WHO Issues New Recommendations on Paxlovid, Remdesivir for COVID-19

The World Health Organization now strongly recommends the use of Pfizer’s Paxlovid (nirmatrelvir-ritonavir) in patients with non-severe illness at the highest risk of hospitalization.

In its WHO Therapeutics and COVID-19: living guideline, WHO also issued a conditional recommendation against using Paxlovid in patients with non-severe illness at a low risk of hospitalization.

The WHO updated its conditional recommendation for the use of Gilead's Veklury (remdesivir) to recommend the antiviral to treat patients with non-severe COVID-19 at the highest risk of hospitalization.

WHO’s Guideline Development Group (GDG) decided that Paxlovid represents a “superior choice because it may have greater efficacy in preventing hospitalization than the alternatives, has fewer concerns with respect to harms than does molnupiravir; and is easier to administer than intravenous remdesivir and the antibodies,” WHO wrote in the new recommendations.

The WHO decided that Veklury “represents a superior choice because it may have greater efficacy in preventing hospitalization than the alternatives, has fewer concerns with respect to harms than does molnupiravir; and is easier to administer than intravenous remdesivir and the antibodies,” the organization wrote.

“The current conditional recommendation for Veklury in patients with non-severe illness at highest risk of hospitalization replaces a previous conditional recommendation against treatment with Veklury in all patients with COVID-19 regardless of disease severity,” Gilead said in a statement. “We anticipate the recommendation for patients with severe or critical illness will be updated as the WHO reviews new evidence.”

The revised recommendation on Veklury is based on evidence from Gilead’s phase 3 double-blind, placebo-controlled trial (PINETREE), which demonstrated that a three-day course of Veklury treatment significantly reduced the risk of hospitalization for non-hospitalized patients at high risk of disease progression, Gilead said

“We welcome today’s updated guideline as affirmation of the importance of early treatment of COVID-19 with an antiviral,” Gilead said.

Gilead anticipates the WHO “will continue to consider robust evidence from multiple randomized, controlled trials, including ACTT-1 and independent meta-analysis, which demonstrate the efficacy of Veklury in later-stage COVID-19 disease, and update their recommendation for patients with severe or critical illness.”

Veklury is recommended worldwide in both mild-to-moderate and severe COVID-19 disease by several key guidelines in more than 40 countries, Gilead said, including the National Institutes of Health and Infectious Diseases Society of America, National Institute for Health and Care Excellence, European Society of Clinical Microbiology and Infectious Diseases, and the Ministry of Health, Labour and Welfare of Japan.