Thursday, April 30, 2020

Remdesivir, antiviral drug developed at UAB, shows "positive effect" on COVID-19 patients in U.S. trial, with emergency FDA approval expected shortly

UAB Medical Center

An antiviral drug developed at UAB has shown  "positive effect" on recovery in a U.S.-funded clinical trial, and the FDA is expected to approve the drug, remdesivir, as a treatment for COVID-19, according to reports at multiple news outlets yesterday. From a story at CNN:

Researchers released some good news about a possible treatment for coronavirus Wednesday -- evidence that the experimental drug remdesivir might help patients recover more quickly from the infection.

The US Food and Drug Administration has not yet approved any drugs for the treatment of the coronavirus. But it plans to announce an emergency-use authorization for remdesivir, according to The New York Times. The authorization could come as soon as Wednesday, The Times reported, citing a senior administration official.

In a statement to CNN, the FDA said it is in talks with Gilead Sciences, the maker of remdesivir, about making the drug available to patients.

"As part of the FDA's commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in ... discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate," FDA spokesman Michael Felberbaum said in statement.

Dr. Richard Whitley, UAB distinguished professor of pediatrics, is the principal investigator on a $37.5-million grant from the National Institute of Allergy and Infectious Diseases (NIAID). The grant funds UAB's Antiviral Drug Discovery and Development Center (AD3C), where much of the research on remdesivir has been conducted, involving scientists from multiple institutions.

Reports roughly a week ago about a remdesivir study in China described the results as "inconclusive," with some accounts even describing the trial as a "failure." That study was stopped early because it did not attract enough patients, leading to incomplete results. The NIH study, which generated yesterday's news reports, does not appear to be a "home run" against COVID-19, but its results were encouraging enough to reportedly prompt FDA approval. Reports Stat News;

A government-run study of Gilead’s remdesivir, perhaps the most closely watched experimental drug to treat the novel coronavirus, showed that the medicine is effective against Covid-19, the disease caused by the virus.

In a statement on Wednesday, the National Institute of Allergy and Infectious Diseases, which is conducting the study, said preliminary data show patients who received remdesivir recovered faster than similar patients who received placebo.

The finding — although difficult to fully characterize without full, detailed data for the study — would represent the first treatment shown to improve outcomes in patients infected with the virus that put the global economy in a standstill and killed at least 218,000 people worldwide.

During an appearance alongside President Trump in the Oval Office, Anthony Fauci, the director of NIAID, part of the National Institutes of Health, said the data are a “very important proof of concept” and that there was reason for optimism. He cautioned the data were not a “knockout.” At the same time, the study achieved its primary goal, which was to improve the time to recovery, which was reduced by four days for patients on remdesivir.

The preliminary data showed that the time to recovery was 11 days on remdesivir compared to 15 days for placebo, a 31% decrease. The mortality rate for the remdesivir group was 8%, compared to 11.6% for the placebo group; that mortality difference was not statistically significant.

What could all of this mean to a public desperate for signs of hope against a lethal and highly contagious virus? Reports Stat News:

That is “the first convincing evidence that an antiviral drug can really benefit Covid-19 patients, specifically hospitalized Covid-19 patients,” said Frederick Hayden, a professor emeritus of clinical virology and medicine at the University of Virginia School of Medicine. “This will change the standard of care in the United States and other countries for the patients who have been shown to be benefited,” he said, adding that determining the exact group that should receive the drug will require further examination of the data.

Over the past few weeks, there have been conflicting reports about the potential benefit of remdesivir, a drug that was previously tried in Ebola. As previously reported by STAT, an early peek at Gilead’s study in severe Covid-19 patients, based on data from a trial at a Chicago hospital, suggested patients were doing better than expected on remdesivir. Days later, a summary of results from a study in China showed that patients on the drug did not improve more than those in a control group.

Full results from the China study were also released Wednesday.

But the NIAID study, which was not expected to be released so soon, was by far the most important and rigorously designed test of remdesivir in Covid-19. The study compared remdesivir to placebo in 800 patients, with neither patients nor physicians knowing who got the drug instead of a placebo, meaning that unconscious biases will not affect the conclusions.

The main goal of the study is the time until patients improve, with different measures of improvement depending on how sick they were to begin with. While the result means that the drug helps patients improve faster, it is not possible to say how dramatic those improvements are.

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