Benefit of Investigational Vir/GSK Covid Treatment Questioned

An independent data safety monitoring board has recommended that the VIR-7831 arm of the National Institute of Health’s Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) Phase 3 trial be closed to enrollment due to questions about the magnitude of the drug’s potential benefit. Vir Biotechnology and its partner GlaxoSmithKline say VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody.

The companies say they were told that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit.

The companies say VIR-7831 is still being evaluated in an outpatient trial for early treatment of Covid-19 in adults at high risk of hospitalization or death.