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0 0.5 1 1.5 2+ Mortality 57% Improvement Relative Risk ICU admission 59% Hospitalization, COVID-19 56% Hospitalization, all cause 46% Progression -33% Bebtelovimab  Molina et al.  EARLY TREATMENT Is early treatment with bebtelovimab beneficial for COVID-19? Retrospective 9,162 patients in the USA (April - October 2022) Lower hospitalization (p<0.0001) and higher progression (p=0.001) Molina et al., Int. J. Infectious Dise.., Apr 2023 Favors bebtelovimab Favors control

Real-World Evaluation of Bebtelovimab Effectiveness During the Period of COVID-19 Omicron Variants including BA.4/BA.5

Molina et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2023.04.396
Apr 2023  
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Retrospective 3,739 patients treated with bebteloviman in the USA and matched controls, showing lower mortality and hospitalization with treatment, but higher emergency department visits.
Confounding by treatment propensity. This study analyzes a population where only a fraction of eligible patients received the treatment. Patients receiving treatment may be more likely to follow other recommendations, more likely to receive additional care, and more likely to use additional treatments that are not tracked in the data (e.g., nasal/oral hygiene, (B), vitamin D (C), etc.) — either because the physician recommending bebtelovimab also recommended them, or because the patient seeking out bebtelovimab is more likely to be familiar with the efficacy of additional treatments and more likely to take the time to use them. Therefore, these kind of studies may overestimate the efficacy of treatments.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BQ.1.1 Planas, BA.5, BA.2.75, XBB Haars.
risk of death, 57.0% lower, RR 0.43, p = 0.14, treatment 3 of 3,739 (0.1%), control 11 of 5,423 (0.2%), NNT 816, adjusted per study, odds ratio converted to relative risk, propensity score matching, multivariable.
risk of ICU admission, 58.6% lower, RR 0.41, p = 0.05, treatment 6 of 3,739 (0.2%), control 21 of 5,423 (0.4%), NNT 441.
risk of hospitalization, 55.5% lower, RR 0.44, p < 0.001, treatment 38 of 3,739 (1.0%), control 107 of 5,423 (2.0%), NNT 105, adjusted per study, odds ratio converted to relative risk, COVID-19, propensity score matching, multivariable.
risk of hospitalization, 46.5% lower, RR 0.54, p < 0.001, treatment 48 of 3,739 (1.3%), control 116 of 5,423 (2.1%), NNT 117, adjusted per study, odds ratio converted to relative risk, all cause, propensity score matching, multivariable.
risk of progression, 32.6% higher, RR 1.33, p = 0.001, treatment 260 of 3,739 (7.0%), control 275 of 5,423 (5.1%), adjusted per study, odds ratio converted to relative risk, ED visit, propensity score matching, multivariable.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Molina et al., 16 Apr 2023, retrospective, USA, peer-reviewed, 11 authors, study period 6 April, 2022 - 11 October, 2022. Contact:
This PaperBebtelovimabAll
Real-World Evaluation of Bebtelovimab Effectiveness During the Period of COVID-19 Omicron Variants including BA.4/BA.5
Pharm.D. Kyle C Molina, MPSH Victoria Kennerley, MS Laurel E Beaty, MD Tellen D Bennett, PhD Nichole E Carlson, PhD David A Mayerij, BSN Jennifer L Peers, MS Seth Russell, MD Matthew K Wynia, MD, MHSc Neil R Aggarwal, MD, MPH Adit A Ginde
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2023.04.396
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Author Contributions AAG conceived and obtained funding for the study. KCM, VK LEB, NEC, NRA and AAG designed the study. VK, LEB, and NEC analysed the data. VK, LEB, TDB, NEC, DAM, and SR accessed and verified the data. KCM drafted the original version of the manuscript. All authors Conflict of Interest Statement The authors report no conflicts of interest.
Aggarwal, Beaty, Bennett, 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, International Journal of Infectious Diseases
Aggarwal, Beaty, Bennett, Real World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients, J Infect Dis
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Heinze, Schemper, A solution to the problem of separation in logistic regression, Statist Med
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Ho, Imai, King, Stuart, MatchIt: Nonparametric Preprocessing for Parametric Causal Inference, Journal of Statistical Software
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Lin, Hung, Lai, Wang, Chen, The impact of neutralizing monoclonal antibodies on the outcomes of COVID-19 outpatients: A systematic review and meta-analysis of randomized controlled trials, J Med Virol
Mccreary, Kip, Collins, Evaluation of Bebtelovimab for Treatment of Covid-19 During the SARS-CoV-2 Omicron Variant Era, Open Forum Infectious Diseases
Nguyen, Collins, Spence, Double-adjustment in propensity score matching analysis: choosing a threshold for considering residual imbalance, BMC Medical Research Methodology
Puhr, Heinze, Nold, Lusa, Geroldinger, Firth's logistic regression with rare events: accurate effect estimates and predictions?, Stat Med
Razonable, Horo, Hanson, Comparable Outcomes for Bebtelovimab and Ritonavir-Boosted Nirmatrelvir Treatment in High-Risk Patients With Coronavirus Disease-2019 During Severe Acute Respiratory Syndrome Coronavirus 2 BA.2 Omicron Epoch, The Journal of Infectious Diseases
Research, De, FDA updates Sotrovimab emergency use authorization
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