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
Mortality 57% improvement lower risk ← → higher risk ICU admission 59% Hospitalization, COVI.. 56% Hospitalization, all ca.. 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) c19early.org Molina et al., Int. J. Infectious Dise.., Apr 2023 0 0.5 1 1.5 2+ RR
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 hygiene1,2, vitamin D3, 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.1.14, BA.5, BA.2.75, XBB5,6, XBB.1.5, XBB.1.9.16.
Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments7. Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
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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: kyle.molina@cuanschutz.edu.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org December 2025 USA Russia Sudan Angola Colombia Kenya Mozambique Vietnam Peru Philippines Spain Brazil Italy France Japan Canada China Uzbekistan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland India DR Congo Madagascar Thailand Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Bosnia-Herzegovina Ukraine Côte d'Ivoire Bulgaria Greece Slovakia Singapore Iceland New Zealand Czechia Mongolia Israel Trinidad and Tobago Hong Kong North Macedonia Belarus Qatar Panama Serbia CAR USA favored high-profit treatments.The average efficacy of treatments was very low.High-cost protocols reduce early treatment, andforgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org December 2025 USA Russia Sudan Angola Colombia Kenya Mozambique Vietnam Peru Philippines Spain Brazil Italy France Japan Canada China Uzbekistan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland India DR Congo Madagascar Thailand Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Ukraine Côte d'Ivoire Eritrea Bulgaria Greece Slovakia Singapore New Zealand Malawi Czechia Mongolia Israel Trinidad and Tobago North Macedonia Belarus Qatar Panama Serbia Syria USA favored high-profit treatments.The average efficacy was very low.High-cost protocols reduce early treatment,and forgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
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.
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