The top U.S. infectious disease official said Gilead Sciences Inc’s (GILD.O) experimental antiviral drug remdesivir will become the standard of care for COVID-19 after early results from a key clinical trial on Wednesday showed it helped patients recover more quickly from the illness caused by the coronavirus.
Preliminary results from a U.S. government trial showing that patients given remdesivir recovered 31% faster than those given a placebo, were hailed by Dr. Anthony Fauci as “highly significant.”
“This is really quite important,” Fauci told reporters at the White House, likening it to a moment in 1986 “when we were struggling for drugs for HIV and we had nothing.”
“This will be the standard of care,” he said, adding “the FDA … is working with Gilead to figure out mechanisms to make this easily available to those who need it.”
Gilead earlier on Wednesday said the trial was positive, and provided additional data suggesting remdesivir worked better when given earlier in the course of illness, sending its shares up more than 7%.
The closely watched drug, which is given by intravenous infusion to hospitalized patients, has moved markets in the past few weeks following the release of data from several studies that painted a mixed picture of its effectiveness, and Fauci cautioned that the latest data still needs to be analyzed.
Interest in Gilead’s drug has been high as there are currently no approved treatments or vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in severe cases, until a preventive vaccine emerges.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said early results from its 1,063-patient trial show that hospitalized COVID-19 patients given remdesivir recovered in 11 days, compared to 15 days for patients given a placebo.
The study showed a trend toward better survival for remdesivir – 8% of patients given the drug died, compared with 11.6% in the placebo group – but the difference was not statistically significant so may not be due to Gilead’s drug.
“It is the first truly high-powered randomized placebo-controlled trial,” Fauci said.
Testing the drug against a placebo can give researchers a definitive answer on whether remdesivir is having an effect.
The trial’s lead researcher told Reuters on Friday that full results could come by mid-May.
‘GLIMMER OF HOPE’
Despite the excitement, Dr. Lawrence K. Altman, global fellow at The Wilson Center in Washington, DC, was not ready to celebrate the preliminary findings.
The new data “offers a glimmer of hope” that remdesivir has an effect against COVID-19, but more scientific analysis is needed “comparing them to other studies of the drug that have shown mixed results,” he said in a statement.
Also on Wednesday, results were published by the Lancet medical journal of a trial conducted in China that concluded remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream. Gilead said previously that those findings were inconclusive because the study was terminated early.
“The drug seems to have antiviral activity – how much is as yet unclear,” Dr. Daniel McQuillen, an infectious disease specialist at Lahey Hospital & Medical Center in Burlington, Massachusetts, told Reuters. “Seems likely that it might need use with another antiviral agent.”
Combination antiviral treatments have proven highly effective against other diseases.
Gilead also provided data on a study in severe COVID-19 patients it has conducted in dozens of medical centers, which does not have a placebo comparison but tested the drug under five-day and 10-day regimens.
In that 397-patient trial, Gilead said 62% of patients treated early with remdesivir were discharged from the hospital, compared with 49% of patients who were treated later in the course of the infection.
Gilead Chief Medical Officer Merdad Parsey in a statement said a five-day regimen, “could significantly expand the number of patients who could be treated with our current supply of remdesivir.”
Gilead Chief Executive Daniel O’Day earlier this month said the company was prepared to donate 1.5 million doses of remdesivir to hospitals dealing with severely ill patients. Regulatory approval of the drug would also clear the way for commercial sales.
Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses make copies of themselves and potentially overwhelm their host’s immune system.
The company is also studying the drug in patients with less severe COVID-19, but those results are not expected until later next month.