The FDA has warned that the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab is not expected to retain activity against the Omicron variants BQ.1 and BQ.1.1.1 Bebtelovimab (LY-CoV1404 – Lilly) is available under an FDA Emergency Use Authorization (EUA) for IV treatment of mild to moderate COVID-19 in high-risk patients ≥12 years old who weigh ≥40 kg for whom alternative treatment options are unavailable or inappropriate.2,3 The drug remains authorized for use in all regions of the US.1
The relative prevalence of SARS-CoV-2 variants BQ.1 and BQ.1.1 has increased in recent weeks. In the week ending November 12, 2022, they were estimated to have caused ~44% of COVID-19 cases in the US, up from ~9% of cases 4 weeks earlier.4
The NIH recommends that high-risk nonhospitalized adults with COVID-19 be treated with either oral ritonavir-boosted nirmatrelvir (Paxlovid) or IV remdesivir (Veklury); ritonavir-boosted nirmatrelvir is preferred.5 Both of these therapies decreased the risk of hospitalization or death significantly more than placebo in large, randomized, double-blind trials.6,7 If these drugs are inappropriate or unavailable, use of molnupiravir (Lagevrio; available under an EUA) or bebtelovimab (only if the majority of circulating SARS-CoV-2 strains in the region are susceptible to bebtelovimab) is recommended.5,8 Ritonavir-boosted nirmatrelvir, remdesivir, and molnupiravir are expected to retain activity against SARS-CoV-2 variants BQ.1 and BQ.1.1.1
- FDA. FDA updates on bebtelovimab. November 4, 2022. Available at: https://bit.ly/3FZq2za. Accessed November 15, 2022.
- An EUA for bebtelovimab for treatment of COVID-19. Med Lett Drugs Ther 2022; 64:41.
- FDA. Fact sheet for health care providers: Emergency Use Authorization for bebtelovimab. November 12, 2022. Available at: https://bit.ly/3HO6goe. Accessed November 15, 2022.
- CDC. COVID data tracker. Variant proportions. November 11, 2022. Available at: https://bit.ly/3Ka3HhH. Accessed November 15, 2022.
- NIH. COVID-19 treatment guidelines. Therapeutic management of nonhospitalized adults with COVID-19. September 26, 2022. Available at: https://bit.ly/3w5TdLB. Accessed November 15, 2022.
- J Hammond et al. Oral nirmatrelvir for high-risk, non-hospitalized adults with Covid-19. N Engl J Med 2022; 386:1397.
- RL Gottlieb et al. Early remdesivir to prevent progression to severe Covid-19 in outpatients. N Engl J Med 2022; 386:305.
- NIH. COVID-19 treatment guidelines. The COVID-19 Treatment Guidelines Panel's statement on Omicron subvariants, pre-exposure prophylaxis, and therapeutic management of nonhospitalized patients with COVID-19. November 10, 2022. Available at: http://bit.ly/3hGyZTT. Accessed November 15, 2022.