Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China.

Abstract

Azvudine and Paxlovid are the primary antiviral agents for the management of COVID-19. However, there is currently insufficient evidence regarding the effectiveness and safety of these drugs in treating COVID-19 patients with pre-existing hypertension. The objective of this study was to assess their effectiveness and safety among those patients in a real-world context. Retrospective cohort study. Electronic medical record data of COVID-19 patients with pre-existing hypertension were extracted from nine hospitals in Henan Province from 5 December 2022 to 31 January 2023. Following 2:1 propensity score matching (PSM), 996 individuals who received treatment with azvudine and 498 individuals who received treatment with Paxlovid were included in the analysis. The primary outcome was all-cause death and the secondary outcome was the composite disease progression. Following adherence to the inclusion and exclusion criteria and 2:1 PSM, 996 individuals were included in the azvudine group and 498 in the Paxlovid group. The Cox regression analysis revealed that the azvudine group had a significantly lower risk of all-cause death compared with the Paxlovid group (HR 0.64, 95% CI 0.455 to 0.911, p=0.013). However, there was no statistically significant difference in composite disease progression between the two groups (HR 0.93, 95% CI 0.711 to 1.229, p=0.629). Subgroup analysis indicated that, compared with Paxlovid, patients with moderate disease receiving azvudine treatment exhibited a significantly reduced risk of composite disease progression (HR 0.46, 95% CI 0.24 to 0.89). The safety analysis showed that the azvudine group had fewer adverse events. Among COVID-19 patients with pre-existing hypertension, the effectiveness of azvudine is not inferior to Paxlovid in reducing all-cause death and composite disease progression, with fewer adverse events. NCT06349655.