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 continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization.
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.
“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, such as ACTT-1,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “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.”
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 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 (NIH) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), 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.
“The WHO’s latest COVID-19 guideline update will help further expand access for remdesivir to those with more significant disease who are in need of effective treatment options,” said Dr. Elizabeth Sapey, BSc, MBBS, PhD, FRCP, Professor of Acute and Respiratory Medicine at the Institute of Inflammation and Ageing, University of Birmingham. “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.”