Remdesivir Approval Is Good News For COVID Patients, But Timing Is Key, Says Sarasota Doctor
President Donald Trump is among those who have been treated with remdesivir, and FDA-approval could widen access to more patients.
The US Food and Drug Administration’s approval of remdesivir as the first and only drug so far to treat COVID-19 is good news for patients, especially those who receive the antiviral early in the course of their illness, said a Sarasota doctor who was involved with a local trial of the drug.
“It’s best used early in the process to keep the virus from replicating and overwhelming the system,” said Dr. Kirk Voelker, a critical care pulmonologist at Sarasota Memorial Hospital.
“If you use it too late in the process, when people are already on ventilators and very, very sick there is very little chance that it is going to do any good.”
The drug has been available under an emergency use authorization from the FDA since this spring, when Sarasota Memorial Hospital took part in a national study, called the Adaptive Covid-19 Treatment Trial (ACTT-1), aimed at testing the drug in more than 1,000 coronavirus patients.
A total of 281 people have received the drug in Sarasota, said a hospital spokeswoman.
“There was benefit in decreasing the length of stay in the hospital, on the average of about five days. If you required oxygen, it decreased the average stay by about seven days,” Voelker said.
The New England Journal of Medicine just published peer-reviewed findings on the ACTT-1 trial, showing that COVID-19 patients who received remdesivir recovered in 10 days on average, compared to 15 days among those who received a placebo.
However, preliminary results from a larger, World Health Organization study published in the British Medical Journal (BMJ) earlier this week, found that remdesivir had little to no impact on survival in patients.
That study, described as the largest trial to date, spanning more than 11,000 patients in 30 countries, also found no measurable benefit from three other drugs considered potentially useful against COVID-19, including hydroxychloroquine, lopinavir-ritonavir, and interferon beta-1a.
"That's a preliminary finding," said Voelker. "All the physicians I know want to look further into it."
Remdesivir is made by Gilead Sciences and will be marketed as Veklury. It received FDA approval on Thursday. The cost for a five-day course is expected to be around $3,000 dollars.
“From a hospital’s perspective, having a patient discharged five or seven days earlier is well worth that several thousand dollars,” said Voelker.
Smaller hospitals will also have access now, making it more readily available to patients.
“Now it has been vetted, it has been shown to be safe and effective and a lot more physicians will feel better about using it knowing it is FDA-approved,” added Voelker.