Safety profile of azvudine in COVID-19 patients with renal impairment: a retrospective analysis

This is the authors' abstract. We don't add key points for this paper.

Objective: Azvudine (FNC), an antiviral drug approved in China for the treatment of Coronavirus disease 2019 (COVID-19) infection, has not yet established a well-defined safety profile in patients with renal impairment. This study aimed to evaluate the safety of using FNC in patients with renal impairment. Methods: . Our main objective was to assess whether there were any differences in the incidence of ADEs between the two groups. Secondly, we attempted to develop predictive models for ADEs that were frequent and closely related to the eGFR grade. Results: Over half of the cohort (51.8%) experienced FNC-associated ADEs, predominantly hepatic function abnormalities (36.6%) and renal function abnormalities (18.9%). The incidence of acute kidney injury (AKI) was 8.8%. Patients with renal impairment exhibited a higher risk of ADEs, particularly among elderly individuals and patients with a high neutrophil count. No differences in hepatic function abnormalities were found between the two groups. Patients with renal impairment had a higher risk of renal function abnormalities and AKI, with decreased eGFR identified as an independent risk factor for these ADEs. The predictors included in the nomogram model for AKI were neutrophil count and eGFR grade. The nomogram model demonstrated predictive performance and calibration, with an area under the curve of 0.812. Conclusion: These findings highlight the need for enhanced safety monitoring and potential dose adjustments when administering FNC to COVID-19 patients with renal impairment.