This guidance comes less than 24 hours after FDA grants an EUA for its use combined with baricitinib.
The World Health Organization (WHO) issued a conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity.
This comes less than 24 hours after The US Food and Drug Administration issued an emergency use authorization (EUA) for the therapy baricitinib, in combination with remdesivir, for adult and pediatric patients 2 years and older hospitalized with COVID-19 and require either supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
“There is currently no evidence that remdesivir improves survival and other outcomes in these patients,” the WHO statement said.
The organization based its recommendation from its SOLIDARITY Trial, which are randomized trials for 4 antiviral drugs in hospitalized COVID-19 patients. They looked at hydroxychloroquine, lopinavir, interferon and remdesivir. In all, data from over 7000 patients across 4 trials were considered.
This recommendation is part of a living guideline on clinical COVID-19 care and comes from a development group, which includes 28 clinical care experts, 4 patient partners and one ethicist.
The guidelines were developed in collaboration with the non-profit Magic Evidence Ecosystem Foundation (MAGIC), which provided methodologic support.
The WHO Solidarity Trial published its interim results in mid-October.
Death rate ratios were consistently underwhelming for each observed regimen:
Investigators observed no definite reduction of mortality, initiation of ventilation, nor hospitalization duration with any of the studied therapies.
At the time the data was released, Gilead, the manufacturer of remdesivir, made a public statement. “We are aware that initial data from the World Health Organization’s (WHO) SOLIDARITY Trial has been made public prior to publication in a peer-reviewed journal. The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury (remdesivir),” the statement said. “We are concerned that the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”