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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality 88% Improvement Relative Risk Hospitalization 61% Sotrovimab for COVID-19  Cheng et al.  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) c19early.org Cheng et al., medRxiv, September 2022 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
Sep 2022  
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Sotrovimab for COVID-19
38th treatment shown to reduce risk in May 2023
 
*, now known with p = 0.0017 from 22 studies, recognized in 37 countries. Efficacy is variant dependent.
Lower risk for hospitalization.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,100+ studies for 60+ treatments. c19early.org
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 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 sotrovimab also recommended them, or because the patient seeking out sotrovimab 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 studies predict lower efficacy for BA.1 Liu, Sheward, VanBlargan, BA.4, BA.5 Haars, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.1 Pochtovyi, and no efficacy for BA.2 Zhou, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.1 Pochtovyi. US EUA has been revoked.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. Contact: mcheng@vir.bio.
This PaperSotrovimabAll
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
doi:10.1101/2022.09.07.22279497
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.
References
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
{ 'DOI': '10.1101/2022.09.07.22279497', 'URL': 'http://dx.doi.org/10.1101/2022.09.07.22279497', 'abstract': '<jats:p>Background \n' '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 ' 'mild-to-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.\n' 'Methods \n' '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.\n' 'Results \n' '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 cohort ' 'was older and had a higher proportion of patients across the majority of high-risk ' 'conditions. In the no mAb cohort, 84,307 (5.57%) patients were hospitalized and 8,167 (0.54%) ' 'deaths were identified, while in the sotrovimab cohort, 418 (2.67%) patients were ' 'hospitalized and 13 (0.08%) deaths were identified. After adjusting for potential ' 'confounders, high-risk COVID-19 patients treated with sotrovimab had a 55% relative risk ' 'reduction of 30-day hospitalization or mortality (RR: 0.45, 95% CI: 0.41,0.49) and an 85% ' 'relative risk reduction of 30-day mortality (RR: 0.15, 95% CI: 0.08, 0.29) compared with ' 'high-risk patients not treated with a mAb. From September 2021 to April 2022, sotrovimab ' 'maintained clinical effectiveness with relative risk reductions of 30-day hospitalization or ' 'mortality ranging from 46% to 71%. Stratifying by high-risk condition, sotrovimab-treated ' 'patients exhibited statistically significant relative risk reductions of 30-day ' 'hospitalization or mortality compared with the no mAb cohort across all high-risk conditions ' '(P&lt;0.0001), ranging from 44% among pregnant women to 70% among patients 65 years and ' 'older. \n' 'Conclusion \n' 'In this large, US real-world, observational study of high-risk COVID-19 patients with ' 'reported diagnosis between September 2021 and April 2022 during the Delta and early Omicron ' 'variant waves, treatment with sotrovimab was associated with reduced risk of 30-day all-cause ' 'hospitalization and facility-reported mortality compared with no mAb treatment. Sotrovimab ' 'clinical effectiveness persisted throughout the months when Delta and early Omicron ' 'sub-lineages were the predominant circulating variants in the US, though there was an ' 'uncertain RR estimate in April 2022 with wide confidence intervals due to the small sample ' 'size. Sotrovimab clinical effectiveness also persisted among all high-risk subgroups ' 'assessed.</jats:p>', 'accepted': {'date-parts': [[2022, 9, 11]]}, 'author': [ {'affiliation': [], 'family': 'Cheng', 'given': 'Mindy M.', 'sequence': 'first'}, {'affiliation': [], 'family': 'Reyes', 'given': 'Carolina', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Satram', 'given': 'Sacha', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Birch', 'given': 'Helen', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Gibbons', 'given': 'Daniel C.', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Drysdale', 'given': 'Myriam', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Bell', 'given': 'Christopher F.', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Suyundikov', 'given': 'Anvar', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Ding', 'given': 'Xiao', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Maher', 'given': 'M. 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