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Clin Kidney J
. 2023 Aug 29;16(11):2048-2058.
doi: 10.1093/ckj/sfad184. eCollection 2023 Nov. 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
Bang Zheng 1 , Jacqueline Campbell 2 , Edward J Carr 3 , John Tazare 1 , Linda Nab 4 , Viyaasan Mahalingasivam 1 , Amir Mehrkar 4 , Shalini Santhakumaran 5 , Retha Steenkamp 5 , Fiona Loud 6 , Susan Lyon 7 , Miranda Scanlon 8 , William J Hulme 4 , Amelia C A Green 4 , Helen J Curtis 4 , Louis Fisher 4 , Edward Parker 1 , Ben Goldacre 4 , Ian Douglas 1 , Stephen Evans 1 , Brian MacKenna 4 , Samira Bell 2 9 , Laurie A Tomlinson 1 , Dorothea Nitsch 1 5 ; OpenSAFELY Collaborative and LH&W NCS (or CONVALESCENCE) Collaborative
Affiliations
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.
Keywords: COVID-19; cohort studies; comparative effectiveness research; renal replacement therapy.
. 2023 Aug 29;16(11):2048-2058.
doi: 10.1093/ckj/sfad184. eCollection 2023 Nov. 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
Bang Zheng 1 , Jacqueline Campbell 2 , Edward J Carr 3 , John Tazare 1 , Linda Nab 4 , Viyaasan Mahalingasivam 1 , Amir Mehrkar 4 , Shalini Santhakumaran 5 , Retha Steenkamp 5 , Fiona Loud 6 , Susan Lyon 7 , Miranda Scanlon 8 , William J Hulme 4 , Amelia C A Green 4 , Helen J Curtis 4 , Louis Fisher 4 , Edward Parker 1 , Ben Goldacre 4 , Ian Douglas 1 , Stephen Evans 1 , Brian MacKenna 4 , Samira Bell 2 9 , Laurie A Tomlinson 1 , Dorothea Nitsch 1 5 ; OpenSAFELY Collaborative and LH&W NCS (or CONVALESCENCE) Collaborative
Affiliations
- PMID: 37915915
- PMCID: PMC10616487
- DOI: 10.1093/ckj/sfad184
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.
Keywords: COVID-19; cohort studies; comparative effectiveness research; renal replacement therapy.