Background <p>Cancer patients are at an elevated risk for SARS-CoV-2 infection and require vigilant monitoring. The efficacy and safety of Azvudine in treating COVID-19 among this vulnerable group remain under-researched.</p> Methods <p>We conducted a multicenter, retrospective cohort study of nine hospitals involving cancer patients with COVID-19 hospitalized from December 2022 to January 2023. To minimize immortal time bias, patients who died or were discharged within 24&#xa0;h of drug administration were excluded. A 2:1 propensity score matching (PSM) was performed to balance baseline characteristics, explicitly adjusting for tumor metastasis, tumor classification, and COVID-19 vaccination status. The primary outcome was 30-day all-cause death, and the secondary outcome was composite disease progression. Robustness was verified using Probit regression and double robust estimation with Augmented Inverse Probability Weighting (AIPW).</p> Results <p>A total of 1,829 patients were included in the final matched cohort (1,200 in the control group and 629 in the Azvudine group). Azvudine treatment was significantly associated with a reduced risk of all-cause death (adjusted hazard ratio [HR]: 0.65, 95% CI: 0.452–0.939, <i>P</i> = 0.022). Furthermore, unlike unadjusted analyses, the multivariate model demonstrated a significant reduction in composite disease progression (adjusted HR: 0.70, 95% CI: 0.518–0.936, <i>P</i> = 0.016). These findings were consistent across all sensitivity analyses. Regarding safety, the Azvudine group exhibited a higher incidence of hypokalemia (<i>P</i> &lt; 0.001) and Grade ≥3<sup>b</sup> platelet count decreased (<i>P</i> = 0.002). Significant fluctuations in lymphocyte counts (increased rates of both decrease and increase) were also observed.</p> Conclusion <p>Azvudine significantly reduced the risk of all-cause mortality and disease progression in hospitalized cancer patients with COVID-19. Although the drug was associated with increased risks of specific laboratory abnormalities (hypokalemia and thrombocytopenia), the substantial survival benefit outweighs these manageable risks. Routine clinical monitoring of electrolytes and blood counts is recommended during treatment.</p>

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Azvudine for the treatment of cancer patients with COVID-19: a multicenter, real-world, retrospective, cohort study

  • Lei Li,
  • Wenjie Liu,
  • Ling Wang,
  • Mengzhao Yang,
  • Juan Wang,
  • Guotao Li,
  • Guowu Qian,
  • Shixi Zhang,
  • Donghai Liu,
  • Hong Luo,
  • Silin Li,
  • Donghua Zhang,
  • Zujiang Yu,
  • Zhigang Ren

摘要

Background

Cancer patients are at an elevated risk for SARS-CoV-2 infection and require vigilant monitoring. The efficacy and safety of Azvudine in treating COVID-19 among this vulnerable group remain under-researched.

Methods

We conducted a multicenter, retrospective cohort study of nine hospitals involving cancer patients with COVID-19 hospitalized from December 2022 to January 2023. To minimize immortal time bias, patients who died or were discharged within 24 h of drug administration were excluded. A 2:1 propensity score matching (PSM) was performed to balance baseline characteristics, explicitly adjusting for tumor metastasis, tumor classification, and COVID-19 vaccination status. The primary outcome was 30-day all-cause death, and the secondary outcome was composite disease progression. Robustness was verified using Probit regression and double robust estimation with Augmented Inverse Probability Weighting (AIPW).

Results

A total of 1,829 patients were included in the final matched cohort (1,200 in the control group and 629 in the Azvudine group). Azvudine treatment was significantly associated with a reduced risk of all-cause death (adjusted hazard ratio [HR]: 0.65, 95% CI: 0.452–0.939, P = 0.022). Furthermore, unlike unadjusted analyses, the multivariate model demonstrated a significant reduction in composite disease progression (adjusted HR: 0.70, 95% CI: 0.518–0.936, P = 0.016). These findings were consistent across all sensitivity analyses. Regarding safety, the Azvudine group exhibited a higher incidence of hypokalemia (P < 0.001) and Grade ≥3b platelet count decreased (P = 0.002). Significant fluctuations in lymphocyte counts (increased rates of both decrease and increase) were also observed.

Conclusion

Azvudine significantly reduced the risk of all-cause mortality and disease progression in hospitalized cancer patients with COVID-19. Although the drug was associated with increased risks of specific laboratory abnormalities (hypokalemia and thrombocytopenia), the substantial survival benefit outweighs these manageable risks. Routine clinical monitoring of electrolytes and blood counts is recommended during treatment.