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c19early.org COVID-19 treatment researchBamlanivimab/etesevimabBamlaniv../e.. (more..)
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Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19

Patel et al., Infectious Diseases and Therapy, doi:10.1007/s40121-024-01031-z, BLAZE-1, NCT04427501, Sep 2024
https://c19early.org/patel9.html
25th treatment shown to reduce risk in May 2021, now with p = 0.00036 from 21 studies, recognized in 11 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments.
6,000+ studies for 176 treatments. c19early.org
RCT 354 outpatients with mild-to-moderate COVID-19, published over 3 years after completion, showing lower risk of persistently high viral load at day 7 and lower COVID-19 related hospitalization with low-dose bamlanivimab plus etesevimab compared to placebo. However, authors pool non-concurrent placebo patients - the concurrent placebo group had 0/141 deaths versus 10/917 for the pooled group. Authors do not report the number of hospitalizations for the concurrent placebo group.
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron1-5.
Patel et al., 4 Sep 2024, Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 9 authors, study period 17 June, 2020 - 9 April, 2021, trial NCT04427501 (history) (BLAZE-1). Contact: hufford_matthew@lilly.com.
Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19
Dipak R Patel, Lisa Macpherson, Martin Bohm, Himanshu Upadhyaya, Carmen Deveau, Ajay Nirula, Paul Klekotka, Mark Williams, Matthew M Hufford
Infectious Diseases and Therapy, doi:10.1007/s40121-024-01031-z
Introduction: The monoclonal antibody therapies bamlanivimab (BAM) + etesevimab (ETE) received emergency use authorization (EUA) from the US Food and Drug Administration (February 9, 2021) for treatment of mild-to-moderate COVID-19. The EUA of BAM + ETE was revoked (December 14, 2023) due to the high prevalence of BAM + ETE-resistant variants of SARS-CoV-2. Efficacy and safety of 700/1400 mg and 2800/2800 mg BAM + ETE are well established and published; however, efficacy and safety of 350/700 mg BAM + ETE have not been disclosed to date. Methods: This portion of phase 3, BLAZE-1 trial (J2X-MC-PYAB) enrolled patients (between June 17, 2020 and April 9, 2021) with mild-tomoderate COVID-19 within 3 days of laboratory diagnosis of SARS-CoV-2 infection. In total, 354 patients with at least one risk factor for severe COVID-19 were enrolled, randomized (2:3), and infused with placebo (N = 141) or 350/700 mg BAM + ETE (N = 213), over ~ 8 min. Primary endpoint was to assess proportion of patients with persistently high SARS-CoV-2 viral load (PHVL) (log viral load > 5.27) 7 days after infusion. Results: Patients were aged (mean) 53 years, 49.7% female, and 82.7% White. Seven days after drug infusion, 10.8% (95% confidence interval: 6.6, 15.0; p < 0.001) of BAM + ETEtreated patients and 34.8% (26.9, 42.6) of placebo-treated patients had PHVL, and the viral load change from baseline (least square mean [standard error]) was -3.50 (0.15; p < 0.001) in BAM + ETE-treated patients versus -2.51 (0.19) in placebo-treated patients. The majority of treatment-emergent adverse events were considered mild or moderate in severity (BAM + ETE: 6.6%; placebo: 14.2%). No deaths were reported. Conclusions: Consistent with previous studies, patients treated with BAM + ETE (350/700 mg) had a significantly lower proportion of PHVL and greater reduction in viral load compared with placebo. The overall safety profile is consistent with higher doses of BAM + ETE. Infusions of over ~ 8 min did not result in meaningful increase in incidence of TEAEs compared to higher doses of BAM + ETE administered over 30-60 min.
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
References
Behr, Maddox, Epstein, Orav, Barnett, Anti-SARS-CoV-2 monoclonal antibody distribution to high-risk Medicare beneficiaries, 2020-2021, JAMA
Benton, Wrobel, Xu, Receptor binding and priming of the spike protein of SARS-CoV-2 for membrane fusion, Nature
Dougan, Azizad, Mocherla, A randomized, placebo-controlled clinical trial of bamlanivimab and etesevimab together in high-risk ambulatory patients with COVID-19 and validation of the prognostic value of persistently high viral load, Clin Infect Dis
Dougan, Nirula, Azizad, Bamlanivimab plus etesevimab in mild or moderate Covid-19, N Engl J Med
Firth, Bias reduction of maximum likelihood estimates Get access Arrow, Biometrika
Gottlieb, Nirula, Chen, Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial, JAMA, doi:10.1001/jama.2021.0202
Infusion, WHICH ONE'S BET-TER?
Li, Moore, Vasilieva, Angiotensinconverting enzyme 2 is a functional receptor for the SARS coronavirus, Nature
Nichols, Macpherson, Patel, Yeh, Peppercorn, Effect of bamlanivimab as monotherapy or in combination with etesevimab or sotrovimab on persistently high viral load in patients with mild-to-moderate COVID-19: a randomized, phase 2 BLAZE-4 trial, Infect Dis Ther
Sheward, Kim, Ehling, Neutralisation sensitivity of the SARS-CoV-2 omicron (B.1.1.529) variant: a cross-sectional study, Lancet Infect Dis
Vanblargan, Errico, Halfmann, An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies, Nat Med
Wang, Zhang, Wu, Structural and functional basis of SARS-CoV-2 entry by using human ACE2, Cell
Yan, Zhang, Li, Xia, Guo et al., Structural basis for the recognition of SARS-CoV-2 by full-length human ACE2, Science
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Hufford are employees and/or stockholders of Eli Lilly and Company. Himanshu Upadhyaya was an employee at Eli Lilly and Company at the time of study and development of the manuscript and is currently employed by Supernus Pharmaceuticals, Inc. Rockville, Maryland, USA. Ajay Nirula was an employee at Eli Lilly and Company at the time of study and development of the manuscript and is currently employed by Recludix Pharma, San Diego, California, USA." }, { "group": { "label": "Ethics Approval and Consent to Participate", "name": "EthicsHeading" }, "name": "Ethics", "order": 3, "value": "The study was conducted in accordance with the principles of the Declaration of Helsinki (2000), the International Conference on Harmonization, and the E6 Guideline for Good Clinical Practice. 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