Head-to-head comparison of azvudine and nirmatrelvir/ritonavir for the hospitalized patients with COVID-19: a real-world retrospective cohort study with propensity score matching
An-Hua Wei, Lu Zeng, Lu Wang, Lin Gui, Wen-Ting Zhang, Xue-Peng Gong, Juan Li, Dong Liu
Frontiers in Pharmacology, doi:10.3389/fphar.2023.1274294
Background: Nirmatrelvir/ritonavir and azvudine have been approved for the early treatment of COVID-19 in China, however, limited real-world data exists regarding their effectiveness and safety.
Methods: We conducted a retrospective cohort study involving the hospitalized COVID-19 patients in China between December 2022 and January 2023. Demographic, clinical, and safety variables were recorded. Results: Among the 6,616 hospitalized COVID-19 patients, we included a total of 725 patients including azvudine recipients (N = 461) and nirmatrelvir/ritonavir (N = 264) recipients after exclusions and propensity score matching (1:2). There was no significant difference in the composite disease progression events between azvudine (98, 21.26%) and nirmatrelvir/ritonavir (72, 27.27%) groups (p = 0.066). Azvudine was associated with a significant reduction in secondary outcomes, including the percentage of intensive care unit admission (p = 0.038) and the need for invasive mechanical ventilation (p = 0.035), while the in-hospital death event did not significantly differ (p = 0.991). As for safety outcomes, 33 out of 461 patients (7.16%) in azvudine group and 22 out of 264 patients (8.33%) in nirmatrelvir/ritonavir group experienced drug-related adverse events between the day of admission (p = 0.565).
Conclusion: In our real-world setting, azvudine treatment demonstrated similar safety compared to nirmatrelvir/ritonavir in hospitalized COVID-19 patients. Additionally, it showed slightly better clinical benefits in this population. However, further confirmation through additional clinical trials is necessary.
Ethics statement The studies involving humans were approved by the institutional review board of Tongji hospital (TJ-IRB20230202). The studies were conducted in accordance with the local legislation and institutional requirements. The ethics committee/institutional review board waived the requirement of written informed consent for participation from the participants or the participants' legal guardians/next of kin because Surveys and observational study.
Author contributions A-HW: Conceptualization, Data curation, Formal Analysis, Investigation, Methodology, Writing-original draft, Writing-review and editing. LZ: Data curation, Formal Analysis, Methodology, Writing-review and editing. LW: Formal Analysis, Methodology, Writing-original draft. LG: Investigation, Writing-review and editing. W-TZ: Investigation, Project administration, Writing-review and editing. X-PG: Project administration, Writing-review and editing. JL: Supervision, Writing-review and editing. DL: Supervision, Writing-review and editing.
Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their
Supplementary material The Supplementary Material for this article can be found online at:..
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