Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China
Objectives Azvudine and Paxlovid are the primary antiviral agents for the management of COVID-19. However, there is currently insufficient evidence regarding the effectiveness and safety of these drugs in treating COVID-19 patients with pre-existing hypertension. The objective of this study was to a...
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BMJ Publishing Group
2025-06-01
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| Online Access: | https://bmjopen.bmj.com/content/15/6/e090230.full |
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| author | Ling Wang Zhigang Ren Xiaoli Jin Hong Luo Donghua Zhang Ming Cheng Fuwei Wang Bohan Jia Guotao Li Mengzhao Yang Guangming Li Shixi Zhang Guowu Qian Silin Li Hongxia Liang |
| author_facet | Ling Wang Zhigang Ren Xiaoli Jin Hong Luo Donghua Zhang Ming Cheng Fuwei Wang Bohan Jia Guotao Li Mengzhao Yang Guangming Li Shixi Zhang Guowu Qian Silin Li Hongxia Liang |
| author_sort | Ling Wang |
| collection | DOAJ |
| description | Objectives Azvudine and Paxlovid are the primary antiviral agents for the management of COVID-19. However, there is currently insufficient evidence regarding the effectiveness and safety of these drugs in treating COVID-19 patients with pre-existing hypertension. The objective of this study was to assess their effectiveness and safety among those patients in a real-world context.Design Retrospective cohort study.Setting Electronic medical record data of COVID-19 patients with pre-existing hypertension were extracted from nine hospitals in Henan Province from 5 December 2022 to 31 January 2023.Participants Following 2:1 propensity score matching (PSM), 996 individuals who received treatment with azvudine and 498 individuals who received treatment with Paxlovid were included in the analysis.Primary and secondary outcome measures The primary outcome was all-cause death and the secondary outcome was the composite disease progression.Results Following adherence to the inclusion and exclusion criteria and 2:1 PSM, 996 individuals were included in the azvudine group and 498 in the Paxlovid group. The Cox regression analysis revealed that the azvudine group had a significantly lower risk of all-cause death compared with the Paxlovid group (HR 0.64, 95% CI 0.455 to 0.911, p=0.013). However, there was no statistically significant difference in composite disease progression between the two groups (HR 0.93, 95% CI 0.711 to 1.229, p=0.629). Subgroup analysis indicated that, compared with Paxlovid, patients with moderate disease receiving azvudine treatment exhibited a significantly reduced risk of composite disease progression (HR 0.46, 95% CI 0.24 to 0.89). The safety analysis showed that the azvudine group had fewer adverse events.Conclusions Among COVID-19 patients with pre-existing hypertension, the effectiveness of azvudine is not inferior to Paxlovid in reducing all-cause death and composite disease progression, with fewer adverse events.Trial registration number NCT06349655. |
| format | Article |
| id | doaj-art-06da1886691f4449bfc946ff4092f2ed |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-06da1886691f4449bfc946ff4092f2ed2025-08-20T03:24:03ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2024-090230Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, ChinaLing Wang0Zhigang Ren1Xiaoli Jin2Hong Luo3Donghua Zhang4Ming Cheng5Fuwei Wang6Bohan Jia7Guotao Li8Mengzhao Yang9Guangming Li10Shixi Zhang11Guowu Qian12Silin Li13Hongxia Liang14Department of Clinical Laboratory, Henan Provincial Chest Hospital Affiliated of Zhengzhou University, Zhengzhou, ChinaDepartment of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Infectious Diseases, Luoyang Central Hospital Affiliated of Zhengzhou University, Luoyang, ChinaGuangshan County People’s Hospital, Guangshan, ChinaDepartment of Infectious Diseases, Anyang City Fifth People’s Hospital, Anyang, ChinaDepartment of Medical Information, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Infectious Diseases, Luoyang Central Hospital Affiliated of Zhengzhou University, Luoyang, ChinaDepartment of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Liver Disease, The Affiliated Infectious Disease Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Infectious Diseases, Shangqiu Municipal Hospital, Shangqiu, ChinaDepartment of Gastrointestinal Surgery, Nanyang Central Hospital, Nanyang, ChinaDepartment of Respiratory and Critical Care Medicine, Fengqiu County People’s Hospital, Xinxiang, ChinaDepartment of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaObjectives Azvudine and Paxlovid are the primary antiviral agents for the management of COVID-19. However, there is currently insufficient evidence regarding the effectiveness and safety of these drugs in treating COVID-19 patients with pre-existing hypertension. The objective of this study was to assess their effectiveness and safety among those patients in a real-world context.Design Retrospective cohort study.Setting Electronic medical record data of COVID-19 patients with pre-existing hypertension were extracted from nine hospitals in Henan Province from 5 December 2022 to 31 January 2023.Participants Following 2:1 propensity score matching (PSM), 996 individuals who received treatment with azvudine and 498 individuals who received treatment with Paxlovid were included in the analysis.Primary and secondary outcome measures The primary outcome was all-cause death and the secondary outcome was the composite disease progression.Results Following adherence to the inclusion and exclusion criteria and 2:1 PSM, 996 individuals were included in the azvudine group and 498 in the Paxlovid group. The Cox regression analysis revealed that the azvudine group had a significantly lower risk of all-cause death compared with the Paxlovid group (HR 0.64, 95% CI 0.455 to 0.911, p=0.013). However, there was no statistically significant difference in composite disease progression between the two groups (HR 0.93, 95% CI 0.711 to 1.229, p=0.629). Subgroup analysis indicated that, compared with Paxlovid, patients with moderate disease receiving azvudine treatment exhibited a significantly reduced risk of composite disease progression (HR 0.46, 95% CI 0.24 to 0.89). The safety analysis showed that the azvudine group had fewer adverse events.Conclusions Among COVID-19 patients with pre-existing hypertension, the effectiveness of azvudine is not inferior to Paxlovid in reducing all-cause death and composite disease progression, with fewer adverse events.Trial registration number NCT06349655.https://bmjopen.bmj.com/content/15/6/e090230.full |
| spellingShingle | Ling Wang Zhigang Ren Xiaoli Jin Hong Luo Donghua Zhang Ming Cheng Fuwei Wang Bohan Jia Guotao Li Mengzhao Yang Guangming Li Shixi Zhang Guowu Qian Silin Li Hongxia Liang Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China BMJ Open |
| title | Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China |
| title_full | Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China |
| title_fullStr | Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China |
| title_full_unstemmed | Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China |
| title_short | Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China |
| title_sort | real world effectiveness and safety of oral azvudine versus paxlovid in patients with covid 19 and pre existing hypertension a multicentre retrospective cohort study in henan province china |
| url | https://bmjopen.bmj.com/content/15/6/e090230.full |
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