A retrospective cohort study of the efficacy and safety of oral azvudine versus nirmatrelvir/ritonavir in elderly hospitalized COVID-19 patients aged over 60 years.
10.1016/j.apsb.2024.12.032
- Author:
Bo YU
1
;
Haiyu WANG
2
;
Guangming LI
3
;
Junyi SUN
2
;
Hong LUO
4
;
Mengzhao YANG
2
;
Yanyang ZHANG
5
;
Ruihan LIU
6
;
Ming CHENG
7
;
Shixi ZHANG
8
;
Guotao LI
9
;
Ling WANG
10
;
Guowu QIAN
11
;
Donghua ZHANG
12
;
Silin LI
13
;
Quancheng KAN
14
;
Jiandong JIANG
15
;
Zhigang REN
2
Author Information
1. Department of Pharmacy, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.
2. Department of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.
3. Department of Liver Disease, the Affiliated Infectious Disease Hospital of Zhengzhou University, Zhengzhou 450052, China.
4. Guangshan County People's Hospital, Guangshan County, Xinyang 465450, China.
5. Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.
6. Xiangya Medical College, Central South University, Changsha 410028, China.
7. Department of Medical Information, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.
8. Department of Infectious Diseases, Shangqiu Municipal Hospital, Shangqiu 476000, China.
9. Department of Infectious Diseases, Luoyang Central Hospital Affiliated of Zhengzhou University, Luoyang 471000, China.
10. Department of Clinical Laboratory, Henan Provincial Chest Hospital Affiliated of Zhengzhou University, Zhengzhou 450008, China.
11. Department of Gastrointestinal Surgery, Nanyang Central Hospital, Nanyang 473009, China.
12. Department of Infectious Diseases, Anyang City Fifth People's Hospital, Anyang 455000, China.
13. Department of Respiratory and Critical Care Medicine, Fengqiu County People's Hospital, Xinxiang 453300, China.
14. Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou University, Zhengzhou 450052, China.
15. State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China.
- Publication Type:Journal Article
- Keywords:
Azvudine;
COVID-19;
Comparative study;
Effectiveness;
Elderly;
Paxlovid;
Real-world;
Safety
- From:
Acta Pharmaceutica Sinica B
2025;15(3):1333-1343
- CountryChina
- Language:English
-
Abstract:
Azvudine and nirmatrelvir/ritonavir (Paxlovid) are recommended for COVID-19 treatment in China, but their safety and efficacy in the elderly population are not fully known. In this multicenter, retrospective, cohort study, we identified 5131 elderly hospitalized COVID-19 patients from 32,864 COVID-19 patients admitted to nine hospitals in Henan Province, China, from December 5, 2022, to January 31, 2023. The primary outcome was all-cause death, and the secondary outcome was composite disease progression. Propensity score matching (PSM) was performed to control for confounding factors, including demographics, vaccination status, comorbidities, and laboratory tests. After 2:1 PSM, 1786 elderly patients receiving azvudine and 893 elderly patients receiving Paxlovid were included. Kaplan-Meier and Cox regression analyses revealed that compared with Paxlovid group, azvudine could significantly reduce the risk of all-cause death (log-rank P = 0.002; HR: 0.71, 95% CI: 0.573-0.883, P = 0.002), but there was no difference in composite disease progression (log-rank P = 0.52; HR: 1.05, 95% CI: 0.877-1.260, P = 0.588). Four sensitivity analyses verified the robustness of above results. Subgroup analysis suggested that a greater benefit of azvudine over Paxlovid was observed in elderly patients with primary malignant tumors (P for interaction = 0.005, HR: 0.32, 95% CI: 0.18-0.57) compared to patients without primary malignant tumors. Safety analysis revealed that azvudine treatment had a lower incidence of adverse events and higher lymphocyte levels than Paxlovid treatment. In conclusion, azvudine treatment is not inferior to Paxlovid treatment in terms of all-cause death, composite disease progression and adverse events in elderly hospitalized COVID-19 patients.
