Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Oct 1;9(10):ofac517.
doi: 10.1093/ofid/ofac517. eCollection 2022 Oct.

Evaluation of Bebtelovimab for Treatment of Covid-19 During the SARS-CoV-2 Omicron Variant Era

Erin K McCreary  1 , Kevin E Kip  2 , Kevin Collins  2 , Tami E Minnier  3 , Graham M Snyder  1 , Ashley Steiner  4 , Russell Meyers  4 , Tina Borneman  5 , Michelle Adam  4 , Lauren Thurau  4 , Donald M Yealy  4 , David T Huang  4   6 , J Ryan Bariola  1 , Mark Schmidhofer  7 , Richard J Wadas  4 , Derek C Angus  6 , Paula L Kip  3 , Oscar C Marroquin  2
Affiliations

Evaluation of Bebtelovimab for Treatment of Covid-19 During the SARS-CoV-2 Omicron Variant Era

Erin K McCreary et al. Open Forum Infect Dis. .

Abstract

Background: Monoclonal antibody (mAb) treatment is associated with decreased risk of hospitalization and death in high-risk outpatients with mild to moderate coronavirus disease 2019 (COVID-19) caused by early severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. Bebtelovimab exhibits in vitro activity against the Omicron variant and its sublineages; however, clinical data are lacking.

Methods: A retrospective cohort study was conducted comparing bebtelovimab-treated patients with propensity score-adjusted and matched nontreated control groups. Participants included high-risk outpatients eligible for bebtelovimab treatment under Emergency Use Authorization with a positive SARS-CoV-2 test from March 30 to May 28, 2022. Treated patients received single-dose intravenous treatment with bebtelovimab. The primary outcome was hospitalization or death over 28 days.

Results: Before matching/statistical adjustment, mAb-treated patients were, on average, 10 years older than nontreated patients (61.6 vs 51.3 years) and had higher prevalence of obstructive sleep apnea, hypertension, chronic kidney disease, cancer, organ or cell transplant, and immunocompromised status (standardized mean differences ≥0.20). The adjusted odds ratio (OR) of hospitalization or death comparing 1006 treated with 2023 nontreated patients was 0.50 (95% CI, 0.31-0.80). Among 930 treated and 930 propensity score-matched nontreated patients, the incidence of hospitalization or death was 3.1% vs 5.5%, respectively (conditional OR, 0.53; 95% CI, 0.32-0.86). The lower odds ratio of hospitalization or death associated with bebtelovimab treatment was most evident in older patients, those with immunocompromised status, and fully vaccinated patients.

Conclusions: Monoclonal antibody treatment with bebtelovimab among COVID-19 outpatients is associated with lower odds of hospitalization or death, particularly among immunocompromised and older patients.

Keywords: Omicron SARS-CoV-2 variant; bebtelovimab; death; hospitalization; immunosuppression; propensity score matching.

PubMed Disclaimer

Conflict of interest statement

Potential conflicts of interest. All authors: no reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
CONSORT diagram of selection of treated and nontreated control patients for analysis. Abbreviations: COVID-19, coronavirus disease 2019; ED, emergency department; EHR, electronic health record; mAb, monoclonal antibody; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
See this image and copyright information in PMC

References

    1. Bariola JR, McCreary EK, Wadas RJ, et al. . Impact of bamlanivimab monoclonal antibody treatment on hospitalization and mortality among nonhospitalized adults with severe acute respiratory syndrome coronavirus 2 infection. Open Forum Infect Dis 2021; 8:XXX–XX. - PMC - PubMed
    1. Weinreich DM, Sivapalasingam S, Norton T, et al. . REGEN-COV antibody combination and outcomes in outpatients with COVID-19. N Engl J Med 2021; 385:e81. - PMC - PubMed
    1. Gottlieb RL, Nirula A, Chen P, et al. . Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA 2021; 325:632–44. - PMC - PubMed
    1. Gupta A, Gonzalez-Rojas Y, Juarez E, et al. . Early treatment for COVID-19 with SARS-CoV-2 neutralizing antibody sotrovimab. N Engl J Med 2021; 385:1941–50. - PubMed
    1. Takashita E, Kinoshita N, Yamayoshi S, et al. . Efficacy of antibodies and antiviral drugs against COVID-19 Omicron variant. N Engl J Med 2022; 386:995–8. - PMC - PubMed