학술논문
Comparative effectiveness of sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in patients on kidney replacement therapy: observational study using the OpenSAFELY-UKRR and SRR databases
ORIGINAL ARTICLE
ORIGINAL ARTICLE
Document Type
Academic Journal
Author
Zheng, Bang; Campbell, Jacqueline; Carr, Edward J; Tazare, John; Nab, Linda; Malalingasivam, Viyaasan; Mehrkar, Amir; Santhakumaran, Shalini; Steenkamp, Retha; Loud, Fiona; Lyon, Susan; Scanlon, Miranda; Hulme, William J; Green, Amelia Ca; Curtis, Helen J.; Fisher, Louis; Parker, Edward; Goldacre, Ben; Douglas, Ian; Evans, Stephen; Mackenna, Brian; Bell, Samira; Nitsch, Dorothea
Source
Clinical Kidney Journal. November 2023, Vol. 16 Issue 11, p2048, 11 p.
Subject
Language
English
ISSN
2048-8505
Abstract
INTRODUCTION People receiving kidney replacement therapy (KRT) remain vulnerable to severe outcomes from COVID-19 [1]. This is multifactorial due to effects from both impaired kidney function and its causes and [...]
Background. Due to limited inclusion of patients on kidney replacement therapy (KRT) in clinical trials, the effectiveness of coronavirus disease 2019 (COVID-19) therapies in this population remains unclear. We sought to address this by comparing the effectiveness of sotrovimab against molnupiravir, two commonly used treatments for non-hospitalised KRT patients with COVID-19 in the UK. Methods. With the approval of National Health Service England, we used routine clinical data from 24 million patients in England within the OpenSAFELY-TPP platform linked to the UK Renal Registry (UKRR) to identify patients on KRT. A Cox proportional hazards model was used to estimate hazard ratios (HRs) of sotrovimab versus molnupiravir with regards to COVID-19-related hospitalisations or deaths in the subsequent 28 days. We also conducted a complementary analysis using data from the Scottish Renal Registry (SRR). Results. Among the 2367 kidney patients treated with sotrovimab (n = 1852) or molnupiravir (n = 515) between 16 December 2021 and 1 August 2022 in England, 38 cases (1.6%) of COVID-19-related hospitalisations/deaths were observed. Sotrovimab was associated with substantially lower outcome risk than molnupiravir {adjusted HR 0.35 [95% confidence interval (CI) 0.17-0.71]; P = .004}, with results remaining robust in multiple sensitivity analyses. In the SRR cohort, sotrovimab showed a trend toward lower outcome risk than molnupiravir [HR 0.39 (95% CI 0.13-1.21); P = .106]. In both datasets, sotrovimab had no evidence of an association with other hospitalisation/death compared with molnupiravir (HRs ranged from 0.73 to 1.29; P > .05). Conclusions. In routine care of non-hospitalised patients with COVID-19 on KRT, sotrovimab was associated with a lower risk of severe COVID-19 outcomes compared with molnupiravir during Omicron waves. Patients on kidney replacement therapy (KRT) have been consistently at the highest risk of severe outcomes from COVID-19. However, understanding the effectiveness of COVID-19 therapeutics among patients with kidney disease has been problematic due to limited inclusion of patients on KRT in clinical trials. In this real-world study, we used data from two national renal registries and multisourced electronic health records to compare the effectiveness of sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in non-hospitalised patients on KRT during the Omicron era. We found that among non-hospitalised COVID-19 patients on KRT across England and Scotland, those treated with sotrovimab had a substantially lower risk of developing severe COVID-19 outcomes than molnupiravir. Keywords: cohort studies, comparative effectiveness research, COVID-19, renal replacement therapy
Background. Due to limited inclusion of patients on kidney replacement therapy (KRT) in clinical trials, the effectiveness of coronavirus disease 2019 (COVID-19) therapies in this population remains unclear. We sought to address this by comparing the effectiveness of sotrovimab against molnupiravir, two commonly used treatments for non-hospitalised KRT patients with COVID-19 in the UK. Methods. With the approval of National Health Service England, we used routine clinical data from 24 million patients in England within the OpenSAFELY-TPP platform linked to the UK Renal Registry (UKRR) to identify patients on KRT. A Cox proportional hazards model was used to estimate hazard ratios (HRs) of sotrovimab versus molnupiravir with regards to COVID-19-related hospitalisations or deaths in the subsequent 28 days. We also conducted a complementary analysis using data from the Scottish Renal Registry (SRR). Results. Among the 2367 kidney patients treated with sotrovimab (n = 1852) or molnupiravir (n = 515) between 16 December 2021 and 1 August 2022 in England, 38 cases (1.6%) of COVID-19-related hospitalisations/deaths were observed. Sotrovimab was associated with substantially lower outcome risk than molnupiravir {adjusted HR 0.35 [95% confidence interval (CI) 0.17-0.71]; P = .004}, with results remaining robust in multiple sensitivity analyses. In the SRR cohort, sotrovimab showed a trend toward lower outcome risk than molnupiravir [HR 0.39 (95% CI 0.13-1.21); P = .106]. In both datasets, sotrovimab had no evidence of an association with other hospitalisation/death compared with molnupiravir (HRs ranged from 0.73 to 1.29; P > .05). Conclusions. In routine care of non-hospitalised patients with COVID-19 on KRT, sotrovimab was associated with a lower risk of severe COVID-19 outcomes compared with molnupiravir during Omicron waves. Patients on kidney replacement therapy (KRT) have been consistently at the highest risk of severe outcomes from COVID-19. However, understanding the effectiveness of COVID-19 therapeutics among patients with kidney disease has been problematic due to limited inclusion of patients on KRT in clinical trials. In this real-world study, we used data from two national renal registries and multisourced electronic health records to compare the effectiveness of sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in non-hospitalised patients on KRT during the Omicron era. We found that among non-hospitalised COVID-19 patients on KRT across England and Scotland, those treated with sotrovimab had a substantially lower risk of developing severe COVID-19 outcomes than molnupiravir. Keywords: cohort studies, comparative effectiveness research, COVID-19, renal replacement therapy