Real-world data of Azvudine-induced hepatotoxicity among hospitalized COVID-19 patients in China: a retrospective case-control study.

Background: The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has led to global health crisis. Although several antiviral drugs have been used to mitigate the severity and mortality of COVID-19, the safety profile remained a critical concern. Azvudine, a new nucleoside analog, has been approved for emergency use in China for COVID-19. However, the incidence and risk factors associated with Azvudine-induced hepatotoxicity in hospitalized patients remained unclear. Objects: To assess the prevalence, risk factors, clinical patterns, and outcomes of Azvudine-induced hepatotoxicity by real-world data. Methods: We conducted a single-center retrospective case-control study at Renmin Hospital of Wuhan University, including patients administered Azvudine for COVID-19 treatment between December 2022 and May 2023. Univariate and multivariate logistic regression analyses were preformed to assess risk factors for Azvudine-associated or -induced hepatotoxicity. Receiver operating characteristic (ROC) curve analysis was performed to calculate the area under the ROC curve (AUC). Results: In total, 669 patients were included in the Azvudine-associated hepatotoxicity research. 47.1% patients exhibited hepatotoxicity, abnormal liver function on admission [OR: 5.55 (3.94-7.90), Conclusion: Our study provided evidence of the significant association between Azvudine and hepatotoxicity in hospitalized COVID-19 patients. These findings underscored the importance of monitoring liver function during Azvudine treatment and caution against concomitant use of certain medications. Further research was warranted to elucidate the mechanisms underlying Azvudine-induced hepatotoxicity and optimize clinical management strategies.