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Effectiveness of Sotrovimab in Preventing COVID-19-Related Hospitalizations or Deaths Among US Veterans During
Yinong Young-Xu1,2, Caroline Korves1,3, Gabrielle Zwain1,3
1US Department of Veterans Affairs, PBM, Center for Medication Safety, Hines, Illinois, USA.
Insights
Sotrovimab significantly reduced COVID-19 hospitalization and mortality risk in high-risk veterans during Omicron BA.1 and BA.2 waves. This real-world study confirms sotrovimab
Area of Science:
- Infectious Diseases
- Clinical Pharmacology
- Real-World Evidence
Background:
- The clinical effectiveness of sotrovimab for COVID-19 treatment, especially post-Omicron emergence, requires further investigation.
- High-risk populations need effective interventions against severe COVID-19 outcomes.
Purpose of the Study:
- To evaluate the real-world effectiveness of sotrovimab in preventing COVID-19-related hospitalization or mortality.
- To assess sotrovimab's efficacy in high-risk veterans during the Omicron variant's dominance.
Main Methods:
- Target trial emulation design using US Department of Veterans Affairs data.
- Inclusion of veterans diagnosed with COVID-19 between December 2021 and April 2022.
- Comparison of sotrovimab-treated patients (n=2816) with untreated controls (n=11,250) using Cox proportional hazards modeling.
Main Results:
- Sotrovimab recipients were predominantly older (90% ≥50 years) and vaccinated.
- During BA.1 dominance, sotrovimab reduced 30-day hospitalization/mortality risk by 70% (HR, 0.30).
- During BA.2 dominance, sotrovimab reduced severe COVID-19 risk by 71% (HR, 0.29).
Conclusions:
- Sotrovimab administration was associated with a reduced risk of 30-day COVID-19-related hospitalization or mortality in high-risk veterans.
- Findings support sotrovimab's utility during Omicron BA.1 variant circulation.
- Real-world data confirms sotrovimab's effectiveness in a predominantly vaccinated, high-risk cohort.
Background:
The real-world clinical effectiveness of sotrovimab in preventing coronavirus disease 2019 (COVID-19)-related hospitalization or mortality among high-risk patients diagnosed with COVID-19, particularly after the emergence of the Omicron variant, needs further research.
Method:
Using data from the US Department of Veterans Affairs (VA) health care system, we adopted a target trial emulation design in our study. Veterans aged ≥18 years, diagnosed with COVID-19 between December 1, 2021, and April 4, 2022, were included. Patients treated with sotrovimab (n = 2816) as part of routine clinical care were compared with all eligible but untreated patients (n = 11,250). Cox proportional hazards modeling estimated the hazard ratios (HRs) and 95% CIs for the association between receipt of sotrovimab and outcomes.
Results:
Most (90%) sotrovimab recipients were ≥50 years old, and 64% had ≥2 mRNA vaccine doses or ≥1 dose of Ad26.COV2. During the period that BA.1 was dominant, compared with patients not treated, sotrovimab-treated patients had a 70% lower risk of hospitalization or mortality within 30 days (HR, 0.30; 95% CI, 0.23-0.40). During BA.2 dominance, sotrovimab-treated patients had a 71% (HR, 0.29; 95% CI, 0.08-0.98) lower risk of 30-day COVID-19-related hospitalization, emergency room visits, or urgent care visits (defined as severe COVID-19) compared with patients not treated.
Conclusions:
Using national real-world data from high-risk and predominantly vaccinated veterans, administration of sotrovimab, compared with contemporary standard treatment regimens, was associated with reduced risk of 30-day COVID-19-related hospitalization or all-cause mortality during the Omicron BA.1 period.
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