Bamlanivimab/etesevimab will be the third monoclonal antibody option authorized to treat OUTpatients with COVID-19. This combo joins bamlanivimab and casirivimab/imdevimab as another single-dose IV infusion. And more are in the works.
These “mabs” block SARS-CoV-2 from entering cells. Combination products may also limit treatment-emergent resistant viral variants. Raise awareness of mabs as a possible COVID-19 treatment. Stay alert for patients who meet emergency use authorization (EUA) criteria. This includes outpatients positive for COVID-19 who are age 12 or older with mild to moderate symptoms for less than 10 days and at high risk of severe complications (age 65 or older, BMI 35 or higher, etc).
Help these patients weigh pros and cons. Early data suggest any available mab option may reduce ED or hospital visits by about 5% versus placebo in eligible patients. But unpublished evidence suggests bamlanivimab/etesevimab may also reduce death by about 2% versus placebo. That’s partly why guidelines currently consider it the preferred mab option. Watch for mortality data with casirivimab/imdevimab soon.
Expect evidence about efficacy against viral variants to evolve over time. For example, bamlanivimab alone won’t be distributed for now due to resistance concerns. And casirivimab/imdevimab seems to be needed for some variants, such as those from South Africa or Brazil.
Still, refer eligible patients if they want to be treated. Educate that rare hypersensitivity reactions can occur, so monitoring is needed for at least 1 hour after the infusion. Reinforce that patients still need to self-isolate. These treatments aren’t a cure and don’t prevent spread of infection. Defer COVID-19 vaccination for at least 90 days after these mabs. They may interfere with the vaccine immune response. You’ll hear about promising PREVENTION data in patients exposed to COVID-19 in households and nursing homes. But mabs can’t be used outside of EUA criteria which don’t include these patients yet.
REFERENCES
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Gottlieb RL, Nirula A, Chen P, Boscia J, Heller B, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Klekotka P, Shen L, Skovronsky DM. Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):632-644. Available at: https://jamanetwork.com/journals/jama/fullarticle/2775647
Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Musser BJ, Soo Y, Rofail D, Im J, Perry C, Pan C, Hosain R, Mahmood A, Davis JD, Turner KC, Hooper AT, Hamilton JD, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Kohli A, Sachdeva Y, Graber X, Kowal B, DiCioccio T, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):238-251. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2035002?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. [online] Available at: https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management