FDA approves Gilead's remdesivir as coronavirus treatment

[BigmanPigman]

Source: CNBC

"The Food and Drug Administration on Thursday approved Gilead Sciences' antiviral drug remdesivir as a treatment for the coronavirus."

The drug will be used for Covid-19 patients at least 12 years old and requiring hospitalization, Gilead said. Remdesivir is now the first and only fully approved treatment in the U.S. for Covid-19, which has infected more than 41.3 million people worldwide and killed more than 1 million, according to data compiled by Johns Hopkins University.

The drug is administered in a hospital setting via an IV. The company said the medication should only be administered in a hospital or in a health-care setting capable of providing acute care comparable with inpatient hospital care.

The majority of patients treated with remdesivir receive a five-day course using six vials of the drug. The company is also developing an inhaled version of the medication, which it will administer through a nebulizer, a delivery device that can turn liquid medicines into mist. The company has said the drug can't be administered in pill form because its chemical makeup would impact the liver.

Remdesivir, now under the brand name Veklury, costs $2,340 for a five-day treatment course for people covered by government health programs and other countries' health-care systems, and $3,120 for U.S. patients with private health coverage. Shares of Gilead were up more than 5% in after-hours trading.

Read more: https://www.cnbc.com/2020/10/22/fda-approves-gileads-remdesivir-as-coronavirus-treatment.html

[atreides1]

1. Interesting

The Secretary of HHS was considering firing the FDA Director...and by the end of the day this drug was approved...and it looks like the Trumps and probably several Republicans in Congress are doing a happy dance, now that their shares in Gilead have increased in value!!!

[dchill]

2. So glad we can all afford it!

I'm sure Trump are will cover it.

In two weeks.

[lapfog_1]

3. this after the WHO released a large scale study

which found that Remdesivir was ineffective at treating Covid-19

[still_one]

4. No it isn't . There were double blind studies done with remdesivir and it demonstrated a

a definite reduction of hospital time

The study WHO did was not a good study, nor was it a double blind study. It also was cut short, and did not sufficient number of people

Months ago Fauci verified the data from the study done here with remdesivir

In that same WHO study they also said dexamethasone was not effective, and that is incorrect also

There continuing studies going on with remdesivir and dexamethasone that are well controlled, and we will see the results

WHO has also removed this from their website

https://www.nih.gov/news-events/nih-research-matters/final-report-confirms-remdesivir-benefits-covid-19

[lapfog_1]

5. really

30-Country trial

The WHO’s Solidarity trial is a 405-hospital, 30-country open-label randomized trial among 11,266 hospital inpatients—of which 2,750 adults were randomized to a 10-day course of remdesivir, consisting of 200mg the first day, followed by doses of 100 mg the other nine days. The trial is designed to assess the effect of remdesivir and the other three treatment options on in-hospital mortality.

Mortality was measured via death rate ratio and drug vs control numbers of deaths reported to date. Remdesivir showed a death rate ratio of 0.95 (301/2743 vs 303/2708). hydroxychloroquine, 1.19 (0.89-1.59, p=0.23; 104/947 vs 84/906), lopinavir/ritonvir, 1.00 (0.79-1.25, p=0.97; 148/1399 vs 146/1372) and interferon, 1.16 (0.96-1.39, p=0.11; 243/2050 vs 216/2050).

Mortality being the most important aspect of outcomes, not something about the length of a hospital stay. .95 is not a very good result.

[still_one]

6. This is what I am referring to

https://sfist.com/2020/10/19/local-experts-question-who-study-that-called-into-question-the-effectiveness-of-remdesivir-for-covid-patients/

"The results of a study released Friday prior to being peer-reviewed are alarming some Bay Area infectious disease specialists because they may mislead other doctors or the public, or discourage insurance companies from paying for the experimental drug remdesivir for severe COVID cases. And they contradict results already found in what they say were more rigorously conducted trials.

Gilead's drug, originally developed to treat ebola, has been discussed as showing promise in reducing the severity of COVID infections since early in the pandemic when it was being deployed at hospitals in Wuhan, China in January and February. And a federally funded double-blind study, the results of which were released in late April, showed significant impact on the speed of recovery among COVID patients who took the drug, compared to those who didn't.

But the World Health Organization on Friday publicized the results of a study that was not double-blind — the patients knew they were getting the drug — but was large in its sample size, and the results suggested little to no impact on mortality from taking remdesivir.

UCSF expert Dr. Peter Chin-Hong dismisses this, telling the Chronicle that first of all, no one had been touting the drug as reducing mortality. "The previous studies have shown decreased time to recovery, so people got better faster," Chin-Hong said. "I think it was on the order of 4 or 5 days, and that is pretty significant."

Also, dexamethasone which they dismissed has been shown effective anecdotally at least with those prone to having a cytokine storm. Those observations were from Europe, though I am not sure if they have double blind studies on this yet

[lapfog_1]

10. dexamethasone

is a steroid and is used to suppress the immune response in severely ill people.

It is effective to saving lives of those who are in danger of dying from their own immune response. However it does nothing to the actual virus ( other than give your own immune response a chance to fight the virus )

so much politics are involved with the anti-viral treatments. I can't imagine why the WHO would withdraw a study that is contradictory to the wishes of a certain President that pulled funding from the WHO ( they have MANY other things to fight that cause much more death in third world countries than COVID-19 ).

So... to get their funding restored maybe they pulled a study. But no study that I'm aware of shows that remdesivir is effective in determining the outcome of a patient sick enough to enter a hospital.

I found it interesting that the Walter Reed medical team treated the Orange Blob with ALL of these drugs... Dexamethasone in particular as in the early stages of the disease you do NOT want to suppress the immune response at all. And then he pops out of the hospital 2 days later with a "superman" t-shirt under his dress shirt (according to insiders). But he can't climb a staircase without being short of breath for 5 minutes.

I say this because 3 weeks ago I was infected with SARS-Cov-2 - I tested positive 2 weeks ago today... after 3 days my blood O2 reached 91 ( normal is 97 for me ), I had a cough, sore throat, massive headache, a few other digestive symptoms... I stayed in bed with my "hope and prayer" medicine of vitamin D (3000 IU) Vitamin C, and zinc. Now, 3 weeks later, I still have fatigue... severe fatigue. I'm out of breath if I do anything active. I hope this isn't a long term effect. But as far as I know, there is nothing to be done for me at this point other than hope I get better.

I have been extremely careful to not be around others since late January, before the first US case was discovered... I was watching what the Chinese were doing in Wuhan... and it scared the crap out of me. But even that didn't prepare me for how long this pandemic would last. I have watched Dr. Campbell (UK teaching nurse) almost every day for his analysis of the various treatments, the pandemic spread, etc.

The other drug given to Trump is one that, in theory, might be very effective in treating early stage infections... Regeneron is a mono-clonal (cloned from one genetically modified cell) anti-body treatment geared to attach to 2 specific proteins on the "spike" of the virus... by attaching to those proteins, if effectively blocks the virus from attaching to your cells and inserting the RNA of the virus for replication. It looks promising. Again, in theory. If Trump had a much more severe case of Covid-19 and walked out 2 days later, I attribute his recovery to this drug and not remdesivir or Dexamethasone (why would they even GIVE that to him)?

I really can't explain what happened to the orange turd.

[still_one]

12. I realize that leapfrog regarding dexamethasone. Sorry about your ordeal with sars cov2 lapfog

and hope you are feeling better and coming out of it

I have a cousin who was also infected with COVID. He lives in Florida. He would definitely be considered high risk. They gave him remdesivir, dexamethasone, and convalescent plasma, so it is not out of the ordinary why they would give Orangeman the drug cocktail, since observationally the earlier in the course the better, and trump would be considered in the high risk category

He was testing positive for 5 weeks, and when he tested negative he went to a rehab place, before he went home. He is coming out of it, but the fatigue as you describe is still there

It is a nasty bug. I don’t know if you saw Chris Cuomo when he was dealing with it, but he was educating people on his program in his basement when he was going through it, it took him some time to get over it also

Anyone, wishing you all the best, and will get better and stronger a little more everyday



Take care

[yardwork]

21. Here's my thinking on Trump's COVID.

I think he had a mild case. Because of his age, his obvious other health issues and because he's the president, they admitted him to Walter Reed for a few days. He was given oxygen. He was given "low doses" of each of the experimental treatments so that he could promote them as cures. I'm sure he owns stock in all those companies.

It was a combination of a con and precautions.

I'm glad you're feeling better.

[agingdem]

7. trump politically delegitimized the FDA

until I hear the all-clear from Fauci I remain skeptical...

[still_one]

8. Faucet and the NIH already gave the all clear for remdisivir in shortening the length of hospital

time


https://sfist.com/2020/10/19/local-experts-question-who-study-that-called-into-question-the-effectiveness-of-remdesivir-for-covid-patients/

[agingdem]

11. it's a viral suppressant much like

the HIV cocktail...and it's not a cure...

[still_one]

13. As far as I am aware no one ever claimed it to be a cure

[yardwork]

19. Trump called it a cure but he lies all the time.

[still_one]

20. +++

[secondwind]

9. Isn't Gilead a Jared Kushner company????

[still_one]

14. He may own stock, but he doesn't own the company as a majority stock holder

[yardwork]

17. No.

[LogicFirst]

15. WAIT. Doesn't he play golf with that Remdesivir guy?

The FDA has now officially interfered in this election.

[JCMach1]

16. This and dexamethasone saved my life, it's becoming pretty standard

Treatment now if you land in hospital with Covid pneumonia.

[yardwork]

18. I'm glad you're here!