Remdesivir is promising Against Him, COVID-19! But!
Virology experts warn that the results of randomized clinical trials have yet to be repeated.
This is always necessary, since it is important to determine whether the antiviral medicine is effective and safe!
Remdesivir is an antiviral medication developed by Gilead Sciences. It shows promising activity against the new coronavirus that causes potentially fatal Acute Respiratory Syndrome.
Experts warn, however, that more data from randomized controlled trials is needed.
Earlier this month, researchers published results from Gilead's compassionate use program, which provides remedies for people with advanced illnesses outside of formal studies. Now the STAT revealed some of the first data from an ongoing clinical trial of the drug.
Patients lose a lot of weight. Muscle mass is consumed.
A Chicago hospital that treats serious Covid-19 patients with remediation of Gilead Sciences antiviral medicine in a closely watched clinical trial is quickly recovering from fever and respiratory symptoms, with almost all patients being discharged in less than a week. Redemsevir Has reduced treatment to one week!
Remdesivir is a nucleotide analog, in the same class of drugs as the drug Viread for HIV and hepatitis B (tenofovir disoproxil fumarate) and the hepatitis C direct-acting antiviral Sovaldi, sofosbuvir).
Both also manufactured by Gilead. These drugs interfere with the viral polymerase enzyme (which in the case of HIV is known as reverse transcriptase), acting as defective blocks that prevent the virus from copying its genetic material.
ORIGINAL DESTINATION OF REDEMSEVIR WAS EBOLA
As the director of National Institutes of Health (NIH) National Institute of Health Francis Collins, MD, PhD, described in a recent blog post, it is not uncommon for drugs to show activity against various viruses in the laboratory. But they must be tested on patients to determine whether they really work against a specific disease. Remdesivir was originally developed to treat the Ebola virus, but has been shown to be ineffective. In animal studies, it has shown activity against SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome), caused by coronavirus related to the one that causes COVID-19 (officially known as SARS-CoV-2).
Anti-retroviral drugs are developed for arduous missions.
The latest results are from a Chicago hospital that is seriously treating patients with COVID-19 as part of a Phase III clinical trial. It is one of more than 150 study sites that together registered more than 2.000 participants with serious illness.
The STAT report was based on comments by researcher Kathleen Mullane, DO, PharmD, of the University of Chicago, made during a video discussion with colleagues. Their observations were not intended for the public and the study results have not yet been peer-reviewed or published in a scientific journal.
Infusion with Redemsevir decreased recovery time
This analysis included 125 participants, 113 of whom were seriously ill. All were treated with daily IV infusions of remdesivir. Patients recovered more quickly than would be expected without treatment. Their fevers subsided quickly, their respiratory symptoms improved - some managed to turn off the ventilators soon after starting treatment - and most were discharged within a week. Only two patients died.
Non-randomized patients in these tests
However, Mullane emphasized that patients were not randomized to receive remdesivir or placebo, which means that they cannot be sure whether the favorable results were attributable to the drug.
Most people with COVID-19 recover without treatment, although this is less likely among people with severe illness. Remdesivir is also being studied in several other clinical trials, some of which included people with mild to moderate disease and included a placebo group. But two trials with remdesivir in China were recently stopped after the epidemic was brought under control and it became difficult to recruit enough patients.
However, preliminary results have led to optimism among those who desperately want effective treatments as soon as possible.
"Even without control, if these results persist, it is very promising," Bob Wachter, MD, chairman of the Department of Medicine at the University of California at San Francisco, tweeted after seeing the leaked findings.
Gilead declined to provide more information about the Chicago findings.
"We understand the urgent need for treatment with COVID-19 and the resulting interest in the data from our antiviral drug under investigation," the company said in a statement. “The totality of the data needs to be analyzed to draw conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine remdesivir's safety and efficacy profile as a treatment for COVID-19. "
Discoveries of compassionate use
Another group of researchers published initial data from the Gilead compassionate use program in April 10 edition of The New England Journal of Medicine.
This analysis included 61 patients hospitalized with COVID-19 who had low oxygen levels or were receiving oxygen support. Most were men over 60 with underlying health problems, including hypertension or diabetes - a population known to be at higher risk for more severe COVID-19.
All patients were treated with 10 days of remdesivir administered by intravenous infusion. Post-treatment data were available for 53 of them (22 in the United States, 22 in Europe or Canada and 9 in Japan). Of these, 30 (57%) used mechanical ventilators and four (8%) were receiving oxygenation through an extracorporeal membrane, a technique that removes blood, adds oxygen and returns it to the body.
During an average follow-up period of 18 days, 36 patients (68%) needed less oxygen support, including 17 who managed to get off the ventilators. Almost half of the patients (47%) were discharged from the hospital. Seven people died, producing mortality rates of 18% among those who used ventilators and 5% (representing a patient) among those who did not need ventilators. Everyone who was removed from a fan survived
The Side Effects were “the usual ones”.
No unexpected side effects have been reported. About a quarter of patients experienced mild to moderate elevations of liver enzymes from ALT or AST, and two of the four people who stopped treatment prematurely did so because of elevated liver enzymes. Twelve people on ventilators had serious adverse results, including multiple organ failure, septic shock, acute kidney injury or severe blood pressure.
There is no treatment against COVID-19
“Currently, there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations of this group of hospitalized patients who received remdesivir are auspicious, ”said lead researcher Jonathan D. Grein, MD, of Cedars-Sinai Medical Center in Los Angeles, in Gilead press release.. "We are looking forward to the results of controlled clinical trials to potentially validate these findings."
Just as antivirals for HIV and hepatitis C work best when used early, before they cause severe damage to the immune system or liver, it is possible that remdesivir will be more effective before severe lung damage occurs.
The National Institute of Allergy and Infectious Diseases announced this week that early treatment with remdesivir, compared with a placebo, significantly reduced respiratory distress, virus levels in the lungs and lung damage in SARS-CoV-2 infected rhesus monkeys.
Will it be effective and second against COVID-19?
These results were published on the bioRxiv prepress server and have not yet been peer reviewed. "When studying remdesivir, the question is not only whether it is safe and effective against COVID-19, but in which patients it shows activity, how long they should receive treatment and at what stage of the disease the treatment would be most beneficial," he said. Gilead President and CEO Daniel O'Day said in a open letter on April 10. “Many answers are needed, which is why we need several studies involving many types of patients.
The Pipeline and Responses
Some of these responses will begin to emerge in the coming weeks, as we receive the first data from the various clinical trials underway. "
O'Day said preliminary results from a study of people with severe COVID-19 will be available in late April, with results from patients with moderate illness in May. As COVID-19 cases continue to increase worldwide.
Researchers are testing dozens of treatment candidates, many of whom are currently approved for other conditions. Hundreds of clinical trials of possible therapies are underway.
Chloroquine has disappointed and even killed!
* I lived to see something worse than AZT!
Studies on chloroquine and hydroxychloroquine (Plaquenil), two cheap malaria drugs, promoted by President Donald Trump and his inseparable disciple, have so far produced mixed, but largely disappointing results. A study in Brazil was recently stopped after patients who received high doses of chloroquine experienced severe cardiac side effects.
As POZ recently reported, the antiretroviral pill for HIV Kaletra (lopinavir / ritonavir) was not more effective than than standard supportive care in one of the first clinical trials of the drug, although it can help people treated early.
The company that makes another HIV protease inhibitor, Prezista (darunavir), has warned that it is unlikely that the drug has significant activity against the coronavirus. [/ vc_column_text] [/ vc_column] [/ vc_row]
Not in Brazil!
Doctors are allowed to prescribe approved drugs for other conditions (known as unlabeled use) of COVID-19. However, medical experts and lawyers recommend caution about the premature use of experimental therapies before randomized clinical trials prove they are safe and effective.
Translated by Cláudio Souza on April 22, 2020 of the original in Remdesivir Appears Promising for COVID-19 Treatment!