Gilead Sciences Inc.’s two clinical trials of its possible remedies for the treatment of coronavirus are due to expire in late May, cutting off patient access to the antiviral medications, according to US researchers involved in the studies.
The drug received approval from the U.S. Food and Drug Administration on May 1, but hospitals are concerned about access.
“We would like to see this very precious resource distributed fairly and transparently,” said Dr. Helen Boucher, chief of infectious diseases at Tufts Medical Center in Boston, to Reuters.
Gilead studies – one in patients with severe COVID-19 and the other in moderate disease – enrolled about 8,000 subjects, according to FDA statistics. The studies are ‘open label,’ meaning they don’t compare treatment to a placebo and participants know they are getting the drug.
There is a lot of interest in Gilead’s drug, given some promising early data and the lack of approved treatments or preventative vaccines for COVID-19, the disease caused by the new coronavirus that has infected more than 4 million people and has more than 305,000 worldwide killed.
Preliminary results from a trial conducted by the U.S. National Institutes of Health showed that remdesivir reduced hospital admissions by 31% compared to a placebo. The NIH is now studying Remdesivir alone compared to Remdesivir in combination with Olumiant, an anti-inflammatory drug approved for rheumatoid arthritis and sold by Eli Lilly and Co.
Remdesivir is still available on a compassionate use basis for pregnant women or children under 18 years of age, but most COVID-19 patients will soon have access only under the emergency use authorization.
“We are participating in Gilead’s clinical trials here at Tufts,” said Dr. Boucher. “We were told they will expire … by the end of May at the latest.”
Gilead told Tufts that it will switch to product distribution under the Emergency Use Consent.
Researchers at Beth Israel Deaconess Medical Center in Boston have also learned that the two Gilead studies would end patient enrollment by the end of the month.
Gilead, who has pledged to donate 1.5 million vial of brake desivir to fight the global pandemic, has not responded to requests for comment. The drug is administered by infusion in the hospital.
The Department of Health and Human Services said on Saturday that Gilead had committed to providing US hospitals with approximately 607,000 vials of remdesivir – approximately 40% of the donation, or enough to treat at least 78,000 patients.
After doctors questioned the transparency of the allocation process, the federal agency said the state’s health services would distribute the drug.
The Infectious Diseases Society of America asked Thursday to meet with the Trump administration to discuss how brake desivir will be allocated.
Gilead has said that the early results from its first study showed that the drug improved outcomes for patients with severe COVID-19, and it plans to release the findings of its second study later this month.