WHO recommends against use of remdesivir for COVID-19
A WHO guideline committee recommended against the use of remdesivir in patients hospitalized with COVID-19, regardless of how sick they are.
The conditional recommendation, published in BMJ, was based on evidence suggesting that the antiviral has “no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes” among patients with COVID-19, the authors wrote.
“Importantly, given the low certainty evidence for these outcomes, the panel concluded that the evidence did not prove that remdesivir has no benefit; rather, there is no evidence based on currently available data that it does improve patient-important outcomes,” Bram Rochwerg, MD, MSc, FRCPC, an associate professor of medicine at McMaster University in Ontario, Canada, and colleagues wrote.
“Especially given the costs and resource implications associated with remdesivir, but consistent with the approach that should be taken with any new drug, the panel felt the responsibility should be on demonstrating evidence of efficacy, which is not established by the currently available data,” they wrote.
The FDA approved remdesivir last month to treat patients aged as young as 13 years who are hospitalized with COVID-19 — the first approved therapy for the coronavirus. The approval was based on three randomized controlled trials, including one that showed the drug shortened the time to recovery in patients hospitalized with COVID-19. By contrast, a large WHO-launched trial called Solidarity indicated that remdesivir appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.
In its own living guidelines, the Infectious Diseases Society of America has recommended remdesivir over no antiviral treatment in patients with severe COVID-19. The IDSA told Healio that it was updating its COVID-19 treatment guidelines and would address the use of remdesivir in a press briefing next week.
Rochwerg and other members of the panel reviewed data from four international randomized trials consisting of more than 7,000 hospitalized patients with COVID-19. They ranked the evidence quality of various findings regarding patients’ outcomes as very low, low, moderate, high or very high using the number of events per 1,000 patients or the average number of days an event occurred, depending on the outcome.
The researchers determined the evidence quality to be low for remdesivir in regard to improving time to clinical improvement, hospitalization duration and mechanical ventilation duration. They also determined that evidence quality was low for the drug’s positive impact on mortality, mechanical ventilation, severe adverse events and risk for acute kidney injury, and evidence quality was very low for remdesivir’ s impact on viral clearance at 7 days and delirium.
The authors also outlined four individual considerations for the use of remdesivir in supportive care, including the administration of the drug via IV infusion, cost and availability, unclear timing, dosing and duration of the drug and whether or not the drug is a significant inducer or inhibitor of cytochrome P450 enzymes.
“The guideline recommendations for COVID-19 therapeutics demonstrate remaining uncertainties concerning treatment effects for all outcomes of importance to patients,” the authors wrote. “There is also a need for better evidence on prognosis and values and preferences of patients with COVID-19.”