Gilead’s decision to offer an experimental Covid-19 treatment to patients in groups should speed access to the drug, despite initial confusion caused by the company’s shift away from processing requests individually.
Gilead developed remdesivir, an unapproved antiviral for Ebola. It’s now shifting how it’s handling requests for “expanded access,” a legal way for patients with life-threatening conditions to access experimental drugs outside of a clinical trial. The process for accessing these drugs is also sometimes called “compassionate use.”
Gilead Sciences Inc. will now manage compassionate use requests in groups instead of on an a case-by-case basis.
There’s currently no vaccine or approved treatment for Covid-19, the lung disease caused by the new coronavirus. Researchers all throughout the country are working around the clock to develop new ways to combat the novel disease, and one method is trying existing drugs on patients to see if their conditions improve. But it must be done in a controlled, systematic process to ensure patients’ safety and that the drug actually works. Remdesivir, or some version of it, could be a useful tool in treating people with the disease.
“In the past two weeks, there has been a dramatic increase in requests that has necessitated a new approach to providing emergency access,” Gilead spokesman Ryan McKeel said in an email. “By transitioning to multi-patient expanded access programs, we are eliminating the need for review of individual patients by the company and regulators. This significantly streamlines the process to receive emergency access to remdesivir, particularly when there is a high volume of patients in need.”
Another way for patients to access the drug is by entering a clinical trial. There are currently half a dozen clinical trials in process to see if remdesivir can help patients with mild or severe cases of Covid-19. Gilead said it expects to know the results of one trial next month.
“These ongoing trials are the best way for patients to access remdesivir, enabling access to medication and collecting data to inform the use of this investigational compound and support potential regulatory approvals that can enable broader use of remdesivir,” McKeel said. “We are urging physicians to enroll patients in clinical trials.”
But not all patients are in a position to enter a clinical trial, which typically have strict criteria about who’s allowed to enroll. That’s where the compassionate use requests come in. Food and Drug Administration regulations have different categories of compassionate use. The most common is for an “individual patient,” but there are options for larger groups that have a separate set of protocols. Gilead previously had offered the drug on an individual basis for Covid-19 and will now shift to group processing.
Gilead is working with the FDA on a framework for emergency treatment under the new protocols. “We share a sense of urgency and are working as quickly as possible to develop and initiate the programs,” McKeel said.
The company continues to process its existing individual requests and is transitioning new requests to the group protocol. The group requests should proceed on a similar time frame as individual ones, the company said.
The change also means Gilead will have a more systematic way of collecting data from patient requests to try the Ebola drug. This will add much-needed information for researchers working to develop treatments for Covid-19.
But the announcement caused confusion at first. Some researchers thought Gilead was suspending its expanded access for remdesivir. There was also concern the change could lead to delays in access because of the need to get approval from ethics boards known as institutional review boards, or IRBs. When administering experimental drugs to groups of patients, the review board rules are stricter.
But McKeel said Gilead will continue to process previously approved compassionate use requests as it transitions from individual to group access requests. “We anticipate the expanded access programs will initiate in a similar expected time frame that any new requests for compassionate use would have been processed,” he said.
Alison Bateman-House, a bioethicist who is the co-chairwoman of the New York University School of Medicine Working Group on Compassionate Use and Pre-Approval Access, said, she hopes to allay what she described as “inevitable confusion over expanded access.”
“Overall this is a good thing,” Bateman-House said in an interview. “This is going to save doctors time and it’s going to save IRBs time in dealing with future patients.”
There might be problems getting an ethics board review for physicians in smaller hospitals that don’t have a standing ethics boards. But companies like WCG, which is a large commercial review board, confirmed to Bloomberg Law that it reviews for individual expanded access submissions free of charge.