GILEAD SCIENCES 885823 (Seite 112)

[vivamiga]

Die US-Futures sind nach positivem Gilead-Statement zu einer remdesivir-Studie auf neue Hochs geschossen. Wie die Studie ergeben hat, sprechen Patienten gut auf eine fünf bis zehntägige Behandlung an, wobei die Mortalitätsrate (ex Italien) bei sieben Prozent lag. Der Konzern will die genauen Details in den nächsten Wochen in einem wissenschaftlichen Journal veröffentlichen. In einer zweiten Studie soll die Wirksamkeit bei moderaten Krankheitsverläufen untersucht werden. Die Ergebnisse dürften Ende Mai vorliegen. Quelle Guidants News

[vivamiga]

Aus dem Yahoo Forum:

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Gilead Sciences Inc. (GILD) Halted due to pending news
DOW JONES & COMPANY, INC. 5:25 AM ET 4/29/2020

(END) Dow Jones Newswires
04-29-200825ET
Copyright (c) 2020 Dow Jones & Company, Inc.


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Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19
BUSINESS WIRE 5:30 AM ET 4/29/2020
Symbol Last Price Change
GILD 78.67down 0 (0%)
QUOTES AS OF 04:00:00 PM ET 04/28/2020
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences. Inc.(GILD) is aware of positive data emerging from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of the investigational antiviral remdesivir for the treatment of COVID-19. We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.

Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19. Gilead will share additional remdesivir data from the company’s open-label Phase 3 SIMPLE trial in patients with severe COVID-19 disease shortly. This study will provide information on whether a shorter, 5-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials. Gilead expects data at the end of May from the second SIMPLE study evaluating the 5- and 10-day dosing durations of remdesivir in patients with moderate COVID-19 disease.

Gilead will continue to discuss with regulatory authorities the growing data set regarding remdesivir as a potential treatment for COVID-19.

[mr11x]

Antwort auf Beitrag Nr.: 63.484.439 von mr11x am 28.04.20 16:25:27

Hier noch eine meiner Meinung nach sehr gute, fundierte Zusammenfassung zum Stand der Forschung zu corona, die auch remdesivir auf dem Schirm hat.

https://s.wsj.net/public/resources/documents/Scientists_to_S…

[mr11x]

Antwort auf Beitrag Nr.: 63.480.476 von H2Future am 28.04.20 12:50:05

Die Japaner positionieren sich zu mindest so, dass falls remdesivir wirkt, sie so schnell wie möglich die Zulassungsvoraussetzungen schaffen, dass auch ihrer Bevölkerung das Medikament möglichhst ohne Zeitverzögerungen bei der Administration bekommen kann.

Ansonst bleibt es dabei: In 1 bis 2 Wochen wird uns Gild über Reuters einen kleinen Hinweis geben und die endgültigen Ergebnisse gibt es Ende Mai von der alles entscheidenden NIAID Studie. SThe most clarity will come from the study from NIAID. It is controlled with a placebo, and patients and doctors are blinded to treatment. Full results are not expected until the end of May, but the study’s lead investigator, Andre Kalil, told Reuters on Friday that an interim look at the data may be available in a week or two NIAID kommt bestätigend auch laut Gild homepage Ende Mai - bis dahin wird es noch viel auf und ab geben, bevor es dann endgültig eindeutig runter oder (hoffentlich) nachhaltig und eindeutig rauf geht - wenn man eine Prognose für Ende Mai wagen möchte

GILEAD SCIENCES 885823 | wallstreet-online.de - Vollständige Diskussion unter:
https://www.wallstreet-online.de/diskussion/1041671-2511-252…



Japan to approve Remdesivir for coronavirus patients in May
Today 06:00 am JST 27 Comments
TOKYO
Prime Minister Shinzo Abe said Monday that Japan will soon approve the anti-viral drug remdesivir for the treatment of coronavirus patients, in what will be the country's first such decision amid the pandemic.

A government official said separately that the drug will be approved as early as next month to treat patients with COVID-19, the respiratory illness caused by the novel coronavirus, as moves to develop therapeutic drugs and vaccines have been accelerating around the globe.

"The pharmaceutical approval (of remdesivir) will be possible shortly," Abe told a parliamentary session.

Remdesivir has been developed by U.S. biopharmaceutical company Gilead Sciences Inc. as a possible treatment for Ebola.

A clinical test conducted by an international team on patients with severe COVID-19 symptoms will conclude this month.

The New England Journal of Medicine recently published a study showing the drug's effectiveness in nearly 70 percent of 53 coronavirus patients with severe symptoms, while it caused serious side-effects, such as deterioration of kidney function, in a quarter of them.

A spokesperson of the Japan unit of Gilead Sciences said, "We are currently conducting clinical tests and are focused on confirming the drug's efficacy and safety."

Once an application by Gilead Sciences is made, the Japanese government is set to fast-track its approval. This streamlining of the process -- which involves postponing reports on domestic clinical tests to a later date -- is available on condition that the drug has been approved in another country.

In Japan, the anti-influenza drug Avigan is also going through clinical tests on COVID-19 patients, which will last through June. A scientific study in China has shown its efficacy in treating the disease.

The Japanese government has requested Fujifilm Toyama Chemical Co, a group firm of Fujifilm Holdings Corp, to boost production of Avigan, also known as favipiravir. As it is feared to cause birth defects, it cannot be administered to expecting mothers or those who may become pregnant.

Also Monday, Shionogi & Co said it will develop a vaccine for the novel coronavirus, aiming to start clinical trials this year.

The Japanese company has decided to develop a recombinant protein vaccine for the virus that causes COVID-19 through its subsidiary UMN Pharma Inc., while also seeking to discover therapeutic drugs for the disease. Shionogi said it is looking to offer the vaccine for 10 million people.

The company is coordinating its plans with relevant parties including the Ministry of Health, Labor and Welfare.

© KYODO

[H2Future]

Coronavirus: Wollte sich China heimlich Patent auf Wirkstoff Remdesivir sichern? – Meldung
https://tekk.tv/gesundheit/coronavirus-wollte-sich-china-hei…

[mr11x]

Meist komplizierter als man so gemeinhin annimmt

The world wants answers on Gilead’s Covid-19 drug. Experts worry next studies may increase uncertainty
By MATTHEW HERPER @matthewherper and ADAM FEUERSTEIN @adamfeuersteinAPRIL 27, 2020

For weeks, the world has been eagerly awaiting clinical trial results for one experimental drug, remdesivir, to treat Covid-19. On some days, the entire stock market has moved up and down based on limited amounts of data about the therapy from Gilead Sciences.

The signals, so far, have been contradictory. An early peek at one study, based on data from patients treated 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.

A fuller picture on remdesivir is expected any day now. Gilead has said that it will release data from one of its U.S. trials — the one from which the Chicago results were disclosed — by the end of this week. Even more data, from other trials including the China study, could follow shortly thereafter.

Related: New type of checkpoint inhibitor offers early promise against tumors, but will it last?
But outside experts in clinical trial design worry that the results, instead of leading to a clear picture of whether the medicine is effective, will instead muddy the waters further.

The main concern, they say, stems from the fact that the Gilead trial expected to read out this week, which was conducted among patients with severe disease, lacks a control group — that is, patients who are randomly assigned to receive the best treatment available, but not remdesivir. As designed, the only randomization is the duration of treatment: either five days or 10 days of drug. Without a true control group of patients, many experts say, it will be difficult to determine whether remdesivir is effective.

“The overall study itself has little or no scientific value since all patients are receiving the drug,” said Steven Nissen, the chief academic officer at the Cleveland Clinic and lead investigator of many trials for heart drugs that have been approved by the Food and Drug Administration.

“The study, as designed, is essentially useless and cannot be used by the FDA for consideration of remdesivir for approval to treat coronavirus,” Nissen said.

Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, called the situation “frustrating.”

“For them to run the trial in severe but not include a control group, it’s just such a waste,” Bach said.

The predicament is symptomatic of one of the biggest problems in medicine: Collecting data quickly can actually slow things down if studies are not designed in a way that gives clear, definitive answers.

Related: Custom cell therapy shrinks lung tumors, seeding hope for a new cancer treatment
Not everyone is as grim about prospects for useful data. Scott Gottlieb, the former commissioner of the FDA and a fellow at the American Enterprise Institute, defended the Gilead study. He noted that while the trial expected to read out first is “open label”— meaning that both doctors and patients know who is getting the drug and who is not — more trials are still being conducted.

“There’s a rigorous, placebo-controlled trial that’s now fully enrolled and will read out soon, but there’s also a place for open label studies to broaden the safety database and answer discrete questions,” Gottlieb said, referring to a study sponsored by the National Institute for Allergy and Infectious Diseases.

Gilead says it had ‘only limited supply’
Gilead said that its study was never meant to be the first word on remdesivir’s efficacy. Instead, it was meant to follow two studies from China and the U.S. government study, run by NIAID.

“In the early stages of the pandemic, we not only had a limited supply of remdesivir but also a limited supply of the matched placebo required for placebo-controlled studies,” said Amy Flood, a Gilead spokesperson. “We chose to prioritize manufacturing active drug over placebo, and we provided our supply of placebo to China and NIAID for their studies of remdesivir.”

Given that three randomized, placebo-controlled trials were either underway or about to start, Flood said, Gilead designed its own studies to be open label. But this makes any conclusion from a study far weaker, because unconscious biases can affect the results.

Critics point to Gilead’s decision to compare two groups given remdesivir for either five days or 10 days. The problem with this strategy, they say, is that an ineffective drug that did nothing and a very effective drug that consistently helped patients overcome the virus would look the same in such a study. Only if the 10-day course were more effective, or if it was worse because of side effects, would the study have any clear result.

Gottlieb defended Gilead, arguing that increasing the size of the study from 400 patients to 6,000 expanded access to the drug at a time when it was needed to help with the public health emergency, but also allows the company to collect more rigorous data. “I think it’s far better to provide access in an open label setting than to merely give drug away in an expanded access protocol where you’re collecting minimal or no data,” he said.

Yet another trial in less sick patients, also run by Gilead, does have a control group and may give a clearer answer. Nissen sees “a reasonable study design.” But Bach was more critical, saying that even though that study has a control group, the lack of a placebo means the study might not be trustworthy. That’s because its main goal, time to improvement of symptoms, could be affected by the perceptions of clinicians and the patients themselves.

Bach said the hospitals conducting the study “are easily capable of wrapping syringes in brown paper and blinding the whole thing. I don’t understand why you would run a trial like this.”

The problem of placebo
When case numbers in the U.S. started to spike in mid-March, Northwell Health, New York’s largest health care provider, immediately staffed a 200-person unit to run Covid-19 clinical trials. Kevin Tracey, Northwell’s executive vice president of research, said that the group’s goal was to conduct rigorous clinical trials that included control groups. Why not have a placebo arm in the Gilead-run study of severe patients?

“Obviously, that’s my first choice,” Tracey said. One reason it didn’t happen was that everyone needed to move very fast.

“In a quiet time when you have a few years to figure out the best way to lower cholesterol or the best way to treat arthritis, there’s a dialogue between the investigators and the company and the FDA and you negotiate the trial design,” Tracey said. “We didn’t do that with Gilead, in this case, because our hospitals were filling up with people who were dying.”

Related: Covid-19 Drugs and Vaccines Tracker
But Tracey points to another problem, too. He said that more severely affected patients and their families, having read optimistic news reports about a medicine, may not agree to be randomly assigned to placebo.

“That’s a reality,” he said. “You know that your mother, your wife, or your father, your brother is in the bed dying and you’re supposed to sign the papers that say you might get a placebo? No thank you, a lot of people say.”

At the same time, it can be hard to answer questions without randomized data, and even then results can be confusing.

What to expect from Gilead’s study
Gilead’s severe Covid-19 study is enrolling approximately 6,000 participants from 152 different clinical trial sites all over the world. The primary analysis to be disclosed this week is expected to encompass data from at least 400 patients, with a statistical comparison of patient improvement between the two remdesivir treatment arms — the five-day and 10-day treatment course. Improvement will be measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.

Video footage of a town hall at the University of Chicago, seen by STAT, provides some clues about what the results might bring. The researcher speaking in the video, Kathleen Mullane from the University of Chicago, said, “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out 10 days, maybe three.”

If Chicago’s experience holds true at the other hospitals participating in Gilead’s study, there will be little or no difference in patient improvement between the two remdesivir arms, making the comparison uninterpretable.

That, though, will not be the end of the conversation or the debate.

Gilead could also provide additional analyses on the time to clinical improvement for different subsets of remdesivir patients, based on disease severity, onset of symptoms, or how quickly treatment was started. Without a control arm, these data will be hard to interpret on their own.

One approach: compare to other trials, like the 199-patient study of the HIV drug lopinavir that was published in the New England Journal of Medicine in March. In the study conducted in China, lopinavir was 31% better than standard of care in time to clinical improvement, but the result was not statistically significant. Mortality was similar, with 19% of lopinavir-treated patients versus 25% of standard of care patients dead after one month.

Baird analyst Brian Skorney, for instance, points out that 79% of the lopinavir-treated patients were cured at one month, yet there was still no significant difference from the 70% cure rate in the control arm. This suggests that high rates of patient recovery should be expected, and that remdesivir — a modestly effective antiviral at best — will not make a big difference.

But RBC Capital biotech analyst Brian Abrahams suggests using the control arm from the lopinavir trials as an admittedly rough comparator when the Gilead data are released.

At seven days, 2% of the patients treated with standard of care showed a clinical improvement, increasing to 30% at day 14 and 70% at day 28. If remdesivir improves upon those results, perhaps doubling the time to clinical improvement at day 14, that might be seen as suggesting a benefit, Abrahams believes.

Umer Raffat, an analyst at Evercore ISI, pushes back against the conclusion that lopinavir failed in the China study — which might bode well for remdesivir. Raffat points to an analysis in the NEJM study that showed in a small group of less sick patients treated before their symptoms worsened significantly, the lopinavir mortality rate was 45% lower.

Antiviral medicines should be more effective when given earlier. This is what Gilead is trying to do with remdesivir in its severe Covid-19 study. The company is expected to report mortality rates when it announces results later this week. If remdesivir lowers mortality to 10-15% from the mid-20% range reported in other studies, that might also suggest a benefit.

Comparisons across different clinical trials may help paint a clearer picture of remdesivir’s efficacy, but they’re not likely to persuade FDA to approve the drug. That will only come from positive data in subsequent clinical trials.

What to expect: the China-run severe study
The trial in severe patients conducted in China — the one accidentally posted on the WHO’s website last week — failed to show that remdesivir sped the time it took for patients to improve. After one month, it appeared 13.9% of the remdesivir patients had died compared to 12.8% of patients in the control arm. The difference was not statistically significant.

But the WHO did not post full data; rather, it was an abstract of the study and published without the full manuscript. It’s possible that the published version will be different.

It’s even possible this study will be supportive of some effect for remdesivir. The key is a statistic, known as a hazard ratio, showing that the time to clinical improvement for patients in one group was 23% more than the other. The key question is whether patients did better on remdesivir or placebo.

Raffat, the Evercore ISI analyst, obtained a copy of the study protocol, a plan for how it was going to be run, and wrote in a note to the bank’s clients that this figure was planned to be 1.4 if remdesivir were to have a statistically significant benefit. If that holds true, the 1.23 figure means that the study just missed showing the drug was effective, leaving hope that future studies could show the drug would be effective.

“It’s not a silver bullet, but I do believe remdesivir is active,” Raffat said on a podcast for investors Friday.

The most clarity will come from the study from NIAID. It is controlled with a placebo, and patients and doctors are blinded to treatment. Full results are not expected until the end of May, but the study’s lead investigator, Andre Kalil, told Reuters on Friday that an interim look at the data may be available in a week or two


NIAID kommt laut Gild homepage Ende Mai - bis dahin wird es noch viel auf und ab geben, bevor es dann endgültig eindeutig runter oder (hoffentlich) nachhaltig und eindeutig rauf geht - wenn man eine Prognose für Ende Mai wagen möchte.

[User_Using]

https://english.kyodonews.net/news/2020/04/96de780ad3e1-japa…

[mr11x]

Antwort auf Beitrag Nr.: 63.460.244 von mr11x am 27.04.20 07:54:33

https://www.gilead.com/stories/-/media/gilead-blog/files/cli…

[mr11x]

Antwort auf Beitrag Nr.: 63.460.100 von mr11x am 27.04.20 07:10:23

Und hier noch einmal der Gild Zeitplan von deren hompage zu den laufenden Corona Studien
[urlhttps://www.gilead.com/stories/-/media/gilead-blog/files/cli…[/url]

[mr11x]

Antwort auf Beitrag Nr.: 63.459.008 von mr11x am 26.04.20 20:42:51

Von den Amis rauskopiert:

1. This week (week of 4/27)
Expecting Open-label clinical study results of some 1200 patients: both severe and moderate. Not Placebo controlled. But definitely must tell us, which direction it may go.

2. Around May 15th (earlier thought, May end; but recent reports indicate earlier results)
NIAID study that is double-blinded, Placebo controlled, randomized. Definitive scientific outcome. About 600 (?) patient study.

..................

Anonymous11 hours ago
At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.

CONCLUSIONS
In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%).

7 Dead ... this is a reduction of mortality. What happened to the other 17 patients? Regardless this is a major reduction of mortality.

SO, 68% were vented which correlates with a >80% mortality without antiviral intervention.

Antivirals are not what I as a doc would have suspected working on vented patients. No different than giving Tamiflu to a pneumo pt.

Two takeaways from this NEJM study

1. It works on hemodynamically unstable patients that would have had a higher mortality died

2. The Chinese are playing games with the numbers. I have read the material about trying to patent it and their inability to do so. This is an insult on America if the data does in fact show efficacy in the double blind.

Further thought, I am impressed with what have seen with Rem. I am in the medical field and treat patients with Covid. I am not going to pump this on Yahoo because there are so many more studies that will have to be completed with so many variables.

I do not know anything about renal complications or other side effects but suspect a severely ill person with high viral load will have all the associated nephrology issues... in fact, the benzene ring from NSAIDs and esp Tylenol are probably greater than from REMD. There are about 40K deaths a year from Tylenol ODs and "overconsumption" of Tylenol. You don't hear much about that , do you? But you are hearing about it from this drug. I suspect now it's a load of crock but like so many things long term, we need the studies. Regardless, again, I would rather take this than get severely ill.

The reason I reacted is what is going on in China to attack this drug. The reduction in sperm count? Are you kidding me? I think there is a coordinated response by the Chinese to go after Gilead and specificall, an American Pharma Co. Time will see if the suspicions are correct.