Citing a lack of evidence that it improves survival, the need for ventilation or time to clinical improvement, the World Health Organization (WHO) has advised doctors against using Gilead Sciences Inc.’s antiviral Veklury (remdesivir) to treat COVID-19. Gilead called the medicine, the first and only antiviral treatment approved for patients with COVID-19, a recognized standard of care. The WHO guidelines, it said, appear to ignore evidence of the drug's benefits.
The panel behind WHO’s new advice recognized that current evidence "did not prove that remdesivir has no benefit," but said "there is no current evidence that it improves important patient outcomes."
The recommendation was informed by results from a systematic review and network meta-analysis that pooled data from four randomized trials with 7,333 participants hospitalized for COVID-19. Those were the National Institute of Allergy and Infectious Diseases' ACTT-1 study, the Gilead-sponsored SIMPLE-Moderate trial and the multi-sponsor SOLIDARITY study, as well as a somewhat smaller trial run in China.
"A novel therapy typically requires higher certainty evidence of important benefits than currently available for remdesivir, preferably supported wherever possible by cost-effectiveness analysis," the authors of the guidelines wrote. "Given the remaining possibility of important harm, as well as the relatively high cost and resource implications" associated with Veklury, the panel said the recommendation against its use was appropriate.
If not Veklury, then what? In the meantime, WHO pointed to alternative treatments for COVID-19, "such as the well-known, cheap, and widely available corticosteroid dexamethasone," that has been proved to reduce mortality among severely ill COVID-19 patients.
Gilead shares (NASDAQ:GILD) fell 1% to $60.11 on Friday.