Tag Archives: remdesivir

WHO advises against treating hospitalized COVID-19 patients with remdesivir

Gilead’s remdesivir is not recommended for patients hospitalized with COVID-19, regardless of how ill they are, as there is no evidence the drug improves survival or reduces the need for ventilation, a World Health Organization panel said on Friday.

The panel found “a lack of evidence that remdesivir improved outcomes that matter to patients,” the guideline said.

“Especially given the costs and resource implications associated with remdesivir … the panel felt the responsibility should be on demonstrating evidence of efficacy, which is not established by the currently available data.”

The WHO said it has suspended remdesivir from its so-called prequalification list, an official list of medicines used as a benchmark for procurement by developing countries, after issuing the guidance.

“Yes we have suspended it from the PQ [prequalification list],” Tarik Jasarevic said in an emailed response to Reuters. “The suspension is a signal to countries that WHO, in compliance with the treatment guidelines, does not recommend countries procure the drug for COVID.”

The advice is another setback for the drug, which grabbed worldwide attention as a potentially effective treatment for COVID-19 in the summer after early trials showed some promise.

The antiviral, known by the brand name Veklury, is one of only two medicines currently authorized to treat COVID-19 patients across the world. But a large WHO-led trial known as the Solidarity Trial showed last month that it had little or no effect on 28-day mortality or length of hospital stays for COVID-19 patients.

The medication was one of the drugs used to treat U.S. President Donald Trump’s coronavirus infection, and had been shown in previous studies to have cut time to recovery. It is authorized or approved for use as a COVID-19 treatment in more than 50 countries. That includes Canada, where a limited number of patients have been treated with the drug under Health Canada’s Special Access Program.

Gilead has questioned the Solidarity Trial’s results and said in a statement on Friday it was “disappointed” at the new WHO guideline.

“Veklury is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations,” it said.

“The WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19.”

The WHO advice raises questions about whether the European Union will need the 500,000 courses of the antiviral, worth 1 billion euros ($ 1.86 billion Cdn), it ordered last month.

Italy’s drugs regulator, AIFA, said it had been “stressing for weeks the modest effectiveness of remdesivir.”

“In practice we have been saying for some time that it is not use for much,” the regulator said.

Expensive, no noticed impact on death rates

The WHO’s Guideline Development Group (GDG) panel said its recommendation was based on an evidence review that included data from four international randomized trials involving more than 7,000 patients hospitalized with COVID-19.

After reviewing the evidence, the panel said it concluded that remdesivir, which has to be given intravenously and is therefore costly and complex to administer, has no meaningful effect on death rates or other important outcomes for patients.

Peter Horby, a professor of emerging infectious diseases at Britain’s Oxford University, said the WHO’s new advice should prompt “a rethink about the place of remdesivir in COVID-19.”

“Remdesivir is an expensive drug that must be given intravenously for five to 10 days, so this recommendation will save money and other health-care resources,” he said.

At the end of October, Gilead cut its 2020 revenue forecast, citing lower-than-expected demand and difficulty in predicting sales of remdesivir.

The fresh advice also comes after one of the world’s top bodies representing intensive care doctors said remdesivir should not be used for COVID-19 patients in critical care.

The recommendation, which is not binding, is part of its so-called “living guidelines” project, designed to offer ongoing guidance for doctors. The panel said that it supported continued enrolment into clinical trials evaluating remdesivir in patients with COVID-19, which it said should “provide higher certainty of evidence for specific groups of patients.”

The European Commission on Friday said there had been no change in the authorized uses of remdesivir.

“We take note that the WHO has now updated its guidelines on the use of remdesivir,” a Commission spokesperson said in an email.

The European drugs regulator has requested full data from the WHO-led Solidarity trial into the drug and will assess the evidence, together with other available data, to see if any changes are needed to its market authorization, he said.

Let’s block ads! (Why?)

CBC | World News

World’s top intensive care body advises against use of remdesivir for sickest COVID-19 patients

The antiviral drug remdesivir should not be used as a routine treatment for COVID-19 patients in critical care wards, the head of one of the world’s top bodies representing intensive care doctors said, in a blow to the drug developed by U.S. firm Gilead.

Remdesivir, also known as Veklury, and the steroid dexamethasone are the only drugs authorized to treat COVID-19 patients across the world.

But the largest study on remdesivir’s efficacy, run by the World Health Organization (WHO), showed on Oct. 15 that it had little or no impact, contradicting previous trials.

In light of the new interim data from the WHO’s Solidarity trial, “remdesivir is now classified as a drug you should not use routinely in COVID-19 patients,” the president of the European Society of Intensive Care Medicine (ESICM), Jozef Kesecioglu, said in an interview with Reuters.

Gilead contests findings

Kesecioglu said the recommendation would be discussed in a scientific paper on COVID-19 therapies that ESICM is preparing with the Society of Critical Care Medicine, another intensive care body, expected to be published by January.

The first version of the paper, released in March, said there was not enough information to recommend the use of remdesivir and other antivirals in critically ill COVID-19 patients.

Gilead, which has questioned the WHO’s findings, said in an emailed statement: “We are confident that doctors on the front lines recognize the clinical benefit of Veklury based on robust evidence from multiple randomized, controlled studies.”

ESICM represents thousands of anesthesiologists, respiratory physicians, nurses and other critical care professionals in more than 120 countries.

While doctors and hospitals are not obliged to follow its advice, its recommendation could curb the use of remdesivir.

At the end of October, Gilead cut its 2020 revenue forecast, citing lower-than-expected demand and difficulty in predicting sales of remdesivir.

Widely used

The drug remains, however, widely used in hospitals. It is authorized or approved for use in more than 50 countries and was one of the medicines administered to U.S. President Donald Trump when he tested positive for coronavirus in October.

The European Union signed a one billion euro ($ 1.55 billion Cdn) deal with Gilead for 500,000 courses of remdesivir at 2,070 euros ($ 3,220 Cdn) each, days before the Solidarity results.

The deal does not oblige European countries to buy remdesivir, but governments decided to place large orders even after the Solidarity results, with Germany buying a big stock in November, saying the drug was useful, especially early in the course of the disease.

WATCH | Remdesivir does little to help COVID-19 patients, WHO study says:

A clinical trial by the World Health Organization finds that antiviral medication remdesivir has little or no effect on length of hospital stay or mortality in COVID-19 patients. Dr. Srinivas Murthy weighs in on what this could mean for treating the virus going forward. 2:04

Kesecioglu said there was not enough data available about when remdesivir might be effective or for which patients, leading to the decision to discourage its routine use in intensive care.

This means doctors should use remdesivir only occasionally and not as a standard treatment for COVID-19 patients.

Because of remdesivir’s unclear benefits, the critical care department at the University Medical Center of Utrecht in the Netherlands, where Kesecioglu works, has not used it to treat COVID-19 patients, he said.

Possible side effects

Ten months into the pandemic, a debate continues to rage in the medical industry about which drugs are best to treat hospitalized COVID-19 patients.

Remdesivir has potential side effects on the kidneys, according to data shared by Gilead with the European Medicines Agency, which is assessing its possible toxicity.

Arnaud Hot, head of medicine at Edouard Herriot hospital in Lyon, France, told Reuters that some patients at his hospital had experienced kidney injury and so it was no longer using remdesivir, except in rare cases.

Kesecioglu said convalescent plasma, which is also experimentally administered to some COVID-19 patients despite not having been approved, was also not recommended by ESICM for routine intensive care use, as its benefits were unclear.

He said the potential side effects of convalescent plasma — the liquid part of blood extracted from COVID-19 patients — were also not clear

In contrast, Kesecioglu said dexamethasone was recommended for use in hospitalised patients because there was sufficient information on its efficacy.

Let’s block ads! (Why?)

CBC | World News

Remdesivir has little effect on hospital stay or mortality in COVID-19 patients, WHO study finds

Gilead Sciences Inc.’s remdesivir had little or no effect on COVID-19 patients’ length of hospital stay or chances of survival, a clinical trial by the World Health Organization (WHO) has found.

The antiviral medication, among the first to be used as a treatment for COVID-19, was one of the drugs recently used to treat U.S. President Donald Trump’s coronavirus infection.

The results are from WHO’s “solidarity” trial, which evaluated the effects of four potential drug regimens, including remdesivir, hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon, in 11,266 adult patients across more than 30 countries.

The study found the regimens appeared to have little or no effect on 28-day mortality or the length of the in-hospital course among patients hospitalized with COVID-19, the WHO said on Thursday.

The results of the trial are yet to be reviewed and were uploaded on the preprint server medRxiv. 

Earlier this month, data from a U.S. study of remdesivir by Gilead, the company that developed the drug, showed the treatment cut COVID-19 recovery time by five days compared with patients who got a placebo in a trial that involved 1,062 patients.

“The emerging [WHO] data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir,” Gilead told Reuters.

“We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”

WHO chief scientist Soumya Swaminathan said on Wednesday that during the study, hydroxychloroquine and lopinavir/ritonavir were stopped in June after they proved ineffective, but other trials continued in more than 500 hospitals and 30 countries.

“We’re looking at what’s next. We’re looking at monoclonal antibodies, we’re looking at immunomodulators and some of the newer anti-viral drugs that have been developed in the last few months,” Swaminathan said.

Remdesivir received emergency use authorization from the U.S. Food and Drug Administration on May 1, and has been authorized for use in several countries.

Let’s block ads! (Why?)

CBC | World News

Health Canada authorizes drug remdesivir for severe COVID-19 cases

Health Canada has authorized with conditions the drug remdesivir for patients with severe COVID-19, though Canada’s top doctor says the supply is limited.

The drug — which will go by the brand name Veklury — is manufactured by Gilead Sciences Canada.

On Tuesday, Health Canada announced the drug is now authorized for use in adults and adolescents aged 12 years and older with a body weight of at least 40 kilograms. 

The company did not seek permission to use the drug to treat pregnant women or children under 12.

In April, a study run by the U.S. National Institutes of Health tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. It found that 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.

But Dr. Theresa Tam, chief public health officer of Canada, warned that “the supply with this company is very low globally.”

WATCH | U.S. buys global supply of remdesivir:

The U.S. has bought the global supply of remdesivir, an antiviral drug that has been found to help certain patients recover more quickly from COVID-19. 4:20

Remdesivir is administered intravenously and used only in health-care facilities where patients can be closely monitored.

“It’s not something people can go out and access by themselves,” Tam said Tuesday during a press conference.

Because the drug has been given an expedited review, the manufacturer will have to ensure the continued safety, efficacy and quality of the drug, a statement by Health Canada said

Some already treated with drug

Remdesivir has also been granted emergency or conditional authorization in the U.S., Europe, Australia, Singapore and Japan.

In Canada, a small number of patients have been or are being treated with the drug under the Special Access Program.

Asked about reports the drug will be expensive, Tam said that may be the case, but the price will be subject to “appropriate reviews.”

“I am aware some of these drugs are going to cost a fair amount of money,” Tam said. “We have to look at access, as well as what’s a reasonable price.”

Matthias Götte, professor and chair of the medical microbiology and immunology department at the University of Alberta, said the drug’s approval is “excellent news.”

“I guess there’s no doubt this is really the the only antiviral agent with with a clear-cut advantage shown in the large clinical trial,” he said. 

Götte explained that the drug targets what he calls “the engine of the virus.”

“This is an enzyme that is absolutely required for replication of the virus, for spread and so forth. So if you target that engine, the virus cannot spread, cannot replicate.” 

Let’s block ads! (Why?)

CBC | Health News

Antiviral drug remdesivir shortens time to recover from pandemic virus, top U.S. health official says

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.

“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.

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.



 
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.       

Mixed results

Despite the excitement, Dr. Lawrence K. Altman, global fellow at The Wilson Center in Washington, DC, said more information is needed.
 
“While a new study offers a glimmer of hope that … remdesivir has an effect against COVID-19, determination of its benefit for the general population must await release of pertinent details to evaluate the study’s findings and 
scientific analysis comparing them to other studies of the drug that have shown mixed results,” he said in a statement.

Watch | Doctor talks of the ‘desperation, sadness and hope’ of life support

Dr. Nadia Alam of Georgetown, Ont., describes how one elderly patient didn’t want to be on a ventilator and how her children are afraid that she, too, may get sick. 10:28
 
Gilead also provided data on a study in severe COVID-19 patients it has conducted in dozens of medical centres, which does not have a placebo comparison but tested the drug given by intravenous infusion under five-day and 10-day regimens.
 
In that 397-patient trial, Gilead said 62 per cent of patients treated early with remdesivir were discharged from the hospital, compared with 49 per cent of patients who were treated later in the course of the infection.
 
Gilead Chief Medical Officer Merdad Parsey in a statement said a five-day regimen, “could significantly expand the number of patients who could be treated with our current supply of remdesivir.”
 
Also on Wednesday, results were published by the Lancet medical journal of a trial conducted in China that concluded remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream. Gilead said previously that those findings, released inadvertently by the World Health Organization last week, were inconclusive because the study was terminated early.
 
Gilead chief executive Daniel O’Day earlier this month said the company was prepared to donate 1.5 million doses of remdesivir to hospitals dealing with severely ill patients. Regulatory approval of the drug would also clear the way for commercial sales.
 
Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses make copies of themselves and potentially overwhelm their host’s immune system.
 
The company is also studying the drug in patients with less severe COVID-19, but those results are not expected until later next month. 

Dr Mike Ryan, head of the WHO’s emergencies program, told an online briefing it can sometimes take a number of publications to determine a drug’s efficacy.
 
“Clearly we have the randomized control trials that are underway both in the U.K. and U.S, the ‘Solidarity trials’ with WHO. Remdesivir is one of the drugs under observation in many of those trials. So I think a lot more data will come out,” he said.
 
Ryan added: “But we are hopeful this drug and others may prove to be helpful in treating COVID-19.” 

Let’s block ads! (Why?)

CBC | World News