Gilead revises access to remdesivir for COVID-19 amid surge in demand
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Gilead Sciences said it cannot accept new compassionate use requests for its investigational antiviral remdesivir due to “overwhelming demand” from physicians hoping to repurpose the drug as a potential therapy for patients with COVID-19, but there are still ways to get access to the medication.
As an exception, Gilead will continue to accept compassionate use requests for pregnant women and children aged younger than 18 years with confirmed COVID-19 and “severe manifestations of the disease.”
The company said it has provided emergency access to remdesivir for “several hundred” patients in Europe, Japan and the United States but has seen an “exponential increase” in compassionate use requests for the drug in recent weeks.
“This has flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic,” Gilead said.
“To streamline the emergency access process, Gilead is currently in the process of transitioning from individual compassionate use requests to expanded access programs. This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients. These programs are currently under rapid development in conjunction with national regulatory authorities worldwide, and they may vary by region based on local laws and regulations.”
Gilead said it would focus on processing previous approved requests and anticipates that the expanded access programs “will initiate a similar expected time frame that any new requests for compassionate use would have been processed.”
Infectious Disease News Editorial Board Member Peter Chin-Hong, MD, professor of medicine and director of the transplant infectious disease program at the University of California, San Francisco, has managed patients with COVID-19, including some who are critically ill, and has requested remdesivir for compassionate use.
He said the decision by Gilead to suspend compassionate use requests for remdesivir is “a good thing overall.” Previously, physicians had to go through several steps over the course of days to make their requests for each patient, beginning with filling out an online form. [Editor’s note: The steps were described by Chin-Hong in this story.]
“In the proposed plan, you would do it once,” Chin-Hong said. “Every site that signs up for this, the company will send them drugs to have on hand, so when the patient signs a consent form that’s been approved by the local [institutional review board (IRB)], you order it like you would any other drug, You don’t have to wait days.”
Chin-Hong said institutions will have to amend their IRB procedure to make this process shorter, allowing for instant approval by the IRB chair or committee, if possible.
In addition, patients can be enrolled in multiple clinical trials underway to test remdesivir’s safety and efficacy in patients with COVID-19. The first began last month at the University of Nebraska. Unlike expanded access, in which every patient is guaranteed to receive the medicine, patients enrolled in the clinical trials will be randomly assigned to receive either remdesivir, which was developed as a therapy for Ebola, or placebo.
The trials, which could take about a month, are important to understand if remdesivir works against COVID-19, Chin-Hong said.
“We need data,” he said. “But when the randomized control trials stop, the only thing left will be this expanded access program while they finalize the results.” – by Gerard Gallagher
Disclosure: Chin-Hong reports no relevant financial disclosures.
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