October 09, 2021
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Mylonakis E. et al. Summary LB4. Presented at: IDWeek; September 29th-Oct. 02/03/2021 (virtual meeting).
Disclosure:
Mylonakis reports numerous connections to industry. Please refer to the abstract and study for all relevant financial information from the other authors.
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The antibody cocktail from Casirivimab and imdevimab significantly reduced viral loads in hospitalized patients with COVID-19 who received low or no supplemental oxygen, data presented at IDWeek showed.
Combination therapy, known as REGEN-COV (Regeneron Pharmaceuticals), also reduced the risk of death by about 36% (95% CI 7.3% – 55.7%) overall and about 56% (95% CI) within 28 days 24.25 – 74%) in patients who were seronegative at baseline.
Mylonakis E. et al. Summary LB4. Presented at: IDWeek; September 29th-Oct. 02/03/2021 (virtual meeting).
Eleftherios E. Mylonakis, MD, PHD., Professor of Infectious Diseases and Assistant Dean of Medicine at Brown University, and colleagues evaluated REGEN-COV in a randomized, double-blind, placebo-controlled study in hospitalized patients.
The therapy was approved for emergency use in the USA last November. In July, approval was extended to include post-exposure prophylaxis.
“You need to give monoclonal antibodies as early as possible,” Mylonakis told Healio. “The question concerns people who are already in the hospital. Are they too advanced in their disease for the monoclonal antibodies to help? And do the monoclonal antibodies cause damage? “
“It’s personal care”
For the study, Mylonakis and colleagues included patients hospitalized with COVID-19 and randomly assigned them in a 1: 1: 1 ratio to get either 2.4 g or 8 g IV REGEN-COV (n = 360 ) or a placebo (n =.) 160).
Patients who were seronegative and treated with REGEN-COV showed a significant reduction in viral load after 7 days (time-weighted average = -0.28 log10 copies / ml; 95% CI, -0.51 to -0.05).
“We saw no harm in the seropositive patients, but the benefit was not statistically significant,” said Mylonakis.
In the seronegative patients who received the cocktail, there was also a 47% relative risk reduction (RRR) in the proportion of patients who died or required mechanical ventilation from days 1 to 29 (10.3% treated vs. 19, 4% placebo). In addition, there was an RRR of 55.6% (6.7% treated vs. 15% placebo) and 35.9% (7.3% treated vs. 11.5% placebo) of mortality in the treatment group up to the age of 29 . Day.
“This is extremely important because not only does it give us an understanding that we are not doing harm, but it also helps us identify the patients who would benefit most, and it also gives us clinicians a way to stratify patients . ”Said Mylonakis. “We now have opportunities to think about which treatment is best for this person compared to another patient. It’s personal care. “
Outpatient study
The results of an additional study recently published in the New England Journal of Medicine showed that REGEN-COV increased the risk of COVID-19-related hospitalization and all cause death in COVID-19 outpatients with high compared to placebo Reduced risk of serious illness.
Of 1,355 patients who received 2,400 mg REGEN-COV, 18 (1.3%) were hospitalized or died compared to 62 of 1,341 (4.6%) in the placebo arm (RRR = 71.3%; p <0.001).
Of 736 patients who received a 1,200 mg dose of the cocktail, seven (1%) were hospitalized or died compared to 24 of 748 (3.2%) patients who received a placebo (RRR = 70.4% ; p = 0.002).
The median time to symptom resolution was 4 days shorter in patients who received REGEN-COV compared to those who received placebo (10 days vs. 14 days).
References:
Mylonakis E. et al. Summary LB4. Presented at: IDWeek; September 29th-Oct. 02/03/2021 (virtual meeting).
Weinreich DM, et al. N Engl J Med. 2021; doi: 10.1056 / NEJMoa2108163.
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