anti-viral drug Archives - Amazing Health Advances

FDA Approves First COVID-19 Drug: Antiviral Remdesivir

AHA Publisher — Mon, 26 Oct 2020 07:00:56 +0000

Associated Press via CBN News – US regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given to hospitalized patients through an IV. The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health. It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month. Veklury is approved for people at least 12 years old and weighing at least 88 pounds (40 kilograms) who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization. The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness. “We now have enough knowledge and a growing set of tools to help fight COVID-19,” Gilead’s chief medical officer, Dr. Merdad Parsey, said in a statement. The drug is either approved or has temporary authorization in about 50 countries, he noted. Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit. The FDA’s approval statement noted that, besides the NIH-led one, two other studies found the drug beneficial. Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income, and other factors. So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs. To read the original article click here. For more articles from CBN News click here.

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Investigational Therapy Gaining Reputation as Promising Antiviral Drug to Fight COVID-19

AHA Publisher — Sun, 19 Apr 2020 07:00:15 +0000

Houston Methodist via Newswise – Houston Methodist sole Remdesivir clinical trial site in Houston for treating novel coronavirus. Newswise — COVID-19 patients in a clinical trial at Houston Methodist Hospital are responding quickly to the antiviral drug Remdesivir. The trial’s criteria allows for the treatment of patients early in their clinical course and, in some cases, at times where they might have otherwise been intubated. “Early results are promising, and that is important right now. Much of what we are learning about COVID-19 management is centered around preventing quick deterioration. Timing is everything. I can’t say for certain they would have been intubated otherwise, but it’s encouraging,” said infectious diseases pharmacist Katherine K. Perez, Pharm.D. One of the most challenging things with COVID-19 is the way this virus makes copies of itself once it finds its way into the body. This is how COVID-19 can ultimately take over and send someone into respiratory distress and in need of intubation if not stopped early enough. Remdesivir has demonstrated a potent ability to inhibit this viral replication in human cells and is now being tried in clinical trials of patients with the SARS-CoV-2 virus, which causes COVID-19. Houston Methodist is the only clinical trial site in Houston for this investigational new drug. Working with pharmaceutical company Gilead Sciences, Remdesivir’s manufacturer and sponsor of the studies, Houston Methodist Hospital was the fifth site in the U.S. to join the clinical trials and has been enrolling and treating patients since mid-March. Initially, five patients received early access to Remdesivir on a compassionate use basis, and since being activated as a clinical trial site, more than 35 patients have been enrolled. The two Phase 3 clinical trials at Houston Methodist are randomized, open-label, multicenter studies and are treating patients with moderate to severe symptoms to evaluate the safety and efficacy of Remdesivir in adults diagnosed with COVID-19. One study is for patients with moderate COVID-19 and tests either a 5-day or 10-day Remdesivir treatment. The second study is evaluating a 10-day course of Remdesivir for patients with severe COVID-19, including those on mechanical ventilation. Infectious diseases physician Kevin A. Grimes, M.D., M.P.H., and Perez are leading efforts for both the clinical trials at Houston Methodist and say they’ve been encouraged by the results. Perez says early results at Houston Methodist have been promising, courses have been well tolerated, and a number of COVID-19 patients who have undergone treatment with Remdesivir are showing signs of recovery and have been released from the hospital to go home. While it’s too early to tell, she says there also are indications that treatment with Remdesivir can possibly stave off being intubated. Grimes agrees that acting quickly is critical. “If given early enough, we’re hoping that Remdesivir interferes with the virus and blocks its ability to replicate in patients’ cells,” Grimes said. “The goal is that it staves off the deadly inflammatory cascade that leads to respiratory failure and the need to be intubated and put on a ventilator.” That crucial turning point is what makes COVID-19 become deadly. The main cause of death from this disease results from an extreme inflammatory response in the lungs brought on by the coronavirus. The immune system becomes hyperactive with its inflammatory disease-fighting processes going into overdrive, attempting to defeat the virus, but doing more harm than good by destroying cells in the lungs. A broad-spectrum antiviral drug, Remdesivir was originally developed to treat Ebola more than a decade ago. It’s known to be generally safe in humans and is backed by a large body of preclinical research, as well as a number of studies that have shown it be quite successful in stopping SARS and MERS, the viral cousins of the new coronavirus strain. The testing stopped short of clinical trials, so its efficacy against SARS and MERS in patients is unknown. Published in the journal Nature, a study in China earlier this year showed Remdesivir could successfully block COVID-19 from replicating in human cells. A paper in the New England Journal of Medicine chronicles the case of the man at ground zero in Washington state who was the first known U.S. COVID-19 patient. He received Remdesivir at the recommendation of the CDC and was said to have started improving within 24 hours. On April 10, the first available results from one of Gilead’s compassionate-use cohorts was published in the New England Journal of Medicine. The study showed clinical improvement in a two-thirds majority (68 percent) of patients hospitalized for severe COVID-19 who received compassionate-use Remdesivir. Forthcoming data from several ongoing randomized, controlled clinical trials, including the ones at Houston Methodist, will provide more definitive, evidence-based conclusions regarding the safety and efficacy of Remdesivir for treating COVID-19. The clinical observations in this compassionate-use program are the only currently available data. The study authors expect results from some of Gilead’s controlled clinical trial sites to potentially validate these findings in the coming weeks. To read the original article click here.

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A New Antiviral Drug Heading into Clinical Trials Offers Hope for COVID-19 Treatment

AHA Publisher — Tue, 07 Apr 2020 07:00:36 +0000

University of North Carolina at Chapel Hill via EurekAlert – Scientists are hopeful that a new drug — called EIDD-2801 — could change the way doctors treat COVID-19. The drug shows promise in reducing lung damage, has finished testing in mice and will soon move to human clinical trials. As of April 3, the novel coronavirus SARS-CoV-2 had infected more than 1 million people with COVID-19 and caused more than 58,000 deaths in a worldwide pandemic. Currently, no antiviral drugs have been approved to treat SARS-CoV-2 or any of the other coronaviruses that cause human disease. Researchers at the UNC-Chapel Hill Gillings School of Global Public Health are playing a key role in the development and testing of EIDD-2801. Virologists in the lab of William R. Kenan Jr. Distinguished Professor of epidemiology Ralph Baric, are working with colleagues in the lab of Mark Denison, Edward Claiborne Stahlman Professor of pediatrics at Vanderbilt University Medical Center (VUMC), and with George Painter, chief executive officer of the nonprofit DRIVE (Drug Innovation Ventures at Emory) and director of the Emory Institute for Drug Development (EIDD), where EIDD-2801 was discovered. The results of the team’s most recent study were published online April 6 by the journal Science Translational Medicine. The paper includes data from cultured human lung cells infected with SARS-CoV-2, as well as mice infected with the related coronaviruses SARS-CoV and MERS-CoV. The study found that, when used as a prophylactic, EIDD-2801 can prevent severe lung injury in infected mice. EIDD-2801 is an orally available form of the antiviral compound EIDD-1931; it can be taken as a pill and can be properly absorbed to travel to the lungs. When given as a treatment 12 or 24 hours after infection has begun, EIDD-2801 can reduce the degree of lung damage and weight loss in mice. This window of opportunity is expected to be longer in humans, because the period between coronavirus disease onset and death is generally extended in humans compared to mice. “This new drug not only has high potential for treating COVID-19 patients, but also appears effective for the treatment of other serious coronavirus infections,” said senior author Baric. Compared with other potential COVID-19 treatments that must be administered intravenously, EIDD-2801 can be delivered by mouth as a pill. In addition to ease of treatment, this offers a potential advantage for treating less-ill patients or for prophylaxis — for example, in a nursing home where many people have been exposed but are not yet sick. “We are amazed at the ability of EIDD-1931 and -2801 to inhibit all tested coronaviruses and the potential for oral treatment of COVID-19. This work shows the importance of ongoing National Institutes of Health (NIH) support for collaborative research to develop antivirals for all pandemic viruses, not just coronaviruses” said Andrea Pruijssers, the lead antiviral scientist in the Denison Lab at VUMC. Denison was senior author of a December 2019 study that first reported that EIDD-1931 blocked the replication of a broad spectrum of coronaviruses. These interinstitutional collaborators, supported by an NIH grant through the University of Alabama at Birmingham, also performed the preclinical development of remdesivir, another antiviral drug currently in clinical trials of patients with COVID-19. In the new Science Translational Medicine paper, Maria Agostini, a postdoctoral fellow in the Denison lab, demonstrated that viruses that show resistance to remdesivir experience higher inhibition from EIDD-1931. “Viruses that carry remdesivir resistance mutations are actually more susceptible to EIDD-1931 and vice versa, suggesting that the two drugs could be combined for greater efficacy and to prevent the emergence of resistance,” said Painter. Clinical studies of EIDD-2801 in humans are expected to begin later this spring. If they are successful, the drug could not only be used to limit the spread of SARS-CoV-2, but also could control future outbreaks of other emerging coronaviruses. “With three novel human coronaviruses emerging in the past 20 years, it is likely that we will continue to see more,” said first author Timothy Sheahan, a Gillings assistant professor of epidemiology and a collaborator in the Baric Lab. “EIDD-2801 holds promise to not only treat COVID-19 patients today, but to treat new coronaviruses that may emerge in the future.” To read the original article click here.

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UCLA Clinical Trial Tests Anti-Viral Drug Remdesivir and Other Therapies Against COVID-19

AHA Publisher — Mon, 06 Apr 2020 07:00:56 +0000

University of California, Los Angeles (UCLA), Health Sciences via Newswise – UCLA Health is one of 75 sites around the globe participating in a clinical trial sponsored by the National Institutes of Health to test the effectiveness of a candidate anti-viral drug against COVID-19. The drug, called remdesivir, was originally developed as a treatment for Ebolavirus. Although found to be safe, it was not effective in treating those patients. However, in laboratory tests it appears to work against the SARS-CoV-2, which causes COVID-19, raising hope for its efficacy against this new, novel virus that has swept the globe, sickening and killing thousands. At its worst, the disease attacks the lung in particularly vulnerable people. People age 60 and older who have other health issues are especially susceptible to the disease’s most severe effects and are likeliest to die from it. This evidence has initiated formal investigations into the efficacy of the drug such as the one launched by the NIH through its National Institute of Allergy and Infectious Diseases. UCLA, an academic medical center at the forefront of health research, is part of this and trials of other drugs to fight the virus – with others potentially launching soon. Dr. Otto Yang, professor of medicine, division of infectious diseases, at the David Geffen School of Medicine at UCLA, is leading this trial, with substantial support from the UCLA Clinical and Translational Science Institute. “Remdesivir is a drug that has good activity against the virus in lab experiments, and it seems to effectively treat similar viruses in animals,” said Yang, who is also a professor of microbiology, immunology & molecular genetics at the Geffen School. “We don’t know yet whether it is effective in humans with COVID-19 so it is undergoing clinical tests in patients.” There are a few big trials underway in China and the U.S. combining data from many patients at various medical facilities, with UCLA being one of the sites for one of the biggest trials, he noted. Patients are offered enrollment if they have known COVID-19, are admitted to the hospital and have moderate or worse illness. The trial is placebo-controlled, meaning that half of patients get the actual drug and half get a placebo, or substance that has no therapeutic effect. It is also double-blind, meaning that the researchers do not know which patients are getting the drug or placebo, thus preventing any intentional or unintentional bias. Placebo-controlled trials are necessary to maintain the integrity of the findings. And it is important to note that there are now no known effective treatments against COVID-19, Yang said. Participants who receive the placebo are contributing as much to the fight against COVID-19 as those getting the actual drug. “So, participating in a trial is really about figuring out what might work, and it is a valuable contribution to helping science and developing useful treatments for the future,” Yang said. “Receiving the placebo is just as important as receiving the drug from this standpoint, when we don’t know if an experimental treatment has a benefit at all.” This is only one of several trials of different agents under investigation at UCLA to use against the disease, said Dr. Judith Currier, chief of the UCLA Division of Infectious Diseases at the Geffen School. Currier and Dr. Arash Naeim, chief medical officer for clinical research for UCLA Health, are co-chairs of a clinical research task force that is coordinating these studies across multiple units on campus, such as the UCLA Clinical and Translational Science Institute and the UCLA Fielding School of Public Health. For instance, one trial is examining sarilumab, a treatment for rheumatoid arthritis. There are several more trials expected soon as we work to evaluate promising therapies including biologics, antivirals and immune-based treatments for people with different stages of COVID disease,” Currier said. To read the original article click here.

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