501Y.V2 and 501Y.V3 variants of SARS-CoV-2 lose binding to Bamlanivimab<i>in vitro</i>

Liu, Haolin; Wei, Pengcheng; Zhang, Qianqian; Chen, Zhongzhou; Aviszus, Katja; Downing, Walter; Peterson, Shelley; Reynoso, Lyndon; Downey, Gregory P.; Frankel, Stephen K.; Kappler, John W.; Marrack, Philippa; Zhang, Gongyi

doi:10.1101/2021.02.16.431305

Cited by 42 publications

(60 citation statements)

References 16 publications

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“…While reported rates of clinically concerning variants were low in Pennsylvania during much of this time frame, there is concern that use of bamlanivimab monotherapy will lead to escape variants and/or that variants are underreported. 18 We were unable to evaluate any such existing prevalence or emergence in our patients. Finally, during the time of this study, we utilized bamlanivimab monotherapy exclusively, so we are unable to comment on any comparison to the other available monoclonal antibodies for treatment of mild-moderate COVID-19 infection.…”

Section: Discussionmentioning

confidence: 84%

Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection

Bariola

et al. 2021

Preprint

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Background: Monoclonal antibody (mAb) treatment may prevent complications of COVID-19. We sought to quantify the impact of bamlanivimab monotherapy on hospitalizations and mortality, as well as Emergency Department (ED) visits without hospitalization, among outpatients at high risk of COVID-19 complications. Methods: We compared patients receiving mAb to patients who met criteria but did not receive mAb from December 2020 through March 2021. The study population selection used propensity scores to match 1:1 by likelihood to receive mAb. The primary outcome was hospitalization or all-cause mortality within 28 days; the secondary outcome was hospitalization or ED visit without hospitalization within 28 days. Odds ratios (OR) calculation used logistic regression modeling including propensity score and mAb receipt predictors. Results: The study population included 234 patients receiving mAb and 234 matched comparator patients not receiving mAb. Patients receiving mAb were less likely to experience hospitalization or mortality (OR 0.31, 95% confidence interval [95%CI] 0.17-0.56, p=0.00001) and hospitalization or ED visit without hospitalization (OR 0.50, 95%CI 0.43-0.83, p=0.007). The impact of mAb was more pronounced in prevention of hospitalization (among all age groups, OR 0.35, 95%CI 0.19-0.66, p=0.001) than mortality or ED visit without hospitalization, and most strongly associated with patients age 65 years and older (primary outcome OR 0.28, 95%CI 0.14-0.56, p=0.0003). Conclusions: Bamlanivimab monotherapy was associated with reduction in the composite outcome of hospitalizations and mortality in patients with mild-moderate COVID-19. The benefit may be strongest in preventing hospitalization in patients ages 65 years or older.

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Section: Discussionmentioning

confidence: 84%

Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection

Bariola

et al. 2021

Preprint

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“…The coronavirus disease 2019 (Covid- 19) global pandemic is estimated to have killed over 3 million individuals worldwide. 1 In the United States alone, there were an estimated 960,000 to 2.4 million hospitalizations through Fall 2020 and, at the peak of the pandemic in January 2021, 79% of intensive care hospital beds were occupied by Covid-19 patients.…”

Section: Introductionmentioning

confidence: 99%

Early Covid-19 Treatment With SARS-CoV-2 Neutralizing Antibody Sotrovimab

Gupta

Gonzalez‐Rojas²,

Juárez³

et al. 2021

Preprint

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Background: Coronavirus disease 2019 (Covid-19) disproportionately results in hospitalization and death in older patients and those with underlying comorbidities. Sotrovimab is a pan-sarbecovirus monoclonal antibody designed to treat such high-risk patients early in the course of disease, thereby preventing Covid-19 progression. Methods: In this ongoing, multicenter, double-blind, phase 3 trial, nonhospitalized patients with symptomatic Covid-19 and at least one risk factor for disease progression were randomized (1:1) to an intravenous infusion of sotrovimab 500 mg or placebo. The primary efficacy endpoint was the proportion of patients with Covid-19 progression, defined as hospitalization longer than 24 hours or death, through day 29. Results: In this preplanned interim analysis, which included an intent-to-treat population of 583 patients (sotrovimab, 291; placebo, 292), the primary efficacy endpoint was met. The risk of Covid-19 progression was significantly reduced by 85% (97.24% confidence interval, 44% to 96%; P = 0.002) with a total of three (1%) patients progressing to the primary endpoint in the sotrovimab group versus 21 (7%) patients in the placebo group. All five patients admitted to intensive care, including one who died by day 29, received placebo. Safety was assessed in 868 patients (sotrovimab, 430; placebo, 438). Adverse events were reported by 17% and 19% of patients receiving sotrovimab and placebo, respectively; serious adverse events were less common with sotrovimab (2%) versus placebo (6%). Conclusion: Sotrovimab reduced progression of Covid-19 in patients with mild/moderate disease, was well tolerated, and no safety signals were identified. Funded by Vir Biotechnology, Inc. and GlaxoSmithKline; ClinicalTrials.gov NCT04545060

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“…Our follow-up experiments do show that the E484K mutation abolishes the binding between Bamlanivimab and RBD in vitro. 14 Thus, this monoclonal may not be effective in treatment of COVID-19 patients with either South Africa or Brazilian variant.…”

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confidence: 98%