Why coronavirus treatment drug remdesivir from Gilead is so important for COVID-19

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Remdesivir, the experimental coronavirus treatment from biotech giant Gilead, is steadily marching toward a Food and Drug Administration (FDA) approval.

A cascade of events in the past several days appear to ensure that the treatment will gain rapid regulatory approval, though the exact date is still unknown. Stock markets spiked on news from a pair of ongoing studies showing remdesivir’s efficacy against COVID-19, one being conducted by the federal government and another late-stage trial by Gilead.

That underscores the widespread hunger for something, anything, that may help us tame this pandemic. But it’s important to balance hope with the hard facts of the situation. Remdesivir, based on the data we’re now learning about, could very well be an effective treatment. But it’s unlikely to be a miracle cure, and its use will likely be limited at first to patients with the most severe COVID-19 cases.

This isn’t a knock on remdesivir. Reducing the burden on hospitals overwhelmed with coronavirus patients is critical. That can open up critical financial and medical resources for health care providers feeling the crunch.

“[Remdesivir is] the first step in what we project will be better and better drugs coming along,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), which conducted one of the remdesivir trials, during an appearance on NBC’s Today showon Thursday. “It’s good news, but I was very serious when I said this is not the total answer, by any means, but it’s a very important first step.”

A combination of aggressive moves by states hard hit by the pandemic and social distancing measures that have, in some regions, begun to flatten the infection curve has helped prevent a true doomsday scenario for hospital capacity. But that doesn’t mean the nation’s health care providers are out of the woods—especially if a second wave of coronavirus infections flares up in the fall and winter in conjunction with flu season, according to Fauci, who has also called a second wave “inevitable” in the U.S.

“If by that time we have put into place all of the countermeasures that you need to address this, we should do reasonably well,” he told CNN on Wednesday. “If we don’t do that successfully, we could be in for a bad fall and a bad winter.”

There are a few reasons why remdesivir won’t automatically flip the switch on the spread of the coronavirus. For one thing, it’s being tested on “the most severe manifestations” of COVID-19 in multiple trials, according to both Gilead and the NIAID, an arm of the National Institutes of Health (NIH). Barring further data from different patient populations, it’s difficult to tell if remdesivir would be effective in earlier stages of the disease.

But the good news is that the NIAID study is a fairly rigorous one—it’s a randomized trial that pits remdesivir against a placebo, which presents stronger evidence of the drug’s efficacy. “Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo,” wrote the agency.

The other late-stage trial touted by Gilead suggests that a five-day course of remdesivir treatment—which is administered intravenously—was just as effective, if not more so, in helping patients get discharged from the hospital as a 10-day course of treatment. More than half of patients receiving the pair of dosing regimens were discharged.

This is particularly important since expanding hospital bed capacity and opening up the number of ventilators available for seriously ill COVID-19 patients is critical to cutting the strain on the health system. A single day of hospital ventilation can cost $25,000 to the health system, says SVB Leerink analyst Geoff Porges.

Opening up hospitals’ financial and operational capacity is critical in the short term. But ultimately easing social distancing measures and returning to something approaching normal will require more drug and vaccine development, a better understanding of coronavirus immunity for those who have recovered, and continued vigilance.