April 29, 2020

USA: Dr. Fauci Says Phase 1 Of A Study Testing The Drug Remdesivir Showed Promising Results For Treating People Infected With COVID-19. Wuhan Institute of Virology In China Sought to Patent Gilead’s Remdesivir.

NBC News
written by Erika Edwards
Wednesday April 29, 2020

An experimental drug for the coronavirus has a proven benefit, according to Dr. Anthony Fauci, the head of the National Institutes of Allergy and Infectious Diseases.

"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery," Fauci said at the White House on Wednesday. The data he referred to is from a large study of more than 1,000 patients from multiple sites around the world. Patients either received the drug, called remdesivir, or a placebo.

Results from clinical trials are typically published in medical journals after review from outside experts. That hasn't happened yet with this latest study, but Fauci said that the results were so promising, there is "an ethical obligation to immediately let the placebo group know so they can have access" to the drug.

Fauci said the remdesivir study group was able to be discharged from the hospital within 11 days, on average, compared to 15 days in the placebo group.

"What it has proven is that a drug can block this virus," Fauci said.

There were indications the drug led to fewer deaths, but that part of the analysis is still under review.

Fauci, who is normally measured in tone, expressed genuine excitement over the results, calling them "reminiscent of 34 years ago in 1986 when we were struggling for drugs for HIV."

Fauci's team uncovered the first drug to show a modest impact on the virus that causes AIDS — research that was built upon over subsequent years to find HIV drug cocktails.

Dr. Michael Saag, associate dean for global health at the University of Alabama at Birmingham, said the results seemed promising. Antiviral drugs such as remdesivir tend to work earlier in the course of an illness, so "the thing that I think is important in this study is the patients had advanced disease," said Saag, who is not involved with any remdesivir trials.

"I think they were trying to give it the toughest test they could."

The study raised questions about whether the Food and Drug Administration would issue emergency use authorization for remdesivir, a move that would expand doctors' ability to use it.

In a statement to NBC News, an FDA official said, "the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate." It was unclear whether the FDA would take immediate action.

Meanwhile, information on two other remdesivir studies released Wednesday provided seemingly conflicting outcomes.

But both studies had flaws, making results difficult to interpret in the absence of more research.

The first study, from Gilead Sciences, found that patients who were given a 10-day treatment course of the drug "achieved similar improvement in clinical status compared with those taking a 5-day treatment course," the company, which makes the drug, said in a press release Wednesday.

The other study, published in The Lancet, found remdesivir had no effect on reducing COVID-19 death rates, or even on making people feel better faster.

Gilead has not yet released enough information from its trial to show what that "improvement" means for patients. The company said full results would be published "in the coming weeks."

The analysis did not compare remdesivir to a placebo, so it's impossible to determine whether any benefits were due to the drug or whether patients would have improved on their own.

Separately, The Lancet study's conclusion was muddied because the research was stopped early, because the investigators in Wuhan, China, were only able to recruit half of the patients they'd planned to study.

"This is not the outcome we hoped for," Bin Cao, the study's author and a professor at China-Japan Friendship Hospital and Capital Medical University in China, said in a press release. "We are mindful that we were only able to enroll 237 of the target 453 patients because the COVID-19 outbreak was brought under control in Wuhan."

The Gilead research was meant to determine how long hospitalized patients would need to be on the drug for a potential clinical benefit. If patients only need five days of treatment, rather than 10, it would mean Gilead could double the number of people treated.

"This is particularly important in the setting of a pandemic," Dr. Merdad Parsey, Gilead's chief medical officer, said in the press release.

Remdesivir is not approved by the Food and Drug Administration, and has not been proven as an effective treatment for patients with the coronavirus. Results from other trials are expected in the coming weeks.
Financial Times
written by Donato Paolo Mancini in London and Hannah Kuchler in NY
Thursday April 23, 2020

A potential antiviral drug to treat coronavirus has flopped in its first randomised clinical trial, disappointing scientists and investors who had high hopes for remdesivir, according to draft documents published accidentally by the World Health Organization and seen by the Financial Times.

The Chinese trial showed remdesivir — developed by California-based Gilead Sciences — did not improve patients’ condition or reduce the pathogen’s presence in the bloodstream. Researchers studied 237 patients, giving the drug to 158 and comparing their progress with the remaining 79. The drug also showed significant side effects in some, which meant 18 patients were taken off it.

The WHO said the draft document, which is undergoing peer review, was published early in error. “In response to WHO asking for information and studies to be shared early, a draft document was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed,” it said. 

Gilead warned that the post included “inappropriate characterisations of the study”. 

“Importantly, because this study was terminated early due to low enrolment, it was underpowered to enable statistically meaningful conclusions,” it said. “As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.”

Gilead trading was briefly halted on the Nasdaq on Thursday after the shares fell sharply on the news of the results of the study, and ended the day down more than 4 per cent at about $77.78. The stock surged to a high of almost $84 last week on hopes for remdesivir, valuing the company at nearly $100bn.

Until now, evidence from the use of Gilead’s remdesivir on treating Covid-19 had relied on studies that did not meet the robust scientific standards of being randomised and having a control arm. 

There are multiple ongoing Phase 3 studies that are designed to provide the additional data needed to determine the potential for remdesivir as a treatment for Covid-19. These studies will help inform whom to treat, when to treat and how long to treat with remdesivir. The studies are either fully enrolled for the primary analysis or on track to fully enroll in the near future.

Positive feedback from a clinical trial being conducted at the University of Chicago, leaked last week, buoyed the entire stock market as investors looked for any sign that the availability of a successful drug could help open up locked down economies. 

“In this study of hospitalised adult patients with severe Covid-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the filing said.

The WHO collates current trials for possible Covid-19 interventions on a website titled “landscape analysis of candidate therapeutics for Covid-19.” A previous version of the website, which contained five pages and a column called “outcomes,” is no longer available. The new one only contains four pages and no “outcome” column.

The study was terminated early because of a lack of patients. It was conducted in China, which after a surge in cases earlier this year has seen a taper in the number of those affected. 

Earlier this month, a study in the New England Journal of Medicine showed early positive results for remdesivir, with 68 per cent of patients improving on the drug. However, the study was not an official trial but rather the collation of data from patients who had been given the drug on a “compassionate use” basis — and was not compared to any control arm. The scientists behind the study and Gilead warned at the time that it was not conclusive.

There had been other positive signs too. Early impressions from a study showed rapid recoveries in almost all of the more than a hundred severely ill patients, when they were leaked to healthcare industry publication Stat news.

A recent US National Institutes of Health animal study also found the drug was effective at treating the disease in monkeys, when taken early in its progression.

Much larger randomised controlled trials are under way, comparing remdesivir with controls, which in Covid-19 usually means standard care for a respiratory illness, and to other drugs including the antimalarial hydroxychloroquine.

Gilead originally developed remdesivir as a treatment for Ebola, where it showed promise at stopping the virus from replicating in clinical trials, but it has never been approved.
TrialSiteNews.com
written by Staff
Monday March 16, 2020

Gilead’s experimental drug remdesivir shows possibly the most promise of all experimental COVID-19 vaccine prospects as evidenced by China’s reported possible move, via the Wuhan Institute of Virology of the Chinese Academy of Sciences, to patent the drug to treat coronavirus. The experimental drug isn’t licensed or approved anywhere yet, but it surely looks promising. Both remdesivir and chloroquine show promise, according to Chinese authorities.

The Promise of Remdesivir

According to a report from IPRdaily, Gilead’s Remdesivir, a new antiviral drug of nucleotide analogs’ group, was initially introduced by Gilead to fight the Ebola virus, but the results there were not successful. However, at one point The New England Journal of Medicine promulgated that Remdesivir could challenge the brand-new coronavirus, as at some point an American patient with 2019-nCoV was prescribed the drug and doctors observed after about a week conditions improved. NEJM did advocate the use of randomly controlled trials to produce more evidence.

Chinese researchers observed that Remdesivir and chloroquine, a malaria treatment, could have an impact in slowing down the coronavirus.

The Move for a Patent Application

On January 21, it was reported that China’s Wuhan Institute of Virology of the Chinese Academy of Sciences filed a patent for commercial use of remdesivir in China. Also involved is the Military Medicine Institute of that nation. They sought to secure this patent “out of national interest” and noted they were not interested in enforcement should foreign pharma companies seek to collaborate in China to stop the pandemic. An IP attorney based in Shanghai, China observed that the Wuhan Institute of Virology would be wise to secure approval from the drug’s maker and owner—Gilead.

Remdesivir-based Clinical Trials in China

As TrialSite News has reported, Remdesivir is currently an experimental drug in use in at least a couple clinical trial programs in China. In one clinical trial, Jin Yin-tan Hospital in WuHan and others are conducting a study sponsored by Capital Medical University and the Chinese Academy of Medical Sciences for up to 308 patients with mild to moderate COVID-19 symptoms. In another study concerning patients with severe COVID-19 conditions, Capital Medical University is sponsoring another study led by professor Bin Cao.

According to one report, the Chinese Healthcare Department has selected the Friendship Hospital in Beijing for conducting an additional study, including one with 270 coronavirus patients.

Conclusion

It could be deemed a provocative move for the local Wuhan institute to attempt to patent the Gilead drug without working with them. Remdesivir currently has entered China via clinical trials for patients with novel coronavirus. According to reports, the Northern California-based biotech has distributed at least enough doses for 500 patients—they are purportedly ramping up for more supply in case the clinical trials fail. Gilead’s chief medical officer reports that Remdesivir is being tested in at least two clinical trials in China.
UPDATE 4/29/20 at 6:59pm: Added info below.
UPDATE 4/29/20 at 7:19pm: Added info below.
UPDATE 4/29/20 at 7:41pm: Added info below.
UPDATE 4/29/20 at 9:01pm: Added info below.
UPDATE 4/30/20 at 6:56pm: Added info below.
I took a screenshot for you
Expertise in Communicable Diseases: Worldwide

All of you on the Left and even in the media have the nerve to call Dr. Didier Raoult in France a quack doctor when he is listed as the NUMBER ONE expert in communicable diseases worldwide. You hate Dr. Didier Raoult simply because he has had great success treating coronavirus patients with hydroxychlorine combined with other medications that President Trump mentioned. READ LIST ABOVE. Notice that Dr. Anthony Fauci is NUMBER THIRTY-SIX. (emphasis mine)

Posted by Princess Mononoke at 6:45 PM

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)