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Gilead’s Veklury WHO recommendation expanded for treatment of severe COVID-19

The antiviral showed a 17% lower relative risk of death or progression compared to standard of care


Gilead Sciences (Gilead) has announced updates to the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline, which now conditionally recommends Veklury (remdesivir) for the treatment of patients with severe COVID-19.

WHO continues to conditionally recommend Veklury for those with non-severe COVID-19 deemed to be at the highest risk of hospitalisation, Gilead noted.

In the WHO guideline, patients with severe COVID-19 are defined as those with oxygen saturation less than 90% on room air, signs of pneumonia or signs of severe respiratory distress.

The recommendation is based predominantly on the final results of the WHO-sponsored SOLIDARITY study, which showed a statistically significant 17% lower relative risk of death or progression to needing ventilation in patients requiring supplemental oxygen at baseline, compared to standard of care.

The study also showed a 13% lower relative risk of mortality with Veklury treatment for those patients hospitalised on supplemental oxygen and not requiring mechanical ventilation, compared with standard of care.

Also supporting the recommendation were results from the National Institute of Allergy and Infectious Diseases' double-blind placebo-controlled ACTT-1 trial, which demonstrated a mortality reduction in Veklury-treated patients on low flow oxygen at baseline, compared to placebo.

Merdad Parsey, chief medical officer, Gilead, said: “The WHO guideline plays an important part in informing COVID-19 treatment in many parts of the world. We are pleased this guideline update reflects the critical role that Veklury plays in helping to reduce disease progression or death from COVID-19.

“Veklury and generic remdesivir have been made available to more than 11 million patients around the world, and it’s the only antiviral treatment recommended by the WHO for both patients at high risk of progression not requiring oxygen and those requiring supplemental oxygen.”

Veklury directly inhibits viral replication in cells by targeting the SARS-CoV-2 viral RNA polymerase. Based on sequence analyses, the treatment should remain active against Omicron BA.4 and BA.5 as there are no new substitutions in the polymerase of BA.4 and BA.5, the company said, suggesting that Veklury will continue to be active against known Omicron variants.

“With this new recommendation, the WHO guideline now better reflects the full body of evidence supporting remdesivir’s role in COVID-19 treatment and aligns more closely with recommendations in most major guidelines and protocols,” said Elizabeth Sapey, professor of acute and respiratory medicine at the Institute of Inflammation and Ageing, University of Birmingham.

Article by
Emily Kimber

16th September 2022

From: Research, Regulatory



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