Characteristics and Outcomes of COVID-19 Patients Presumed to be Treated with Sotrovimab in NHS Hospitals in England

Abstract

Introduction:There is limited real-world evidence describing the effectiveness of early treatments for Coronavirus disease 2019 (COVID-19) during the period where Omicron was the dominant variant. Here we describe characteristics and acute clinical outcomes in patients with COVID-19 treated with a monoclonal antibody (mAb; presumed to be sotrovimab) across six distinct periods covering the emergence and subsequent dominance of Omicron subvariants (BA.1, BA.2 and BA.5) in England.Methods:Retrospective cohort study using data from Hospital Episode Statistics database between 1stJanuary – 31stJuly 2022. Included patients were aged ≥12 years and received a mAb delivered by a National Health Service (NHS) hospital as a day-case, for which the primary diagnosis was COVID-19. Patients were presumed to have received sotrovimab on the basis of available NHS data showing that 99.98% of individuals who received COVID-19 treatment during the period covered by the study were actually treated with sotrovimab. COVID-19-attributable hospitalisations were reported overall and across six distinct periods of Omicron sub-variant prevalence. A multivariate Poisson regression model was used to estimate incidence rate ratios for each period. Subgroup analyses were conducted in patients with severe renal disease and active cancer.Results:In total, 10,096 patients were included. The most common high-risk comorbidities were Immune-Mediated Inflammatory Disorders (43.0%; n = 4,337), severe renal disease (14.1%; n = 1,422), rare neurological conditions (10.4%; n = 1,053) and active cancer (9.0%; n = 910). The proportions of patients with a COVID-19-attributable hospitalisation was 1.0% (n = 96), or with a hospital visit due to any cause was 4.6% (n = 465) during the acute period. The percentage of patients who died due to any cause during the acute study period was 0.3% (n = 27). COVID-19-attributable hospitalisation rates were consistent among subgroups and no significant differences (p-values ranged from 0.13 to 0.64) were observed across periods of Omicron subvariants.Conclusion:Low levels of COVID-19-attributable hospitalisations and deaths were recorded in mAb-treated patients. Results were consistent for patients with severe renal disease and active cancer. No evidence of differences in hospitalisation rates were observed whilst Omicron BA.1, and BA.2 or BA.5 subvariants were predominant, despite reported reductions in in vitro neutralisation activity of sotrovimab against BA.2 and BA.5.

Real-world effectiveness of sotrovimab for the treatment of SARS-CoV-2 infection during Omicron BA.2 and BA.5 subvariant predominance: a systematic literature review

“…Seven studies were conducted via secondary analyses of healthcare data, with sources including OpenSAFELY, 38,39 Discover-NOW dataset, 36 SAIL Databank, 33 and the Hospital Episode Statistics database. 35 Other data sources included patient electronic medical records or charts, 27,28,32,37 insurance claims, 26 and laboratory data. 29…”

“…38,39 Four studies comprised a single-arm treatment design and compared clinical outcomes of sotrovimab-treated patients during BA.2 and/or BA.5 predominant periods versus the BA.1 period. 30,32,34,35 Descriptive reporting rates of clinical outcomes (e.g. hospitalization) in sotrovimab-treated patients were used in five studies.…”

“…Nine studies reported outcomes for sotrovimab during both Omicron BA.1 and BA.2 predominance. 26,29,30,32–34,36–38 One study reported outcomes during periods of Omicron BA.1, BA.2 and BA.5 predominance, 36 two studies during periods of Omicron BA.2 and BA.5 predominance, 35,39 and one Japanese study during periods of Omicron BA.1 and BA.5 predominance. 27 Of note, Cheng et al also reported clinical outcomes for March and April 2022 when Omicron BA.2 was becoming predominant in the United States, with estimated prevalence of 50% and 100%, respectively.…”

“…Eleven of the 14 studies employed an ecological design, with the date or month of COVID-19 diagnosis used as a proxy for the likelihood of an infection being attributable to the prevalent Omicron subvariant circulating in the country/region at the time. 26,27,30–33,35–39 The other three studies used sequencing data to ascertain the SARS-CoV-2 subvariant of infection. 28,29,34…”

“…Five studies were conducted in adults aged ≥18 years, 28,33,37–39 eight studies included patients aged ≥12 years, 26,31,35,3629,30,32,34 and one study did not report the age of patients. 27 The reported mean age of sotrovimab-treated patients in the selected studies ranged from 40 31 to 79 27 years.…”