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

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,...

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Veröffentlicht in:Clinical kidney journal 2023-11, Vol.16 (11), p.2048-2058
Hauptverfasser: Zheng, Bang, Campbell, Jacqueline, Carr, Edward J, Tazare, John, Nab, Linda, Mahalingasivam, Viyaasan, Mehrkar, Amir, Santhakumaran, Shalini, Steenkamp, Retha, Loud, Fiona, Lyon, Susan, Scanlon, Miranda, Hulme, William J, Green, Amelia C A, Curtis, Helen J, Fisher, Louis, Parker, Edward, Goldacre, Ben, Douglas, Ian, Evans, Stephen, MacKenna, Brian, Bell, Samira, Tomlinson, Laurie A, Nitsch, Dorothea
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Sprache:eng
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Zusammenfassung: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. Lay Summary 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
ISSN:2048-8505
2048-8513
DOI:10.1093/ckj/sfad184