Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk COVID-19 patients in north west London: a retrospective cohort study
Dr Myriam Drysdale, Evgeniy R Galimov, Marcus James Yarwood, Vishal Patel, Bethany Levick, Daniel C Gibbons, Jonathan D Watkins, Sophie Young, Benjamin F Pierce, Emily J Lloyd, William Kerr, Helen J Birch, Tahereh Kamalati, Stephen J Brett
BMJ Open Respiratory Research, doi:10.1136/bmjresp-2023-002238
Background We assessed the effectiveness of sotrovimab vs no early COVID-19 treatment in highest-risk COVID-19 patients during Omicron predominance. Methods Retrospective cohort study using the Discover dataset in North West London. Included patients were nonhospitalised, aged ≥12 years and met ≥1 National Health Service highest-risk criterion for sotrovimab treatment. We used Cox proportional hazards models to compare HRs of 28-day COVID-19-related hospitalisation/death between highest-risk sotrovimab-treated and untreated patients. Age, renal disease and Omicron subvariant subgroup analyses were performed. Results We included 599 sotrovimab-treated patients and 5191 untreated patients. Compared with untreated patients, the risk of COVID-19 hospitalisation/death (HR 0.50, 95% CI 0.24, 1.06; p=0.07) and the risk of COVID-19 hospitalisation (HR 0.43, 95% CI 0.18, 1.00; p=0.051) were both lower in the sotrovimab-treated group; however, statistical significance was not reached. In the ≥65 years and renal disease subgroups, sotrovimab was associated with a significantly reduced risk of COVID-19 hospitalisation, by 89% (HR 0.11, 95% CI 0.02, 0.82; p=0.03) and 82% (HR 0.18, 95% CI 0.05, 0.62; p=0.007), respectively. Conclusions Risk of COVID-19 hospitalisation in sotrovimab-treated patients aged ≥65 years and with renal disease was significantly lower compared with untreated patients. Overall, risk of hospitalisation was also lower for sotrovimab-treated patients, but statistical significance was not reached. ⇒ This study begins to fill the evidence gap in relation to early treatments for mild-to-moderate COVID-19, particularly their effectiveness against disease caused by Omicron variants to date. on April 14,
Contributors MD, MJY, VP, BL, DCG, JDW, SY, BFP, HJB, TK and SJB designed the study; ERG performed inverse probability of treatment weighted survival analysis; MJY performed descriptive analysis; MD, ERG, MJY, BL, DCG, JDW, SY, BFP, EJL, WK, TK and SJB interpreted results. MD is responsible for the overall content as the guarantor. All authors took part in drafting, revising or critically reviewing the manuscript; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. Competing interests MD, DCG, EJL, WK and HJB are employees of, and/or shareholders in, GSK. VP was an employee of GSK at the time of the study and is now an employee of KVM Analytics. ERG, MJY, JDW, SY, BFP and TK are (or were at time of study) employees of Imperial College Health Partners, which received funding from GSK and Vir Biotechnology to conduct the study. BL is an employee of OPEN Health, which received funding from GSK and Vir Biotechnology, Inc, to conduct the study. A consultancy fee was paid to SJB's institutional account. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not applicable. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement Data are available upon reasonable request. The..
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doi:10.1016/j.lanepe.2023.100741DOI record:
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"abstract": "<jats:sec><jats:title>Background</jats:title><jats:p>We assessed the effectiveness of sotrovimab vs no early COVID-19 treatment in highest-risk COVID-19 patients during Omicron predominance.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Retrospective cohort study using the Discover dataset in North West London. Included patients were non-hospitalised, aged ≥12 years and met ≥1 National Health Service highest-risk criterion for sotrovimab treatment. We used Cox proportional hazards models to compare HRs of 28-day COVID-19-related hospitalisation/death between highest-risk sotrovimab-treated and untreated patients. Age, renal disease and Omicron subvariant subgroup analyses were performed.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>We included 599 sotrovimab-treated patients and 5191 untreated patients. Compared with untreated patients, the risk of COVID-19 hospitalisation/death (HR 0.50, 95% CI 0.24, 1.06; p=0.07) and the risk of COVID-19 hospitalisation (HR 0.43, 95% CI 0.18, 1.00; p=0.051) were both lower in the sotrovimab-treated group; however, statistical significance was not reached. In the ≥65 years and renal disease subgroups, sotrovimab was associated with a significantly reduced risk of COVID-19 hospitalisation, by 89% (HR 0.11, 95% CI 0.02, 0.82; p=0.03) and 82% (HR 0.18, 95% CI 0.05, 0.62; p=0.007), respectively.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Risk of COVID-19 hospitalisation in sotrovimab-treated patients aged ≥65 years and with renal disease was significantly lower compared with untreated patients. Overall, risk of hospitalisation was also lower for sotrovimab-treated patients, but statistical significance was not reached.</jats:p></jats:sec>",
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