Real-world efficacy and safety of azvudine in hospitalized older patients with COVID-19 during the omicron wave in China: A retrospective cohort study.

Yuanchao ZHU; Fei ZHAO; Yubing ZHU; Xingang LI; Deshi DONG; Bolin ZHU; Jianchun LI; Xin HU; Zinan ZHAO; Wenfeng XU; Yang JV; Dandan WANG; Yingming ZHENG; Yiwen DONG; Lu LI; Shilei YANG; Zhiyuan TENG; Ling LU; Jingwei ZHU; Linzhe DU; Yunxin LIU; Lechuan JIA; Qiujv ZHANG; Hui MA; Ana ZHAO; Hongliu JIANG; Xin XU; Jinli WANG; Xuping QIAN; Wei ZHANG; Tingting ZHENG; Chunxia YANG; Xuguang CHEN; Kun LIU; Huanhuan JIANG; Dongxiang QU; Jia SONG; Hua CHENG; Wenfang SUN; Hanqiu ZHAN; Xiao LI; Yafeng WANG; Aixia WANG; Li LIU; Lihua YANG; Nan ZHANG; Shumin CHEN; Jingjing MA; Wei LIU; Xiaoxiang DU; Meiqin ZHENG; Liyan WAN; Guangqing DU; Hangmei LIU; Pengfei JIN

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Real-world efficacy and safety of azvudine in hospitalized older patients with COVID-19 during the omicron wave in China: A retrospective cohort study.

Author: Yuanchao ZHU ¹ ; Fei ZHAO ¹ ; Yubing ZHU ² ; Xingang LI ³ ; Deshi DONG ⁴ ; Bolin ZHU ¹ ; Jianchun LI ¹ ; Xin HU ¹ ; Zinan ZHAO ¹ ; Wenfeng XU ¹ ; Yang JV ⁵ ; Dandan WANG ⁵ ; Yingming ZHENG ³ ; Yiwen DONG ³ ; Lu LI ⁴ ; Shilei YANG ⁴ ; Zhiyuan TENG ⁶ ; Ling LU ⁶ ; Jingwei ZHU ⁶ ; Linzhe DU ² ; Yunxin LIU ² ; Lechuan JIA ⁷ ; Qiujv ZHANG ⁷ ; Hui MA ⁷ ; Ana ZHAO ⁸ ; Hongliu JIANG ⁸ ; Xin XU ⁹ ; Jinli WANG ⁹ ; Xuping QIAN ⁹ ; Wei ZHANG ¹⁰ ; Tingting ZHENG ¹⁰ ; Chunxia YANG ¹¹ ; Xuguang CHEN ¹¹ ; Kun LIU ¹² ; Huanhuan JIANG ¹² ; Dongxiang QU ¹³ ; Jia SONG ¹³ ; Hua CHENG ¹⁴ ; Wenfang SUN ¹⁴ ; Hanqiu ZHAN ¹⁵ ; Xiao LI ¹⁵ ; Yafeng WANG ¹⁶ ; Aixia WANG ¹⁶ ; Li LIU ¹⁷ ; Lihua YANG ¹⁷ ; Nan ZHANG ¹⁸ ; Shumin CHEN ¹⁹ ; Jingjing MA ²⁰ ; Wei LIU ²¹ ; Xiaoxiang DU ²² ; Meiqin ZHENG ²³ ; Liyan WAN ²⁴ ; Guangqing DU ²⁵ ; Hangmei LIU ²⁶ ; Pengfei JIN ¹
Author Information

1. Department of Pharmacy, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application (Beijing Hospital), Beijing 100730, China.
2. Department of Pharmacy, Nanjing First Hospital, Nanjing Medical University, Nanjing 210006, China.
3. Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.
4. Department of Pharmacy, First Affiliated Hospital of Dalian Medical University, Dalian 116011, China.
5. Department of Respiratory and Critical Care Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China.
6. Department of Pharmacy, the Second People's Hospital of Guiyang (Jinyang Hospital)/the Affiliated Jinyang Hospital of Guizhou Medical University, Guiyang 550023, China.
7. Department of Pharmacy, General Hospital of Ningxia Medical University, Yinchuan 750004, China.
8. Department of Pharmacy, Changchun Central Hospital, Changchun 130051, China.
9. Department of Pharmacy, Affiliated Hospital of Nantong University, Nantong 226001, China.
10. Department of Pharmacy, Beijing Jishuitan Hospital, Capital Medical University, Beijing 100035, China.
11. Department of Pharmacy, Beijing Shunyi Hospital, Beijing 101300, China.
12. Department of Pharmacy, North China University of Science and Technology Affiliated Hospital, Tangshan 063000, China.
13. Department of Pharmacy, the First Hospital of Qiqihar, Qiqihar 161005, China.
14. Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, Beijing 101100, China.
15. Department of Pharmacy, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
16. Department of Pharmacy, Qinghai Provincial People's Hospital, Xining 810007, China.
17. Department of Pharmacy, the Fifth People's Hospital of Ningxia, Shizuishan 753000, China.
18. Department of Pharmacy, Beijing Chuiyangliu Hospital, Beijing 100022, China.
19. Department of Pharmacy, Fuxing Hospital, Capital Medical University, Beijing 100038, China.
20. Department of Pharmacy, the Fourth Affiliated Hospital of Soochow University, Suzhou Dushu Lake Hospital, Medical Center of Soochow University, Suzhou 215000, China.
21. Department of Pharmacy, Beijing YouAn Hospital, Capital Medical University, Beijing 100069, China.
22. Department of Pharmacy, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China.
23. Department of Pharmacy, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China.
24. Department of Pharmacy, the First Hospital of Tsinghua University, Beijing 100016, China.
25. Department of Pharmacy, Beijing Rehabilitation Hospital Affiliated to Capital Medical University, Beijing 100144, China.
26. Department of Pharmacy, Emergency General Hospital, Beijing 100028, China.
Publication Type:Journal Article
Keywords: Azvudine; COVID-19; Efficacy; Older; Omicron; SARS-CoV-2; Safety
From: Acta Pharmaceutica Sinica B 2025;15(1):123-132
CountryChina
Language:English
Abstract: Debates persist regarding the efficacy and safety of azvudine, particularly its real-world outcomes. This study involved patients aged ≥60 years who were admitted to 25 hospitals in mainland China with confirmed SARS-CoV-2 infection between December 1, 2022, and February 28, 2023. Efficacy outcomes were all-cause mortality during hospitalization, the proportion of patients discharged with recovery, time to nucleic acid-negative conversion (T _NANC), time to symptom improvement (T _SI), and time of hospital stay (T _HS). Safety was also assessed. Among the 5884 participants identified, 1999 received azvudine, and 1999 matched controls were included after exclusion and propensity score matching. Azvudine recipients exhibited lower all-cause mortality compared with controls in the overall population (13.3% vs. 17.1%, RR, 0.78; 95% CI, 0.67-0.90; P = 0.001) and in the severe subgroup (25.7% vs. 33.7%; RR, 0.76; 95% CI, 0.66-0.88; P < 0.001). A higher proportion of patients discharged with recovery, and a shorter T _NANC were associated with azvudine recipients, especially in the severe subgroup. The incidence of adverse events in azvudine recipients was comparable to that in the control group (2.3% vs. 1.7%, P = 0.170). In conclusion, azvudine showed efficacy and safety in older patients hospitalized with COVID-19 during the SARS-CoV-2 omicron wave in China.