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0 0.5 1 1.5 2+ Death/hospitalization 30% Improvement Relative Risk Sotrovimab for COVID-19  Kip et al.  EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? Retrospective 2,571 patients in the USA (December 2020 - August 2022) Lower death/hosp. with sotrovimab (not stat. sig., p=0.14) Kip et al., Annals of Internal Medicine, Apr 2023 Favors sotrovimab Favors control

Evolving Real-World Effectiveness of Monoclonal Antibodies for Treatment of COVID-19

Kip et al., Annals of Internal Medicine, doi:10.7326/M22-1286
Apr 2023  
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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.
Retrospective 2,571 patients treated with mAbs in the USA, and 5,135 control patients, showing lower combined mortality/hospitalization for bamlanivimab, bamlanivimab/etesevimab, casirivimab/imdevimab, sotrovimab, and bebtelovimab, with statistical significance only for casirivimab/imdevimab.
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 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 US EUA has been revoked.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/hospitalization, 30.0% lower, RR 0.70, p = 0.14, treatment 22 of 500 (4.4%), control 63 of 999 (6.3%), NNT 52, delta and omicron variants, day 28.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kip et al., 4 Apr 2023, retrospective, USA, peer-reviewed, 16 authors, study period 8 December, 2020 - 31 August, 2022.
This PaperSotrovimabAll
Evolving Real-World Effectiveness of Monoclonal Antibodies for Treatment of COVID-19
PhD Kevin E Kip, PharmD Erin K Mccreary, MBA Kevin Collins, MS; Tami E Minnier, MD Graham M Snyder, MS William Garrard, PhD; Jeffrey C Mckibben, MS; Donald M Yealy, MD Christopher W Seymour, MD, MSc David T Huang, MD, MPH J Ryan Bariola, MD Mark Schmidhofer, MD Richard J Wadas, MD Derek C Angus, MD, MPH Paula L Kip, PhD Oscar C Marroquin
Annals of Internal Medicine, doi:10.7326/m22-1286
Background: Treatment guidelines and U.S. Food and Drug Administration emergency use authorizations (EUAs) of monoclonal antibodies (mAbs) for treatment of high-risk outpatients with mild to moderate COVID-19 changed frequently as different SARS-CoV-2 variants emerged. Objective: To evaluate whether early outpatient treatment with mAbs, overall and by mAb product, presumed SARS-CoV-2 variant, and immunocompromised status, is associated with reduced risk for hospitalization or death at 28 days. Design: Hypothetical pragmatic randomized trial from observational data comparing mAb-treated patients with a propensity score-matched, nontreated control group. Setting: Large U.S. health care system. Participants: High-risk outpatients eligible for mAb treatment under any EUA with a positive SARS-CoV-2 test result from 8 December 2020 to 31 August 2022. Intervention: Single-dose intravenous mAb treatment with bamlanivimab, bamlanivimab-etesevimab, sotrovimab, bebtelovimab, or intravenous or subcutaneous casirivimab-imdevimab administered within 2 days of a positive SARS-CoV-2 test result. Measurements: The primary outcome was hospitalization or death at 28 days among treated patients versus a nontreated control group (no treatment or treatment ≥3 days after SARS-CoV-2 test date). Results: The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In sensitivity analyses, the corresponding RRs for 1-and 3-day treatment grace periods were 0.59 and 0.49, respectively. In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period. Relative risk estimates for individual mAb products all suggested lower risk for hospitalization or death. Among immunocompromised patients, the RR was 0.45 (CI, 0.28 to 0.71). Limitations: Observational study design, SARS-CoV-2 variant presumed by date rather than genotyping, no data on symptom severity, and partial data on vaccination status. Conclusion: Early mAb treatment among outpatients with COVID-19 is associated with lower risk for hospitalization or death for various mAb products and SARS-CoV-2 variants.
The bottom section depicts 1:2 propensity score matching of treated and nontreated patients. mAb = monoclonal antibody.
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