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Published on: May 4, 2017
Real-World Effectiveness of Sotrovimab in Ambulatory Patients With COVID-19: A Retrospective Cohort Study Using a
Christopher F Bell1, Tasneem Lokhandwala2, Daniel C Gibbons3
1GSK, Research Triangle Park, Durham, North Carolina.
Insights
Sotrovimab significantly reduced severe outcomes in high-risk COVID-19 patients during Delta and Omicron variants. This monoclonal antibody treatment lowered hospitalization and mortality risks, particularly in older adults.
Area of Science:
- Infectious Diseases
- Virology
- Pharmacology
Background:
- Coronavirus disease 2019 (COVID-19) poses significant public health challenges.
- Monoclonal antibodies have been developed as therapeutic options for COVID-19.
- Effectiveness of treatments can vary with emerging viral variants.
Purpose of the Study:
- To evaluate the real-world effectiveness of sotrovimab in preventing severe clinical outcomes in COVID-19 patients.
- To compare sotrovimab treatment against no treatment during the Delta and early Omicron variant periods.
Main Methods:
- Retrospective analysis of US administrative claims data (May 2021 - April 2022).
- Inclusion of cohorts for early treatment (sotrovimab, other monoclonal antibodies, antivirals), prophylaxis, and untreated patients.
- Matched cohort analysis comparing sotrovimab-treated and untreated patients for severe outcomes (hospitalization, mortality, ventilatory support/ECMO, length of stay) within 29 days post-treatment.
Main Results:
- Sotrovimab treatment significantly reduced hospitalization (4.0% vs 4.7%), hospitalization and/or mortality (4.0% vs 5.2%), and need for ventilatory support/ECMO (3.6% vs 6.5%) compared to no treatment.
- Benefits were most pronounced in patients aged 55 years and older, especially those ≥65 years (OR 0.56).
- Effectiveness was observed across Delta, Omicron BA.1, and BA.2 variant periods.
Conclusions:
- Sotrovimab is associated with a reduced risk of severe clinical outcomes in high-risk COVID-19 patients.
- The benefit was evident during the Delta and early Omicron variant waves.
- Findings support the use of sotrovimab for eligible high-risk individuals.
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.
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