Evusheld Protected Unvaccinated High-Risk Patients From COVID-19 Progression or Death

AstraZeneca is aiming to expand the use of its dual-antibody COVID-19 treatment Evusheld (tixagevimab–cilgavimab) to nonhospitalized patients with mild-to-moderate COVID 19 based on data from a late-stage study that showed it reduced the risk of progression to severe disease or death by 50 percent in a group of unvaccinated patients at high risk of poor outcomes.

The drug was particularly effective when given in the first three days after symptom onset, according to a report in the journal Lancet Respiratory Medicine. In this group, Evusheld reduced the risk of disease progression or death from any cause by 88 percent relative to placebo. Among those who got it within the first five days, the risk reduction was 67 percent.

The ongoing study comprises 1,014 unvaccinated, nonhospitalized patients with mild-to-moderate COVID-19. Severe disease or death occurred in 18 (4 percent) of those who received Evusheld compared to 37 (9 percent) of those who got a placebo injection. The absolute 4.5 percent case reduction translated to a relative risk reduction of 50.5 percent.

Evusheld also hit on the secondary endpoint, cutting the risk of respiratory failure by 72 percent relative to placebo. Three patients who got the drug (0.7 percent) needed respiratory support measures (mechanical ventilation or extracorporeal membrane oxygenation) compared to 11 (3 percent) in the placebo group.

Evusheld uses humanized antibodies extracted from COVID-19 convalescent serum and engineered to last many times longer than innate antibodies. Each of the antibodies in the treatment binds to a different area of the SARS CoV-2 virus.

A growing body of evidence also shows that Evusheld prevents disease progression regardless of SARS-CoV2 variant – including the highly contagious BA.2, as well as Omicron BA.1 and BA.1.1. According to the company, preclinical data suggest that it’s active against the emerging Omicron BA.4 and BA.5 variants, as well.

Evusheld won FDA Emergency Use Authorization last December for prevention of COVID-19 in adults and children age 12 years and older with weak immune systems (DID, Dec. 9, 2021).

Trial participants will continue to be followed for 15 months.

Read the Lancet Respiratory Medicine study here: bit.ly/3Qccd2Z. — Michele G. Sullivan