Gilead’s Veklury (remdesivir) cuts risk of severe COVID-19 by 87%

Gilead Sciences has released data from its IV Outpatient Study (GS-US-540-9012, PINETREE) showing that its anti-viral drug Veklury (remdesivir) cuts the risk of severe COVID for people at high risk of progression due to comorbidities or age.

Although initially planned to study the effects of Veklury versus placebo in 1,264 participants, enrolment in the trial was stopped early, a decision blamed on the “changing epidemiology and adoption of additional treatment options”, said the company.

In the trial, Veklury demonstrated a statistically significant 87% reduction in risk for hospitalisation or all-cause death by Day 28 and 81% reduction in risk for medical visits due to COVID-19 or all-cause death by Day 28. No deaths were observed.

These results “complement positive results from ACTT-1 and other studies in hospitalised patients”, said Gilead, pointing out that Veklury helped patients recover faster and with reduced likelihood of disease progression.

“Antiviral medications provide maximal benefit when used early in the disease course. This latest data shows remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” said Robert Gottlieb, the trial’s principal investigator and a cardiologist at Baylor University Medical Center in Texas. “We are seeing very high numbers of hospitalised patients as new COVID-19 infections surge, placing increased demands on already over-burdened healthcare systems.”

However, this new data contradicts the results of two other, much larger studies. Neither the World Health Organization’s Solidarity – the world’s largest study for potential COVID treatments – nor the European Union-funded DisCoVeRy trial observed any clinical benefit of the anti-viral drug.

The DisCoVeRy trial, data from which was published in The Lancet Infectious Diseases last week, studied more than 850 people at nearly 50 sites across five European countries who had shown symptoms for seven days and required oxygen between March 2020 to January 2021.

Responding to the DisCoVeRy data, Gilead stressed the need to focus on clinical outcomes rather than “measures of treatment efficacy”, adding that it did not believe this data “alters the demonstrated benefit risk profile of Veklury”.

Veklury is the only drug approved for the treatment of COVID-19 and is indicated for adults and paediatric patients 12 years and older for the treatment of COVID-19 requiring hospitalisation in the US, EU and around the world.

In the US, Regeneron’s antibody cocktail REGEN-COV (casirivimab and imdevimab) has been authorised for emergency use for both the treatment and prevention of COVID-19 in high-risk patients, with nearly 3 billion doses ordered by the government.

The European Union has signed contracts with Roche/Regeneron as well as Eli Lilly and GSK for the supply of antibody treatments for COVID-19.