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The clinical effectiveness of REGEN-COV in SARS-CoV-2 infection with Omicron versus Delta variants

Gershengorn et al., PLOS ONE, doi:10.1371/journal.pone.0278770

Dec 2022

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Casirivimab/imdevimab

16th treatment shown to reduce risk in March 2021

^*, now known with p = 0.000018 from 28 studies, recognized in 42 countries. Efficacy is variant dependent.

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

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,100+ studies for 60+ treatments. c19early.org

Retrospective 2,083 outpatients in the USA, showing higher risk of hospitalization with casirivimab/imdevimab, without statistical significance. There may be significant unadjusted confounding by indication.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for many omicron variants Haars, Liu, Pochtovyi, Sheward, Tatham, VanBlargan.

This study is excluded in the after exclusion results of meta analysis: substantial unadjusted confounding by indication possible.

1. 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.

2. 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.

3. 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.

4. 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.

5. Tatham et al., Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV 2 Omicron variant (B.1.1.529) in K18-hACE2 mice, bioRxiv, doi:10.1101/2022.01.23.477397.biorxiv.org, doi.org.

6. 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.

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risk of hospitalization, 95.0% higher, OR 1.95, p = 0.09, treatment 369, control 5,915, adjusted per study, multivariable, day 30, RR approximated with OR.

risk of hospitalization, 104.9% higher, RR 2.05, p = 0.009, treatment 21 of 369 (5.7%), control 41 of 1,476 (2.8%), propensity score matching, day 30, Figure 2, PSM cohort.

risk of hospitalization, 100% higher, RR 2.00, p = 0.07, treatment 11 of 213 (5.2%), control 22 of 852 (2.6%), delta, propensity score matching, day 30, Figure 2, PSM cohort.

risk of hospitalization, 110.5% higher, RR 2.11, p = 0.06, treatment 10 of 156 (6.4%), control 19 of 624 (3.0%), omicron, propensity score matching, day 30, Figure 2, PSM cohort.

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

Gershengorn et al., 2 Dec 2022, retrospective, USA, peer-reviewed, 6 authors. Contact: hbg20@med.miami.edu, hsro@miami.edu.

This Paper Casirivimab/i..All

The clinical effectiveness of REGEN-COV in SARS-CoV-2 infection with Omicron versus Delta variants

Hayley B Gershengorn, Samira Patel, Tanira Ferreira, Sankalp Das, Dipen J Parekh, Bhavarth Shukla

PLOS ONE, doi:10.1371/journal.pone.0278770

Background In vitro studies suggesting that REGEN-COV (casirivimab plus imdevimab monoclonal antibodies) had poor efficacy against Omicron-variant SARS-CoV-2 infection led to amendment of REGEN-COV's Emergency Use Authorization to recommend use only in regions without high Omicron prevalence. REGEN-COV's relative clinical effectiveness for Omicron is unknown. Methods and findings We conducted a retrospective cohort study of non-hospitalized adults who tested positive for SARS-CoV-2 by polymerase chain reaction at the

Supporting information S1 Table .

References

Brehm, Pfefferle, Possel, Karolyi, Zoufaly et al., Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for SARS-CoV-2 delta and omicron variants, J Med Virol, doi:10.1002/jmv.27916

Cao, Wang, Jian, Song, Yisimayi, Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies, Nature, doi:10.1038/s41586-021-04385-3

Chen, Winkler, Case, Aziati, Bricker et al., In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains, Nature, doi:10.1038/s41586-021-03720-y

Deyo, Cherkin, Ciol, Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases, J Clin Epidemiol, doi:10.1016/0895-4356%2892%2990133-8

Falcone, Tiseo, Valoriani, Barbieri, Occhineri et al., Efficacy of Bamlanivimab/ Etesevimab and Casirivimab/Imdevimab in Preventing Progression to Severe COVID-19 and Role of Variants of Concern, Infect Dis Ther, doi:10.1007/s40121-021-00525-4

Hachmann, Miller, Collier, Ventura, Yu et al., Neutralization Escape by SARS-CoV-2 Omicron Subvariants BA.2.12.1, BA.4, and BA.5, N Engl J Med, doi:10.1056/NEJMc2206576

Keating, Dong, Meko, Visualizing the omicron wave striking and rolling across the country, The Washington Post

Lusvarghi, Pollett, Neerukonda, Wang, Vassell, SARS-CoV-2 BA.1 variant is neutralized by vaccine booster-elicited serum but evades most convalescent serum and therapeutic antibodies, Sci Transl Med, doi:10.1126/scitranslmed.abn8543

Shaughnessy, Emergency Use Authorization 091

Tao, Tzou, Pond, Ioannidis, Shafer, Susceptibility of SARS-CoV-2 Omicron Variants to Therapeutic Monoclonal Antibodies: Systematic Review and Meta-analysis, Microbiol Spectr, doi:10.1128/spectrum.00926-22

Vanblargan, Errico, Halfmann, Zost, Crowe et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies, Nat Med, doi:10.1038/s41591-021-01678-y

Ward, Bermingham, Ayoubkhani, Gethings, Pouwels et al., Risk of covid-19 related deaths for SARS-CoV-2 omicron (B.1.1.529) compared with delta (B.1.617.2): retrospective cohort study, BMJ, doi:10.1136/bmj-2022-070695

Weinreich, Sivapalasingam, Norton, Ali, Gao et al., REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2108163

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