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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,...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10616487/ https://www.ncbi.nlm.nih.gov/pubmed/37915915 http://dx.doi.org/10.1093/ckj/sfad184 |
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author | 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 |
author_facet | 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 |
author_sort | Zheng, Bang |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10616487 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-106164872023-11-01 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 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 Clin Kidney J Original Article 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. Oxford University Press 2023-08-29 /pmc/articles/PMC10616487/ /pubmed/37915915 http://dx.doi.org/10.1093/ckj/sfad184 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the ERA. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article 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 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10616487/ https://www.ncbi.nlm.nih.gov/pubmed/37915915 http://dx.doi.org/10.1093/ckj/sfad184 |
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