respiratory Medicine.

[13]  M. Hassany,et al.  Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. , 2021, JAMA.

[14]  Wenling Wang,et al.  Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial , 2020, The Lancet Infectious Diseases.

[15]  Junbiao Chang,et al.  Azvudine (FNC): a promising clinical candidate for COVID-19 treatment , 2020, Signal Transduction and Targeted Therapy.

[16]  G. Guyatt,et al.  A living WHO guideline on drugs for covid-19 , 2020, BMJ.

[17]  Yongli Yang,et al.  Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. , 2020, JAMA.

[18]  J. Chen,et al.  Mechanistic insight into antiretroviral potency of 2'-deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a long-lasting effect on HIV-1 prevention. , 2020, Journal of medicinal chemistry.

[19]  Z. Ren,et al.  A Randomized, Open‐Label, Controlled Clinical Trial of Azvudine Tablets in the Treatment of Mild and Common COVID‐19, a Pilot Study , 2020, Advanced science.

[20]  Jessica M Franklin,et al.  Alternative approaches for confounding adjustment in observational studies using weighting based on the propensity score: a primer for practitioners , 2019, BMJ.