Data support EUA for bebtelovimab for COVID-19 during omicron dominance
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Rates of severe disease and ICU admissions do not significantly differ among patients with COVID-19 receiving either bebtelovimab or Paxlovid, according to a recent study.
“There is no large clinical study to support the use of bebtelovimab for treatment of COVID-19,” Raymund R. Razonable, MD, FIDSA, FAST, professor of medicine and director of Mayo Clinic’s infectious diseases fellowship program, told Healio. “This is the main reason we performed this study so we can assess the outcomes of patients who were treated with this monoclonal antibody.”
Razonable and colleagues compared the outcomes of patients treated with bebtelovimab with those who received oral Paxlovid through a retrospective study of adults aged 18 years and older using data from the Monoclonal Antibody Treatment (MATRx) Program at Mayo Clinic.
According to the study, MATRx screened patients with a positive SARS-CoV-2 PCR or antigen test result to assess their eligibility for outpatient therapeutics and then randomly assigned patients to receive treatment with Paxlovid, remdesivir or bebtelovimab.
Overall, 3,607 high-risk patients participated in the study, the majority of whom (54.1%) were 65 years old and older, female (58.4%), and white (94.9%). Common comorbid conditions among these patients were hypertension (46.3%), diabetes mellitus (19.4%), and immunosuppressed status (16.3%). These patients were divided into bebtelovimab (n = 2,833) and Paxlovid (n = 774) treatment groups.
The bebtelovimab cohort had significantly higher proportions of cardiac disease, lung disease, kidney disease, rheumatologic disease, cancer and immunocompromised status — the most common of which were receipt of drugs for inflammatory and autoimmune conditions, cancer and transplantation.
In contrast, the Paxlovid patient group had a higher median body mass index and a higher proportion of diabetes mellitus. Both groups had similarly high rates of having completed primary COVID-19 vaccination.
In total, 50 (1.4%) of 3,607 patients progressed to a severe outcome by 30 days after treatment. Data showed that rates of severe disease did not differ significantly between the bebtelovimab (1.4%; 95% CI, 1.2%-1.7%) and Paxlovid (1.2%; 95% CI, 0.8%-1.5%) groups, although the rate of admission to the ICU was 0.4% and comparable between the bebtelovimab (0.5%) and Paxlovid (0.3%) cohorts.
“Bebtelovimab is an effective option for the treatment of COVID-19 in the era dominated by omicron subvariants,” Razonable concluded. “Bebtelovimab may be used as another treatment option for patients with COVID-19, especially among patients who cannot take other treatments such as Paxlovid due to drug interactions and other contraindications.”
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