Characteristics and outcomes of patients treated with sotrovimab to prevent progression to severe COVID-19 in Belgium

Abstract

AbstractBackgroundSotrovimab, a dual-action, engineered human monoclonal antibody, has been demonstrated to significantly reduce the risk of hospitalization and death in high-risk patients with COVID-19. Here, we describe the real-world use of, and outcomes from, sotrovimab treatment in Belgium during the Delta and Omicron waves among patients with COVID-19 at high risk of developing severe disease.MethodsThis was a multicentric, single-arm observational cohort study of non-hospitalized patients receiving outpatient sotrovimab treatment between 1 November 2021 and 2 August 2022. We performed a retrospective analysis of hospital, pharmacy and administrative data from nine hospitals in Belgium. The primary outcomes were all-cause and COVID-19-related hospitalizations and all-cause deaths during the 29-day acute follow-up period from first administration of sotrovimab.ResultsA total of 634 patients were included in the analysis (63.4% aged <65 years; 50.3% male). A high proportion (67.7%;n= 429/634) of patients were immunocompromised, with 36.9% (n= 234/634) actively treated for malignancy. During the 29-day acute period, 12.5% (n= 79/634) of sotrovimab-treated patients were hospitalized due to any cause (median duration 4 days; median time to hospitalization 14 days) and 1.1% (n= 7/634) died due to any cause. In total, 0.8% (n= 5/634) of patients were admitted to an intensive care unit (ICU). COVID-19-related hospitalization was experienced by 2.5% (n= 16/634) of patients (median duration 10 days; median time to hospitalization 10.5 days), with 0.5% (n= 3/634) of patients admitted to an ICU. COVID-19-related hospitalization was experienced by 6.3% (n= 3/48) of patients during Delta predominance (04/11/2021–23/12/2021), 6.3% (n= 1/16) of patients during Delta/BA.1 codominance (24/12/2021–01/01/2022), 1.4% (n= 3/218) of patients during BA.1 predominance (02/01/2022–09/02/2022), 2.1% (n= 2/97) of patients during BA.1/BA.2 codominance (10/02/2022–07/03/2022) and 2.7% (n= 7/255) of patients during BA.2/BA.5 codominance (08/03/2022–02/08/2022).ConclusionsThis observational study demonstrated consistently low rates of COVID-19-related hospitalizations and all-cause deaths in sotrovimab-treated patients during the Omicron subvariant periods in Belgium, despite over two-thirds of the study population being immunocompromised. Comparative effectiveness studies are warranted to confirm sotrovimab effectiveness in highly immunocompromised patients with COVID-19.