February 17, 2022
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Kohli A, et al. LB 102. Presented at: Conference on retroviruses and opportunistic infections; 12.-16. February 2022 (virtual meeting).
Information: Kohli reports to be part of clinical trials with Eli Lilly, Gilead Sciences, Pfizer, Regeneron and Vir Biotechnology and to be a consultant for Gilead.
A 500 mg intramuscular injection of sotrovimab was not inferior to an IV infusion of the monoclonal test antibody to treat mild to moderate COVID-19 in a phase 3 trial, the researchers reported.
FDA issued an emergency use permit for IV sotrovimab in May last year for the treatment of mild to moderate COVID-19 in patients at risk of developing serious disease. GlaxoSmithKline and Vir Biotechnology, which developed sotrovimab together, submitted an EUA request last month to also have the therapy approved as an intramuscular injection based on the results of a trial published earlier on a preprint server and presented this week at the retrovirus conference and Opportunistic Infections.
Anita Kohli, MD, MSThe Clinical Research Director at Arizona Liver Health, reported data from COMET-TAIL, a Phase 3 randomized, multicenter, open-label, noninferiority study of sotrovimab for the treatment of mild to moderate COVID-19 in participants 12 years of age or older; disease progression.
The study enrolled participants from June to August, which coincided with the increase in the delta variant in the United States. About 85% of the patients were Hispanic, and about 25% were aged 65 years or older.
The primary objective of the study was to evaluate the efficacy of sotrovimab given as a 500 mg intramuscular injection versus a 500 mg IV infusion to prevent hospitalization for more than 24 hours “for the acute treatment of illness due to any cause or death.”
Of the 376 participants who received 500 mg sotrovimab intramuscularly, 2.7% met the primary endpoint compared to 1.3% of the 378 participants who received an IV infusion – an adjusted risk difference of 1.07% (95% CI , –1.25% to 3.39%), which met the non-inferiority margin of 3.5%.
“Sotrovimab targets a highly conserved epitope in the SARS-CoV-2 spike protein that may allow sotrovimab to retain activity against very new variants that may be resistant to other monoclonal antibodies,” Kohli said.
“The ability to administer sotrovimab via intramuscular administration is expected to provide increased access for patients in need of emergency treatment,” she said.
GSK and Vir are submitting an application for emergency use to the FDA for intramuscular administration of sotrovimab for the early treatment of COVID-19. https://investors.vir.bio/news-releases/news-release-details/gsk-and-vir-submit-emergency-use-authorization-application-fda. Published January 13, 2022. Visited February 17, 2022.