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.

Oral Azvudine for hospitalised patients with COVID-19 and pre-existing conditions: a retrospective cohort study

“…These results were consistent with the interim analysis of an unpublished phase 3 multi-centre randomised clinical study 6 and our previous real-world study. 15 Interestingly, we found that Azvudine had a stronger protective effect on severe patients with COVID-19 who were not recommended for the use of Paxlovid and molnupiravir. 20 , 21 A previous single arm clinical trial reported that all patients with severe COVID-19 were recovered after oral Azvudine.…”

“… 6 Our previous study also showed that Azvudine helped to improve the prognosis in general patients with COVID-19. 15 However, whether Azvudine reduces the adverse clinical outcomes in hospitalised patients with COVID-19 with pre-existing comorbidities remains unknown.…”

Real‐world effectiveness of Azvudine versus nirmatrelvir–ritonavir in hospitalized patients with COVID‐19: A retrospective cohort study

“…[2][3][4] Nevertheless, the real-world effectiveness of Azvudine versus nirmatrelvir-ritonavir is still lacking, despite clinical studies showing their effectiveness compared with matched controls. [9][10][11]13,14 In this retrospective cohort study, a total of 2118 hospitalized patients with COVID-19 were identified during the study period.…”

“…Current guidelines prioritize the use of nirmatrelvir–ritonavir and Azvudine in COVID‐19 patients 2–4 . Nevertheless, the real‐world effectiveness of Azvudine versus nirmatrelvir–ritonavir is still lacking, despite clinical studies showing their effectiveness compared with matched controls 9–11,13,14 …”

“…Though the results of the phase III study have not been launched officially, the interim analysis showed a faster time of symptom improvement and a higher proportion of COVID‐19 patients with improved clinical symptoms, compared with matched controls 13 . More importantly, a real‐world study by Shen et al suggested that Azvudine treatment is associated with significantly lower risks of composite disease progression outcome and all‐cause death 14 . These results supported the use of Azvudine in COVID‐19 patients.…”