A slim ray of hope amid the coronavirus pandemic landed in Colorado this week: The state received its first federal shipment of the experimental drug remdesivir.
The antiviral drug is a twice-failed misfit of a pharmaceutical invention that now, suddenly, has a new chance at glory following studies that found it could potentially improve the recovery times for patients suffering from COVID-19, the disease caused by the new coronavirus. On the basis of that research, the Food and Drug Administration granted the drug a rare “emergency use authorization.”
Federal authorities took over distribution of the drug in the United States — eventually winging a small shipment of the drug to Colorado that arrived on Tuesday. The state on Wednesday sent the drug out to hospitals, which have already begun to provide it to patients.
But there’s a lot more still to learn, so here are five things to know about remdesivir’s use in Colorado.
There’s not nearly enough for everyone
The shipment that arrived in Colorado this week contained enough to treat 130 patients. But that’s assuming each patient receives the same five-day course of treatment. If treatment courses need to be longer, fewer patients could benefit.
On Thursday afternoon, there were 685 people hospitalized in Colorado with confirmed or suspected cases of COVID-19. So this first shipment is really only enough for Colorado hospitals to test the drug out, not to put it into widespread use.
“We knew that that shipment prior to its arrival was likely to be inadequate in terms of supply versus demand,” Dr. Dan Shodell, an official with the Colorado Department of Public Health and Environment, said during a meeting Thursday of the Governor’s Expert Emergency Epidemic Response Committee, or GEEERC.
It’s still very experimental
Remdesivir, which is administered once daily to patients via an intravenous line, is so new that it comes with an unusual caveat: Doctors can’t tell patients it will do anything.
“We’re using medication for experimental reasons and for valid reasons based on early data,” said Dr. Eric France, CDPHE’s chief medical officer, “but we’re actually not allowed to say that it’s either safe or effective.”
That caution underlies the broader uncertainty over whether remdesivir will be the drug that leads us out of the pandemic or whether it’s a pharmaceutical false prophet. Several Colorado hospitals have previously been the site of early clinical trials for remdesivir, but that doesn’t mean the state has any better insight into the drug’s efficacy for coronavirus.
“The clinical evidence, honestly, behind it is fairly limited,” Shodell said.
“It really is not a slam dunk,” he added. “It is an emergency use authorization. But the safety profile is reasonable, and the promise of effectiveness does seem to be real.”
Doctors don’t know the best way to use it yet
Among the bigger puzzles facing physicians: If remdesivir does help, which patients should get it and when?
The FDA authorization allows the drug to be given to any adult or child with a severe case of diagnosed or suspected COVID-19. The inclination, then, might be to give it to the sickest patients most in need of a turnaround.
But Dr. Stephen Cantrill, an emergency medicine specialist at Denver Health, said it’s possible that patients with advanced COVID-19 won’t benefit from the drug as much as patients in whom the disease has not progressed as far.
“One of the complicating factors is we don’t even know which patients would benefit the most from it,” Cantrill said during the GEEERC meeting. “So it really is a crapshoot.”
Dr. Darlene Tad-y, the vice president of clinical affairs for the Colorado Hospital Association, said the early studies on remdesivir are guiding hospitals’ decisions.
“They’re looking to these studies to help identify patients who are in similar situations as those in the study,” she said.
It’s not clear where the drug is being distributed and why
A swarm of criticism has met federal efforts to distribute the drug, which is made by the California-based pharmaceutical company Gilead Sciences. Doctors say the process has not been transparent, and even federal officials have acknowledged they made mistakes in rolling out the highly sought-after drug, a process originally undertaken by the Federal Emergency Management Agency.
“We can’t get it in Colorado because all of Gilead’s supply went to FEMA and FEMA is distributing it across the country in a way that is not transparent and we don’t understand,” Dr. Alex Benson, who leads pulmonary and critical care for Centura Health’s 17 hospitals in Colorado and Kansas, said on Monday. “Colorado has gotten zero, and we don’t know when and if we are going to get it.”
France said during the GEEERC meeting that Colorado’s shipment arrived Tuesday on short notice. The state quickly came up with a system of distributing the supply to hospital systems based on their share of coronavirus patients. The hospitals with the most patients got the biggest share.
CDPHE has not named the hospitals receiving parts of the shipment, but Tad-y said all the state’s major hospital systems received a portion of the supply.
France said it’s not clear how many more federal shipments Colorado could be in line for, but he said he’s been told to expect another one as soon as this week. It’s not known how many doses will be included in that shipment.
The state will need a better system for allocating it
A major topic of conversation during the GEEERC meeting focused on how to create a better system for allocating future remdesivir supplies.
“We want to really pursue a distribution or allocation system that would allow the most equitable and fair distribution to patients who are eligible,” Tad-y said.
More discussion is needed to determine what that looks like. France said CDPHE will be collecting data on remdesivir’s early use in the state to better understand which patients it helps and which it might harm. There was also interest at the GEEERC meeting in collecting demographic data on the patients who receive the drug — to make sure that biases aren’t affecting who receives the drug and who doesn’t.
In the coming months, the issue will likely end up back before the GEEERC, which makes recommendations to the governor on how to respond to the pandemic.
“It’s about the allocation of a scarce resource in a fair and equitable way,” France said. “… It can percolate up as a recommendation by the GEEERC to the governor on how best to distribute this scarce resource.”
Staff writer Jesse Paul contributed to this report.