Casirivimab and Imdevimab Antibody combination for COVID-19 Prophylaxis

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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