The Impact of COVID-19 Monoclonal Antibody Therapy on Progression to Hospitalization in A Population with a High Percentage of the SARS-CoV-2 Alpha Variant

Main Article Content

Gabriel Johnson, PharmD Sarah Lim, MBBCh Daniel O Griffin, MD, PhD Xiong Wang, PhD Lida R Etemad, PharmD

Abstract

Objective: Several investigational monoclonal antibody (mAb) therapies have Emergency Use Authorizations (EUA) for the treatment of mild to moderate coronavirus disease 2019 (COVID-19). In well-designed randomized clinical trials (RCTs), mAb therapies have demonstrated a reduction in the progression to hospitalization and death in high-risk individuals. This study assessed the real-world efficacy of treatment with mAb therapy during a time with a high percentage of the Alpha variant circulating.


Methods: We performed a prospective study looking at the progression to hospitalization in a high-risk treatment population that qualified for mAb therapy under the current EUA and that consented to have their viral isolates undergo whole genome sequencing (WGS) to assess for the presence of genetic variants. A total of 125 patients consented to participate and ultimately 81 participants that both had obtainable sequence data and completed follow-up were included in the final analysis. Based on the risk profile of these participants we anticipated a >10% hospitalization without therapy and a 70-80% reduction based on prior RCTs. Five of the 81 patients (6%) were hospitalized despite monoclonal antibody therapy. The most common variant was Alpha (n=66, 81%), followed by other unknown variants (n=6, 7%), Iota (n=3, 4%), Epsilon (n=2, 2%), Gamma (n=2, 2%), and no variant detected (n=2, 2%).


Conclusion: Monitoring of the local variants, proper procurement decisions regarding specific mAb treatment effective against circulating variants and following real world efficacy has the potential to positively impact the use of mAb therapies. Future studies are needed to assess the efficacy of different mAb treatment results in real world settings with various SARS-CoV-2 variants, various treatment delays and various populations.

Article Details

How to Cite
JOHNSON, Gabriel et al. The Impact of COVID-19 Monoclonal Antibody Therapy on Progression to Hospitalization in A Population with a High Percentage of the SARS-CoV-2 Alpha Variant. Medical Research Archives, [S.l.], v. 10, n. 2, feb. 2022. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/2703>. Date accessed: 29 nov. 2022. doi: https://doi.org/10.18103/mra.v10i2.2703.
Section
Research Articles

References

1. Wang D, Hu B, Hu C, et al. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. Feb 7 2020;doi:10.1001/jama.2020.1585
2. Griffin DO, Brennan-Rieder D, Ngo B, et al. The Importance of Understanding the Stages of COVID-19 in Treatment and Trials. AIDS Rev. Feb 8 2021;doi:10.24875/AIDSRev.200001261
3. Kim SE, Jeong HS, Yu Y, et al. Viral kinetics of SARS-CoV-2 in asymptomatic carriers and presymptomatic patients. Int J Infect Dis. Jun 2020;95:441-443. doi:10.1016/j.ijid.2020.04.083
4. Gottlieb RL, Vaca CE, Paredes R, et al. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med. Dec 22 2021;doi:10.1056/NEJMoa2116846
5. Weinreich DM, Sivapalasingam S, Norton T, et al. REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. N Engl J Med. Jan 21 2021;384(3):238-251. doi:10.1056/NEJMoa2035002
6. Falcone M, Tiseo G, Valoriani B, et al. Efficacy of Bamlanivimab/Etesevimab and Casirivimab/Imdevimab in Preventing Progression to Severe COVID-19 and Role of Variants of Concern. Infectious diseases and therapy. Dec 2021;10(4):2479-2488. doi:10.1007/s40121-021-00525-4
7. Dougan M, Nirula A, Azizad M, et al. Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19. N Engl J Med. Oct 7 2021;385(15):1382-1392. doi:10.1056/NEJMoa2102685
8. Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. Nov 18 2021;385(21):1941-1950. doi:10.1056/NEJMoa2107934
9. Chen RE, Winkler ES, Case JB, et al. In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains. Nature. Aug 2021;596(7870):103-108. doi:10.1038/s41586-021-03720-y
10. Khunti K, Griffiths A, Majeed A, Nagpaul C, Rao M. Assessing risk for healthcare workers during the covid-19 pandemic. Bmj. Mar 15 2021;372:n602. doi:10.1136/bmj.n602
11. Planas D, Veyer D, Baidaliuk A, et al. Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization. Nature. Aug 2021;596(7871):276-280. doi:10.1038/s41586-021-03777-9
12. Ho D, Wang P, Liu L, et al. Increased Resistance of SARS-CoV-2 Variants B.1.351 and B.1.1.7 to Antibody Neutralization. Res Sq. Jan 29 2021;doi:10.21203/rs.3.rs-155394/v1