Early peek at Remdesivir data shows promise against Covid 19

[GoodLife]

Excerpt:

Last month, President Trump touted the potential for remdesivir — as he has for many still-unproven treatments — and said it “seems to have a very good result.” :popcorn:

Gilead data suggests coronavirus patients are responding to treatment (https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/)

[DianeM]

Excerpt:

Last month, President Trump touted the potential for remdesivir — as he has for many still-unproven treatments — and said it “seems to have a very good result.” :popcorn:

Gilead data suggests coronavirus patients are responding to treatment (https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/)

Thank you for sharing

[blueash]

Remdesivir has shown past efficacy against other severe corona viruses, MERS and SARS in animal models (https://cloudflare-ipfs.com/ipfs/bafykbzaced4xstofs4tc5q4irede6uzaz3qzcdvcb2eedxgfa kzwdyjnxgohq/pdfs/2018%20Coronavirus%20Susceptibility%20to%20the%20A ntiviral%20Remdesivir%20%28GS-5734%29%20Is%20Mediated%20by%20the%20Viral%20Polym erase%20and%20the%20Proofr.pdf), not human testing. So the theoretical hope is that it will also work against this corona virus.

There are ongoing controlled studies testing remdesivir both in the US and elsewhere. I am hopeful this will be an effective therapy. The one downside is that this drug is under patent and price will be, I suspect, substantial. It also is an IV drug, not oral.

[Bay Kid]

What is used to help hospital patients with the flu? Still more people die and are hospitalized for the flu.

[graciegirl]

What is used to help hospital patients with the flu? Still more people die and are hospitalized for the flu.

Do you mean "the seasonal flu" that we are given an opportunity each year to vaccinate for? That we have antivirals for?.... Or this new and completely different one; Covid-19 that is much more deadly to us older people???

[blueash]

What is used to help hospital patients with the flu? Still more people die and are hospitalized for the flu.

Patients with influenza are given supportive therapy and treated for any problems which are treatable.. sounds foolish. There are drugs such as Tamiflu which are effective against the influenza virus itself, but they only seem to be helpful if given within a couple days of onset of symptoms (https://academic.oup.com/jac/article/66/5/959/785705). If you've been flu sick for 5 days then suddenly get worse, those medications have not been shown to help. Influenza often leads to secondary bacterial pneumonia. There are regular antibiotics which can be used to treat the bacterial secondary infection.

Covid seems to damage, often fatally damage, the lungs without any contribution from secondary bacterial pneumonia. Lessons learned from use of antiviral and antibacterial medications in treating influenza have not helped in treatment of Covid. Covid is not flu.

[allus70]

Currently, in the US
Death rate for the flu is about .1%
For covid, about 2-4%

[Dean62]

What is used to help hospital patients with the flu? Still more people die and are hospitalized for the flu.

You can't compare yearly deaths from the flu with COVID-19 which has only been affecting the US for less than two months. Currently, there are over 37,000 deaths in the US with infections and deaths continuing to climb. The yearly flu does not overwhelm hospitals with cases like we are seeing in hot spots like New York City.

[vermonster]

Currently, in the US
Death rate for the flu is about .1%
For covid, about 2-4%
And in Sumter County about 10%, the highest rate of any county in Florida.

[Leadbone1]

Excerpt:

Last month, President Trump touted the potential for remdesivir — as he has for many still-unproven treatments — and said it “seems to have a very good result.” :popcorn:

Gilead data suggests coronavirus patients are responding to treatment (https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/)

Unproven treatments? They may be unproven to our FDA but that’s no surprise. The drugs that the president has touted are being used all over the rest of the world and have had clinical trials. Why is it the United States feels we have to reinvent the wheel. I will say the FDA has been fairly responsible and allowing these treatments since they are working in many other countries

[Leadbone1]

Currently, in the US
Death rate for the flu is about .1%
For covid, about 2-4%

Not true, it’s at about 1% now and dropping as more people are tested

[Leadbone1]

Do you mean "the seasonal flu" that we are given an opportunity each year to vaccinate for? That we have antivirals for?.... Or this new and completely different one; Covid-19 that is much more deadly to us older people???

What you get for the flu is a flu shot, it is not a vaccine. Don’t understand why people do not know the difference. A vaccine is something you take one time and you’re done, like smallpox or polio. If they develop something for Covid it will be probably like the flu shot, I may even be combined with the flu shot?

[hollywoodz]

Excerpt:

Last month, President Trump touted the potential for remdesivir — as he has for many still-unproven treatments — and said it “seems to have a very good result.” :popcorn:

Gilead data suggests coronavirus patients are responding to treatment (https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/)
Having been in the medical-legal field for nearly five decades, my suggestion is to ONLY follow the words of expert physicians and scientists, and NOT those not so qualified or experienced in advancing your health with scientifically unproven or untested pharmaceuticals. This includes the words that come from politicians that have no such qualifications either!

[theruizs]

What is used to help hospital patients with the flu? Still more people die and are hospitalized for the flu.
Why do people keep saying this? The infection rate of this virus is something like three times that of the flu. So if no measures are taken it could easily eclipse the flu infection rate. Also, the death rate of those infected from flu is a fraction of a percent, but from this virus it is 2.76% here in Florida, 4.60% in the US, and 6.83% worldwide (46 times the flu death rate minimum). If no measures are taking this would make flu look like a hiccup. Also, the rate of hospitalization from this virus is far higher than the flu, so it is a huge strain on our health care system. If no measures are taken at all it would be overwhelmed. This is not like the flu!.

[MOMOH]

FROM MY FRIEND THE DOCTOR:

Is remdesivir the COVID miracle we've been waiting for?
Gilead certainly hopes you think it is

Gregory Katz
Apr 17


The medical world was buzzing after data on the drug remdesivir was published in the New England Journal of Medicine showing that 68% of COVID patients treated with remdesivir improved. Now we’re seeing reports from all over the place - CNN, the New York Times, Axios - touting the “promise” and “encouraging signs” of this medication in preliminary data from another clinical trial.

Gilead, the company that makes this drug, has unsurprisingly seen a bump in its stock after these reports.

What is remdesivir?

Remdesivir is a broad spectrum antiviral drug that works by blocking viral replication. In an isolated lab setting, it has demonstrated effects against multiple different virus families, including filoviruses like Ebola and corona viruses like SARS, MERS, and SARS-CoV-2 (the virus responsible for COVID-19). Remdesivir seems to reduce lung injury in both mice and macaques infected with MERS. It also has effectiveness in test tubes against SARS-CoV-2.

The medical term for the effects that it has blocking the virus in a lab setting is “in vitro,” which basically means that it happens outside of a living organism. Lots of compounds have in vitro effects that don’t pan out when we study them in actual humans with actual diseases.

This is why we do randomized clinical trials in medicine - because what makes biologic sense based on our predicted models doesn’t always pan out when we put it to the test in real life.

All models are wrong, but some models are useful.

Indeed, when remdesivir was studied in real Ebola patients, it was actually removed from the trial protocol during an interim analysis because it was less effective than the other treatments being tested.

Tell me about the recent trial showing improvement in 68% of remdesivir patients

The COVID patients treated with remdesivir in the recently published NEJM trial were patients approved for use of the drug by Gilead on something called a “compassionate use” basis. This was a group of 53 patients with an average age of 62. They were required to have a need for oxygen support, and they couldn’t have any evidence of kidney or liver failure. In other words, sick enough to need hospitalization and respiratory support, but fairly young and not having failure of any other organ system. About 25% of them had diabetes and about 17% had hypertension.

Important to note that in this study, remdesivir was not compared to a placebo. This is a report of what happened to the patients who received remdesivir, NOT a comparison of this treatment to any others. And keep in mind that all patients needed to be approved by Gilead before receiving the drug.

The investigators found that 36 of the 53 patients (68%) had improvement in oxygen needs while 15% got worse in this area. There was a lot of attention paid to the fact that the sickest patients (30 who were intubated and 4 who were on ECMO) had decent outcomes, with 17 of the intubated patients having breathing tubes removed and 3 of the ECMO patients stopped receiving it.

But hold your horses: the fact that there’s no comparison in this trial means that we have no idea whether patients got better because of remdesivir or in spite of it.

What about this new report?

According to STAT news, where this update was first reported, they’re seeing great effects from remdesivir given to 113 patients with severe disease. However, buried deep in the article there’s evidence that you should take these results with a huge grain of salt. Take a look at this quote from the lead investigator at University of Chicago, where these patients were treated:

“It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison. “But certainly when we start [the] drug, we see fever curves falling,” she said. “Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”

Not to sound like a broken record, but until there is a randomized trial where remdesivir is being compared to a placebo, we just don’t know whether patients got better because of remdesivir or in spite of remdesivir.

So what will the randomized trial tell us?

Gilead is currently enrolling 2,400 patients in a randomized, placebo controlled trial. After the initial paper came out showing results from patients receiving remdesivir, there were some changes to the trial protocol, which a cynic would interpret as standard pharma funny business.

The bottom line is that we don’t know anything until the trial results come out. Remdesivir might work, but it also might make things worse. When it was properly studied in Ebola, results weren’t particularly encouraging. When hydroxychloroquine was studied compared to placebo in COVID-19, it seemed to have no benefit but had increased side effects.

We do trials to test hypotheses, and right now all we have about remdesivir are hypotheses. I don’t think I’m ready to recommend using your stimulus check on Gilead stock until we get actual data from a true randomized trial.


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[graciegirl]

And in Sumter County about 10%, the highest rate of any county in Florida.

Can you link us to those statistics? I was just thinking the opposite. I have been closely following the deaths in Sumter, Lake and Marion counties and Lake is higher than us, but the highest death toll are in the two counties around Miami. Thank you to Blueash for pointing out it was RATE...percentage discussed here.

Also someone on this thread said that the seasonal flu shot was not a vaccine. That is incorrect; Key Facts About Seasonal Flu Vaccine | CDC (https://www.cdc.gov/flu/prevent/keyfacts.htm)

Also someone said that they don't appreciate the posts from the M.D.s who live here. I certainly do and I know that many do as well.

There is a lot of misinformation circling about. A lot of it is simply because we have not had enough time and statistics to really evaluate the hard data that changes every day. The world has only been following this completely new and dangerous virus since late November when the outbreak and deaths were first reported in Wuhan in China.

[shelley77]

Why do people keep saying this? The infection rate of this virus is something like three times that of the flu. So if no measures are taken it could easily eclipse the flu infection rate. Also, the death rate of those infected from flu is a fraction of a percent, but from this virus it is 2.76% here in Florida, 4.60% in the US, and 6.83% worldwide (46 times the flu death rate minimum). If no measures are taking this would make flu look like a hiccup. Also, the rate of hospitalization from this virus is far higher than the flu, so it is a huge strain on our health care system. If no measures are taken at all it would be overwhelmed. This is not like the flu!.
There's no way you could possibly know that because no one knows how many people have gotten it. No one knows, including the experts. Remember they were telling is 2 miilion could die, now it's 60,000. Remember you don't need masks, now they're suggested or required? You read everything and make up your own mind.

[bhendricks772@gmail.com]

Good advice. :coolsmiley:

[davem4616]

when you're trying to solve a complex challenge you don't take anything off the table until it is proven to not be a viable approach, or a viable solution has been found and is being successfully implemented

Thankfully our leaders stepped up and are leading.... no leader in history has ever made everyone happy 100% of the time

[kanoa1kale2]

And in Sumter County about 10%, the highest rate of any county in Florida.

Without any knowledge of how many had the virus, there is no way to calculate the death toll percentage. We have insufficient testing capability to even make a swag about the death rate.

[roscoguy]

FROM MY FRIEND THE DOCTOR:

Is remdesivir the COVID miracle we've been waiting for?
Gilead certainly hopes you think it is

Gregory Katz
Apr 17


The medical world was buzzing...

Wow. Logical, professional, informative & non-political... WHAT'S WRONG WITH YOU?!?!?! :1rotfl:

[blueash]

Originally Posted by vermonster
And in Sumter County about 10%, the highest rate of any county in Florida.

Without any knowledge of how many had the virus, there is no way to calculate the death toll percentage. We have insufficient testing capability to even make a swag about the death rate.

Let's start with that one. Death rate for COVID is calculated using deaths divided by cases, times 100. This is true in every county and every country. Obviously lack of broad testing despite its promised universal availability does artificially inflate the calculation. But the same problem is everywhere. Vermonster is correct. Sumter also has the highest average age of COVID patients. I think these two data points are related.

CASE DATA FOR SUMTER (https://fdoh.maps.arcgis.com/apps/opsdashboard/index.html#/8d0de33f260d444c852a615dc7837c86) as of 9 AM 4/18
Total Cases: 120 [these are test positive cases]
Deaths: 11 11/120 = .092 times 100 = 9.2%
Demographics of Cases
Age: Age Range: 18 to 92
Median Age: 68

[blueash]

Next
Originally posted by devorejh
Unproven treatments? They may be unproven to our FDA but that’s no surprise. The drugs that the president has touted are being used all over the rest of the world and have had clinical trials. Why is it the United States feels we have to reinvent the wheel. I will say the FDA has been fairly responsible and allowing these treatments since they are working in many other countries

Remdesivir (https://en.wikipedia.org/wiki/Remdesivir), the drug being discussed in this thread, was indeed touted by Trump. But, completely contrary to your posting, Remdesivir has never been used all over the world. It has not even been commercially manufactured. It is an experimental drug that has never left the testing phase. It has not had adequate successful clinical trials yet for any condition which is why it is not being marketed anywhere for anything. The FDA is not behind the rest of the world as this drug is unproven worldwide. This trial and others are attempting to find a clinical use for a product with in vitro and theoretical reasons to hope will work.

Please look things up before you post. Certainty is not the same as accuracy.

[blueash]

Next
Originally posted by devorejh
What you get for the flu is a flu shot, it is not a vaccine. Don’t understand why people do not know the difference. A vaccine is something you take one time and you’re done, like smallpox or polio
When you suggest people do not know the difference, it would be best if you knew the difference. Gracie provided you a link. It is especially enlightening that you picked those two diseases. Polio requires 4 doses, not one, to complete the primary and booster series. Smallpox is no longer given.
The word vaccine does however relate to the history of smallpox. Edward Jenner noticed that milkmaids who contracted cowpox seemed resistant to getting smallpox. He theorized that the milder cowpox illness was protective. He tested taking fluid from cowpox blisters and inoculating people with that fluid. In Latin cow is "vacca" The word vaccine is now used medically and commonly for all the shots and oral products used.

[GoodLife]

Having been in the medical-legal field for nearly five decades, my suggestion is to ONLY follow the words of expert physicians and scientists, and NOT those not so qualified or experienced in advancing your health with scientifically unproven or untested pharmaceuticals. This includes the words that come from politicians that have no such qualifications either!

LOL I included that excerpt from the article only to show that POTUS has spoken about other drugs besides hydroxychloroquine.

Maybe he should say that there are no drugs that offer hope and we're all gonna die?

[Swoop]

Why do people keep saying this? The infection rate of this virus is something like three times that of the flu. So if no measures are taken it could easily eclipse the flu infection rate. Also, the death rate of those infected from flu is a fraction of a percent, but from this virus it is 2.76% here in Florida, 4.60% in the US, and 6.83% worldwide (46 times the flu death rate minimum). If no measures are taking this would make flu look like a hiccup. Also, the rate of hospitalization from this virus is far higher than the flu, so it is a huge strain on our health care system. If no measures are taken at all it would be overwhelmed. This is not like the flu!.
Simply not true: “ A group of researchers analyzed data from China and found that the overall mortality rate of COVID-19 was 1.38%. But if they adjusted for cases that likely went unaccounted for due to their mild or asymptomatic nature, the overall mortality rate decreased to around 0.66%, they reported on March 30 in journal The Lancet Infectious Diseases.”

[jklfairwin]

Prof Simon Maxwell, Professor of Clinical Pharmacology and Prescribing, University of Edinburgh, said:

“The research is interesting but doesn’t prove anything at this point: the data are from a small and uncontrolled study. Remdesivir is currently being assessed in large scale clinical studies, which will be critical in determining whether it is a safe and effective treatment for COVID-19. This is not least because there were some adverse events (60%) reported in the current study, some of them serious (23%), including multiple organ failure, septic shock, acute kidney injury, and hypotension.”

[GoodLife]

Prof Simon Maxwell, Professor of Clinical Pharmacology and Prescribing, University of Edinburgh, said:

“The research is interesting but doesn’t prove anything at this point: the data are from a small and uncontrolled study. Remdesivir is currently being assessed in large scale clinical studies, which will be critical in determining whether it is a safe and effective treatment for COVID-19. This is not least because there were some adverse events (60%) reported in the current study, some of them serious (23%), including multiple organ failure, septic shock, acute kidney injury, and hypotension.”

Yes we know this because we read the study I linked, just like Prof Simon Maxwell.

[blueash]

LOL I included that excerpt from the article only to show that POTUS has spoken about other drugs besides hydroxychloroquine.

Maybe he should say that there are no drugs that offer hope and we're all gonna die?

Maybe he should let the physicians who actually understand the material do the commenting on medications. He can and should offer hope and include statements like "I understand that there are trials of many treatments ongoing here and elsewhere in the world. I'll let Dr. Fauci answer any questions about details of those trials." Instead when a question about medicine was directed at Dr. Fauci he interrupted him and ordered him not to answer.

[GoodLife]

Maybe he should let the physicians who actually understand the material do the commenting on medications. He can and should offer hope and include statements like "I understand that there are trials of many treatments ongoing here and elsewhere in the world. I'll let Dr. Fauci answer any questions about details of those trials." Instead when a question about medicine was directed at Dr. Fauci he interrupted him and ordered him not to answer.

He was just relaying info from PHYSICIANS who were and are reporting results from various drugs. POTUS has never said take this drug you'll be cured. Just measured statements like "It may or may not work" "I am not a Doctor" "I may take it, I'll have to ask my Doctors"

Besides, DR Fauci is not infallible and has made several blunderous statements.

“it’s a very, very low risk to the United States. … It isn’t something the American public needs to worry about or be frightened about. Because we have ways of preparing and screening of people coming in [from China] "

“in all the history of respiratory viruses, asymptomatic transmission has never been the driver of outbreaks. An epidemic is not driven by asymptomatic carriers.”

[DianeM]

when you're trying to solve a complex challenge you don't take anything off the table until it is proven to not be a viable approach, or a viable solution has been found and is being successfully implemented

Thankfully our leaders stepped up and are leading.... no leader in history has ever made everyone happy 100% of the time

Thank you for common sense

[Katieburr]

You are exactly right! Politicians, and that includes the president, are not equipped or educated to make decisions on when we will be safe again from this pandemic. We should not be in such a rush to re-open anything. We all miss going to the squares, out to restaurants and going to a movie, but people shouldn’t be such complaining babies about it. And the argument I keep hearing about your freedom being trampled on is just ridiculous! Would you rather be dead? Would you rather expose people to your selfishness and stupidity? We will all be ok if we listen to medical professionals and stop crying about it and learn how to cope.