All Studies Meta Analysis

Bamlanivimab for the Prevention of Hospitalizations and Emergency Department Visits in SARS-CoV-2–Positive Patients in a Regional Health Care System

Priest et al., Infectious Diseases in Clinical Practice, doi:10.1097/IPC.0000000000001130

Jan 2022

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Bamlanivimab/etesevimab

22nd treatment shown to reduce risk in May 2021, now with p = 0.00036 from 21 studies, recognized in 11 countries. Efficacy is variant dependent.

Lower risk for mortality, hospitalization, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine treatments.

5,500+ studies for 119 treatments. c19early.org

Retrospective 379 bamlanivimab patients and 379 matched controls in the USA, showing no significant differences with treatment.

Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron1-5.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments6. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.

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risk of death, no change, RR 1.00, p = 1.00, treatment 6 of 379 (1.6%), control 6 of 379 (1.6%).

risk of hospitalization, 3.9% higher, RR 1.04, p = 0.86, treatment 79 of 379 (20.8%), control 76 of 379 (20.1%), all-cause hospital revisit.

risk of hospitalization/ER, 5.0% higher, OR 1.05, p = 0.86, treatment 379, control 379, RR approximated with OR.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.biorxiv.org, doi.org.

2. Sheward et al., Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), bioRxiv, doi:10.1101/2021.12.19.473354.biorxiv.org, doi.org.

3. VanBlargan et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, bioRxiv, doi:10.1101/2021.12.15.472828.biorxiv.org, doi.org.

4. Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines, doi:10.3390/vaccines11101533.mdpi.com, doi.org.

5. Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.mdpi.com, doi.org.

6. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

Priest et al., 27 Jan 2022, retrospective, propensity score matching, USA, peer-reviewed, 5 authors, study period October 2020 - March 2021, average treatment delay 6.0 days.

This Paper Bamlaniv../e..All

Bamlanivimab for the Prevention of Hospitalizations and Emergency Department Visits in SARS-CoV-2-Positive Patients in a Regional Health Care System

MD, MPH David H Priest, PharmD, MHA Lisa M Blanchette, MMS, PA-C Aliza L Hekman, MS Rahul Maddikunta, BSBA Paula E Burleson

Introduction: Bamlanivimab (LY-CoV555) was approved by Emergency Use Authorization by the United States Food and Drug Administration in the ambulatory setting to prevent hospitalizations and emergency department visits. We report a retrospective, case-control study of bamlanivimab use in a regional health care system. Methods: A retrospective case-control study for SARS-CoV-2-positive patients receiving bamlanivimab and matched controls between October 2020 and March 2021 was performed. End points included all-cause hospitalization, emergency department visits, and mortality. Results: No statistically significant difference was noted in all-cause hospitalization, emergency department visits, or mortality, including patients 65 years or older, body mass index of 35 or higher, diagnosis of diabetes mellitus, or cancer (high-risk patients). No difference was seen based on timing of bamlanivimab infusion relative to symptom onset or timing of infusion within the study period. Conclusions: Based on the evaluated endpoints, there was no benefit from bamlanivimab, regardless of when it was received in a patient's clinical course or when during the study period it was received. A lack of efficacy of monoclonal antibodies in patients infected with COVID-19 variants has been noted, but the impact of local variants on these results could not be assessed given a lack of available variant diagnostic tools. These findings do not support bamlanivimab for the prevention of hospitalization or emergency department visits for patients with mild to moderate SARS-CoV-2 infection.

References

Chen, Nirula, Heller, SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2029849

Dhand, Lobo, Wolfe, Bamlanivimab for treatment of COVID-19 in solid organ transplant recipients: early single-center experience, Clin Transpl, doi:10.1111/ctr.14245

Focosi, Maggi, Neutralising antibody escape of SARS-CoV-2 spike protein: risk assessment for antibody-based Covid-19 therapeutics and vaccines, Rev Med Virol, doi:10.1002/rmv.2231

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

Kaplon, Reichert, Antibodies to watch in 2021, MAbs, doi:10.1080/19420862.2020.1860476

Liu, Wei, Zhang, V2 and 501Y.V3 variants of SARS-CoV-2 lose binding to Bamlanivimab in vitro, MAbs, doi:10.1080/19420862.2021.1919285

Ly-Cov555 Study Grouplundgren, Grund, Barkauskas, A neutralizing monoclonal antibody for hospitalized patients with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2033130

Mcginley, Only one Covid-19 treatment is designed to keep people out of the hospital

Pallotta, Kim, Gordon, Monoclonal antibodies for treating COVID-19, Cleve Clin J Med, doi:10.3949/ccjm.88a.ccc074

Starr, Greaney, Dingens, Complete map of SARS-CoV-2 RBD mutations that escape the monoclonal antibody LY-CoV555 and its cocktail with LY-CoV016, Cell Rep Med

Tuccori, Ferraro, Convertino, Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline, MAbs, doi:10.1080/19420862.2020.1854149

Tulledge-Scheitel, Bell, Larsen, A mobile unit overcomes the challenges to monoclonal antibody infusion for COVID-19 in skilled care facilities, J Am Geriatr Soc, doi:10.1111/jgs.17090

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Late treatment
is less effective

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