A large international study has found that remdesivir, an antiviral drug that was the first to combat COVID-19, does not reduce deaths from disease.
The World Health Organization’s Solidarity trial, which combined data from 405 hospitals in 30 countries, randomly assigned more than 11,000 people hospitalized with COVID-19 to receive one of four standard medications or care, which could include other medications such as steroids. Tested drugs include remdesivir, the anti-malarial drug hydroxychloroquine, an HIV drug called lopinavir, and interferon-beta1a. Interferon is a chemical in the immune system that triggers the body's antiviral defenses.
None of the drugs showed any benefit in reducing deaths, the need for ventilation, or the length of hospital stays, researchers reported on Oct. 15 in a preliminary study published on medRxiv.org. The work has not yet been examined by other scientists and some analyzes may change during the peer review process, experts say.
Other studies have shown that neither lopinavir, given in combination with ritonavir, a drug that increases lopinavir levels in the body, nor hydroxychloroquine were effective against the new coronavirus (SN: 19/03/20; SN: 02/02 / 20). These studies, in addition to the new data, offer a clear message that these drugs are not useful in treating COVID-19, says David Brett-Major, a medical epidemiologist at the University of Nebraska Medical Center in Omaha.
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But remdesivir was shown to shave four days off from hospital stays in a trial conducted by the U.S. National Institute of Allergy and Infectious Diseases (SN: 4/29/20). In that study, the drug “showed a trend toward reduced deaths,” but the result was not statistically significant. Preliminary results from small studies conducted by the remdesivir manufacturer, Gilead Sciences of Foster City, California, also suggested that the drug could reduce the chances of dying from the disease (SN: 13/07/20).
The drug currently has an emergency authorization from the U.S. Food and Drug Administration for use in all hospitalized patients.
In the WHO study, 301 of 2,743 people hospitalized with COVID-19 who took remdesivir died, compared with 303 of 2,708 people in the group who received standard care. That result indicates that remdesivir has no mortality benefits, says Helen Boucher, head of infectious diseases at Tufts Medical Center in Boston.
But that doesn’t mean remdesivir isn’t helpful, she says. Boucher claims that shortening hospital stays is the reason why remdesivir has been accepted, at least in the United States. The new WHO study aside, “the data we have now suggests it’s a four-day, 11-day versus 15-day benefit” with a placebo, she says. "This is significant for sick people in the hospital."
“I’m very comfortable when a doctor recommends this medication based on data that shows a shorter time to be better,” Boucher says.
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Although the new WHO study found that remdesivir does not reduce the length of hospital stays, the trial was designed only to show whether the drugs could reduce the risk of dying. Therefore, their findings on whether remdesivir shortens hospital stays or reduces the risk of going up to a ventilator need a closer look, says Brett-Major.
That’s also partly because the WHO study combined data from hundreds of hospitals in 30 countries. A more detailed analysis of the data from individual study sites can show a clearer picture of how remdesivir works in different scenarios. Hospitalization time and having someone put in a ventilator can also depend on other factors, such as how many hospital beds or ventilators are available. Remdesivir can still improve outcomes for individual patients under the right circumstances, says Brett-Major.
In the short term, the new study will likely not change the way remdesivir is used, says Joanne Turner, an immunologist and vice president of research at the Texas Biomedical Research Institute in San Antonio. But as more studies are done, “we’ll have clarity on when it should be used,” she says.
Many hospitalized patients, for example, suffer from more overexpressing immune systems trying to fight the virus. At that point, it may be too late for a drug that prevents viral replication like remdesivir to make a difference. In the WHO study, “if the drug stopped viral replication (for patients), it was clearly not changing the results for them,” Turner says. "This will make doctors think about whether this medicine is really useful in very sick people."
But giving remdesivir to sick people before can help, experts say. Boucher and colleagues are part of a study that tested the drug on people who were recently diagnosed with COVID-19 to see if it can prevent hospitalization and serious illness.
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