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

Sun, Yuming; Jin, Liping; Dian, Yating; Shen, Min; Zeng, Furong; Chen, Xiang; Deng, Guangtong

doi:10.1016/j.eclinm.2023.101981

Cited by 29 publications

(31 citation statements)

References 20 publications

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“…15,16 In this study, the relative effects of starting the drug after 5-day onset were comparable with the recommended patients, suggesting antiviral therapy may also help in latent cases. 15,16 These findings expanded the potential use of nirmatrelvir-ritonavir in wider patients, but the limited sample size prevented precision estimates of drug effects. Since the end of PHEIC put COVID-19 care in routine practice, 3 these potential extended uses of oral antivirals call for validation in larger trials that can benefit more people facing the issue.…”

Section: Safety Outcomessupporting

confidence: 58%

“…32 However, individuals with socioeconomic disadvantages may encounter difficulties in accessing timely COVID-19 healthcare services in the first few days of onset. 3,15,16 During the first COVID-19 wave in China in December 2022, fewer than half of patients were admitted to hospitals with accessible antiviral drugs within 5 days from symptom onset. 15,16 In this study, the relative effects of starting the drug after 5-day onset were comparable with the recommended patients, suggesting antiviral therapy may also help in latent cases.…”

Section: Safety Outcomesmentioning

confidence: 99%

“…3,15,16 During the first COVID-19 wave in China in December 2022, fewer than half of patients were admitted to hospitals with accessible antiviral drugs within 5 days from symptom onset. 15,16 In this study, the relative effects of starting the drug after 5-day onset were comparable with the recommended patients, suggesting antiviral therapy may also help in latent cases. 15,16 These findings expanded the potential use of nirmatrelvir-ritonavir in wider patients, but the limited sample size prevented precision estimates of drug effects.…”

Section: Safety Outcomesmentioning

confidence: 99%

“…10,11 However, its effectiveness has only been reported in two clinical trials and one single-arm study [10][11][12] with small sample size and the interim analysis of an unpublished phase III study, 13,14 with sparse observational studies confirming these results. 15,16 In regions with limited healthcare resources, patients may be unable to access antiviral agents within 5 days of onset and hospitals are admitting more severe patients. In December 2022, only 9.4%-18.2% of patients with COVID-19 who were admitted to hospitals were accessible antiviral drugs within 5 days after onset in China.…”

Section: Introductionmentioning

confidence: 99%

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Azvudine and nirmatrelvir–ritonavir in hospitalized patients with moderate‐to‐severe COVID‐19: Emulation of a randomized target trial

Zhou,

Liu,

Jiang

et al. 2023

Journal of Medical Virology

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To examine the effectiveness of azvudine and nirmatrelvir–ritonavir in treating hospitalized patients with moderate‐to‐severe COVID‐19. We emulated a target trial with a multicenter retrospective cohort of hospitalized adults with moderate‐to‐severe COVID‐19 without contraindications for azvudine or nirmatrelvir–ritonavir between December 01, 2022 and January 19, 2023 (during the Omicron BA.5.2 variant wave). Exposures included treatment with azvudine or nirmatrelvir–ritonavir for 5 days versus no antiviral treatment during hospitalization. Primary composite outcome (all‐cause death and initiation of invasive mechanical ventilation), and their separate events were evaluated. Of the 1154 patients, 27.2% were severe cases. In the intent‐to‐treat analyses, azvudine reduced all‐cause death (Hazard ratio [HR]: 0.31; 95% CI: 0.12–0.78), and its composite with invasive mechanical ventilation (HR: 0.47; 95% CI: 0.24–0.92). Nirmatrelvir–ritonavir reduced invasive mechanical ventilation (HR: 0.42; 95% CI: 0.17–1.05), and its composite with all‐cause death (HR: 0.38; 95% CI: 0.18–0.81). The study did not identify credible subgroup effects. The per–protocol analyses and all sensitivity analyses confirmed the robustness of the findings. Both azvudine and nirmatrelvir–ritonavir improved the prognosis of hospitalized adults with moderate‐to‐severe COVID‐19

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Section: Safety Outcomessupporting

confidence: 58%

Section: Safety Outcomesmentioning

confidence: 99%

Section: Safety Outcomesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Azvudine and nirmatrelvir–ritonavir in hospitalized patients with moderate‐to‐severe COVID‐19: Emulation of a randomized target trial

Zhou,

Liu,

Jiang

et al. 2023

Journal of Medical Virology

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“…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].…”

Section: Discussionmentioning

confidence: 99%

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

Han

Xiao

Wang

et al. 2023

Preprint

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Background: Clinical effectiveness of Azvudine against coronavirus infection and optimal time for initiation of Azvudine treatment to hospitalized COVID-19 patients are not fully understood. Methods: This is a multi-center retrospective cohort study, and five clinical centers of the Chinese People’s Liberation Army General Hospital participated. From omicron pandemics, 6218 hospitalized patients confirmed with COVID-19 from December 10, 2022, to February 20, 2023, were retrieved for this study. After exclusions and propensity score matching , 428 Azvudine recipients and 428 controls were included with a follow-up of 28 days. The primary outcome was all-cause mortality during 28 days of hospitalization, and the secondary outcome was the proportion of patients with clinical improvement up to day 28. Results: The Azvudine group had a lower crude all-cause death rate when compared to the control group (2.82 per 1000 person-days vs. 4.52 per 1000 person-days; HR: 0.63, 95%CI: 0.40-1.00; P=0.038). Notably, the incidence rate of clinical improvement outcome was significantly higher in patients who received Azvudine within 5 days from the onset of symptoms, compared to the control group (Median days: 9 vs. 10; P=0.007). Subgroup analyses showed that chronic lung disease and corticosteroid treatment acted as protective factors (P=0.010; P=0.050). Conclusions: Clinical effectiveness of Azvudine in improving all-cause mortality in COVID-19 patients was seen, and initiation of Azvudine treatment within 5 days of the onset of symptoms was found to be significant. Additionally, the findings revealed the protective effect of Azvudine in COVID-19 patients with chronic lung disease.

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Azvudine for the Treatment of COVID‐19 in Pre‐Existing Cardiovascular Diseases: A Single‐Center, Real‐World Experience

Wu,

He,

Huang

et al. 2024

Advanced Science

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COVID‐19 can lead to adverse outcomes in patients with pre‐existing diseases. Azvudine has been approved for treating COVID‐19 in China, but the real‐world data is limited. It is aimed to investigate the efficacy of Azvudine in patients with COVID‐19 and pre‐existing cardiovascular diseases. Patients with confirmed COVID‐19 and pre‐existing cardiovascular diseases are retrospectively enrolled. The primary outcome is all‐cause death during hospitalization. Overall, 351 patients are included, with a median age of 74 years, and 44% are female. 212 (60.6%) patients are severe cases. Azvudine is used in 106 (30.2%) patients and not in 245 (69.8%). 72 patients died during hospitalization. After multivariate adjustment, patients who received Azvudine a lower risk of all‐cause death (hazard ratio: 0.431; 95% confidence interval: 0.252–0.738; p = 0.002) than controls. Azvudine therapy is also associated with lower risks of shock and acute kidney injury. For sensitivity analysis in the propensity score‐matched cohort (n = 90 for each group), there is also a significant difference in all‐cause death between the two groups (hazard ratio: 0.189; 95% confidence interval: 0.071–0.498; p < 0.001). This study indicated that Azvudine therapy is associated with better outcomes in COVID‐19 patients with pre‐existing cardiovascular diseases.

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

Cited by 29 publications

References 20 publications

Azvudine and nirmatrelvir–ritonavir in hospitalized patients with moderate‐to‐severe COVID‐19: Emulation of a randomized target trial

Azvudine and nirmatrelvir–ritonavir in hospitalized patients with moderate‐to‐severe COVID‐19: Emulation of a randomized target trial

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

Azvudine for the Treatment of COVID‐19 in Pre‐Existing Cardiovascular Diseases: A Single‐Center, Real‐World Experience

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