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Remdesivir study finally published, and an expert in critical care medicine gives us his verdict

Remdesivir study finally published – an expert in critical care medicine gives us his verdict
A patient receiving supplemental oxygen is likely to benefit the most. Credit: 99Art/Shutterstock

The results of the ACTT-1 trial, which looked at the effectiveness of remdesivir as a treatment for COVID-19, have finally been published. So far the only drug that has been shown to reduce deaths from the disease has been dexamethasone, a steroid that suppresses the immune system through its anti-inflammatory effects. Steroids have a secondary effect on the disease—they don’t target the virus itself. Remdesivir, on the other hand, goes straight to the cause of the disease by inhibiting the virus.

The drug, which was developed by Gilead Sciences, was approved for use by the US Food and Drug Administration under an “emergency use authorisation” on May 1. It was recently used to treat President Donald Trump.

Gilead Sciences has claimed that the drug has significant benefits for patients—but robust data has been lacking until now. This makes the long-awaited results of the ACTT-1 trial important. Having read the study, most physicians treating patients with COVID-19 will be asking themselves the same question: “Should I be using remdesivir for my patients?”

Should all COVID-19 patients get remdesivir?

The trial follows a gold-standard design of being double blind, randomized and controlled, and like most trials published in top medical journals, at first glance the outcomes are fairly impressive. They found that patients receiving the drug improved and recovered more quickly, were less likely to progress to severe disease, were discharged from hospital sooner, and had a lower death rate of 11.4% compared with 15.2% in patients receiving “usual” treatment.

Based on these positive findings, it would be tempting to conclude that all patients who have the disease should receive the drug, but since it costs around US$2,340 (£1,795) to treat one patient, and is likely to be in short supply in the UK for the foreseeable future, the question warrants a more considered analysis.

The use of any drug also has potentially negative consequences. Remdesivir has not been around long enough to have a track record for safety, and the reports of side-effects in COVID patients continue to grow.

When we unpick the data and look at analyzes of smaller groups (subgroup analyzes), the only patients for whom benefit was conclusively demonstrated were those who were less severely ill and receiving only supplemental oxygen rather than being on a ventilator. It is worth remembering that ACTT-1 is a relatively small trial and sicker patients may well benefit, but it has yet to be proven. Another interesting subgroup analysis showed that patients receiving dexamethasone showed added benefit with the addition of remdesivir, which is good news.

No magic bullet

So when I go into my hospital this week and am confronted on the wards with patients who are ill with COVID-19, ACTT-1 tells me that, provided I can find remdesivir on the pharmacy shelf, I should be confident to use it in any patients who are receiving oxygen alone, in the hope that they will recover sooner and, more

Remdesivir study shows promise for COVID-19, but no magic bullet

Oct. 12 (UPI) — The results of the ACTT-1 trial, which looked at the effectiveness of remdesivir as a treatment for COVID-19, have finally been published. So far the only drug that has been shown to reduce deaths from the disease has been dexamethasone, a steroid that suppresses the immune system through its anti-inflammatory effects. Steroids have a secondary effect on the disease — they don’t target the virus itself. Remdesivir, on the other hand, goes straight to the cause of the disease by inhibiting the virus.

The drug, which was developed by Gilead Sciences, was approved for use by the U.S. Food and Drug Administration under an “emergency use authorization” on May 1. It was recently used to treat President Donald Trump.

Gilead Sciences has claimed that the drug has significant benefits for patients — but robust data has been lacking until now. This makes the long-awaited results of the ACTT-1 trial important. Having read the study, most physicians treating patients with COVID-19 will be asking themselves the same question: “Should I be using remdesivir for my patients?”

Who should get it?

The trial follows a gold-standard design of being double blind, randomized and controlled, and like most trials published in top medical journals, at first glance the outcomes are fairly impressive. They found that patients receiving the drug improved and recovered more quickly, were less likely to progress to severe disease, were discharged from hospital sooner, and had a lower death rate of 11.4% compared with 15.2% in patients receiving “usual” treatment.

Based on these positive findings, it would be tempting to conclude that all patients who have the disease should receive the drug, but since it costs around $2,340 to treat one patient, and is likely to be in short supply in the United Kingdom for the foreseeable future, the question warrants a more considered analysis.

The use of any drug also has potentially negative consequences. Remdesivir has not been around long enough to have a track record for safety, and the reports of side effects in COVID-19 patients continue to grow.

When we unpick the data and look at analyses of smaller groups (subgroup analyses), the only patients for whom benefit was conclusively demonstrated were those who were less severely ill and receiving only supplemental oxygen rather than being on a ventilator. It is worth remembering that ACTT-1 is a relatively small trial and sicker patients may well benefit, but it has yet to be proven. Another interesting subgroup analysis showed that patients receiving dexamethasone showed added benefit with the addition of remdesivir, which is good news.

No magic bullet

So when I go into my hospital this week and am confronted on the wards with patients who are ill with COVID-19, ACTT-1 tells me that, provided I can find remdesivir on the pharmacy shelf, I should be confident to use it in any patients who are receiving oxygen alone, in the hope that they will recover sooner and, more importantly, avoid progression to needing ventilation

Remdesivir Effective, Well-Tolerated in Final Trial Report

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I

Gilead Sciences to sell Europe 500,000 doses of remdesivir

Oct. 8 (UPI) — Gilead Sciences announced Thursday that it’s selling 500,000 doses of remdesivir to European countries as many experience a spike in cases of COVID-19.

The company, which produces the antiviral under the name Veklury, said it reached a deal allowing the European Commission to purchase the drug for 36 countries over the next six months.

Gilead says it ramped up its production of remdesivir in recent months after studies indicated it showed shortened recovery times for some coronavirus patients. The U.S. Food and Drug Administration took control of the distribution of the drug in May after giving it emergency approval for COVID-19 treatment.

Gilead resumed control of distribution earlier this month. The company said it’s on track to produce more than 2 million treatment courses of the drug this year.

“Supply of Veklury is expected to meet global demand by the end of this month, enabling the purchase of Veklury both to treat patients and to support national stockpiling of the medicine for current and future surges of COVID-19,” the company said in a statement.

Clinical results for the antiviral have been mixed. A new National Institute of Allergy and Infectious Diseases study published Thursday in the New England Journal of Medicine said treatment with remdesivir shortened recovery time by five days compared to a placebo, and reduced mortality by 70% at Day 29 in patients with low-flow oxygen.

Another study in August showed the drug doesn’t improve outcomes in people hospitalized with moderate pneumonia caused by COVID-19.

Researched published last month showed that remdesivir administered in combination with baricitinib — treatment for rheumatoid arthritis — can reduce the recovery time for people with COVID-19 when compared to people treated with just the antiviral.

Originally developed to treat Ebola virus, remdesivir works by slowing the production of enzymes that play a key role in the replication of viruses, including coronaviruses, according to Gilead Sciences.

President Donald Trump received remdesivir as part of his own treatment for COVID-19.

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What is Trump’s medicine Remdesivir and is the drug used in the UK?

President Donald Trump has been taken to a military hospital after his coronavirus symptoms worsened and is being treated with the anti-viral drug Remdesivir.



a man wearing a suit and tie


© Provided by The Independent


Trump revealed via Twitter yesterday that he and first-lady Melania Trump had both tested positive for the virus after they took a test following the announcement that senior aid Hope Hicks had contracted covid.

On Friday night, he communicated on Twitter for the first time while in hospital, saying: “Going well, i think! Thank you to all. LOVE!!!”

Commentators have noted that it remains rare for a president to stay overnight in hospital, given the extensive medical facilities available in The White House.

White House physician, Dr Sean Conley, said that the president was “fatigued but in good spirits.”

In a follow up, Mr Conley said that Trump was “doing very well [and] not requiring any supplemental oxygen.”

He added that the president is being treated with the anti-viral drug Remdesivir, used in the US to shorten patient’s hospital stays.

The drug was created in 2009 by Gilead Sciences Inc and was originally proposed for treating hepatitis C, however scientists incidentally discovered that Remdesivir was effective for treating many other viral infections.

In 2014, the drug was studied as a possible treatment for ebola and found to be useful against Severe Acute Respiratory Syndrome (SARS) as well as the Middle East Respiratory Syndrome (MERS). Both viruses are structurally similar to Covid-19.

However, studies on the drug have only been carried on test tubes and animals and no human trials have ever taken place with Gilead maintaining that Remdesivir is an “experimental medicine that does not have established safety or efficacy for the treatment of any condition.”

Subsequently, scientific experts have warned that Remdesivir is no “silver bullet” and its effectiveness is widely debated.

A Chinese study, recently published in The Lancet, found the drug did not improve recover time or reduce mortality risk when it was tested on patients in comparison with a placebo.

However, a report published in The New England Journal of Medicine in April, found that the drug shortened recovery time by four days, from 15 to 11.

The drug was first approved as an effective means to treat covid symptoms in May 2020 and in the US Remdesivir is given to patients with severe and prolonged symptoms, from 10 days onwards.

Meanwhile in the UK, health officials announced that it would only be available to “selected NHS patients.”

The Department of Health said in a statement: “The drug will be used in adults and adolescents hospitalised with severe Covid-19 infection who meet clinical criteria suggesting they have the greatest likelihood of benefitting.”

Other countries that have approved the drug for use against Covid-19 include Japan, South Korea, Taiwan, India, Singapore and Australia.

Earlier this month, it was reported that India and Pakisran have ramped up their Remdesivir production after signing licensing agreements with Gilead.

The Trump administration stockpiled the drug in July, buying up 500,000 doses from

Trump taking Regeneron drug, Remdesivir therapy for coronavirus diagnosis: ex-WH doctor explains

President Trump is taking experimental coronavirus drugs Remdesivir and a Regeneron drug after being diagnosed with COVID-19 this week, his former White House physician told “Fox & Friends Weekend.”

“The two of those in combination should help clear the virus out of his body much sooner than his body could do it on its own,” Dr. Ronny Jackson said Saturday morning.

TRUMP TWEETS FROM HOSPITAL AS DOC CONFIRMS REMDESIVIR TREATMENT: ‘GOING WELL, I THINK!’

The president was taken to Walter Reed National Military Medical Center “out of an abundance of caution” Friday night and is being treated with experimental drugs in response to a compassionate use request.

“The Regeneron product [known as Regeneron-Covid 2 or REGN-COV2] is an antibody product,” Trump’s former doctor explained.

“They found two particular antibodies in the research they did coming up to developing this product. One of them attaches to the spiked protein and prevents the virus from entering into the host cell, the human cell. So what it does basically is it attaches itself to the virus and it disables the virus where it can’t get into the body, into the cells of the body and cause infection, and so that essentially drops the viral count,” he said. “Eventually your body clears those viruses.”

REGENERON IS TRUMP’S COVID-19 TREATMENT: WHAT TO KNOW

The other drug, Remdesivir, he explained, stops viral replication: “So we’re blocking the virus that’s already in his body and we’re preventing the replication of the virus with the Remdesivir,” he said.

Jackson, who helped design and build the presidential wing at Walter Reed, predicts that Trump will spend three to four days there.

“I think they’ll monitor him and check to make sure the fever is not getting worse and that his symptoms are improving. After a couple of days, I think he will be back to the White House,” he said.

Prior to moving to Walter Reed, on Friday afternoon, Dr. Sean P. Conley, the president’s physician, released an update on the president’s condition.

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“Following PCR-confirmation of the president’s diagnosis, as a precautionary measure he received a single 8-gram dose of Regeneron’s polyclonal antibody cocktail,” a memo released Friday afternoon by Dr. Sean P. Conley, the president’s physician stated. “He completed the infusion without incident.”

“In addition to the polyclonal antibodies, the president has been taking zinc, Vitamin D, famotidine, melatonin and a daily aspirin,” Conley said.

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What Is Remdesivir? President Trump Receiving Treatment Following COVID-19 Hospitalization

President Trump is reportedly receiving an experimental antiviral medication called remdesivir after contracting for Covid-19.

NBC News reported that Trump was given his first dose of the drug at Walter Reed National Military Medical Center in Bethesda, Maryland on Friday. The president is expected to continue to receive the drug over the course of five days via IV.

Remdesivir is a drug that was manufactured by Gilead Sciences and is used to lower the amount of the virus within the body. Clinical trials from May revealed that the drug lowered the hospitalization of COVID-19 patients by about four days.

Trump is reportedly receiving remdesivir as a part of a double-barreled treatment plan that includes an antibody cocktail.

Although the medication Trump has received is still in its clinical phase, Dr. Hugh Cassiere, director of critical care services for Sandra Atlas Bass Heart Hospital at North Shore University Hospital, told the outlet that both of the drugs appear to be safe.

“The remdesivir is supposed to stop viral replication, but if there is some virus that does replicate, the monoclonal antibodies would mop that up,” he said.

The administration of remdesivir to Trump comes after the U.S. Food and Drug Administration’s August announcement in which they revealed they planned on broadening the scope of the emergency use authorization for the drug Veklury (remdesivir) for hospitalized adults and children, who have been confirmed to have the virus.

“The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients. The data to support today’s action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” FDA Commissioner Stephen M. Hahn, M.D. said.

“We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.”

Trump received a single dose of Regeneron's antibody cocktail, according to a letter issued by White House physician Sean Conley Trump received a single dose of Regeneron’s antibody cocktail, according to a letter issued by White House physician Sean Conley Photo: AFP / JIM WATSON

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Trump receiving remdesivir antiviral drug as part of experimental treatment

President Donald Trump is receiving an experimental antiviral for Covid-19 called remdesivir as he remains hospitalized at Walter Reed National Military Medical Center in Bethesda, Maryland. The drug is being given as part of a double-barreled treatment plan that includes an antibody cocktail meant to give the president’s immune system a boost to fight off the coronavirus.

The president was given the first dose of remdesivir Friday evening and will be on a five-day course of the IV drug, his physician, Dr. Sean Conley, said during a news conference Saturday.

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Remdesivir, manufactured by Gilead Sciences, works by lowering the amount of virus in the body. Clinical trial data published in May found that the drug reduced patients’ length of hospital stay by about four days, from 15 days to a median of 11 days.

In July, additional data showed remdesivir may reduce deaths.

“It’s not really a treatment in the sense that it’ll cure people,” Dr. Irwin Redlener, director of the Pandemic Resource and Response Initiative at Columbia University’s National Center for Disaster Preparedness, said Saturday on MSNBC. “It will just hopefully reduce the fatality rate and reduce the course of the illness.”

Remdesivir is generally used for patients who need supplemental oxygen, although Conley said Trump did not need help breathing Saturday morning. When pressed during the briefing about whether the president had ever received supplemental oxygen, Conley persistently said the president had not received oxygen on Thursday or while at Walter Reed on Friday and Saturday.

It was unclear whether the president needed oxygen at another time.

Conley told reporters Saturday that Trump is doing “very well” but the coming days will be critical to the president’s recovery.

“With the known course of the illness, day seven to 10, we get really concerned about the inflammatory phase, phase two,” Conley said. “Given that we provided some of these advanced therapies so early in the course, a little bit earlier than most of the patients we know and follow, it’s hard to tell where he is on that course.”

Not the usual care

In addition to remdesivir, the president has received a combination antibody treatment. It’s a cocktail of two monoclonal antibodies. Antibodies act by recognizing specific germs — in this case, SARS-CoV-2, the virus that causes Covid-19 — and harnessing the immune system to fight them off.

“We are maximizing all aspects of his care, attacking this virus with a multi-pronged approach,” Conley said. “He’s the president, and I didn’t want to hold anything back. If there was any possibility that it would add value to his care and expedite his return, I wanted to take it.”

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The double-barreled approach is not usual care for patients in the president’s condition, especially since both treatments are still in clinical trial.

But in theory, the two would work “synergistically,” said Dr. Hugh Cassiere, director of critical care services for

Trump Received Experimental Antibody and Remdesivir for Coronavirus

President Trump, who has tested positive for Covid-19, is taking a volley of therapies, including an experimental antibody infusion that has shown promise in early-stage patients but hasn’t finished being tested, as well as the antiviral drug remdesivir that has been cleared for emergency use by regulators.

As a precautionary measure, the president received an eight-gram dose of

Regeneron Pharmaceuticals Inc.’s

antibody drug cocktail, the White House said Friday. Remdesivir, made by

Gilead Sciences Inc.,

has been authorized for treatment of hospitalized Covid-19 patients.

Regeneron said that Mr. Trump received its experimental drug under a compassionate-use request, which allows unapproved medicines to be used in patients with serious diseases who don’t have other treatment options.

The company describes its drug as providing a substitute immune response for patients who haven’t mounted their own yet and who have high virus levels in lab tests.

“Older people are among those who have trouble mounting an immune response, which would mean that they have less ability to fight the virus,” said George D. Yancopoulos, Regeneron president and chief scientific officer. These patients “should benefit the most from getting an immune response from the outside,” he said.

The president’s physician, Sean Conley, said in a memo late Friday that the president had also completed his first dose of remdesivir.

It is among just a few drugs that studies have shown to treat Covid-19, and been cleared by the U.S. Food and Drug Administration for such use.

The FDA authorized use of remdesivir, which is sold under the brand name Veklury, after researchers reported it shortened the recovery times of hospitalized Covid-19 patients. Remdesivir patients recovered in 11 days, four days faster than the placebo group, the researchers reported.

Since the authorization, remdesivir has become a standard course of treatment for hospitalized Covid-19 patients.

“While we cannot comment on individual patient cases, our thoughts are with everyone who is fighting Covid-19. We join the rest of the country in wishing the President and First Lady a speedy recovery,” Gilead said.

White House officials said Mr. Trump, who is 74 years old, was experiencing mild symptoms after his diagnosis. As a precaution, the officials said, Mr. Trump was taken to Walter Reed National Military Medical Center, where he will work from the presidential offices there the next few days.

Most people who contract the virus experience mild symptoms and recover. Yet Mr. Trump is at a higher risk of facing severe illness than younger people. The risk for a severe case of Covid-19 increases with age, along with factors including whether a person has other medical conditions like cancer, diabetes or obesity, studies show.

Mr. Trump weighed 244 pounds as of his last physical, made public in June, and stood 6 feet, 3 inches tall, which meant he narrowly met the Centers for Disease Control and Prevention’s definition of obesity.

The obesity rate among adults in the U.S. is 42.4%, according to the CDC. Obesity may triple the risk that a patient is hospitalized due to

President Donald Trump treated with remdesivir at Walter Reed, doctor says

A pedestrian walks past a bar established in 1933 after Los Angeles County officials closed it for the second time following a spike in COVID-19 cases in Los Angeles on August 10. Photo by Jim Ruymen/UPI | License Photo