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0 0.5 1 1.5 2+ Mortality 88% Improvement Relative Risk Hospitalization 61% Cheng et al. Sotrovimab for COVID-19 EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? PSM retrospective 1,530,501 patients in the USA (Sep 2021 - Apr 2022) Lower mortality (p<0.0001) and hospitalization (p<0.0001) Cheng et al., medRxiv, doi:10.1101/2022.09.07.22279497 Favors sotrovimab Favors control

Real-world Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron Waves in the United States

Cheng et al., medRxiv, doi:10.1101/2022.09.07.22279497 (Preprint)
Cheng et al., Real-world Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron.., medRxiv, doi:10.1101/2022.09.07.22279497 (Preprint)
Sep 2022   Source   PDF  
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Retrospective 1,530,501 high-risk patients in the USA, 15,633 treated with sotrovimab, showing significantly lower mortality and hospitalization with treatment. Sotrovimab maintained efficacy throughout the period analyzed - September 2021 to April 2022.
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 receive adjuvant treatments that are not tracked in the data (e.g., nasal/oral hygiene [, (B)], vitamin D [ (C)], etc.) — either because the physician recommending sotrovimab also recommended them, or because the patient seeking out sotrovimab is more likely to be familiar with the efficacy of additional treatments. Therefore, these kind of studies may overestimate the efficacy of treatments. .
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 [Liu, Sheward, VanBlargan] and a lack of efficacy for BA.2 [Zhou]. US EUA has been revoked.
risk of death, 88.0% lower, RR 0.12, p < 0.001, NNT 219, adjusted per study, propensity score matching, multivariable.
risk of hospitalization, 61.0% lower, RR 0.39, p < 0.001, NNT 35, adjusted per study, propensity score matching, multivariable.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cheng et al., 11 Sep 2022, retrospective, USA, preprint, 13 authors, study period 1 September, 2021 - 30 April, 2022.
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Real-world Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron Waves in the United States
PhD Mindy M Cheng, PhD Carolina Reyes, PhD Sacha Satram, PhD Helen Birch, MB Daniel C Gibbons, MPH Myriam Drysdale, Christopher F Bell, PhD Anvar Suyundikov, PhD Xiao Ding, M Cyrus Maher, MD Wendy Yeh, MD, PhD Amalio Telenti, MD Lawrence Corey
Background Sotrovimab, a recombinant human monoclonal antibody (mAb) against SARS-CoV-2 had US FDA Emergency Use Authorization (EUA) for the treatment of high-risk outpatients with mildto-moderate COVID-19 from May 26, 2021 to April 5, 2022. The study objective was to evaluate the real-world effectiveness of sotrovimab in reducing the risk of 30-day all-cause hospitalization and/or mortality during the time period when the prevalence of circulating SARS-CoV-2 variants was changing between Delta and Omicron sub-lineages in the US. Methods A retrospective analysis was conducted on de-identified claims data for 1,530,501 patients diagnosed with COVID-19 (ICD-10: U07.1) from September 1, 2021, to April 30, 2022, in the FAIR Health National Private Insurance Claims (FH NPIC ® ) database. Patients meeting EUA high-risk criteria were identified via pre-specified ICD-10-CM diagnoses in records ≤24 months prior to their first COVID-19 diagnosis and divided into two cohorts based on claimed procedural codes: treated with sotrovimab ("sotrovimab") and not treated with a mAb ("no mAb"). All-cause hospitalizations and facility-reported all-cause mortality within 30 days of diagnosis ("30-day hospitalization or mortality") were identified. Multivariable and propensity score-matched Poisson and logistic regressions were conducted to estimate the adjusted relative risk (RR) and odds of 30-day hospitalization or mortality among those treated with sotrovimab compared with those not treated with a mAb. Results Of the high-risk COVID-19 patients identified, 15,633 were treated with sotrovimab and 1,514,868 were not treated with a mAb. Compared with the no mAb cohort, the sotrovimab All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
Aggarwal, Beaty, Bennett, Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients During the Omicron Phase, MedRxiv, doi:10.1101/2022.06.17.22276575
Aggarwal, Beaty, Bennett, Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients, JID, doi:10.1093/infdis/jiac206
Case, Mackin, Errico, Resilience of S309 and AZD7442 Monoclonal Antibody Treatments Against Infection by SARS-CoV-2 Omicron Lineage Strains, Nature Communications
Cathcart, Havenar-Daughton, Lempp, The Dual Function Monoclonal Antibodies VIR-7831 and VIR-7832 Demonstrate Potent in Vitro and in Vivo Activity Against SARS-CoV-2, BioRxiv, doi:10.1101/2021.03.09.434607
Covid-, Estimating Excess Mortality Due to the COVID-19 Pandemic: a Systematic Analysis of COVID-19 Related Mortality, Lancet
Elbe, Buckland-Merrett, Data, Disease and Diplomacy: GISAID's Innovative Contribution to Global Health, Global Challenges
Gavriatopoulou, Ntanasis-Stathopoulous, Korompoki, Emerging treatment strategies for COVID-19 infection, Clin Exp Med
Gupta, Gonzalez-Rojas, Juarez, Early Treatment for COVID-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab, NEJM
Gupta, Gonzalez-Rojas, Juarez, Effect of Sotrovimab on Hospitalization or Death Among High-Risk Patients with Mild to Moderate COVID-19, A Randomized Clinical Trial, JAMA
Lee, Wong, Chai, Efficacy of COVID-19 Vaccines in Immunocompromised Patients: Systemic Review and Meta-analysis, BMJ
Parker, Desai, Marti, Response to Additional COVID-19 Vaccine Doses in People who are Immunocompromised: a Rapid Review, The Lancet Global Health
Telenti, Hodcroft, Robertson, The Evolution and Biology of SARS-CoV-2 Variants, Cold Spring Harb Perspect Med
Zaqout, Almaslamani, Chemaitelly, Effectiveness of the Neutralizing Antibody Sotrovimab Among High-risk Patients With Mild to Moderate SARS-CoV-2 in Qatar, MedRxiv, doi:10.1101/2022.04.21.22274060
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, 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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