ROCHESTER, Minn. — Mayo Clinic researchers say the monoclonal antibody bebtelovimab, already authorized by the Food and Drug Administration for emergency use on the omicron variant of COVID-19, is a reliable option to treat BA.2 and other COVID-19 subvariants. The findings of their multisite, retrospective study involving 3,607 high-risk patients appear in the Journal of Infectious Diseases.
"This study gives us confidence that bebtelovimab is reliable for the treatment of high-risk patients during this omicron epoch characterized by increasingly new variants, and gives us another tool in the effort against COVID-19," says Raymund Razonable, M.D., a Mayo Clinic infectious diseases specialist and researcher, and the study's lead author.
Researchers compared outcomes of 2,833 patients infused with bebtelovimab within seven days of their first symptoms to a group of 774 patients prescribed oral nirmatrelvir-ritonavir within five days of symptoms. Because bebtelovimab was authorized for emergency use based on limited clinical data, it was designated by guidelines as an alternative therapy for high-risk patients who could not take nirmatrelvir-ritonavir or IV remdesivir.
Findings of the study showed that only 1.4% of the patients receiving bebtelovimab progressed to serious disease within 30 days. Researchers say that this is comparable to other outcomes with nirmatrelvir-ritonavir at 1.2% and the other previously authorized monoclonal antibody treatments used before the rise of BA.2. Admission to the ICU was 0.4% with bebtelovimab and 0.2% with nirmatrelvir-ritonavir.
High-risk patients included those with a wide range of conditions, but in this population, the most common were hypertension, diabetes mellitus and some form of an immunosuppressed condition. The study group was predominantly white, with a median age of 66 years.
The researchers say this is the first real-world study comparing the effectiveness of these two treatment options in large numbers of patients with COVID-19 during the BA.2 surge. This is the largest cohort of patients treated with bebtelovimab. The results support the use of bebtelovimab as a valuable option for high-risk patients who can't be treated with oral nirmatrelvir-ritonavir. The authors continue to assess its effectiveness as new variants emerge.
The study was funded by Mayo Clinic. The study's senior author is John O'Horo, M.D., a Mayo Clinic infectious diseases specialist. The co-authors are Sidna Tulledge-Scheitel, M.D.; Sara N. Hanson, D.O.; Richard Arndt, Pharm.D.; Leigh Speicher, M.D.; Teresa Seville, M.D.; Jennifer Larsen; and Ravindra Ganesh, M.D., all of Mayo Clinic.
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