Sotrovimab Recommendation Revised in COVID-19 Treatment Guidelines

April 01, 2022

The anti-SARS-CoV-2 monoclonal antibody sotrovimab is active against the Omicron BA.1 and BA.1.1 subvariants, but it has substantially decreased in vitro activity against the BA.2 subvariant. The Food and Drug Administration recently updated the Emergency Use Authorization (EUA) for sotrovimab to note that sotrovimab is not authorized for use in geographic regions where infection is likely to have been caused by nonsusceptible SARS-CoV-2 variants, and distribution of sotrovimab has been paused in these regions.

The COVID-19 Treatment Guidelines Panel (the Panel) previously recommended sotrovimab as one of the preferred therapies for the treatment of nonhospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease. However, due to the recent changes to the EUA and the increasing prevalence of the BA.2 subvariant across all regions, the Panel now recommends using sotrovimab ONLY in regions where the Omicron BA.2 subvariant is not the dominant subvariant and ONLY in cases where none of the preferred or alternative treatment options are available, feasible to use, or clinically appropriate (CIII).

The Panel has also added new information on bebtelovimab, distribution information for sotrovimab, and updated dosing information for tixagevimab plus cilgavimab (Evusheld).

For complete details on these updates, see What's New in the Guidelines on the COVID-19 Treatment Guidelines website.