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Real-world effectiveness and safety of azvudine in hospitalized patients with SARS-CoV-2 infection: A multicenter, retrospective cohort study - 06/12/24

Doi : 10.1016/j.jinf.2024.106355 
Zhigang Ren a, , 1 , Mengzhao Yang a, 1, Guanyue Su a, 1, Guowu Qian b, 1, Yiqiang Yuan c, 1, Jia Yu a, Silin Li d, Changshuang Wang e, Mingxia Lu e, Hong Luo f, Shixi Zhang g, Guangming Li h, Donghua Zhang i, Ling Wang c, Guotao Li j, Xiaoli Jin j, Juan Wang h, Mingming Wang g, Ming Cheng k, Haiyu Wang a, Junbiao Chang l, , Zujiang Yu a,
a Department of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China 
b Department of Gastrointestinal Surgery, Nanyang Central Hospital, Nanyang 473009, China 
c Department of Cardiovascular Medicine, Henan Provincial Chest Hospital Affiliated to Zhengzhou University, Zhengzhou 450008, China 
d Department of Respiratory and Critical Care Medicine, Fengqiu County People's Hospital, Xinxiang 453300, China 
e Henan Center for Disease Control and Prevention, Zhengzhou 450016, China 
f Guangshan County People’s Hospital, Guangshan County, Xinyang 465450, China 
g Department of Infectious Diseases, Shangqiu Municipal Hospital, Shangqiu 476000, Henan Province, China 
h Department of Liver Disease, the Affiliated Infectious Disease Hospital of Zhengzhou University, Zhengzhou 450052, China 
i Department of Infectious Diseases, Anyang City Fifth People’s Hospital, Anyang 455000, China 
j Department of Infectious Diseases, Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang 471000, China 
k Department of Medical Information, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China 
l State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, Zhengzhou University, Zhengzhou 450001, China 

Correspondence to: Department of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, the First Affiliated Hospital of Zhengzhou University, #1 Jianshe East Road, Zhengzhou 450052, China.Department of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, the First Affiliated Hospital of Zhengzhou University#1 Jianshe East RoadZhengzhou450052China⁎⁎Correspondence to: State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, Zhengzhou University, #100 Kexue Road, Zhengzhou 450001, China.State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, Zhengzhou University#100 Kexue RoadZhengzhou450001China

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Summary

Objectives

Azvudine has been designated as a priority treatment for patients infected with SARS-CoV-2, however, clinical evidence in hospitalized cases remains insufficient.

Methods

We performed a multi-center, retrospective cohort study to evaluate the effectiveness and safety of azvudine in hospitalized patients with SARS-CoV-2 in China (NCT06349655). Kaplan-Meier method, Cox regression model, subgroup analysis, and seven sensitive analyses were employed.

Results

A total of 32864 hospitalized patients with SARS-CoV-2 were enrolled, in which 5735 azvudine recipients and 5735 controls were selected using 1:1 propensity score matching. Based on Kaplan-Meier analysis, azvudine significantly reduced rates of all-cause death (P < 0.0001) and composite disease progression (P = 0.00019). Cox regression analysis demonstrated that hazard ratios of all-cause death and composite disease progression were 0.68 (95%CI: 0.598–0.775, P < 0.001) and 0.88 (95% CI: 0.795–0.976, P = 0.016), respectively. Subgroup analysis showed preference of azvudine for patients receiving antibiotics in reducing all-cause death and composite disease progression. Seven sensitivity analyses verified the robustness of our results. Safety analysis on adverse events showed no significant difference between both groups.

Conclusions

This study suggested that azvudine may reduce all-cause death and composite disease progression in hospitalized patients with SARS-CoV-2 infection without serious adverse events. However, the findings are susceptible to some potential biases, and further studies still need to identify the efficacy of azvudine.

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Highlights

Azvudine recipients may potentially experience a reduced mortality and composite disease progression.
Azvudine exhibited acceptable safety in patients with SARS-CoV-2 infection.
Azvudine may be a promising antiviral agent for treating COVID-19.

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Keywords : SARS-CoV-2, Azvudine, Real-world, All-cause death, Composite disease progression


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Vol 89 - N° 6

Article 106355- décembre 2024 Retour au numéro
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