- Treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalisation or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial.
- In vitro data indicate sotrovimab maintains activity against all known variants of concern, including the variant from India.
- Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the U.S. in the coming weeks.
The coronavirus disease 2019 (Covid-19) global pandemic is estimated to have killed over 3 million individuals worldwide. Older patients and those with certain comorbidities, such as obesity, diabetes mellitus, chronic pulmonary diseases, and chronic kidney disease, have been identified as those at highest risk of hospitalization or death. Now, Adrienne E. Shapiro & colleagues reported the results from a preplanned interim analysis COvid-19 Monoclonal antibody Efficacy Trial-Intent to Care Early (COMET-ICE) study evaluating the efficacy and safety of treatment with sotrovimab in high-risk, ambulatory patients with mild/moderate Covid-19. They demonstrated that, Sotrovimab (previously VIR-7831), an engineered human monoclonal antibody, can significantly reduce high risk for progression to severe COVID-19, including hospitalisation or death. Their study recently appeared in medRxiv.
Sotrovimab has been recently granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to facilitate the availability and use of this investigational monoclonal antibody for the treatment of COVID-19 in the U.S. while the pandemic remains a public health emergency.
The EUA was granted to sotrovimab based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial in high-risk adult outpatients.
In the interim analysis of the COMET-ICE study, a single 500-mg dose of sotrovimab profoundly reduced the risk of hospitalization (>24 hours) or death in high-risk adults with symptomatic Covid-19 by 85% compared with placebo (P = 0.002). For every 17 high-risk patients with symptomatic Covid-19, sotrovimab prevented one hospitalization.
Importantly, among those who were hospitalized, no patient who received sotrovimab required admission to intensive care compared with five patients who received placebo, suggesting that sotrovimab may also prevent more severe complications of Covid-19 in addition to preventing the need for hospitalization itself.
Furthermore, as a result of investigator site selection, over 60% of the study population consisted of patients self-identifying as Hispanic or Latino; thus, this trial is one of the first to demonstrate efficacy in a population that has been largely underrepresented in Covid-19 clinical trials, despite the disproportionately negative impact the pandemic has had in this ethnic group.
Finally, they demonstrated that, Sotrovimab reduced progression of Covid-19 in patients with mild/moderate disease, was well tolerated, and no safety signals were identified in their study. There was also no evidence of antibody-dependent enhancement with sotrovimab, which would have manifested as worsening of disease compared with placebo.
Their study is sponsored by Vir Biotechnology, Inc., in collaboration with GlaxoSmithKline.
Reference: Anil Gupta, Yaneicy Gonzalez-Rojas, Erick Juarez, Manuel Crespo Casal, Jaynier Moya, Diego Rodrigues Falci, Elias Sarkis, Joel Solis, Hanzhe Zheng, Nicola Scott, Andrea L. Cathcart, Christy M. Hebner, Jennifer Sager, Erik Mogalian, Craig Tipple, Amanda Peppercorn, Elizabeth Alexander, Phillip S. Pang, Almena Free, Cynthia Brinson, Melissa Aldinger, Adrienne E. Shapiro, for the COMET-ICE Investigators, “Early Covid-19 Treatment With SARS-CoV-2 Neutralizing Antibody Sotrovimab”, medRxiv 2021.05.27.21257096; doi: https://doi.org/10.1101/2021.05.27.21257096
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