Bebtelovimab for high-risk outpatients with early COVID-19 in a large US health system

Dryden-Peterson et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac565

Oct 2022

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Retrospective 377 outpatients in the USA and matched controls, showing lower hospitalization/mortality with bebtelovimab treatment, without statistical significance. Notably, none of the patients that died in the control group were hospitalized within 14 days (later hospitalization is not reported). There may be a difference in the populations in terms of propensity to receive SOC.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BQ.1.11, BA.5, BA.2.75, XBB2,3, XBB.1.5, XBB.1.9.13.

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risk of death, 85.7% lower, RR 0.14, p = 0.25, treatment 0 of 377 (0.0%), control 3 of 377 (0.8%), NNT 126, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).

risk of death/hospitalization, 43.0% lower, RR 0.57, p = 0.14, treatment 10 of 377 (2.7%), control 17 of 377 (4.5%), NNT 54.

risk of hospitalization, 28.6% lower, RR 0.71, p = 0.53, treatment 10 of 377 (2.7%), control 14 of 377 (3.7%), NNT 94.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. Planas et al., Resistance of Omicron subvariants BA.2.75.2, BA.4.6 and BQ.1.1 to neutralizing antibodies, bioRxiv, doi:10.1101/2022.11.17.516888.biorxiv.org, doi.org.

2. Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.mdpi.com, doi.org.

3. Uraki et al., Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate, iScience, doi:10.1016/j.isci.2023.108147.sciencedirect.com, doi.org.

Dryden-Peterson et al., 27 Oct 2022, retrospective, USA, peer-reviewed, 7 authors, study period 16 March, 2022 - 31 May, 2022, average treatment delay 3.0 days. Contact: awoolley@bwh.harvard.edu, sldrydenpeterson@bwh.harvard.edu.

This Paper Bebtelovimab All

Bebtelovimab for high-risk outpatients with early COVID-19 in a large US health system

MD, MSc Scott Dryden-Peterson, BS Andy Kim, MS Mary-Ruth Joyce, MD Jennifer A Johnson, MD Arthur Y Kim, MD Lindsey R Baden, MD, MPH Ann E Woolley

doi:10.1093/ofid/ofac565/6775265

There are limited data for the clinical efficacy of bebtelovimab in preventing severe COVID-19. Among outpatients unable to take nirmatrelvir-ritonavir at a large health system, 10 of 377 (2.7%) patients who received bebtelovimab and 17 of 377 (4.5%) matched untreated patients were hospitalized or died. The 43% observed risk reduction with bebtelovimab was not statistically significant (p = 0.14).

Author contributions. S.D.P. and A.E.W. designed the study. S.D.P., A.K., M.J., and A.E.W. collected and adjudicated the data. S.D.P., J.A.J., A.Y.K., L.R.B., and A.E.W. provided scientific interpretation of the data. S.D.P. and A.E.W. performed the statistical analysis. S.D.P., A.K., M.J., and A.E.W. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. S.D.P. and A.E.W. drafted the manuscript. All

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