The WHO Expands Recommendation For Veklury®

California-based Gilead Sciences, Inc. 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.

And the WHO continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization.

Veklury was approved by the U.S. FDA in October 2020.

“When the full results of SOLIDARITY were published in May 2022, it showed that Veklury reduced mortality and progression to ventilation for those patients who were oxygenated and not ventilated. These findings are consistent with other studies,” said Merdad Parsey, MD, Ph.D., Chief Medical Officer, Gilead Sciences, in a press release issued on September 15, 2022.

“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.”

The WHO conditional recommendation for Veklury’s use in the treatment of patients with severe COVID-19 is mainly driven by 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 (RR: 0.83; 95% CI: 0.75–0.93).

Additionally, SOLIDARITY showed a statistically significant 13% lower relative risk of mortality with Veklury treatment for those patients hospitalized on supplemental oxygen and not requiring mechanical ventilation, compared with standard of care (RR: 0.87; 95% CI: 0.76–0.99).

In the study, Veklury had no significant effect on patients with COVID-19 who were already being ventilated.

These findings complement results from the National Institute of Allergy and Infectious Diseases' double-blind placebo-controlled ACTT-1 trial, in which a mortality reduction was seen in Veklury-treated patients on low flow oxygen at baseline, as compared to placebo, in a post-hoc subgroup analysis (HR: 0.30; 95% CI: 0.14–0.64).

Veklury did not demonstrate a mortality benefit in the overall population or other baseline oxygen subgroups in either ACTT-1 or SOLIDARITY.

In the WHO guideline, patients with severe COVID-19 are defined as those with oxygen saturation of less than 90% on room air, signs of pneumonia and/or signs of severe respiratory distress; it does not include critically ill patients on mechanical ventilation.

Numerous credible national and international organizations, including the U.S. National Institutes of Health and the European Society of Clinical Microbiology and Infectious Diseases, recommend Veklury for the treatment of COVID-19 across a broad spectrum of disease severity, including both non-severe COVID-19 patients at high risk of hospitalization and patients with severe COVID-19.

Veklury is a nucleotide analog invented by Gilead.

At this time, more than half of patients hospitalized with COVID-19 in the United States are treated with Veklury.

It can help reduce disease progression across a spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.

This media statement was curated for mobile readership.