Vaccinated or Not; Would You Accept Monoclonal Antibody Therapy for Your Symptomatic COVID-19?

Updated: Sep 16

According to results of the BLAZE-1 trial (Eli-Lilly funded study comparing placebo to an infusion of bamlanivimab-etesevimab in mild to moderate COVID-19 with high risk for severe disease progression), ambulatory patients treated with monoclonal antibody therapy had significantly lower COVID-19 related hospitalizations and deaths than those patients who received placebo therapy.1 In the study, convalescent plasma (plasma obtained from recovered COVID-19 patients) was utilized, and neutralizing monoclonal antibodies (bamlanivimab and etesevimab) were isolated from the plasma. These monoclonal antibodies specifically target the surface spike glycoprotein implicated in the viral entry into host cells, which is ultimately postulated to reduce viral load and neutralize the viral clinical impact.1


Because of these significant positive results in specific patient populations, infectious disease specialists are recommending this combination therapy that was granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) in February 2021.2,3 Primary outcomes of the study demonstrated a reduced incidence of severity progression (COVID-19 related hospitalizations and death) for high-risk symptomatic ambulatory patients. Secondary outcomes showed reduction in viral load in the patients randomized to the monoclonal antibody treatment group.1


Patient benefit is demonstrated in this study. Infectious disease specialist guidelines recommend either bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab in mild to moderate COVID-19 ambulatory patients at high risk for disease progression.3 Viral variants (beta, gamma) may have in vitro resistance to monoclonal antibodies (including bamlanivimab and etesevimab), however usefulness of neutralizing antibody therapy against other variants has not yet been fully studied.1 Infectious disease specialists are recommending the combination therapy of casirivimab and imdevimab (Regen-Cov) due to possible variant resistance to other therapies. Healthcare providers speculate that these therapies will pose logistical challenges in overcrowded healthcare facilities with limited resources. However, the benefit of having less COVID-positive patients return to the Emergency Department or incur severe disease progression (or even death) will likely outweigh these challenges.


If you or your family member had mild or moderate symptoms of COVID-19, were at risk for progression to serious disease, and were offered monoclonal antibody therapy in the Emergency Department or medical clinic, would you choose to receive this passive immunotherapy?


Pacific Apex law partner Julie McCoy is a pharmacist-attorney, with a special interest in clinical trials. She assists clients bring pharmaceuticals and medical devices to market. She also assists providers and scientists navigate the institutional review board (IRB) process for medical studies, clinical inquiry protocols, and clinical trials. As a pharmacist, Julie keeps abreast of the best drug therapy for medical treatment, and as an attorney, she focuses on healthcare and life sciences compliance and patient safety.


Please contact Julie if you are in the process of performing a medication utilization evaluation (MUE), or developing a pharmaceutical, medical device or medical study. Julie frequently counsels clients on FDA regulation, IRB strategy, structure and process, and HIPAA compliance.


References:

1. Dougan M, et al. N Engl J Med. 2021;doi:10.1056/NEJMoq2102685

2. Antibody cocktail lowers risk for death, hospitalization from COVID-19

3. IDSA Guidelines on the Treatment and Management of Patients with COVID-19

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