Real-World Effectiveness of Sotrovimab in Ambulatory Patients With COVID-19: A Retrospective Cohort Study Using a Large Administrative Claims Database in the United States.

Abstract

Purpose: To assess real-world effectiveness of sotrovimab for reducing severe clinical outcomes in patients with coronavirus disease 2019 (COVID-19) versus no treatment during the Delta/early Omicron variant periods.

Methods: Patients diagnosed with COVID-19 between May 26, 2021, and April 5, 2022, were identified from US administrative claims data (Komodo Health). Cohorts included early treatment (sotrovimab, other monoclonal antibodies, or antivirals), prophylaxis monoclonal antibody treatment, and untreated for COVID-19. Patient characteristics and severe clinical outcomes (assessed in the 29-day post-treatment period, including hospitalization, mortality, ventilatory support/extracorporeal membrane oxygenation [ECMO], and hospital length of stay) were described for all cohorts, with comparative effectiveness analysis conducted among matched cohorts of sotrovimab-treated and untreated patients.

Findings: In the descriptive analysis (N = 434,766 early treated; N = 2015 prophylaxis treated; N = 4,231,748 untreated), differences in age, comorbidity, and high-risk status were observed. Clinical outcomes occurred at low frequencies in all cohorts. In the effectiveness analysis (N = 34,160 sotrovimab treated; N = 68,320 untreated), treatment with sotrovimab significantly (P < 0.001 for all) reduced hospitalization (4.0% vs 4.7%), hospitalization and/or mortality (4.0% vs 5.2%), ventilatory support and/or ECMO (3.6% vs 6.5%), and length of inpatient stay (4.8 vs 6.2 days) versus no treatment. Stratification by age showed the significant reduction in the likelihood of 29-day all-cause hospitalization was only observed in patients aged >55 years, with greatest benefit observed among patients aged ≥65 years (odds ratio [OR] 0.56; 95% confidence interval [CI] 0.49-0.63). Likelihood of all-cause hospitalization was lower among sotrovimab-treated versus untreated patients during the Delta (OR 0.66; 95% CI 0.57-0.76), Omicron BA.1 (OR 0.88; 95% CI 0.81-0.95), and BA.2 (OR 0.58; 95% CI 0.43-0.79) variant predominant periods.

Implications: Sotrovimab was associated with a reduced risk of severe clinical outcomes in patients with COVID-19 at high risk of progression during the Delta and early Omicron (BA.1 and BA.2) variant periods.