NIH Panel Releases New Statement on Use of Monoclonal Antibodies or Remdesivir versus Omicron Variant Prioritization for Treatment or Prevention in the Face of Logistical/Supply Constraints

December 24, 2021

The COVID-19 Treatment Guidelines Panel (the Panel) has released new statements:

1. The COVID-19 Treatment Guidelines Panel’s Statement on the Use of Anti-SARS-CoV-2 Monoclonal Antibodies or Remdesivir for the Treatment of COVID-19 in Nonhospitalized Patients When Omicron Is the Predominant Circulating Variant
   

   The Omicron (B.1.1.529) variant of concern (VOC) has become the dominant variant in many parts of the United States. Omicron has markedly reduced susceptibility to the anti-SARS-CoV-2 monoclonal antibodies (mAbs) bamlanivimab plus etesevimab and casarivimab plus imdevimab. However, sotrovimab, another mAb, is expected to retain activity against the variant. Intravenous remdesivir is approved by the Food and Drug Administration for the treatment of COVID-19 in hospitalized patients. A 3-day regimen of remdesivir has been studied in nonhospitalized patients and resulted in a significant reduction in hospitalizations and deaths compared to placebo. Remdesivir is expected to retain activity against the Omicron variant.

   With the rapid rise in the prevalence of the Omicron VOC, it is anticipated there will be a limited supply of therapeutic agents that are active against the variant (e.g., sotrovimab and small molecule antiviral agents, once they become available) for patients who are at high risk of progression to severe COVID-19 and who might benefit from these therapies.

   In this statement, the Panel issues interim recommendations for the use of anti-SARS-CoV-2 mAbs and remdesivir in nonhospitalized patients with COVID-19. The Panel will update these recommendations as additional options for COVID-19 outpatient treatment become available.

2. The COVID-19 Treatment Guidelines Panel’s Interim Statement on Patient Prioritization for Outpatient Anti-SARS-CoV-2 Therapies or Preventive Strategies When There are Logistical or Supply Constraints
   

   With the increase in cases of COVID-19 and the emergence of the Omicron VOC, logistical or supply constraints may make it impossible to offer available outpatient therapies to all eligible patients. When these constraints limit the availability of anti-SARS-CoV-2 mAbs or small molecule antiviral drugs, the Panel recommends that patients at highest risk of clinical progression should be prioritized to receive these therapies. This statement provides the Panel’s recommendations on patient prioritization based on 4 key patient elements: age, vaccination status, immune status, and clinical risk factors.

For complete details, please see the full update on the COVID-19 Treatment Guidelines website.