The antiviral remdesivir should not be used as treatment for hospitalized Covid-19 patients, the World Health Organization said Thursday, only a month after the Food and Drug Administration approved the drug to treat patients over age 12 who are hospitalized with Covid-19.
Remdesivir, also known as Veklury, and the steroid dexamethasone are the only drugs authorized to treat Covid-19 patients. But a recent massive global study of remdesivir’s effectiveness, run by the WHO, showed that remdesivir had little or no impact on hospitalized patients, contradicting previous trials.
“Remdesivir has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement,” experts from the WHO Guideline Development Group wrote in a statement. The review was published in The BMJ, a medical journal.
In light of the interim data from the WHO’s “Solidarity” trial — which included data from more than 11,200 people in 30 countries — “remdesivir is now classified as a drug you should not use routinely in Covid-19 patients,” the president of the European Society of Intensive Care Medicine, Jozef Kesecioglu, said in an interview with Reuters.
Gilead Sciences, which makes remdesivir, has questioned the WHO’s findings. In in an emailed statement, the drugmaker said: “We are confident that doctors on the front lines recognize the clinical benefit of Veklury based on robust evidence from multiple randomized, controlled studies.”
While doctors and hospitals are not obliged to follow the WHO’s advice, the recommendation could curb the use of remdesivir.
The drug, however, remains widely used in hospitals, including in the U.S. It is authorized or approved for use in more than 50 countries, and it was one of the medicines administered to President Donald Trump when he tested positive for the coronavirus in October.
An earlier study conducted by the National Institutes of Health found that remdesivir reduced the length of hospital stays among patients with moderate illness by about four days, from 15 to 11.
Because remdesivir is thought to work by stopping the virus from replicating, it is likely to have more impact earlier in the course of the illness, Dr. Hugh Cassiere, a pulmonologist at Northwell Health in New York, told NBC News.
“If you were to start remdesivir really early on, you’d expect to have more bang for the buck,” Cassiere said.
Dr. Ken Lyn-Kew of National Jewish Health in Denver agreed that it is important to continue to study remdesivir, but he is not as enthusiastic about using the drug for patients in advanced stages of the illness. “The data show it really doesn’t work very well in hospitalized patients,” Lyn-Kew said.
Kesecioglu said there was not enough data about when remdesivir might be effective or for which patients, leading to the decision to discourage its routine use in intensive care.
That means doctors should use remdesivir only occasionally, not as a standard treatment for Covid-19 patients.
Ten months into the pandemic, a debate continues to rage in the medical industry about which drugs are best to treat hospitalized Covid-19 patients.
Remdesivir has potential side-effects on the kidneys, according to data Gilead shared with the European Medicines Agency, which is assessing its possible toxicity.
Separately, the FDA issued emergency use authorization Thursday for remdesivir in combination with Eli Lilly’s baricitinib, a pill used to treat rheumatoid arthritis.
In a clinical trial of hospitalized Covid-19 patients, the combined treatment was shown to reduce time to recovery within 29 days after beginning the medications, compared to patients who received a placebo with remdesivir, the FDA said in a statement. The agency said ongoing research will be needed to confirm the benefit.