Gilead, without details, says COVID-19 drug clears crucial clinical test
An experimental Gilead drug helped patients hospitalized with COVID-19 in a closely watched clinical study, the drugmaker said Wednesday, offering a tantalizing sign that antiviral treatment could curb the disease's assault on the body.
Detailed data from the trial, run by the U.S. National Institutes of Health and viewed as the most rigorous test of the therapy's potential, were not immediately available.
Bolstering the announcement, though, were findings from a Gilead-led study of severe COVID-19 patients, which the company also disclosed Wednesday. Unlike NIH's, Gilead's trial was not placebo controlled, and therefore results from the study are harder or, some argue, even impossible to gauge appropriately.
For its test, Gilead compared 5- and 10-day treatment regimens of remdesivir, as the drug is called. Measured by time to clinical improvement, patients appeared to do equally well on either regimen, showing signs of improvement in either 10 or 11 days.
By the two-week mark, more than half of the roughly 200 patients in each group were discharged from the hospital. Gilead said the drug was relatively well tolerated, although 3% of patients discontinued treatment due to signs of liver toxicity and 7% of those treated overall stopped taking remdesivir.
The results are the first complete data to come from a slate of mid- to late-stage trials testing remdesivir. While scores of repurposed drugs have been pushed quickly into testing, and dozens of research efforts to find new ones are now underway, remdesivir has been viewed as a near-term hope for battling back against a virus that's led to more than 218,000 deaths globally through April 29.
Until now, information on how well remdesivir might work against the new coronavirus has trickled out in snapshots, first from a leaked presentation by doctors at the University of Chicago, then from summary results posted in error to the World Health Organization website.
Those disclosures presented conflicting, but incomplete, views of remdesivir's effectiveness. The study data released by Gilead Wednesday, by contrast, offers a more comprehensive look, though many questions about the drug's potential remain unanswered.
On their own, the data aren't clear evidence remdesivir works. Gilead set up the study without a control arm, instead comparing less or more drug. Without a group of untreated patients to measure against, the data showing patients improving after receiving remdesivir is much more difficult to assess.
"In a month's time, we've had some promising results," said Kevin Grimes, an infectious disease specialist and associate professor of clinical medicine at Houston Methodist, which is a site for the Gilead trial. "Whether those people would've gotten better with supportive care, we don't know," he added in an interview ahead of Wednesday's data.
Gilead emplyoees unloading filled vials of investigational remdesivir
Permission granted by Gilead Sciences
Recent figures from New York City doctors, for example, showed about two-thirds of a group of some 390 adults with COVID-19 were eventually discharged and 10% died. And in a recent randomized clinical study, 78% of COVID-19 patients taking the HIV drug Kaletra improved after 28 days, but so too had 70% of those on placebo. Investigators concluded the therapy offered no benefit.
By comparison, 61% of the 320 patients treated outside of Italy in Gilead's study were discharged by two weeks, while 7%, or 23, had died.
"There's a critique to be had that Gilead classifies it as an efficacy study," said Brian Skorney, a biotech analyst at investment bank Baird, in an interview before the data was announced. "The better way to look at it is as a large, data-generating compassionate use study."
Still, the positive-seeming findings, coupled with news of the NIH study's success, are likely to heighten expectations remdesivir could play a role in treating COVID-19, placing new pressure on the company and on regulators tasked with assessing the drug's safety and efficacy.
Both will soon have more information in hand. A second Gilead-led study, in patients considered to be in moderate condition, is expected to deliver data from 600 patients by the end of May. Unlike today's news, those results will show how remdesivir fares against standard of care.
The National Institutes of Health trial, meanwhile, is viewed as the most definitive, having included a placebo and stipulated both doctors and physicians be "blinded" to who is receiving treatment. In a Wednesday statement, Gilead said it understood that trial has "met its primary endpoint" and that the institute would be providing more detailed information in an upcoming briefing.
Author: NedPagliarulo
Published: https://www.biopharmadive.com/news/coronavirus-remdesivir-gilead-nih-study-results/576330/