Repurposed for COVID-19, antiviral drug offers hope at two South Florida hospitals
For more than a week, doctors at two South Florida hospitals have been administering a closely watched antiviral, remdesivir, and studying the effects it has for treating COVID-19. Fewer than 20 patients in South Florida have received the drug so far.
On Wednesday, the prospects became more encouraging for the medicine, developed by California-based Gilead Sciences initially to treat Ebola virus, when the early results from a clinical trial were made public. The trial, funded by the National Institutes of Health, showed that people who received the drug recovered quicker and died at a lower rate.
In South Florida, the drug has been used, under conditions set by the company, for six patients at Mount Sinai Medical Center in Miami Beach and nine patients at Memorial Regional Hospital in Hollywood.
Jackson Health System, Miami’s public hospital, said it was recently approved for the program but hasn’t received the medication yet. The drug is also being used at other Florida hospitals, including Sarasota Memorial Hospital.
The patients must be on ventilators and meet certain criteria, such as not having serious additional diseases. They are then given a 10-day course of intravenous remdesivir and monitored by daily laboratory tests, X-rays and other measures.
Of the nine patients to receive the treatment at Memorial, one has been discharged. Three others have been taken off ventilators and are recovering. The remaining five are on ventilators and are ill with “varying degrees of severity,” according to Dr. Candi Sareli, chief medical research officer at Memorial Healthcare System.
“The outcomes are purely observational,” Sareli cautioned.
But the NIH study, a randomized clinical trial of more than 1,000 patients throughout the country as well as Europe and Asia, found that patients who were treated with the drug recovered about 31% faster than those who didn’t receive it. Patients who got the antiviral had a median recovery period of 11 days, compared to 15 days for those who received a placebo.
The study, which has not yet undergone peer review, also showed a small drop in mortality rates — 8% for those who got remdesivir compared to 12% for those who didn’t.
The results make remdesivir the first COVID-19 treatment scientifically proven to be effective, a distinction celebrated by Dr. Anthony Fauci, a key White House coronavirus adviser and director of the National Institute of Allergy and Infectious Diseases.
“What it has proven is that a drug can block this virus,” Fauci said, according to The Associated Press. “This will be the standard of care.”
Dr. Richard Sutton, an infectious disease specialist and Yale School of Medicine professor, said it’s difficult to separate hype from reality in assessing early results from experimental treatments, but there is now real science showing that remdesivir can stop the virus from replicating.
Remdesivir works by targeting the virus itself, rather than fortifying the body’s own host proteins to protect against the virus, Sutton said, noting that Gilead is “one of the best in the world in terms of drug development. They know what they’re doing.”
But while Sutton was optimistic the drug could have some effect, he also cautioned that it has to be studied more.
“It’s encouraging,” Sutton said. “We’ll have to see what the real data looks like.”
At Mount Sinai Medical Center, Dr. Seth Gottlieb, the chief of pulmonary medicine, said the hospital is on its ninth day of treating patients with the drug. He said it was still too early to comment on outcomes, but the preliminary results appeared promising.
“But that’s a very cautious statement, because we’re going along with this very early on,” he said.
At Sarasota Memorial Hospital, eight patients are receiving the treatment, but hospital officials said it was too early to assess the results, especially because the drug was being used on people who already required mechanical ventilation.
“We are seeing positive indications in the trial and are hopeful that this treatment, along with other therapies we are researching, will be effective,” Kirk Voelker, a critical care pulmonologist at the hospital, said in a press release.
Both Gottlieb and Sareli said they welcomed a new tool to combat the virus.
“In this particular time, with what’s going on and the awful nature of this disease, getting some actual proof that something may be working using the scientific method is important to us now,” Gottlieb said.
Sareli, of Memorial, said she first used the drug on other patients under emergency use authorization, but Gilead stopped that supply to focus on randomized clinical trials. Those initial patients are still being monitored.
Remdesivir gives doctors something important, Sareli said: another option for patients and family members who are desperate to find any way they can help their loved ones.
“This is a particularly difficult disease because the families are not at the bedside,” she said. “The fact that you can offer them a research study gives them at least a little bit of hope.”
This story was originally published April 30, 2020 at 5:37 PM.
