WHO panel recommends against use of remdesivir for COVID-19 patients
A World Health Organization (WHO) panel recommended against using remdesivir in hospitalized patients with COVID-19 because there is no evidence it improves survival.
The recommendation breaks with the Trump administration, as remdesivir recently became the only drug approved by the Food and Drug Administration to treat hospitalized COVID-19 patients.
The WHO panel also found the drug, which is delivered intravenously, had no real impact on whether patients would need to be put on ventilators.
The recommendation from the WHO Guideline Development Group was published late Thursday night in the international journal The BMJ.
The recommendation was based on data from four international randomized trials involving more than 7,000 patients hospitalized for COVID-19.
According to the panel, the evidence did not prove that remdesivir has no benefit. Instead, there is no evidence based on currently available data that the drug improves important patient outcomes.
Remdesivir has received worldwide attention as a potentially effective treatment for severe COVID-19, but the evidence has been decidedly mixed.
One gold-standard trial from the National Institutes of Health found remdesivir helped patients leave the hospital faster than if they received a placebo.
But notably, the WHO solidarity trial, billed as the world’s largest randomized control trial on COVID-19 therapeutics, found no impact on the survival of COVID-19 patients or the length of time they stay in the hospital.
Remdesivir received emergency use authorization from the Food and Drug Administration on May 1 after it showed modest results in reducing the hospitalizations of patients with severe cases of COVID-19.
It gained full approval last month.
Remdesivir was one of a number of medications given to President Trump when he was diagnosed with COVID-19.
In announcing the recommendations, WHO said its panel acknowledged the certainty of the evidence they are using is low, because it was only data currently available, and the evidence may become stronger as more becomes available over time.
“But given the remaining possibility of harm, as well as the relatively high cost and resource implications associated with remdesivir, they judged this to be an appropriate recommendation,” the WHO said.
They also support continued enrollment into trials evaluating remdesivir, especially to provide higher certainty of evidence for specific groups of patients.
In the U.S., manufacturer Gilead charges private insurers $3,120 per patient for a five-day course of the treatment.
Other developed countries and direct purchasers in the U.S. government, including Veterans Affairs hospitals, will pay $2,340 for a five-day course of the drug.
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