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.

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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.

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

References

Aggarwal, Beaty, Bennett, Carlson, Ginde, Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients During the Omicron Phase, Medrxiv. Published, doi:10.1101/2022.06.17.22276575

Dougan, Azizad, Chen, Bebtelovimab, alone or together with bamlanivimab and etesevimab, as a broadly neutralizing monoclonal antibody treatment for mild to moderate, ambulatory COVID-19, Medrxiv. Published, doi:10.1101/2022.03.10.22272100

Dougan, Nirula, Azizad, Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19, New Engl J Med, doi:10.1056/nejmoa2102685

Dryden-Peterson, Kim, Kim, Nirmatrelvir plus ritonavir for early COVID-19 and hospitalization in a large US health system, Published online, doi:10.1101/2022.06.14.22276393

Ganatra, Dani, Ahmad, Oral Nirmatrelvir and Ritonavir in Non-hospitalized Vaccinated Patients with Covid-19, Clin Infect Dis Official Publ Infect Dis Soc Am. Published, doi:10.1093/cid/ciac673

Ganesh, Philpot, Bierle, Real-World Clinical Outcomes of Bamlanivimab and Casirivimab-Imdevimab among High-Risk Patients with Mild to Moderate Coronavirus Disease 2019, J Infect Dis, doi:10.1093/infdis/jiab377

Gupta, Gonzalez-Rojas, Juarez, Early Treatment for Covid-19 with SARS-CoV-2

Halekoh, Højsgaard, Yan, The R Package geepack for Generalized Estimating Equations, J Stat Softw, doi:10.18637/jss.v015.i02

Khare, Gurry, Freitas, GISAID's Role in Pandemic Response, China Cdc Wkly, doi:10.46234/ccdcw2021.255

Liang, Zeger, Longitudinal data analysis using generalized linear models, Biometrika

Razonable, Horo, Hanson, Comparable Outcomes for Bebtelovimab and Ritonavir-Boosted Nirmatrelvir Treatment in High-Risk Patients With Coronavirus Disease

Rubin, Liu, Giobbie-Hurder, Performance of a Triage Protocol for Monoclonal Antibodies in a Mixed Vaccinated and Unvaccinated Cohort of COVID-19 Patients Treated With Intravenous Infusion or Subcutaneous Injection, Open Forum Infect Dis, doi:10.1093/ofid/ofac182

Takashita, Yamayoshi, Simon, Efficacy of Antibodies and Antiviral Drugs against Omicron BA.2.12, New Engl J Med. Published, doi:10.1056/nejmc2207519

Weinreich, Sivapalasingam, Norton, REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19, New Engl J Med, doi:10.1056/nejmoa2035002

Yetmar, Beam, Horo, Outcomes of Bebtelovimab and Sotrovimab Treatment of Solid Organ Transplant Recipients with Mild-to-moderate COVID-19 during the Omicron Epoch, Transpl Infect Dis. Published, doi:10.1111/tid.13901

Zou, A Modified Poisson Regression Approach to Prospective Studies with Binary Data, American Journal of Epidemiology, doi:10.1093/aje/kwh090

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