FDA Gives Full OK to Remdesivir for COVID-19

The Seattle Times

President Donald Trump has spilled a lot of Twitter ink about potential treatments for COVID-19. Some of his suggestions have been dangerous or unproven. Others — in particular, those given to the president when he fell ill with COVID-19 a few weeks ago — are more propitious.

One such treatment is remdesivir, an antiviral medicine given to hospitalized patients through an IV.

The drug got some early attention when a Snohomish County man, the first person with a confirmed diagnosis in the United States, was treated with it in late January and recovered. Since then, Seattle Times readers have occasionally inquired about its promise amid the field of potential treatments being studied.

Remdesivir garnered a lot of attention last week when a large World Health Organization (WHO) study found it didn't prevent hospitalized patients from dying.

Then, on Thursday, remdesivir became the first drug to gain full approval from the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19. It had been authorized for use on an emergency basis since spring.

How does remdesivir treat COVID-19, and how effective is it?

Remdesivir works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it's safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.

The drug, which California-based Gilead Sciences  is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health (NIH).

In the recent WHO study involving more than 11,000 people in 30 countries, remdesivir didn't prevent hospitalized COVID-19 patients from dying. Indeed, no studies have found the drug improves a patient's chances of survival.

The WHO study, which was posted on a preprint website  this month, has yet to be published in a medical journal. It made a stir, but it doesn't settle the question of remdesivir's effectiveness, said Dr. Helen Chu, an associate professor of medicine at the University of Washington.

"Generally, when it's been published, you know, that it's gone through the process of having the questions asked and the data challenged,"  Chu said. "And so you trust what you read in a different way than somebody who essentially takes their data, writes something up and posts it online."

The WHO study didn't include a placebo group and was less rigorous than previous ones that found a benefit. Its large size is valuable because it generated a huge amount of data, but the WHO hasn't finished analyzing all that data, and it wasn't a blind study like the NIH one was,  Chu said.

"I don't know that I would make anything of it until we have a more complete picture of what happened," Chu said.

The FDA's approval statement noted that, besides the NIH-led one, two other studies found remdesivir beneficial.

Remdesivir was first used on a COVID-19 patient back in January, before the disease caused by the novel coronavirus had even been given the name COVID-19. Doctors at Providence Regional Medical Center in Everett gave the drug to a 35-year-old Snohomish County man who had the United States' first confirmed infection.

Five days after the man was admitted to Providence, his condition worsened. On the sixth day, he had to be given oxygen, and a lung X-ray showed he was developing pneumonia. Dr. George Diaz, the hospital's section chief for infectious disease, got approval from the FDA to use remdesivir, which had previously been tested on Ebola patients.

The patient's fever went away the day after treatment, and he began feeling better.

"It is only one case," Diaz told the Seattle Times in February. "It's the first person in the world who got this medication for novel coronavirus, but it seems to have worked."

What other treatments are being used for COVID-19? How effective are they?

There is no proven cure for COVID-19. And while remdesivir is the only drug with FDA approval for treating COVID-19 so far, many other treatments are being studied, some have shown strong evidence, and a few have been authorized for emergency use.

Steroids such as dexamethasone are among the most promising because they can lower the risk of dying for severely ill patients. But they may do the opposite for those who are only mildly ill. Guidance from the WHO last month recommended steroids be used only on severely and critically ill patients.

Trump was given  dexamethasone when he was treated for COVID-19  this month. Doctors prescribe that drug for COVID-19 patients to combat lung damage caused by inflammation, which is one of the major ways the disease can kill.

There is also hope that giving patients monoclonal antibodies could fill the gap until vaccines are widely available. These drugs are designed to mimic the body's natural immune response on an industrial scale by delivering doses of mass-produced antibodies. Multiple trials are underway across the country and in Washington state.

"If they are successful, monoclonal antibodies are really going to revolutionize treatment for COVID-19," Dr. Larry Corey, former director of the Fred Hutchinson Cancer Research Center and co-leader of a national network coordinating clinical trials on vaccines and antibodies, told the Seattle Times  this month.