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The COVID-19 Treatment Guidelines Panel’s Update on Bebtelovimab

Last Updated: December 6, 2022

The prevalence of SARS-CoV-2 Omicron subvariants that are anticipated to be resistant to bebtelovimab (i.e., BQ.1, BQ.1.1, XBB) has been rapidly increasing in the United States. As of December 2, 2022, the combined prevalence of these subvariants is estimated to be over 68%.1

Due to the increasing prevalence of these resistant strains, the Food and Drug Administration revised the Emergency Use Authorization for bebtelovimab on November 30, 2022. Bebtelovimab is not currently authorized for the treatment of COVID-19 in any region of the United States.2

The COVID-19 Treatment Guidelines Panel (the Panel) now recommends against the use of bebtelovimab for the treatment of nonhospitalized patients with COVID-19 who are at high risk of progressing to severe COVID-19 (AIII).

The antiviral drugs ritonavir-boosted nirmatrelvir (Paxlovid), remdesivir, and molnupiravir are expected to continue to be active against the currently circulating Omicron subvariants. The Panel recommends the following antiviral drugs as preferred treatments for mild to moderate COVID-19 in nonhospitalized adults who are at high risk of progressing to severe COVID-19. These drugs are listed in order of preference:

  • Ritonavir-boosted nirmatrelvir (Paxlovid) (AIIa)
  • Remdesivir (BIIa)

The Panel recommends molnupiravir as an alternative therapy when neither of the preferred therapies are available, feasible to use, or clinically appropriate (CIIa).

References

  1. Centers for Disease Control and Prevention. COVID data tracker: variant proportions. 2022. Available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Accessed December 5, 2022.
  2. Food and Drug Administration. FDA announces bebtelovimab is not currently authorized in any US region. 2022. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-bebtelovimab-not-currently-authorized-any-us-region. Accessed December 5, 2022.