Gilead Says Critical Study of Covid-19 Drug Shows Patients Are Responding To Treatment (statnews.com) 54
A government-run study of Gilead's remdesivir, perhaps the most closely watched experimental drug to treat the novel coronavirus, showed that the medicine is effective against Covid-19, the disease caused by the virus. From a report: Gilead made the announcement in a statement Wednesday, stating: "We understand that the trial has met its primary endpoint." The company said that the National Institute of Allergy and Infectious Diseases, which is conducting the study, will provide data at an upcoming briefing. The finding -- although difficult to fully characterize without any data for the study -- would represent the first treatment shown to improve outcomes in patients infected with the virus that put the global economy in a standstill and killed at least 218,000 people worldwide.
During an appearance alongside President Trump in the Oval Office, Anthony Fauci, the director of NIAID, said the data are a "very important proof of concept" and that there was reason for optimism, but cautioned the data were not a "knockout." Over the past few weeks, there have been conflicting reports about the potential benefit of remdesivir, a drug that was previously tried in Ebola. As previously reported by STAT, an early peek at Gilead's study in severe Covid-19 patients, based on data from a trial at a Chicago hospital, suggested patients were doing better than expected on remdesivir. Days later, a summary of results from a study in China showed that patients on the drug did not improve more than those in a control group.
During an appearance alongside President Trump in the Oval Office, Anthony Fauci, the director of NIAID, said the data are a "very important proof of concept" and that there was reason for optimism, but cautioned the data were not a "knockout." Over the past few weeks, there have been conflicting reports about the potential benefit of remdesivir, a drug that was previously tried in Ebola. As previously reported by STAT, an early peek at Gilead's study in severe Covid-19 patients, based on data from a trial at a Chicago hospital, suggested patients were doing better than expected on remdesivir. Days later, a summary of results from a study in China showed that patients on the drug did not improve more than those in a control group.
Unfortunately, we need to be patient. (Score:5, Informative)
Science is moving at an unprecedented rate on this stuff, but it never quite moves in a straight line. Today another randomized controlled trial published in The Lancet [thelancet.com] was largely negative:
Which study is right? We can't know for sure, especially as the Gilead result was "announced" but not published anywhere yet. It's possible that both trials came to opposite conclusions and neither has any obvious faults.
A useful drug, even if it weren't a knockout cure, would have a huge impact in dealing with this.
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hey! is right. If you're not patient, you could become one.
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That's literally the same trial as referenced in the article summary above. Not that you're wrong, but your comment is redundant.
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Not clear, as the summary has no references.
Re:Unfortunately, we need to be patient. (Score:5, Informative)
Each study treated patients at a different stage of the illness. The negative study (Lancet) treated patients in late-stage severe illness and failed to show impact. The positive study treated patients early in the illness and did show impact.
All treatments of viral infections attack the virus at different stage in its life cycle. That's why HIV therapies almost always employ drug cocktails where each of 3-5 components attack a different viral mechanism as it grows and propagates.
The implication from these two studies are that Remdesivir *is* useful in treating early stage but not late stage COVID-19.
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Here's the eligibility requirement from the Lancet paper:
That's not particularly late, and it includes patients who would normlaly qualify for no
The same study flaw as with hydroxychloroquine (Score:2)
All the studies where it failed were with severely ill patinents who would die no matter what. Raoult gave (and continues to give) it at the onset of symptoms. Iran gives it early as well to 94% of their C19 patients. Check out their fatality rate.
Zelenko's hydroxychloroquine cocktail update (Score:3, Informative)
Hopefully his paper is published without too many delays.
Re:Zelenko's hydroxychloroquine cocktail update (Score:4, Interesting)
Politically HCQ is not viable in the US. Seems to be doing wonders in Iran, Turkey, India, Bahrain, and a number of other countries which don't have $1K per dose to drop on Tocilizumab.
Synthetic study flaw with hydroxychloroquine DOSE (Score:1)
Big Pharma has a knack to sabotage studies to create or synthesize headlines to feed their greed. Example from today as they drive a high dose situation in a far away country to set a planned negative outcome.
Of course high dose use of most medications lead to fatalities, this one was done to make a headline on an unpatented option too cheap for big pharma.
Greed always comes first before use of medical technology, like invasive ventilators that are there to milk insurance and lead to medical bankruptcy with
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It might be too late once they're on a ventilator (Score:5, Interesting)
For more well-known viruses, the earlier you treat it the better.
For example, Tamiflu needs to be taken within the first 48 hours to be effective.
The data from the study from China suggest that remdesivir might also work best earlier. All of the studies use patients who have already been sick for a while and have progressed to severe symptoms - severe enough to require hospitalization to begin with. The China study also only considered patients with specific, particularly bad, symptoms.
It's entirely possible that the different results from different studies are largely telling us that, like most anti-virals, remdesivir will work best if we don't wait until it's too late. The earlier the study uses remdesivir, the better remdesivir works, perhaps. The data available so far is consistent with that.
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Could be. Unfortunately we don't know anything about the study other than it had some encouraging results in time to recovery.
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The company actually dropped the patent (Score:2, Interesting)
Just FYI, the company actually dropped the patent protection on remdesivir, so anyone can make it.
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It sounds like they both agree. The primary endpoint in the NIAD trial was time to recovery, and a preliminary analysis in 1063 patients found a significant 31% improvement versus placebo. The Lancet study observed an improvment in the same metric, although it didn't reach significance.
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This is a good point. One overlooked variable in the dynamics of the epidemic is recovery time. If you can shorten recovery time it's like adding a huge slice of medical care bandwidth to the system.
Another thing we need to be on the lookout is for treatments that reduce complications.
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I expect they've used recovery time as a primary outcome because it's usually the easiest to test. It's reasonably easy to define, and continuous outcomes with well-behaved distributions usually provide more power for the same sample size than do discrete ones.
The trial (https://clinicaltrials.gov/ct2/show/NCT04280705?term=Adaptive+COVID-19+Treatment+Trial&draw=2&rank=1) appears to have a bunch of biomarkers as secondary outcomes, but #10 is a composite score involving vital signs, #11 is an ordinal
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That's a nice benefit for the medical providers (and that shouldn't be discounted) but if the patient's still die at the same rate it's kind of a bust therapy in my book.
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Which study is right? We can't know for sure, especially as the Gilead result was "announced" but not published anywhere yet. It's possible that both trials came to opposite conclusions and neither has any obvious faults.
Studies that are all over the place for a disease whose effects are all over the place.
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Which study is right? We can't know for sure
My money would be on the one that is not run by the company that stands to profit from widespread use of their drug.
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On the China study... (Score:1, Interesting)
Funny how China claims remdesivir does not work, while at the same time trying to patent it themselves [trialsitenews.com]...
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That story's a month old. That's like ten thousand COVID-19 science years.
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Funny how China claims remdesivir does not work, while at the same time trying to patent it themselves [trialsitenews.com]...
Yes, it would be funny for them to actively discredit a drug they're trying to patent so they could have exclusive rights to manufacture a drug no one wants to use.
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Funny how China claims remdesivir does not work, while at the same time trying to patent it themselves [trialsitenews.com]...
A funny thing about humans is that they see divisions in their own societies, but assume other countries are monolithic.
There are many people in China and many groups of people. It is very likely that the people applying for the patent and the people claiming it doesn't work are different people.
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Works with political parties as well as countries, and even social groups. Even though I'm perfectly aware of the phenomenon I still have to remind myself that not all (for example) Libertarians or anti-vaxxers believe the same set of fantasies.
Maybe not (Score:4, Interesting)
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That's like becoming a non-drinker after Cirrhosis sets in.
When you are on death's door, you are likely going to step through no matter what.
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You left out the for severe COVID-19 qualifier. The abstract itself contradicts your one-liner "among patients with symptom duration of 10 days or less" for which "patients receiving remdesivir had a numerically faster time to clinical improvement".
This Lancet study was not designed to evaluate for early intervention, only late-stage severe cases. They presumably didn't have enough patients with symptom duration less than 10 days in their sample to really test it for them. With decent testing it is cer
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So basically the study says RDV works but since we ran out of patients we could reach a statistically valid number.
No it doesn't work (Score:3)
Studies in many countries have demonstrated that, even if the patent-holder here claims it.
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One curious feature of science is that you can't experimentally prove the non-existence of something, in this case clinical benefit.
It's possible that the trial that Gilead announced did something different. Or was on a distinct group of patients. We can't know until we see the details.
Suppose they didn't do anything different than those other studies, but got a *statistically significant* result. That could be chance, or it could be the size of the study. Sometimes you can detect weak effects that oth
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You can prove non-existence of clinically significant benfit. You cannot prove absence of any benefit at all.
Typical studies claim a positive result if they get a p-value lower than the pre-set threshold. That's statistical significance. Not achieving statistical significance means essentially nothing.
Clinical significance is a minimum threshold for benefit that's agreed upon by some means. You can show that any benefit is confidently less than this value. Most studies don't formally talk about clinically s
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I'm not sure that's true. There may be a clinically significant benefit *for certain patients* whose characteristics you haven't identified yet. You might be administering the drug in the wrong way, at the wrong time, or in the wrong dose.
But in practice sure; at some point you don't really have justification to look for an effect.
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"Clinically significant benefit" is a technical term. It is as I described, and it applies at the group level. It's a threshold for *average* benefit, as measured by a particular metric.
What you're describing is certainly true. Clinical trials use criteria to recruit from a patient population that the designers believe will experience a benefit. Often the data from failed trials is analyzed to look for "responders." If these people share some identifiable characteristic, you might design another trial that
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Oh goody, glad you've sorted that out. Would you mind posting links to all those studies "in many countries" that you referred to? Plus some discussion of the evidential standard for each. That would be great!
Another Phrama Corp. blowing their horn (Score:4, Interesting)
They want those drugs to work (Score:2)
so the can implant microchips into people bodies that implant themselves into the side of the digestive track.
Gilead Lies! (Score:1)
It doesn't work. They've already admitted it doesn't work and their stock took a shit.
This is Gilead or their investors trying to pump the stock back up so that they can get out and leave others holding the bag.
Gilead does NOT have the miracle cure that everyone is hoping for.
Fauci says it works (Score:5, Interesting)
The NIH has stopped their study midway as it was felt unethical to keep giving the placebo when they had clear data that the drug works.
Cant have a stronger signal than that
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Hard to take you seriously when you dont even know the difference between a vaccine and an anti viral
One Positive Study; One Neutral Study; More Study (Score:3)
So if one is positive and one not positive.
We will just need more studies.
My epidemiology professor said that basically one needs multiple positive studies to begin to see if something is repeatedly the case.
One or Two studies only can get us to the point where we know we would like more studies.
Nothing more.
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Really only one study has said they couldnt find evidence it works and that study basically ran out of patients as the Chinese had tried all kinds of medicines on the patients (difficult to have a placebo control group when the entire kitchen sink of drugs have been already thrown at the patients). So it was asically a shrug and we dont know.
All other studies have been positive.
Why the constant flip flopping? (Score:2)
Inconclusive to say the least... (Score:1)
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Inaccurate on both counts.
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