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BMJ Open
. 2025 Jun 27;15(6):e090230.
doi: 10.1136/bmjopen-2024-090230. 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
Fuwei Wang # 1 , Bohan Jia # 1 , Guotao Li 2 , Xiaoli Jin 2 , Mengzhao Yang 1 , Guangming Li 3 , Shixi Zhang 4 , Guowu Qian 5 , Hong Luo 6 , Ming Cheng 7 , Ling Wang 8 , Donghua Zhang 9 , Silin Li 10 , Hongxia Liang 1 , Zhigang Ren 11
Affiliations
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.
Keywords: COVID-19; Hypertension; Public health.
. 2025 Jun 27;15(6):e090230.
doi: 10.1136/bmjopen-2024-090230. 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
Fuwei Wang # 1 , Bohan Jia # 1 , Guotao Li 2 , Xiaoli Jin 2 , Mengzhao Yang 1 , Guangming Li 3 , Shixi Zhang 4 , Guowu Qian 5 , Hong Luo 6 , Ming Cheng 7 , Ling Wang 8 , Donghua Zhang 9 , Silin Li 10 , Hongxia Liang 1 , Zhigang Ren 11
Affiliations
- PMID: 40578868
- DOI: 10.1136/bmjopen-2024-090230
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.
Keywords: COVID-19; Hypertension; Public health.