AWorld Health Organization panel is now recommending against the use of the antiviral remdesivir in hospitalized Covid-19 patients, saying there is no evidence that the drug — which U.S. regulators have approved for the treatment of the coronavirus — improves mortality.
In a revised guidance issued Thursday night, the WHO’s Guideline Development Group said that it now has a “weak or conditional recommendation against” using remdesivir in hospitalized patients because of clinical trial data that showed the drug did not increase survival. The group’s review also found the drug had no meaningful effect on whether patients would need to be put on ventilators.
The group cautioned that its recommendations were based on “currently available data” and that the certainty of the evidence was low.
“The evidence [suggests] no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes,” the WHO’s group wrote. Members added: “The panel interpreted the evidence as not proving that remdesivir is ineffective; rather, there is no evidence based on currently available data that it does improve patient-important outcomes.”
The news from the WHO provides the latest in a series of downs and ups for remdesivir. Soon after the Covid-19 pandemic emerged, attention turned to the potential of remdesivir, developed by Gilead Sciences, because it had shown promise against other coronavirus infections in lab experiments.
One gold-standard clinical trial, overseen by the U.S. National Institutes of Health, found that remdesivir, which is given intravenously, helped Covid-19 patients recover and get out of the hospital faster than placebo.
But other studies have not found benefits, most notably the WHO’s Solidarity trial. Study results last month showed that remdesivir and other drugs studied “appeared to have little or no effect on hospitalized Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.”
In a statement Thursday, Gilead staunchly defended what it says are the benefits of remdesivir (which has the brand name Veklury), citing the NIH-sponsored trial and other studies that indicated the drug can help patients. “We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with Covid-19 in approximately 50 countries,” the company said.
Gilead has also pushed back on the results from the Solidarity trial. In a statement last month, the company said the Solidarity data “appear inconsistent with more robust evidence” from other trials and said that trial had “limitations” that meant it was “unclear if any conclusive findings can be drawn from the study results.”
A week after the Solidarity data came out, the FDA approved remdesivir for hospitalized patients, leaving some experts scratching their heads about how regulators could make that decision after the negative WHO trial. In its approval statement, the FDA did not mention the Solidarity trial, instead citing the NIH-run study as well as other trials that indicated some benefit from remdesivir for improved patient symptoms.
On Thursday, the FDA separately authorized on an emergency basis the drug baricitinib in combination with remdesivir for hospitalized Covid-19 patients who need supplemental oxygen. Baricitinib is an existing therapy for rheumatoid arthritis, approved under the brand name Olumiant.
Both the NIH and the Infectious Diseases Society of America include remdesivir in their recommended clinical guidelines for certain hospitalized patients. The NIH did not respond to a question about whether the WHO update would change the NIH’s guidance. The IDSA said it was working on the next update to its treatment guidelines.
When President Trump had Covid-19, his treatment regimen included remdesivir.
Many infectious disease physicians have taken the view that even if remdesivir is not a total savior of a medication, it may help some patients, particularly if it can be delivered relatively early in the course of someone’s illness. The drug is designed to work by blocking the replication of the virus, so in theory it should have more of an impact if it can slow that process before the infection gets too far along. Plus, some physicians say, they don’t have other therapeutic options that go after the virus itself, so it’s worth continuing to use. (The steroid dexamethasone, which can tamp down the overactive immune response that occurs in some patients with serious Covid-19, has been proven to reduce mortality among patients with severe disease.)
But in its review, the WHO’s group noted that because of the cost of remdesivir, the resources needed to deliver it intravenously, and the potential harm to patients, it should be not given until there was better evidence for it. Additional studies could provide that evidence, the panel said.
Gilead, in its statement Thursday, said that while it “encourages the generation of additional robust and interpretable data around Veklury … we also support the availability of important treatment options for patients and healthcare providers in the midst of this pandemic.”
In the U.S., the price of remdesivir is $3,120 for a course for private insurers and $2,340 for some government plans.