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Redemsivir "standard of care/authorized emergency use likely"
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The F.D.A. is likely to issue an emergency approval, a senior official said.....https://www.nytimes.com/2020/04/29/health/gilead-remdesivir-coronavirus.html?action=click&module=RelatedLinks&pgtype=Article
On the basis of as yet unpublished data, remdesivir "will be the standard of care" for patients with COVID-19, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), during a press conference at the White House today.
The median time to recovery was 11 days for patients treated with remdesivir, compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir and 11.6% for the patients who received placebo (P = .059).
Concerns over leaks compelled the top U.S. infectious disease official to reveal data on Gilead Sciences Inc's experimental drug remdesivir, the first in a scientifically rigorous clinical trial to show benefit in treating COVID-19. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), which is running the trial, said he took the first opportunity to get the word out that patients taking a dummy treatment or placebo should be switched to remdesivir in hopes of benefiting from it......
https://www.reuters.com/article/us-health-coronavirus-gilead-fauci/fauci-says-leak-concerns-fueled-his-white-house-revelation-of-gilead-drug-results-idUSKBN22C0KX
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. "Although a 31% improvement doesn't seem like a knockout 100%, it is very important proof of concept," Fauci said of remdesivir. "What it has proven is that a drug can block this virus."
Remdesivir is among several drugs being tested against Covid-19, but the NIAID trial is the first conducted according to rules aimed at gaining FDA approval. "Four days (fewer) in a hospital is, for me as a clinician -- as a clinical practitioner -- it is not only significant but very meaningful," he said, noting that would matter "to all my patients and even to myself, if I would be in the same situation."
"We have work to do. We are looking for other therapies. This trial is going to continue," said Dr. Andre Kalil.
He said shortening a hospital stay is important because patients who are there longer are at increased risk for complications, particularly if patients require respiratory support.
"Four days (fewer) in a hospital is, for me as a clinician -- as a clinical practitioner -- it is not only significant but very meaningful," he said, noting that would matter "to all my patients and even to myself, if I would be in the same situation."For this study, remdesivir was not tested against a placebo to see whether it was an effective treatment for the virus -- more evidence is needed to prove that. The study used 397 patients with severe Covid-19.
The most common adverse events in more than 10% of patients in some of the groups in the Gilead trial were nausea and acute respiratory failure, the company said.
In a statement, Gilead spokesperson Sonia Choi said the company prioritized manufacturing of remdesivir over a placebo early in the pandemic and prioritized the placebo for certain studies.
"Our goal with these studies was to answer the question of treatment duration, comparing safety and efficacy with five or 10 days of remdesivir treatment. A placebo control was not necessary to answer this question. The open-label study design was necessary to understand whether shortening the duration of therapy can lead to earlier discharge from the hospital," the statement reads.
The study is being expanded and conducted at 180 locations around the world, including in the United States, China, France, Italy and the United Kingdom.
The company's chief executive officer, Daniel O'Day, said in an open letter that Gilead's existing supply of the drug could cover at least 140,000 treatment courses for patients with Covid-19.
The estimate is based on 10 days of treatment with the drug.
Drug maker's smaller trial
Gilead Sciences released its own findings from a different trial of the drug Wednesday. The company said it found patients did just as well taking remdesivir for five days as those who took it for 10.
For this study, remdesivir was not tested against a placebo to see whether it was an effective treatment for the virus -- more evidence is needed to prove that. The study used 397 patients with severe Covid-19.
The most common adverse events in more than 10% of patients in some of the groups in the Gilead trial were nausea and acute respiratory failure, the company said.
In a statement, Gilead spokesperson Sonia Choi said the company prioritized manufacturing of remdesivir over a placebo early in the pandemic and prioritized the placebo for certain studies.
"Our goal with these studies was to answer the question of treatment duration, comparing safety and efficacy with five or 10 days of remdesivir treatment. A placebo control was not necessary to answer this question. The open-label study design was necessary to understand whether shortening the duration of therapy can lead to earlier discharge from the hospital," the statement reads......
https://www.cnn.com/2020/04/29/health/gilead-sciences-remdesivir-covid-19-treatment/index.html
Dr. Anthony Fauci says Gilead's remdesivir will set a new 'standard of care' for coronavirus treatment
On the basis of as yet unpublished data, remdesivir "will be the standard of care" for patients with COVID-19, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), during a press conference at the White House today.
The median time to recovery was 11 days for patients treated with remdesivir, compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir and 11.6% for the patients who received placebo (P = .059).
The study, known as the Adaptive COVID-19 Treatment Trial (ACTT), is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. It is being conducted at 68 sites - 47 in the United States and 21 in countries in Europe and Asia.
The data are being released after an interim review by the independent data safety monitoring board found significant benefit with the drug, Fauci said.
"The reason we are making the announcement now is something that people don't fully appreciate: Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to let the people in the placebo group know so they could have access," he explained.
"When I was looking at the data with our team the other night, it was reminiscent of 34 years ago in 1986 when we were struggling for drugs for HIV," said Fauci, who was a key figure in HIV/AIDS research. "We did the first randomized, placebo-controlled trial with AZT. It turned out to have an effect that was modest but that was not the endgame because, building on that, every year after, we did better and better."
Similarly, new trials of drugs for COVID-19 will build on remdesivir, with other agents being added to block other pathways or viral enzymes, Fauci said.
The study will be submitted to a journal for peer review, he noted, but the New York Times is reporting that the US Food and Drug Administration will approve remdesivir for emergency use later today.
In contrast to the positive results Fauci described from the NIAID-sponsored trial, a randomized, placebo-controlled clinical trial of remdesivir among hospitalized patients with severe COVID-19 in China was inconclusive.
The study, published online in the Lancet today, showed some nonsignificant trends toward benefit but did not meet its primary endpoint.
The study was stopped early after 237 of the intended 453 patients were enrolled, owing to a lack of additional patients who met the eligibility criteria. The trial was thus underpowered.
Results showed that treatment with remdesivir did not significantly speed recovery or reduce deaths from COVID-19, but with regard to prespecified secondary outcomes, time to clinical improvement and duration of invasive mechanical ventilation were shorter among a subgroup of patients who began undergoing treatment with remdesivir within 10 days of showing symptoms, in comparison with patients who received standard care.....https://www.medscape.com/viewarticle/929685
NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced COVID-19
https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
Participants in the NIH-sponsored trial must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including rattling sounds when breathing (rales) with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation. Individuals with confirmed infection who have mild, cold-like symptoms or no apparent symptoms will not be included in the study. In accordance with standard clinical research protocols, eligible patients will provide informed consent to participate in the trial.
Initially, investigators will compare participant outcomes on day 15 in both the remdesivir group and the placebo group to see if the investigational drug increased clinical benefit compared to placebo. Outcomes are scored on a seven-point scale ranging from fully recovered to death. Investigators will reevaluate this scale after reviewing data from the first 100 participants.
An independent data and safety monitoring board (DSMB) will monitor ongoing results to ensure patient well-being and safety as well as study integrity. The DSMB will recommend the study be halted if there is clear and substantial evidence of a treatment difference between drug and placebo.
Published Wed, Apr 29
• White House health advisor Dr. Anthony Fauci said Wednesday that data from a coronavirus drug trial testing Gilead Sciences' antiviral drug remdesivir showed "quite good news" and sets a new standard of care for Covid-19 patients.
• Fauci said the median time of recovery for patients taking the drug was 11 days, compared with 15 days in the placebo group.
• The results suggested a survival benefit, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group, according to a statement from the National Institutes of Health released later Wednesday.
• Fauci said NIAID's remdesivir drug trial, which enrolled about 800 patients, showed "quite good news" and that the drug would set a new standard of care for Covid-19 patients. Speaking to reporters from the White House, Fauci said he was told data from the trial showed a "clear-cut positive effect in diminishing time to recover."
The Food and Drug Administration, in the meantime, has been in "sustained and ongoing" discussions with Gilead to make remdesivir available to Covid-19 patients "as quickly as possible, as appropriate," said FDA senior advisor Michael Felberbaum.
Gilead's smaller clinical trial involved 397 patients with severe cases of Covid-19. The severe study is "single-arm," meaning it did not evaluate the antiviral drug against a control group of patients who didn't receive the drug.
The study tracked two groups of patients who were hospitalized with Covid-19. One group received a five-day treatment of remdesivir, while the other group took the drug for 10 days. The researchers said more than half the patients in both treatment groups were discharged from the hospital within 14 days. They said 64.5% of the patients who received the shorter treatment were discharged, compared with 53.8% of the group who were treated for 10 days.
A number of studies are testing remdesivir to see if it's effective in stopping the coronavirus from replicating.
Dr. Scott Gottlieb, shortly after the Gilead news was released, described remdesivir as "part of a better toolbox" for dealing with the coronavirus. But he said on CNBC's "Squawk Box" that it's "not a home run, a cure by any means."
"It's not going to be a cure, but it is going to be a drug potentially that if you use it particularly early in the course of the disease ... it could reduce their chances of having a really bad outcome," he said.
"These data are encouraging as they indicate that patients who received a shorter, five-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course," said Aruna Subramanian, a lead investigator of the study.
https://www.cnbc.com/2020/04/29/dr-anthony-fauci-says-data-from-remdesivir-coronavirus-drug-trial-shows-quite-good-news.html
Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19 - (04/29/20)
Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests. Key efficacy and safety results from the study are included in the table below.
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