Shorter Course of Gilead Drug as Effective Against Covid-19

Federal health regulators are exploring whether to greenlight the emergency use of a Gilead Sciences Inc. drug in serious Covid-19 patients, after U.S. government researchers reported the therapy helped the patients recover faster.
President Trump said he was pushing the U.S. Food and Drug Administration to grant the emergency-use authorization to the Gilead drug remdesivir.
The National Institute of Allergy and Infectious Diseases said Wednesday that advanced Covid-19 patients taking remdesivir in the institute’s study had a speedier recovery than patients taking placebo, according to preliminary results.
The reported benefit was moderate, however, with remdesivir patients recovering in 11 days, or four days faster than the placebo group.
Also on Wednesday, a separate study in China posted negative results for the drug. The researchers urged more testing, however, because their trial was stopped early due to problems recruiting subjects as the pandemic slowed there.
Gilead is in active discussions with the Food and Drug Administration about securing emergency authorization for remdesivir, Chief Executive Daniel O’Day said in an interview.
“I know they’re working in earnest to determine the path forward and make the decision,” he said. “It’s full-steam ahead with this new clinical data in hand now.”
If emergency authorization is approved, it will allow Gilead to work with the government to directly ship the drug to hospitals with the greatest need, Mr. O’Day said.
Gilead expects to have manufactured 1.5 million doses by the end of May, or up to 210,000 treatment courses, assuming that most patients are treated for five days, and the company will donate the supply to hospitals and doctors free of charge, Mr. O’Day said. He declined to say how much Gilead might charge for remdesivir that it manufactures after June.
The NIAID-funded study could carry more weight for U.S. health regulators considering whether to greenlight wider use of remedesivir, however, since the study was carried out by government researchers and was fully enrolled.
NIAID Director Anthony Fauci said at the White House the results appeared to open the door to drug treatment of Covid-19, though he indicated drugmakers would probably need to build upon the findings to improve the benefit.
“This will be the standard of care,” he said.
Mr. Trump indicated he would support the FDA issuing an “emergency use authorization” that could accelerate approval for use of remdesivir.
“I want them to go as quickly as they can,” he told reporters Wednesday. “We want everything to be safe, but we would like to see very quick approvals, especially with things that work.”
Researchers run drug trials to establish whether a drug works safely. The varying outcomes for remdesivir point to the challenges scientists face finding definitive proof while racing to come up with a treatment in the middle of a pandemic.
Standards for an emergency-use authorization aren’t as high as they are for a typical drug approval. The U.S. Food and Drug Administration grants both. The authorization is to provide speedy access to treatments for serious diseases during a health emergency.
The agency had granted emergency-use authorization to antimalaria drugs chloroquine and hydroxychloroquine, though the evidence supporting their expanded access was thinner.
So far, remdesivir use has been limited to patients testing the drug, or who were able to make the case for its compassionate use.
“The FDA, literally as we speak, is working with Gilead to figure out mechanisms to make this easily available to those who need it with regard to getting to the market,” Dr. Fauci said. “The FDA is very well aware that this is something that is important so I’m sure they’ll move very expeditiously.”
The U.S. study compared recovery times for 1,063 hospitalized patients taking either remdesivir or placebo.
The trial’s findings were based on an interim analysis, and more detailed data will be released in the future, the agency said. The data hasn’t yet been published in a peer-reviewed journal.
Patients taking remdesivir recovered in 11 days, compared with 15 days for patients taking placebo, a 31% improvement that was statistically significant, NIAID said in a news release.
In the remdesivir group, 8% of patients died, compared with 11.6% of patients in the placebo arm. The survival difference wasn’t statistically significant, however.
Timothy Albertson, a critical-care doctor at the University of California, Davis said the improvement in recovery times would be valuable, especially if it helps patients get discharged from the hospital sooner.
He said he would look to additional remdesivir studies to see if the drug improved the survival of patients by a statistically significant degree.
“Survival is the sort of platinum standard that ICU doctors look at and this one doesn’t quite make it,” Dr. Albertson said.
The separate study in China showed that remdesivir didn’t have a statistically significant benefit over placebo, researchers said.
In that study, the median time to clinical improvement in patients taking remdesivir was 21 days, compared with 23 days for patients taking placebo, but the difference wasn’t statistically significant, according to a paper published in the Lancet, a medical journal.
The rate of death was similar in both groups, with 14% of the patients taking remdesivir dying compared with 13% of patients in the placebo group. The difference wasn’t statistically significant.
Bin Cao, a physician who led the Chinese study, said in an interview that he thinks remdesivir did perform somewhat better than placebo in the study, but that the difference was small.
He also said remdesivir may have a role to play in treating Covid-19, but that further studies would have to be done to determine how early in the disease to treat patients and if it should be combined with other drugs.
Dr. Cao noted that patients in the Chinese study were extremely sick and weren’t treated with remdesivir until a median of 10 days after their symptoms appeared. Patients may be too sick at that stage for a single antiviral drug to clear the virus, he said.
He also noted that the remdesivir group had a higher proportion of patients with pre-existing conditions like diabetes and hypertension, which may have also influenced the results.
Some experts said the Chinese study data were inconclusive because the trial was stopped early due to a lack of patients. Researchers intended to enroll 453 patients, but had only 237 patients enrolled when the study was stopped.
“The study has not shown a statistically significant finding that confirms a remdesivir treatment benefit of at least the minimally clinically important difference, nor has it ruled such a benefit out,” wrote John David Norrie of the Usher Institute’s Edinburgh Clinical Trials Unit, in a commentary accompanying the Lancet paper.
Gilead’s remdesivir, an antiviral drug administered intravenously and previously tested in Ebola, is among the most closely watched experimental treatments for Covid-19, and is being studied in multiple clinical trials around the world. If approved by regulators, the drug would be the first proven to be effective against Covid-19.
Also on Wednesday, Gilead said a separate study it funded showed that Covid-19 patients taking remdesivir for five days had similar results as patients taking a 10-day course of the drug. The study didn’t compare the drug with a control group of patients not taking the drug, making the results difficult to interpret.
“The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” Gilead’s Chief Medical Officer Merdad Parsey said.
The company said it is conducting the study at 180 sites, including in countries with high levels of Covid-19 infection such as China, the U.S. and Italy. The study’s initial phase involved 397 patients, and Gilead said it would enroll another 5,600 patients.
Gilead expects data at the end of May from another study assessing the two dosing durations of remdesivir in patients with moderate Covid-19 compared with patients receiving standard treatment.
Remdesivir hasn’t been approved anywhere and has yet to be deemed safe or effective for Covid-19 treatment.
Remdesivir hasn’t been approved anywhere and has yet to be deemed safe or effective for Covid-19 treatment.

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