Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron Waves in the USA

• DOI: 10.1007/s40121-022-00755-0
• Publication Date: 2023-01-11T11:07:08Z
• Authors: Mindy M. Cheng; Carolina Reyes; Sacha Satram; Helen Birch; Daniel C. Gibbons; Myriam Drysdale; Christopher F. Bell; Anvar Suyundikov; Xiao Ding; M. Cyrus Maher; Wendy Yeh; Amalio Telenti; Lawrence Corey
• Keywords: Monoclonal antibody; SARS-CoV-2; COVID-19; Effectiveness; Infectious and parasitic diseases; RC109-216; 3. Good health; Sotrovimab; 03 medical and health sciences; 0302 clinical medicine; Real-world; Original Research

Sotrovimab, a recombinant human monoclonal antibody (mAb) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had US Food and Drug Administration Emergency Use Authorization for the treatment of high-risk outpatients with mild-to-moderate disease 2019 (COVID-19) from 26 May 2021 to 5 April 2022. Real-world clinical effectiveness sotrovimab in reducing risk 30-day all-cause hospitalization and/or mortality was evaluated period when prevalence circulating SARS-CoV-2 variants changed between Delta Omicron USA.A retrospective analysis conducted de-identified patients diagnosed COVID-19 1 September 30 2022 FAIR Health National Private Insurance Claims database. Patients meeting criteria were divided into two cohorts: not treated mAb ("no mAb"). All-cause hospitalizations facility-reported ≤ days diagnosis ("30-day or mortality") identified. Multivariable propensity score-matched Poisson logistic regressions estimate adjusted relative (RR) odds each cohort.Compared no cohort (n = 1,514,868), 15,633) older higher proportion conditions. In cohort, 84,307 (5.57%) hospitalized 8167 (0.54%) deaths identified, while 418 (2.67%) 13 (0.08%) After adjusting potential confounders, 55% lower (RR 0.45, 95% CI 0.41-0.49) an 85% 0.15, 0.08-0.29). Monthly, 2022, RR reduction maintained, ranging 46% 71% compared cohort; uncertain, wide confidence intervals due small sample size.Sotrovimab associated reduced versus treatment. Clinical persisted during early variant waves among all subgroups assessed.