Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
M.D Anil Gupta, M.D Yaneicy Gonzalez-Rojas, M.D Erick Juarez, M.D Manuel Crespo Casal, M.D Jaynier Moya, M.D Diego R Falci, Ph.D Elias Sarkis, M.D Joel Solis, M.D Hanzhe Zheng, Ph.D Nicola Scott, M.Sc Andrea L Cathcart, Ph.D Christy M Hebner, Ph.D Jennifer Sager, Ph.D Erik Mogalian, Ph.D Craig Tipple, Ph.D Amanda Peppercorn, M.D Elizabeth Alexander, M.D Phillip S Pang, Ph.D Almena Free, M.D Cynthia Brinson, M.D Melissa Aldinger, Pharm.D Adrienne E Shapiro
New England Journal of Medicine, doi:10.1056/nejmoa2107934
BACKGROUND Coronavirus disease 2019 (Covid-19) disproportionately results in hospitalization or death in older patients and those with underlying conditions. Sotrovimab is a pan-sarbecovirus monoclonal antibody that was designed to prevent progression of Covid-19 in high-risk patients early in the course of disease.
METHODS
CONCLUSIONS Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified. (Funded by Vir Biotechnology and GlaxoSmithKline; COMET-ICE ClinicalTrials.gov number, NCT04545060.
against the non-receptor-binding motif, which does not directly block the ACE2 receptor interaction, can be clinically therapeutic, and thus the results suggest a role for other receptors. 27 Second, because sotrovimab has potent effector function, the efficacy and absence of safety signals suggest that effector function is neither detrimental nor associated with antibody-dependent enhancement. 26 In fact, preclinical models of Covid-19 suggest that the potent effector function of this agent may be beneficial. 13, 14 The results of this interim analysis of COMET-ICE indicate that sotrovimab can be a therapeutic agent for outpatients with Covid-19. Notably, a 500-mg dose may also permit intramuscular administration, which may increase the convenience of and access to therapeutic antibody agents for patients with Covid-19. Studies are currently under way to evaluate this route of administration. Given its in vitro activity against variants of interest and concern, 14 as well as its ability to neutralize other sarbecoviruses, we speculate that sotrovimab has the potential to remain therapeutically active even as SARS-CoV-2 continues to evolve. Supported by Vir Biotechnology and GlaxoSmithKline. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
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