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
Bo Yu, Haiyu Wang, Guangming Li, Junyi Sun, Hong Luo, Mengzhao Yang, Yanyang Zhang, Ruihan Liu, Ming Cheng, Shixi Zhang, Guotao Li, Ling Wang, Guowu Qian, Donghua Zhang, Silin Li, Quancheng Kan, Jiandong Jiang, Zhigang Ren
Acta Pharmaceutica Sinica B, doi:10.1016/j.apsb.2024.12.032
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 J o u r n a l P r e -p r o o f 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.
Author contributions Bo Yu, Haiyu Wang, Guangming Li, Junyi Sun, and Hong Luo contributed equally to this work. Quancheng Kan, Jiandong Jiang and Zhigang Ren conceived and designed the study; Zhigang Ren, Guangming Li, Guotao Li, Shixi Zhang, Ling Wang, Hong Luo, Donghua Zhang, Silin Li and Guowu Qian managed the patients; Haiyu Wang, Mengzhao Yang, Ming Cheng, Ling Wang, Junyi Sun, Yanyang Zhang and Ruihan Liu collected the data; Bo Yu, Junyi Sun, Mengzhao Yang, and Haiyu Wang analyzed the data; Bo Yu and Haiyu Wang wrote the manuscript; All authors reviewed and approved the manuscript.
Conflicts of interests The authors declare no conflict of interest.
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