Original Title: Casirivimab e imdevimab para COVID-19 en pacientes con variante negativa para Ómicron

Authors' recommendations: No evidence assessing the use of casirivimab and imdevimab in patients with different virus genotypes (Delta or Omicron) and at different epidemiological times of the pandemic has been found. The studies included in this document were published before the various SARS CoV-2 strains appeared. The evidence presented below refers to non-ómicron variants. Moderate-quality evidence shows that combining casirivimab and imdevimab (Ronapreve, REGEN-COV®) in seronegative (non-vaccinated), COVID-19 positive, asymptomatic or mildly to moderately symptomatic patients with risk factors (over 65 years old, obesity, diabetes, respiratory diseases, kidney failure, immunosuppression), probably results in a considerable net benefit in reducing hospitalization rates and SARS CoV-2 viral load, and a lower net benefit in death rates due to COVID-19, when compared with placebo plus the standard of care. Moderate-quality evidence shows that the use of the casirivimab and imdevimab combination in individuals in close contact with COVID-19 patients results in a considerable net benefit in SARS CoV-2 viral infection rates when compared with placebo plus standard of care. Moderate-quality evidence shows that the casirivimab and imdevimab combination in individuals hospitalized due to positive SARS CoV-2 infection or vaccination results in a marginal or null benefit in reducing mortality since it has not shown differences when compared with the standard of care. Moderate-quality evidence shows that the casirivimab and imdevimab combination in individuals hospitalized due to positive SARS CoV-2 infection and with COVID-19 condition results in a marginal or null benefit in reducing mortality since it has not shown differences when compared with the standard of care. The United States Food and Drug Administration did not approve its use in patients with the Omicron variant due to its lack of efficacy in in-vitro studies. This combination has not already been approved for commercial use by Argentina’s National Administration of Medicines, Food and Medical Devices. There was heterogeneity in the recommendations included in the different clinical practice guidelines. The United States, France and Australia suggested its use in suspected cases and in patients with mild to moderate SARS-CoV-2 infections with comorbidities (recommendations issued in 2020-2021). The World Health Organization (December 2021) only recommends its use in patients with comorbidities classified as at high-risk of hospitalization, who have not been vaccinated and in patients with moderate to severe disease with negative antibodies for SARS-CoV-2. The United Kingdom (January 2022) recommends its use in patients 12 years old or more who have been hospitalized due to other causes, and those who have not been vaccinated, in order to prevent in-hospital SARS-CoV-2 infections. Public health funders from Brazil and Mexico do not provide coverage for this treatment. In an economic evaluation carried out in Brazil, the use of this technology in patients hospitalized due to COVID-19 has not been cost-effective.

Project Status: Completed

Year Published: 2022

URL for published report: https://www.iecs.org.ar/publicacion/?id=22060

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)