Effect of Azovudine on Hepatic and Renal Function in Patients with COVID-19：a Case Series Study

ABSTRACT

Background Azovudine is a widely used antiviral drug for COVID-19 in China，but published trials on its effect on hepaticand renal function are extremely scarce. Objective To explore the changes of in hepatic and renal function in patients with COVID-19 infection after using Azovudine，so as to provide a reference for thesafe use of Azovudine in patients with renal insufficiency. Methods Inpatients ina tertiary general hospitalwho used Azovudine for COVID-19 from December 26，2022 to December 31，2022 were consecutively included in the retrospective study and divided into the normal group，mild injury group，moderate injury group，severe injury group，and end-stage groupaccording to estimated glomerularrate（eGFR）levels. The changes of biochemical parametersof liver and kidney including alanine aminotransferase（ALT），aspartate aminotransferase（AST），alkaline phosphatase （ALP），albumin（ALB），total bilirubin（TB），serum creatinine （Scr），eGFR were observed in each group；the formula D_FR=D_NL×［1-F_k （1-K_f）］ was used to correct the maintenance dose of Azivudine in patients with eGFR<60 mL·min-1·（1.73 m2）-1. The patients were divided into the corrected group and uncorrected group according to whether they were administered according to this formula，the biochemical parameters of liver and kidney were compared between the two groups. Results Among 322 patients who used Azovudine，190 patients met the inclusion and exclusion criteria. After grouping by the level of eGFR，there were statistically significant differences in the distribution of age，COVID-19 severity，peak procalcitonin（PCT）values，antihypertensive drugs，loop diuretics and Azovudine maintenance dose in each group（P<0.05）；there were 73 cases（38.4%） with elevated ALT level after Azovudine treatment，and 68 cases（93.2%） with elevated ALT level within one time of the upper normal limit；eGFR decreased in 58 cases（30.5%），of which 7 cases（12.1%） dropped to the next renal function grade；regardless of the grade of renal injury，there were no deterioration in eGFR，ALT，AST，TB，ALP and albumin after the use of conventional dose or corrected dose of Azivudine（P>0.05）；because the patients with moderate and severe renal injury were dose-corrected with Azivudine，the safety of this population was not compared if the dose was not corrected. Conclusion The use of Azivudine is prone to cause the elevation of ALT level and the decrease of eGFR，but the injury with clinical significance is 2.6% and 3.7%，respectively；there was no aggravation of liver and kidney injury in patients with moderate and severe kidney injury after using the corrected dose of Azivudine，however，this conclusion needs to be confirmed in a multicenter randomized controlled study with a large sample. © 2023 Chinese General Practice. All rights reserved.