Data on Gilead drug raises hopes in pandemic fight, Fauci calls it 'highly significant'

[webfact]

Data on Gilead drug raises hopes in pandemic fight, Fauci calls it 'highly significant'

By Deena Beasley and Manas Mishra

 

FILE PHOTO: An ampule of Ebola drug Remdesivir is pictured during a news conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany, April 8, 2020, as the spread of coronavirus disease (COVID-19) continues. Ulrich Perrey/Pool via REUTERS

 

(Reuters) - The top U.S. infectious disease official said Gilead Sciences Inc's experimental antiviral drug remdesivir will become the standard of care for COVID-19 after early results from a key clinical trial on Wednesday showed it helped patients recover more quickly from the illness caused by the coronavirus.

 

Preliminary results from a U.S. government trial showing that patients given remdesivir recovered 31% faster than those given a placebo, were hailed by Dr. Anthony Fauci as "highly significant."

 

"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," he said.

 

The U.S. Food and Drug Administration said it has been in discussions with Gilead about making remdesivir available to patients as quickly as possible, but the agency declined to comment on any plans to grant the drug regulatory approval.

 

"I want them to go as quickly as they can," President Donald Trump said, when asked if he wanted the FDA to grant emergency use authorization for remdesivir. "We want everything to be safe, but we would like to see very quick approvals, especially with things that work."

 

The closely watched drug, given by intravenous infusion to hospitalized patients, has moved markets in the past few weeks following the release of data from several studies that painted a mixed picture of its effectiveness, and Fauci cautioned that the latest data still needs to be analyzed.

 

Gilead's shares rose more than 5% on Wednesday to close at $83.14 and are up 27% so far this year.

 

Interest in remdesivir has been high as there are 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.

 

Doctors on the front lines of the COVID-19 battle have been eager for results from the NIH study because it is a large trial in which patients were randomized to treatment with the drug or a placebo without participants or doctors knowing which group they were in - the gold standard for clinical trials.

 

Gilead earlier this month said the company was prepared to donate to hospitals its existing supply of 1.5 million doses of remdesivir - enough for more than 140,000 patients depending on length of treatment. Regulatory approval of the drug would also clear the way for commercial sales.

 

The company did not immediately respond to a request for comment on other supply plans.

 

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said partial results from its 1,063-patient trial show that hospitalized COVID-19 patients given remdesivir recovered in 11 days, compared to 15 days for patients given a placebo.

 

The study showed a trend toward better survival for remdesivir - 8% of patients given the drug died compared with 11.6% in the placebo group - but the difference was not statistically significant so may not be due to Gilead's drug.

 

The trial's lead researcher told Reuters on Friday that full results could come by mid-May.

 

"The full dataset will provide more clarity on how remdesivir can best be used," said Dr. Aneesh Mehta, a researcher on the NIH trial from Emory University School of Medicine in Atlanta.

 

'GLIMMER OF HOPE'

Despite the excitement, Dr. Lawrence K. Altman, global fellow at The Wilson Center in Washington, DC, was not ready to celebrate the preliminary findings.

 

The new data "offers a glimmer of hope" that remdesivir has an effect against COVID-19, but more scientific analysis is needed "comparing them to other studies of the drug that have shown mixed results," he said in a statement.

 

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 were inconclusive because the study was terminated early.

 

"The drug seems to have antiviral activity - how much is as yet unclear," Dr. Daniel McQuillen, an infectious disease specialist at Lahey Hospital & Medical Center in Burlington, Massachusetts, told Reuters. "Seems likely that it might need use with another antiviral agent."

 

Combination antiviral treatments have proven highly effective against other diseases.

 

Gilead also provided data on a study in severe COVID-19 patients it has conducted in dozens of medical centers, which does not have a placebo comparison but tested the drug under five-day and 10-day regimens.

 

In that 397-patient trial, Gilead said 62% of patients treated early with remdesivir were discharged from the hospital, compared with 49% 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."

 

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.

 

(Additional reporting by Timothy Ahmann and Steve Holland in Washington, D.C. and Carl O'Donnell in New York; Editing by Bill Berkrot)

 

-- © Copyright Reuters 2020-04-30

 

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[Mama Noodle]

This is good. Movement on viable treatments is excellent news while we wait for a vaccine (if possible) and even something that appears to be a little positive movement such as:

 

19 minutes ago, webfact said:

Preliminary results from a U.S. government trial showing that patients given remdesivir recovered 31% faster than those given a placebo

 

Is significant because anything we can do to drive down the fatality rate will make the disease overall more manageable and drive the mortality rate lower. 

[Tug]

Let’s hope it pans out and is a viable treatment 

[cornishcarlos]

53 minutes ago, webfact said:

 

"This will be the standard of care," he said

 

It's great that there may be a possible treatment in the pipeline.

But Fauci making statements like that ?? Will take a lot more testing before it becomes the standard..

 

55 minutes ago, webfact said:

but we would like to see very quick approvals, especially with things that work."

 

 

Classic Trump statement too... As opposed to approving things that don't work !!!

[Chomper Higgot]

Let’s just remind ourselves who researched and developed this drug and the part played by public funding:

 

https://www.uab.edu/news/health/item/11082-investigational-compound-remdesivir-developed-by-uab-and-nih-researchers-being-used-for-treatment-of-novel-coronavirus

 

We should keep this in mind when the price of treatment with this drug is announced.

[Sheryl]

I am surprised this is generating so little response on this forum.

 

It is big news.

 

Important next step will be trials of its use earlier in the disease/in mild cases - if it hastens recovery it may shorten period of infectivity in which case (an if it has a goo enough safety profile) it may be worth giving to mild or even asymptomatc  cases as well. Which of course presupposes they can be identified through testing, and would also need a less invasive means of administration (?nasal spray?)

 

 

[Sheryl]

2 hours ago, Chomper Higgot said:

Let’s just remind ourselves who researched and developed this drug and the part played by public funding:

 

https://www.uab.edu/news/health/item/11082-investigational-compound-remdesivir-developed-by-uab-and-nih-researchers-being-used-for-treatment-of-novel-coronavirus

 

We should keep this in mind when the price of treatment with this drug is announced.

 

Did you miss the "was prepared to donate to hospitals its existing supply of 1.5 million doses of remdesivir" part?

 

Of course after that, there will be a price, but if it turns out to be recommended for all cases (including mil/asymptomatic ones) in order to shorten infectivity it will be in their interests to make it affordable enough  to get  really high volume sales.

[Bkk Brian]

This is very promising anything that can help even if only for a few is very welcome and should cut some deaths and hospitalizations. 

[ThailandRyan]

Just prepare an antibody serum that works, and if it works lets get some injections going as preventative medication.....One can only hope one day it happens.

[JAS21]

Well that’s a change, just six days ago BBC announced that the trial of this drug in China had not been exactly successful ....

 

https://www.bloomberg.com/news/articles/2020-04-23/gilead-plunges-after-report-that-chinese-trial-was-unsuccessful

Edited April 30, 2020 by JAS21

[Surelynot]

10 minutes ago, JAS21 said:

Well that’s a change, just six days ago BBC announced that the trial of this drug in China had not been exactly successful ....

 

https://www.bloomberg.com/news/articles/2020-04-23/gilead-plunges-after-report-that-chinese-trial-was-unsuccessful

Yep. I could have predicted that fall.........I bought-in the day before.

[JAS21]

1 minute ago, Surelynot said:

Yep. I could have predicted that fall.........I bought-in the day before.

Ah.... Was it you who posted somewhere in TV that Gilac Scientfic we’re suggesting that their trial was successful... hope you didn’t sell...

[Surelynot]

Just now, JAS21 said:

Ah.... Was it you who posted somewhere in TV that Gilac Scientfic we’re suggesting that their trial was successful... hope you didn’t sell...

Ha! Yes it was.

 

Managed to get in at $78. Up at the moment and hanging in there.

 

If the trails flop I'll go long.

 

It's a huge company with quite a lot in the pipeline. Fingers crossed

[Eric Loh]

3 hours ago, Sheryl said:

I am surprised this is generating so little response on this forum.

 

It is big news.

 

Important next step will be trials of its use earlier in the disease/in mild cases - if it hastens recovery it may shorten period of infectivity in which case (an if it has a goo enough safety profile) it may be worth giving to mild or even asymptomatc  cases as well. Which of course presupposes they can be identified through testing, and would also need a less invasive means of administration (?nasal spray?)

 

 

Generated a big pop in the DOW last night. Back on the ranch, there are some still reeling from the fact that Remdesivir taken the limelight from chloroquine. Still work to be done before FDA approve. 

[Baerboxer]

28 minutes ago, car720 said:

Keep your eye on the University of Queensland.

 

Why is some magician going to make it disappear?

[simple1]

7 minutes ago, Baerboxer said:

 

Why is some magician going to make it disappear?

https://www.uq.edu.au/news/article/2020/04/uq-covid-19-vaccine-shown-induce-potent-protective-response-pre-clinical-trials

[sirineou]

3 hours ago, Sheryl said:

I am surprised this is generating so little response on this forum.

 

It is big news.

 

Important next step will be trials of its use earlier in the disease/in mild cases - if it hastens recovery it may shorten period of infectivity in which case (an if it has a goo enough safety profile) it may be worth giving to mild or even asymptomatc  cases as well. Which of course presupposes they can be identified through testing, and would also need a less invasive means of administration (?nasal spray?)

 

 

It is big news, The stock market here in the US rallied on the news, and closed almost 3% higher,

When asked about general use , an expert on Bloomberg said that it will probably be only for hospitalized case because it is administered intravenously. I hope he was wrong,

I am sure R&D continues and a home or GP version could be developed.  

 

[Bluespunk]

3 hours ago, JAS21 said:

Well that’s a change, just six days ago BBC announced that the trial of this drug in China had not been exactly successful ....

 

https://www.bloomberg.com/news/articles/2020-04-23/gilead-plunges-after-report-that-chinese-trial-was-unsuccessful

Yes and as the article and the BBC one explained, it is claimed the trial was not successful because they could not, at the time the drug was tested, find enough patients to trial the drug on. 

Edited April 30, 2020 by Bluespunk

[candide]

10 hours ago, webfact said:

The study showed a trend toward better survival for remdesivir - 8% of patients given the drug died compared with 11.6% in the placebo group - but the difference was not statistically significant so may not be due to Gilead's drug.

Keep cool!

[Bkk Brian]

Oxford Vaccine news. Fingers crossed, not long to wait if it works, rolling out in OCT if all ok!

 

Scientists will know by June or July whether the coronavirus vaccine being developed at the University of Oxford will work

 

https://news.sky.com/story/coronavirus-scientists-will-know-by-july-if-university-of-oxfords-covid-19-vaccine-works-11981027

Edited April 30, 2020 by Bkk Brian

[Mavideol]

8 hours ago, Chomper Higgot said:

Let’s just remind ourselves who researched and developed this drug and the part played by public funding:

 

https://www.uab.edu/news/health/item/11082-investigational-compound-remdesivir-developed-by-uab-and-nih-researchers-being-used-for-treatment-of-novel-coronavirus

 

We should keep this in mind when the price of treatment with this drug is announced.

wonder who has recently bought stock/shares on the company....

[Mavideol]

5 hours ago, Sheryl said:

I am surprised this is generating so little response on this forum.

 

It is big news.

 

Important next step will be trials of its use earlier in the disease/in mild cases - if it hastens recovery it may shorten period of infectivity in which case (an if it has a goo enough safety profile) it may be worth giving to mild or even asymptomatc  cases as well. Which of course presupposes they can be identified through testing, and would also need a less invasive means of administration (?nasal spray?)

 

 

don't want to spoil the good news but looking back at some previous statements on potential drugs to alleviate the virus from spreading,  one has to be cautious, Trump claimed to have found a game changer

 

https://www.thehindu.com/news/international/more-than-29-million-hydroxychloroquine-doses-bought-by-us-have-come-from-india-says-president-trump/article31286633.ece

 

“I bought millions of doses (of hydroxychloroquine). More than 29 million. I spoke to Prime Minister Modi, a lot of it (hydroxychloroquine) comes out of India. I asked him if he would release it? He was great. He was really good,” Mr. Trump told Sean Hannity of the Fox News on Monday night.

 

 

 

[Sheryl]

9 minutes ago, Mavideol said:

don't want to spoil the good news but looking back at some previous statements on potential drugs to alleviate the virus from spreading,  one has to be cautious, Trump claimed to have found a game changer

 

https://www.thehindu.com/news/international/more-than-29-million-hydroxychloroquine-doses-bought-by-us-have-come-from-india-says-president-trump/article31286633.ece

 

“I bought millions of doses (of hydroxychloroquine). More than 29 million. I spoke to Prime Minister Modi, a lot of it (hydroxychloroquine) comes out of India. I asked him if he would release it? He was great. He was really good,” Mr. Trump told Sean Hannity of the Fox News on Monday night.

 

 

 

There is a world of difference between claims made by politicians and media hacks (Trump got his "info" from Laura Ingram) and the statements of scientists reporting on scientific studies.

 

There was never this sort of evidence for hydroxychloroquine. Though to be fair some studies on it are still ongoing.

[Chomper Higgot]

6 hours ago, Sheryl said:

 

Did you miss the "was prepared to donate to hospitals its existing supply of 1.5 million doses of remdesivir" part?

 

Of course after that, there will be a price, but if it turns out to be recommended for all cases (including mil/asymptomatic ones) in order to shorten infectivity it will be in their interests to make it affordable enough  to get  really high volume sales.

No I didn’t miss the 1.5 million doses, in the US, let alone a global market, it’s not a big number.

 

I don’t follow your logic on what is in ‘their interests’.

 

Maximizing profits is the usual interest, and doing so while they have the only effective drug would definitely be in their interests.

 

 

[Sheryl]

Profit depends on sales revenue which is a function of both volume and price.

 

It can be more profitable to sell at a lower price if it substantially increases volume of sales.

 

If they price this too high it will be used only in dire cases (and well insure ones, or ithoe under the national health service of an affluent country). If it proves to be beneficial in milder cases (IF) then it is in their interests, in terms of profits, to make it afforable enough that it will be use in such cases.

 

 

[IAMHERE]

More anecdotal evidence; nobody saying 31% survived because of this drug. Normal curve would suggest 31% or more would get better before the other 69% naturally.

[impulse]

13 hours ago, Mama Noodle said:

This is good. Movement on viable treatments is excellent news while we wait for a vaccine (if possible) and even something that appears to be a little positive movement such as:

14 hours ago, webfact said:

Preliminary results from a U.S. government trial showing that patients given remdesivir recovered 31% faster than those given a placebo

Is significant because anything we can do to drive down the fatality rate will make the disease overall more manageable and drive the mortality rate lower. 

 

Where does it say it drove down the fatality rate?  Call me a skeptic, but often, the "positive results" are statistically significant, but not on a practical level.  Then in a year or so, the side effects show up...

 

 

[Chomper Higgot]

2 hours ago, Sheryl said:

Profit depends on sales revenue which is a function of both volume and price.

 

It can be more profitable to sell at a lower price if it substantially increases volume of sales.

 

If they price this too high it will be used only in dire cases (and well insure ones, or ithoe under the national health service of an affluent country). If it proves to be beneficial in milder cases (IF) then it is in their interests, in terms of profits, to make it afforable enough that it will be use in such cases.

 

 

I don’t want to take this off topic, but the pricing of insulin in the US knocks holes in that argument.

 

[metisdead]

A post using content from an unapproved YouTube source has been removed:

 

18) Social Media content is not to be used as  source material unless it is from a recognized or approved news media source,  the source of any such material (Twitter, Facebook  etc.) should always be shown.

 

The above forum rule includes YouTube as YouTube is a social media provider. 

[NotYourBusiness]

OK well I hope any new vaccine developed for corona will be properly tested and safe (double blind placebo controlled and peer reviewed).