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Observational Study
. 2023 Mar:128:310-317.
doi: 10.1016/j.ijid.2022.10.002. Epub 2022 Oct 10.

Change in effectiveness of sotrovimab for preventing hospitalization and mortality for at-risk COVID-19 outpatients during an Omicron BA.1 and BA.1.1-predominant phase

Neil R Aggarwal  1 , Laurel E Beaty  2 , Tellen D Bennett  3 , Nichole E Carlson  4 , David A Mayer  2 , Kyle C Molina  5 , Jennifer L Peers  5 , Seth Russell  6 , Matthew K Wynia  7 , Adit A Ginde  8
Affiliations
Observational Study

Change in effectiveness of sotrovimab for preventing hospitalization and mortality for at-risk COVID-19 outpatients during an Omicron BA.1 and BA.1.1-predominant phase

Neil R Aggarwal et al. Int J Infect Dis. 2023 Mar.

Abstract

Objectives: Sotrovimab effectively prevented progression to severe disease and mortality following infection with pre-Omicron SARS-CoV-2 variants. We sought to determine whether sotrovimab is similarly effective against SARS-CoV-2 Omicron variant infection.

Methods: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from December 26, 2021, to March 10, 2022, using electronic health records from a statewide health system. We propensity-matched patients not receiving authorized treatment for each patient treated with sotrovimab. The primary outcome was 28-day hospitalization; secondary outcomes included mortality. We also propensity-matched sotrovimab-treated patients from the Omicron and Delta phases. Logistic regression was used to determine sotrovimab effectiveness during Omicron and between variant phases.

Results: Of 30,247 SARS-CoV-2 Omicron variant infected outpatients, we matched 1542 receiving sotrovimab to 3663 not receiving treatment. Sotrovimab treatment was not associated with reduced odds of 28-day hospitalization (2.5% vs 3.2%; adjusted odds ratio [OR] 0.82, 95% CI 0.55, 1.19) or mortality (0.1% vs 0.2%; adjusted OR 0.62, 95% CI 0.07, 2.78). Between phases, the observed treatment OR was higher during Omicron than during Delta (OR 0.85 vs 0.39, respectively; interaction P-value = 0.053).

Conclusion: Real-world evidence demonstrated that sotrovimab was not associated with reduced 28-day hospitalization or mortality among COVID-19 outpatients during the Omicron BA.1 phase.

Keywords: COVID-19; Monoclonal antibody; Real-world evidence.

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Conflict of interest statement

Declaration of competing interest The authors do not have a commercial or other association that might pose a conflict of interest (e.g., pharmaceutical stock ownership, consultancy, advisory board membership, relevant patents, or research funding).

Figures

Figure 1
Figure 1
Cumulative incidence plots for all-cause hospitalization to day 28 by sotrovimab treatment status among Omicron BA.1 or BA.1.1 infected outpatients. Abbreviation: mAb, monoclonal antibody.
Figure 2
Figure 2
Severity of hospitalization - secondary outcomes. The total sample size of the hospitalized subset is 155, of which 39 are in the sotrovimab-treated group and 116 are in the untreated group. Abbreviations: HFNC, high-flow nasal cannula; NIV, non-invasive ventilation; IMV, invasive mechanical ventilation.
Figure 3
Figure 3
Forest plot for Omicron BA.1 or BA.1.1 infected outpatient subgroup analysis. The interaction terms for binary age greater or less than 65 years (P-value = 0.012), binarized immunocompromised status (P-value = 0.043), and binarized number of comorbidities (P-value = 0.006) were significant. Abbreviation: Int, interaction; mAb, monoclonal antibody; OR, odds ratio.
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