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·A Retrospective Cohort Study of the Efficacy and Safety of Oral Azvudine Versus Paxlovid in Elderly Hospitalized COVID-19 Patients Aged Over 60 Years
34 Pages Posted: 17 May 2024
More...Abstract
Background: COVID-19 has caused a great test to people's life safety, especially for the elderly group over 60 years old. Azvudine and Paxlovid were widely used as anti-COVID-19 drugs in clinical treatment during first Omicron wave in China. Herein, we aimed to compare the efficacy and safety of the two drugs in the elderly population.
Methods: In this retrospective study conducted at nine hospitals in Henan Province, China, a total of 5131 hospitalized COVID-19 patients were included from December 5, 2022, to January 31, 2023. The main focus was on all-cause mortality and composite disease progression. Comparative evaluations were carried out between the Paxlovid and Azvudine groups using Kaplan–Meier and Cox regression methods. To ensure the reliability of the results, subgroup and sensitivity analyses were employed.
Results: Following exclusions and propensity score matching, 1769 patients treated with Azvudine and 892 patients treated with Paxlovid were selected. The Cox regression analysis revealed Paxlovid group had a higher risk of all-cause death (HR: 1.33, 95% CI: 1.066-1.663, p=0.01) versus Azvudine group, but no difference in composite disease progression (HR: 0.9, 95% CI: 0.752-1.082, p=0.26). Notably, compared to patients without primary malignant tumors, Paxlovid groups exhibited a higher risk of all-cause death (HR: 2.69, 95% CI: 1.39−5.21, p=0.037) in patients with primary malignant tumors. The robustness of these findings was confirmed through three sensitivity analyses.
Interpretation: The results suggest that among elderly COVID-19 hospitalized patients treated with Azvudine have lower risk of all-cause death versus Paxlovid treatment and fewer adverse effects.
Trial Registration: This study also has completed registration on ClinicalTrials under clinical
trial registration number NCT06349655.
Funding: This work was supported by the National Key Research and Development Program of China (2022YFC2303100 to Z.R.). Henan Province Epidemic Prevention and Control Emergency Scientific Research Project (221111311700 to Z.R.), Central Plains Talent Program-Central Plains Youth Top Talents to Z.R., Young and Middleaged Academic Leaders of Henan Provincial Health Commission (HNSWJW-2022013 to Z.R.), the Scientific Research and Innovation Team of The First Affiliated Hospital of Zhengzhou University (QNCXTD2023002 to Z.R.).
Declaration of Interest: The authors declare no conflict of interest
Ethical Approval: This study was endorsed by the research ethics committee at the First Affiliated
Hospital of Zhengzhou University and authorized under approval number 2023-KY0865-001.
Keywords: COVID-19, Azvudine, Paxlovid, Elderly, comparative study, Real-world, Effectiveness, Safety
Suggested Citation: Suggested Citation