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| An ampule of remdesivir is shown during a news conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany, on April 8. One U.S. study suggests it helps patients recover four days faster on average. (Ulrich Perrey/Reuters) |
Dr. Anthony Fauci says drug reduced time it takes patients to recover by 31%
A top U.S. health official said Gilead Sciences Inc’s experimental antiviral drug remdesivir is likely to become the standard of care for COVID-19 after early results from a key clinical trial on Wednesday showed it helped certain patients recover more quickly from the illness caused by the coronavirus.
The study, run by the U.S. National Institutes of Health, tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. At the White House, NIH’s Dr. Anthony Fauci said the drug reduced the time it takes patients to recover by 31 per cent — 11 days on average versus 15 days for those just given usual care.
Gilead earlier on Wednesday said remdesivir helped improve outcomes for patients with COVID-19 in the government-run trial, and provided additional data suggesting it worked better when given earlier in the course of illness. The statement sent its shares up seven per cent on the Nasdaq.
“The data shows that remdesivir has a clear cut significant positive effect in diminishing the time to recover. 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,” Fauci predicted, adding, “The FDA, literally as we speak, is working with Gilead to figure out mechanisms to make this easily available to those who need it.”
Several studies have painted a mixed picture of its effectiveness, and Fauci cautioned that the full data still needs to be analyzed.
The study, run by the U.S. National Institutes of Health, tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. At the White House, NIH’s Dr. Anthony Fauci said the drug reduced the time it takes patients to recover by 31 per cent — 11 days on average versus 15 days for those just given usual care.
Gilead earlier on Wednesday said remdesivir helped improve outcomes for patients with COVID-19 in the government-run trial, and provided additional data suggesting it worked better when given earlier in the course of illness. The statement sent its shares up seven per cent on the Nasdaq.
“The data shows that remdesivir has a clear cut significant positive effect in diminishing the time to recover. 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,” Fauci predicted, adding, “The FDA, literally as we speak, is working with Gilead to figure out mechanisms to make this easily available to those who need it.”
Several studies have painted a mixed picture of its effectiveness, and Fauci cautioned that the full data still needs to be analyzed.
“Although with 31 per cent improvement doesn’t seem like a knockout 100 per cent, it is a very important proof of concept, because what it is proven is that a drug can block this virus.”
U.S. President Donald Trump during a White House meeting greeted Gilead’s reports as good news.
Interest in Gilead’s drug has been high as there are currently no approved treatments or preventive 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.
Interest in Gilead’s drug has been high as there are currently no approved treatments or preventive 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.
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| In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. (Gilead Sciences/Associated Press) |
“There’s now enough data to support consideration of access under an emergency use authorization by FDA,” former U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Twitter.
Gilead provided information on two clinical trials. The study conducted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, met its main goal of helping patients with a range of severity of COVID-19, the disease caused by the novel coronavirus.
Gilead provided information on two clinical trials. The study conducted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, met its main goal of helping patients with a range of severity of COVID-19, the disease caused by the novel coronavirus.
Ok so it looks like there is a lot of confusion on this remdesivir news. Here is a lay person summary.— Dr. Nahid Bhadelia (@BhadeliaMD) April 29, 2020
There are numerous on going trials on remdesivir. Gilead, the manufacturer has 2- one in severe patients getting either 5 or 10 days, one in moderate patients w control arm.
Those preliminary results have been highly anticipated because it compares how patients who received remdesivir fared versus those given a placebo, meaning it should definitively demonstrate whether the drug provides benefit.
“It is the first truly high-powered randomized placebo-controlled trial,” Fauci said.
The trial’s lead researcher told Reuters on Friday that full results could come by mid-May.
Source: The Associated Press | CBC News
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