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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality 86% Improvement Relative Risk Death/hospitalization 25% Hospitalization 11% Bebtelovimab  Sridhara et al.  EARLY TREATMENT Is early treatment with bebtelovimab beneficial for COVID-19? PSM retrospective 2,182 patients in the USA (Apr - Aug 2022) Lower mortality (p=0.25) and death/hosp. (p=0.31), not sig. c19early.org Sridhara et al., PLOS ONE, April 2023 Favors bebtelovimab Favors control

Lack of effectiveness of Bebtelovimab monoclonal antibody among high-risk patients with SARS-Cov-2 Omicron during BA.2, BA.2.12.1 and BA.5 subvariants dominated era

Sridhara et al., PLOS ONE, doi:10.1371/journal.pone.0279326
Apr 2023  
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PSM retrospective 19,778 high-risk outpatients in the USA, showing no significant difference in outcomes with bebtelovimab treatment.
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 c19early.org, c19early.org (B), vitamin D c19early.org (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, 85.7% lower, RR 0.14, p = 0.25, treatment 0 of 1,091 (0.0%), control 3 of 1,091 (0.3%), NNT 364, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), propensity score matching, day 30.
risk of death/hospitalization, 25.0% lower, HR 0.75, p = 0.31, treatment 24 of 1,091 (2.2%), control 28 of 1,091 (2.6%), adjusted per study, propensity score matching, multivariable, Cox proportional hazards.
risk of hospitalization, 11.1% lower, RR 0.89, p = 0.78, treatment 24 of 1,091 (2.2%), control 27 of 1,091 (2.5%), NNT 364, propensity score matching, day 30RETRO.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sridhara et al., 28 Apr 2023, retrospective, USA, peer-reviewed, 13 authors, study period 5 April, 2022 - 1 August, 2022. Contact: btanriover@arizona.edu.
This PaperBebtelovimabAll
Lack of effectiveness of Bebtelovimab monoclonal antibody among high-risk patients with SARS-Cov-2 Omicron during BA.2, BA.2.12.1 and BA.5 subvariants dominated era
Srilekha Sridhara, Ahmet B Gungor, Halil K Erol, Mohanad Al-Obaidi, Tirdad T Zangeneh, Edward J Bedrick, Venkatesh K Ariyamuthu, Aneesha Shetty, Abd A Qannus, Katherine Mendoza, Sangeetha Murugapandian, Gaurav Gupta, Bekir Tanriover
PLOS ONE, doi:10.1371/journal.pone.0279326
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron subvariants are expected to be resistant to Bebtelovimab (BEB) monoclonal antibody (MAb) and the realworld experience regarding its effectiveness is scarce. This retrospective cohort study reports a data analysis in Banner Healthcare System (a large not-for-profit organization) between 4/5/2022 and 8/1/2022 and included 19,778 Coronavirus disease-19 (COVID-19) positive (by PCR or direct antigen testing) patients who were selected from Cerner-Electronic Health Record after the exclusions criteria were met. The study index date for cohort was determined as the date of BEB MAb administration or the date of the first positive COVID-19 testing. The cohort consist of COVID-19 infected patients who received BEB MAb (N = 1,091) compared to propensity score (PS) matched control (N = 1,091). The primary composite outcome was the incidence of 30-day all-cause hospitalization and/or mortality. All statistical analyses were conducted on the paired (matched) dataset. For the primary composite outcome, the event counts and percentages were reported. Ninety-five percent Clopper-Pearson confidence intervals for percentages were computed. The study cohorts were 1:1 propensity matched without replacement across 26 covariates using an optimal matching algorithm that minimizes the sum of absolute pairwise distance across the matched sample after fitting and using logistic regression as the distance function. The pairs were matched exactly on patient vaccination status, BMI group, age group and diabetes status. Compared to the PS matched control group (2.6%; 95% confidence interval [CI]: 1.7%, 3.7%), BEB MAb use (2.2%; 95% CI: 1.4%, 3.3%) did not significantly reduce the incidence
Writing -original draft: Srilekha Sridhara, Ahmet B. Gungor, Halil K. Erol, Mohanad Al-Obaidi, Tirdad T. Zangeneh, Venkatesh K. Ariyamuthu, Aneesha Shetty, Abd A. Qannus, Katherine Mendoza, Sangeetha Murugapandian, Gaurav Gupta, Bekir Tanriover.
References
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Bruel, Hadjadj, Maes, Planas, Seve et al., Serum neutralization of SARS-CoV-2 Omicron sublineages BA.1 and BA.2 in patients receiving monoclonal antibodies, Nat Med, doi:10.1038/s41591-022-01792-5
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Cao, Yisimayi, Jian, Song, Xiao et al., 2.12.1, BA.4 and BA.5 escape antibodies elicited by Omicron infection, Nature, doi:10.1038/s41586-022-04980-y
Covariants, None
Dougan, Azizad, Chen, alone or together with bamlanivimab and etesevimab, as a broadly neutralizing monoclonal antibody treatment for mild to moderate, ambulatory COVID-19, doi:10.1101/2022.03.10.22272100
Esper, Adhikari, Tu, Cheng, El-Haddad et al., Alpha to Omicron: Disease Severity and Clinical Outcomes of Major SARS-CoV-2 Variants, J Infect Dis, doi:10.1093/infdis/jiac411
Gershengorn, Patel, Ferreira, Das, Parekh et al., The clinical effectiveness of REGEN-COV in SARS-CoV-2 infection with Omicron versus Delta variants, PLoS One, doi:10.1371/journal.pone.0278770
Iketani, Liu, Guo, Liu, Chan et al., Antibody evasion properties of SARS-CoV-2 Omicron sublineages, Nature, doi:10.1038/s41586-022-04594-4
Ishak, Mehendale, Alrawashdeh, Sestacovschi, Sharath et al., The association of COVID-19 severity and susceptibility and genetic risk factors: A systematic review of the literature, Gene, doi:10.1016/j.gene.2022.146674
Kousathanas, Pairo-Castineira, Rawlik, Stuckey, Odhams et al., Whole-genome sequencing reveals host factors underlying critical COVID-19, Nature, doi:10.1038/s41586-022-04576-6
Mccreary, Kip, Collins, Minnier, Snyder et al., Evaluation of Bebtelovimab for Treatment of Covid-19 During the SARS-CoV-2 Omicron Variant Era, Open Forum Infect Dis, doi:10.1093/ofid/ofac517
Menni, Valdes, Polidori, Antonelli, Penamakuri et al., Symptom prevalence, duration, and risk of hospital admission in individuals infected with SARS-CoV-2 during periods of omicron and delta variant dominance: a prospective observational study from the ZOE COVID Study, Lancet, doi:10.1016/S0140-6736%2822%2900327-0
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Razonable Rr O'horo, Hanson, Arndt, Speicher, Seville, 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, J Infect Dis, doi:10.1093/infdis/jiac346
Shertel, Lange, Salerno, Hedvat, Jennings et al., Bebtelovimab for Treatment of COVID-19 in Ambulatory Solid Organ Transplant Recipients, Transplantation, doi:10.1097/TP.0000000000004278
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Takashita, Yamayoshi, Simon, Van Bakel, Sordillo et al., Efficacy of Antibodies and Antiviral Drugs against Omicron BA.2.12.1, BA.4, and BA.5 Subvariants, N Engl J Med, doi:10.1056/NEJMc2207519
Westendorf, Zentelis, Wang, Foster, Vaillancourt et al., LY-CoV1404 (bebtelovimab) potently neutralizes SARS-CoV-2 variants, Cell Rep, doi:10.1016/j.celrep.2022.110812
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Yetmar, Beam, Horo, Seville, Brumble et al., Outcomes of bebtelovimab and sotrovimab treatment of solid organ transplant recipients with mild-to-moderate coronavirus disease 2019 during the Omicron epoch, Transpl Infect Dis, doi:10.1111/tid.13901
Zeberg, Paabo, The major genetic risk factor for severe COVID-19 is inherited from Neanderthals, Nature, doi:10.1038/s41586-020-2818-3
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The cohort ' 'consist of COVID-19 infected patients who received BEB MAb (N = 1,091) compared to propensity ' 'score (PS) matched control (N = 1,091). The primary composite outcome was the incidence of ' '30-day all-cause hospitalization and/or mortality. All statistical analyses were conducted on ' 'the paired (matched) dataset. For the primary composite outcome, the event counts and ' 'percentages were reported. Ninety-five percent Clopper-Pearson confidence intervals for ' 'percentages were computed. The study cohorts were 1:1 propensity matched without replacement ' 'across 26 covariates using an optimal matching algorithm that minimizes the sum of absolute ' 'pairwise distance across the matched sample after fitting and using logistic regression as ' 'the distance function. The pairs were matched exactly on patient vaccination status, BMI ' 'group, age group and diabetes status. 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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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