• Preliminary results showed that patients given remdesivir recovered 31% faster
  • Lancet published a study on the same day concluding that data from a trial in China shows that the drug is not effective
  • Gilead said previously that those findings were inconclusive because the study was terminated early.

(Reuters) – Dr. Fauci, the top U.S. infectious disease official said Gilead Sciences Inc's experimental antiviral drug remdesivir will become the standard of care for COVID-19 after early clinical trial results 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.

The U.S. Food and Drug Administration said it has been in discussions with Gilead about making remdesivir available to patients as quickly as possible, but the agency declined to comment on any plans to grant the drug regulatory approval.

“I want them to go as quickly as they can," President Donald Trump said, when asked if he wanted the FDA to grant emergency use authorization for remdesivir. “We want everything to be safe, but we would like to see very quick approvals, especially with things that work."

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.

The trial's lead researcher told Reuters on Friday that full results could come by mid-May.

“The full dataset will provide more clarity on how remdesivir can best be used," said Dr. Aneesh Mehta, a researcher on the NIH trial from Emory University School of Medicine in Atlanta.

 

China trial shows experimental drug's failure to improve COVID-19 patient health

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.

Lancet published a study concluding that Gilead Sciences Inc's experimental drug remdesivir does not speed up recovery from COVID-19

Also on Wednesday, Lancet published a study concluding that Gilead Sciences Inc's experimental drug remdesivir does not speed up recovery from COVID-19 compared with placebo in critically-ill, hospitalised patients, according to data from a trial in China.

The authors of the study warned that interpreting the trial finding is limited as it was stopped early after they were unable to recruit enough patients due to the steep decline in cases in China.

 

‘Glimmer of Hope'

The authors conclude that more evidence from ongoing clinical trials is needed to better understand if remdesivir can provide meaningful clinical benefit.

“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 clinical improvements were similar regardless of treatment duration, and patients treated early on with remdesivir did better than patients who were treated later in the course of infection.

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.