Casirivimab and Imdevimab Antibody combination for COVID-19 Prophylaxis
Casirivimab and Imdevimab are two non-competing, high-affinity human IgG1 anti-SARS- CoV-2 monoclonal antibodies, which bind specifically to the receptor-binding domain of the spike (S) the glycoprotein of SARS-CoV-2, blocking viral entry into host cells. These two distinct antibodies bind non-competitively to the COVID-19 virus-cell surface and prevent the virus from infecting healthy cells. Casirivimab and Imdevimab antibody cocktail was granted Emergency Use Authorization (EUA) by US FDA on November 21, 2020, and in India, the antibody cocktail received approval for restricted use in an emergency situation by DCGI on 03 Play 2021.
A recent Phase 3 study explored the possibility that subcutaneous Casirivimab Imdevimab antibody cocktail (REGEN-COV) prevents SARS-CoV-2 infection and subsequent COVID- 19 in individuals at high risk of contracting SARS-CoV-2 by close exposure in a household with a documented SARS-CoV-2-infected individual. The study included 2475 individuals <12 years within 96 hours of a household contact being diagnosed with SARS-CoV-2.
Results showed that:
- Overall, symptomatic SARS-CoV-2 infection developed in 11 of 753 participants in the REGEN-COV group (1.5%) and in 59 of 752 participants in the placebo group (7.8%) (relative risk reduction 81.4%, P< 0.001).
- Within the first week after administration of REGEN-COV or placebo, 9 of 753 participants in the REGEN-COV group (1.2%) and 32 of 752 participants in the placebo group (4.3%) had symptomatic SARS-CoV-2 infection (relative risk reduction,71.9%).
- In weeks 2 to 4, a total of 2 of 753 (0.3%) and 27 of 752 (3.6%), respectively, had symptomatic SARS-CoV-2 infection (relative risk reduction, 92.6%).
- 93.1% reduction in the aggregated total number of weeks with symptoms (12.9 weeks vs. 187.7weeks, respectively; P<0.0001).
- Prevented overall infections, either symptomatic or asymptomatic COVID-19 (66.4% risk reduction).
- 85.8% Risk reduction in the proportion of all participants with high SARS-CoV-2 viral load (defined as >10^4 copies/mLvia nasopharyngeal RT-qPCR)(1.6% vs. 11.3%, respectively: OR 0.13: P< 0.0001]
Infected participants:
- The median time for resolution of symptoms was 2 weeks shorter with REGEN-COV vs. placebo(1.2vs. 3.2 weeks, respectively) 93°/» risk reduction.
- Duration of time with high viral load(>10^4 copies/mL) was lower (0.4 vs. 1.3 weeks, respectively) 90% risk reduction.
Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS- CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load.
CDSCO approves Casirivimab and Imdevimab antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
Adults (>/= 18 years ) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
- not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS- CoV-2 vaccination (for example. individuals with immunocompromising conditions including those taking immunosuppressive medications) and
- have been exposed to an individual infected with SARS-CoV-2 having direct physical contact with the person or sharing eating and drinking utensils and being exposed to respiratory droplets from an infected person.
- Who are at high risk of exposure to an individual infected with SARS-CoV-2 because of the occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons).
Limitation of Use:
Post-exposure prophylaxis with REGEN-COV (casirivimab and imdevimab) is not a substitute for vaccination against COVID-19.
REGEN-COV (casirivimab and imdevimab) is not authorized for pre-exposure prophylaxis for the prevention of COVID-19.
For more details about the prescribing information, click here
Reference:
Marovich M. Mascola JR, Cohen MS. Monoclonal Antibodies for Prevention and Treatment of COVID-19. JAMA. 2020 Jul14:324(2):131-132.
O'Brien M et al. Subcutaneous REGEN-COV Antibody Combination for Covid-19 Prevention. N Engl J Med 2021:385:1184-95.
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