Remdesivir, the first antiviral drug authorized by the FDA for COVID-19 treatment, does not work to prevent deaths among COVID-19 patients. This is according to a recent international study sponsored by the World Health Organization.
Remdesivir was originally developed by Gilead Sciences as a treatment for Ebola and SARS but did not see wide usage after delivering lackluster results. It interferes with the creation of new viruses by inserting itself into new viral genes.
In May, Remdesivir received emergency authorization for coronavirus treatment. Randomized control trials revealed it could reduce COVID-19 hospital recovery time from 15 to 11 days. In August, it was made available to all COVID-19 patients. Thousands had the drug administered, including President Donald Trump. Trump received a five-day course of Remdesivir intravenously in early October after testing positive for COVID-19.
Health experts have criticized the FDA’s decision, saying there is not yet enough medical research to permit such widespread use of the drug. The recent international study adds merit to this concern. More than 11,000 people in 30 countries were given single doses or combinations of Remdesivir, Hydroxychloroquine, Interferon, Lopinavir, or Interferon plus Lopinavir. Meanwhile, 4,100 received no drug treatment. The study concluded that no drug or combination reduced death rates or time spent in the hospital.
“The big story is the finding that Remdesivir produces no meaningful impact on survival,” Martin Landray, a professor of medicine and epidemiology at Oxford University, told the Associated Press.
“This puts the issue to rest—there is certainly no mortality benefit,” Dr. Ilan Schwartz, an infectious disease physician at the University of Alberta in Canada, told the New York Times.
Others were skeptical because of the many variables involved in the study. Dr. Peter Chin-Hong, an infectious diseases expert at the University of California-San Francisco, told the Times that the number of hospitals involved—more than 400—made it tough to determine what factors beyond Remdesivir were impacting a patient’s survival.
“I don’t think this study is the nail in the coffin,” Dr. Taison Bell, a critical care physician at the University of Virginia, said. “But I do think it shows that we have to be selective about the patient population we use it in.”
Remdesivir may be effective at the onset of coronavirus treatment because the virus causes the immune system to overreact after infection. Administering the drug in these early stages might help calm the immune system down, but after that, experts believe Remdesivir does not work to combat coronavirus. Gilead Sciences has pushed back on the WHO-backed research, noting in a company release that the Remdesivir study has yet to be peer-reviewed or published in a scholarly journal.
In any case, Remsedivir is only realistic for some. The drug takes 10 days to be administered and can cost up to $3,120 for Americans with private insurance.