Evaluating the effectiveness and safety of Azvudine for hospitalised patients with COVID-19 and hypertension: a multicenter retrospective cohort study

Hypertension is widely acknowledged as a major risk factor for disease severity and death in patients with coronavirus disease 2019 (COVID-19). Azvudine is recommended for COVID-19 patients in China. However, its clinical efficacy and safety for individuals with hypertension remain unclear. This nine-center retrospective cohort study included 32,864 hospitalized COVID-19 patients in Henan Province, China, from December 2022 to January 2023. Among these patients, those with hypertension were identified and divided into the Azvudine and control groups (standard treatment without antiviral medication) after propensity score matching (PSM) at a 1:1 ratio. The primary outcomes measured were all-cause mortality and composite disease progression. Subgroup analyses and sensitivity tests were conducted to verify the robustness of the results. Safety was assessed based on adverse events (AEs). After PSM to balance baseline characteristics, the analysis included 2434 Azvudine recipients and 2434 controls, forming a final matched cohort. Azvudine was associated with a lower risk of all-cause mortality (HR: 0.64, 95% CI 0.519-0.780; P < 0.001) and composite disease progression (HR: 0.84, 95% CI 0.719-0.985; P = 0.032) in hypertensive patients with COVID-19. In five sensitivity analyses, Azvudine showed a highly robust effect in reducing all-cause mortality, while the evidence for a reduction in the progression of composite disease progression was less consistent. No significant difference in severe AEs (≥ Grade 3) was observed between groups. These real-world findings suggest Azvudine may be a promising antiviral option for hypertensive COVID-19 patients, but further prospective trials are necessary to confirm these results.