The COVID-19 Treatment Guidelines Panel's Statement on the Role of Bebtelovimab for the Treatment of High-Risk, Nonhospitalized Patients With Mild to Moderate COVID-19
Last Updated: March 2, 2022

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On February 11, 2022, the Food and Drug Administration issued an Emergency Use Authorization (EUA) for the anti-SARS-CoV-2 monoclonal antibody (mAb) bebtelovimab for the treatment of nonhospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease.1 Bebtelovimab is a recombinant neutralizing human mAb that binds to the spike protein of SARS-CoV-2. Based on in vitro data, bebtelovimab is expected to have activity against a broad range of SARS-CoV-2 variants, including the B.1.1.529 (Omicron) variant of concern (VOC) and its BA.1 and BA.2 subvariants.2,3

Purpose of This Statement
The COVID-19 Treatment Guidelines Panel (the Panel) previously provided recommendations for 4 drugs with activities against the Omicron VOC (ritonavir-boosted nirmatrelvir [Paxlovid], sotrovimab, remdesivir, and molnupiravir) that can be used as treatment for nonhospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease (see Therapeutic Management of Nonhospitalized Adults With COVID-19 for more information). The purpose of this statement is to provide clinicians with guidance on the role of bebtelovimab as an additional treatment option for this patient population.

Recommendations
Preferred Therapies
For nonhospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease, the Panel recommends using 1 of the following therapies (listed in order of preference):

Nirmatrelvir 300 mg with ritonavir 100 mg (Paxlovid) orally twice daily for 5 days, initiated as soon as possible and within 5 days of symptom onset in those aged ≥12 years and weighing ≥40 kg (AIIa).
Sotrovimab 500 mg as a single intravenous (IV) infusion, administered as soon as possible and within 7 days of symptom onset in those aged ≥12 years and weighing ≥40 kg (AIIa).
Remdesivir 200 mg IV on Day 1, followed by remdesivir 100 mg IV once daily on Days 2 and 3, initiated as soon as possible and within 7 days of symptom onset in those aged ≥12 years and weighing ≥40 kg (BIIa).

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