Real-world effectiveness of Azvudine in hospitalized patients with COVID-19: a retrospective cohort study

Abstract

Current guidelines prioritize the use of the Azvudine in coronavirus disease 2019 (COVID-19) patients. However, the clinical effectiveness of Azvudine in real-world studies was lacking, despite the clinical trials showed shorter time of nucleic acid negative conversion. To evaluate the clinical effectiveness following Azvudine treatment in hospitalized COVID-19 patients, we identified 1505 hospitalized COVID-19 patients during the study period, with a follow-up of up to 29 days. After exclusions and propensity score matching, we included 226 Azvudine recipients and 226 matched controls. The lower crude incidence rate of composite disease progression outcome (4.21 vs. 10.39 per 1000 person-days, P=0.041) and all-cause mortality (1.57 vs. 6.00 per 1000 person-days, P=0.027) were observed among Azvudine recipients compared with matched controls. The incidence rates of initiation of invasive mechanical ventilation were also statistically different between the groups according to the log-rank tests (P=0.020). Azvudine treatment was associated with significantly lower risks of composite disease progression outcome (hazard ratio [HR]: 0.43; 95% confidence interval [CI]: 0.18 to 0.99) and all-cause death (HR: 0.26; 95% CI: 0.07 to 0.94) compared with matched controls. Subgroup analyses indicated robustness of the point estimates of HRs (ranged from 0.14 to 0.84). Notably, male Azvudine recipients had a stronger effectiveness than female recipients with respect to both composite outcome and all-cause death. These findings suggest that Azvudine treatment showed substantial clinical benefits in hospitalized COVID-19 patients, and should be considered for use in this population of patients.

Effectiveness and Optimal Timing of Azvudine in COVID-19 Patients: A Multi-center Retrospective Study in Beijing, China

“…In this retrospective analysis, the crude all-cause death rate was 2.82 per 1000 person-days in patients who received Azvudine vs. 4.52 per 1000 person-days in the control group, suggesting that Azvudine administration caused a lower mortality rate. Consistently, a previous single-center retrospective cohort study conducted in Xiangya Hospital founded that Azvudine treatment was associated with a reduced risk of composite disease progression and all-cause mortality in COVID-19 patients [4].…”

“…Similar conclusions were drawn in mild and severe COVID-19 cases by subsequent studies [3]. In a single-center retrospective cohort study that analyzed 2118 hospitalized patients from Xiangya Hospital in Changsha, Hunan province, Azvudine treatment resulted in a lower rate of composite disease progression of COVID-19 in patients with pre-existing conditions, but had no signi cant difference in all-cause death, compared to the control group [4]. Azvudine has been commonly recommended for COVID-19 patients in the Chinese Diagnosis and Treatment Protocol for COVID-19 (trial version 10) [5], but the time of initiating Azvudine administration has not yet been recommended [1,5].…”

“…Thus, the current subgroup analyses included diverse factors such as age, sex, previous comorbidities, concomitant treatment, and respiratory support at admission. Some previous studies showed that Azvudine provided better protection in male and elderly patients [4,9]. A previous study conducted in Shanghai found that Azvudine improved 60-day mortality among severely and critically ill patients with COVID-19 who received one or more therapeutic interventions [17].…”

“…As the rst launched Chinese oral anti-COVID-19 drug [8], Azvudine exhibited antiviral activity effectively against coronavirus in preliminary clinical trials [2,4,9,10,11]. Meanwhile, several retrospective cohort studies suggested that Azvudine showed more effectiveness in hospitalized COVID-19 patients compared with Nirmatrelvir-ritonavir and Paxlovid in terms of composite disease progression outcome [12,13].…”

“…As the rst launched Chinese oral anti-COVID-19 drug [8], Azvudine exhibited antiviral activity effectively against coronavirus in preliminary clinical trials [2,4,9,10,11]. Meanwhile, several retrospective cohort studies suggested that Azvudine showed more effectiveness in hospitalized COVID-19 patients compared with Nirmatrelvir-ritonavir and Paxlovid in terms of composite disease progression outcome [12,13]. In this retrospective analysis, the crude all-cause death rate was 2.82 per 1000 person-days in patients who received Azvudine vs. 4.52 per 1000 person-days in the control group, suggesting that Azvudine administration caused a lower mortality rate.…”