Gilead Sciences via AP
In this March 2020, photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States.
Thursday, May 7, 2020 | 2 a.m.
The antiviral drug remdesivir, recently lauded by infectious disease expert Dr. Anthony Fauci of the White House’s coronavirus task force for showing promise in treating those infected with COVID-19, has been prescribed to only a handful of patients in Southern Nevada.
The Food and Drug Administration last week lifted a barrier for hospitals in obtaining the drug by authorizing it for emergency use, but it is still unknown how soon it will be available in Nevada hospitals.
Remdesivir was first developed by the biopharmaceutical company Gilead Sciences to combat other viruses like Ebola and SARS, but it proved ineffective. Earlier this year, it was a candidate in a National Institutes of Health-sponsored clinical trial, with preliminary results indicating it as the most promising treatment for COVID-19. Patients given remdesivir recovered faster than those given a placebo.
The drug, which is administered intravenously, is designed to disrupt the way the coronavirus replicates itself, said Dr. Shadaba Asad, University Medical Center’s medical director of infectious disease.
“Remdesivir is what we call a nucleoside analog,” she said. “It can get incorporated into the genetic material of the virus, and when that happens, it’s damaging to the virus in a way that it kills the virus. It synthesizes with the RNA of the virus — that is its target.”
The clinical trial, which began on Feb. 21 and is known as the Adaptive COVID-19 Treatment Trial, or ACTT, was the first trial in the U.S. to study the experimental treatment. Asad said that seeing preliminary results released this soon is highly unusual.
“This is a super-fast release of results,” she said. “These are not the kind of peer-reviewed studies we are used to using when we treat patients, but this is the best we have right now, and when lives are a factor we’ll use what we have.”
Like any drug treatment, there are risks and side effects that come with remdesivir, most notably increased liver enzymes, diarrhea, rash, kidney impairment and low blood pressure, according to reports. But Asad said she’d be more inclined to prescribe remdesivir to a patient than most other drug treatments available.
Hydroxychloroquine, for example, despite its early promise, has not panned out in her opinion. The risks are also more significant, she said.
“I’m cautiously optimistic about remdesivir, and the reason for that is because it’s the only drug out there where a well-conducted, randomized trial has shown some evidence of benefit,” she said. “Everything else out there has shown anecdotal evidence in not well-designed studies.”
Asad said she prescribed the drug for two patients in March while it was authorized to be prescribed on a “compassionate-use” basis, where an unapproved drug can be used to treat a seriously ill patient when no other treatments are available. The drug is now only available for “compassionate use” for pregnant women and patients under 18, according to Gilead’s website.
Other Las Vegas-area hospitals have struggled to procure the drug at all, which until recently was primarily obtained through participation in a clinical trial.
Southern Hills Hospital applied to be part of the clinical trials a month ago but heard nothing back, spokeswoman Cyndi Lundeberg said. It has since submitted an emergency-use application through the Nevada State Board of Pharmacy.
Dr. Alka Rebentish, founder of Infectious Diseases Associates in Las Vegas, said she has only prescribed the drug on one patient at Dignity Health under compassionate use. But since Gilead changed its rules concerning compassionate use and no hospitals in Nevada have been part of any clinical trial, she hasn’t been able to prescribe it since.
Even though remdesivir is now accessible through emergency-use authorization, states with a higher number of cases and higher mortality rates like New York, New Jersey and California will likely get it first, Rebentish said.
“It’s based on the need and where patients are,” she said. “But I think the situation will change when the drug gets full approval (from the FDA).”
The largest barrier right now for making it more widely available is the supply of the drug, she added.
The World Health Organization announced Monday that it will work with the federal government and Gilead on ways to make the drug more available for patients. Gilead announced that it expects to produce 140,000 rounds of the 10-day treatment by the end of May, and 1 million by the end of the year.
“Remdesivir looks like it's effective and it is promising but, unfortunately, it’s an IV drug, which really limits its utility to the sickest patients who are admitted in hospitals,” Rebentish said. “The utility of most antiviral drugs is really when they’re administered early on in the disease. That is the only shortcoming of this drug for me.”
She said she continues to hold on to the hope that the drug will soon be more widely available, even for patients in Nevada.
“When this all started in January, we had nothing,” she said. “Now we have something.”
