On the heels of an early announcement that coronavirus patients given Gilead & # 39; s Ebola drug remdesivir performed better than those who did not receive the treatment, the company's CEO, Daniel O & # 39, considered ; Day, the results a reason for hope at a time when it is badly needed, & # 39; in an open letter received by Fox News.
& # 39; Positive data & # 39; of an NIH trial by the National Institutes of Health (NIH) of Remdesivir boosted the stock market by 530 points Wednesday.
Although the pre-brand trade was halted for Gilead, the announcement was no doubt a fortune for O & # 39; Day & # 39; s business.
After the revelation of Dr. Anthony Fauci that participants of NIH tests taking remdesivir had shorter recovery times and were 30 percent less likely to die from coronavirus, the New York Times reported that the Food and Drug Administration (FDA) was planning to authorize drug use to treat the virus already on you day.
It comes as cases of coronavirus in & # 39; American excitement exceed one million and deaths from & # 39; Trump & # 39; s & # 39; Best Case Scenario & # 39; of 60,000 deaths in the country.
Daniel O & # 39; Day, CEO of Gilead Sciences, wrote in an open letter received by Fox News that earlier results on the benefits of his & # 39; s medical reimbursement for coronavirus patients & # 39; hope & # 39; bid
The FDA can announce its decision allowing authorization for emergency use of an antiviral remedial virus (pictured) for patients with coronavirus as of Wednesday
So far, there are no proven treatments for coronavirus, but the results of remdesivir indicate that it may soon be.
& # 39; There is still more work to be done and remdesivir has not been approved, but all of us in Gilead are humbled by what these promising results can mean for patients, & # 39; wrote O & # 39; Day.
Outcomes for members of the & # 39; trial of & # 39; e NIH of more than 1,090 people who were treated with remdesivir were better off by a wide enough margin that Dr Fauci insinuated those who had not received a placebo to get the drug now.
& # 39; You have an obligation to the people in & # 39; e-placebo group immediately so they can have access (to the possible treatment), & # 39; said Fauci in a White House meeting.
Remdesivir is an antiviral medication that Gilead originally developed to treat ebola, but disturbed it in trials.
Early petri dish and animal studies showed that it could recover the coronavirus, and smaller studies were promising enough to require the NIH to request a large, & # 39; gold standard & # 39; trial of & # 39; drug launch.
During a White House meeting, Dr. Anthony Fauci details of & # 39; the study, and said he & # 39; optimistic & # 39; was about its potential benefits for coronavirus patients
& # 39; The results of & # 39; A worldwide, placebo-controlled trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) is positive, & # 39; wrote O & # 39; Day.
& # 39; They show that patients with COVID-19 who did not receive remdesivir recover more rapidly than similar patients who did not receive placebo. & # 39;
In connection with his company's previous attempts to use the drug to treat Ebola, he added: & # 39; After years of research and hard work on remdesivir, there is relief and gratitude today that our efforts so worth the effort. & # 39;
In the White House meeting, Dr Fauci explained that remdesivir seems to block an enzyme that requires coronavirus to attack human cells and hijack their machine to make more copies of themselves.
& # 39; We have a drug that can block the virus, & # 39; he said.
& # 39; This will be the standard of care. & # 39;
One of & # 39; s doctors who administer the drug to patients in & # 39; an NIH trial reflected both Dr Fauci's and O's Day's optimism about Good Morning America.
Dr Aneesh Mehta, who helped conduct the NIH trial, called remdesivir a & # 39; glimmer of hope & # 39;
& # 39; Eight weeks we have now taken care of patients … we have gotten patients better, but we are now looking for a medication that will get them better and faster and is home to their families, & # 39; said Dr Aneesh Mehta of & # 39; Emory University, one of & # 39; institutions that & # 39; t participate in & # 39; e study.
& # 39; Now, we have the first glimmer of hope of something that can do that. & # 39;
Dr Mehta added that data from the & # 39; NIH study are still preliminary, and Dr Fauci acknowledged that the early results did not & # 39; knock out & # 39; despite his sensual presentation of them.
A remdesivir study of 237 patients with coronavirus done in China, also published yesterday, returned disappointing results.
People who did not receive the drug did not recover rapidly and were not at lower risk of death compared to those who received a placebo.
The trial was stopped short of its scheduled end date because the researchers had difficulty recruiting participants.
Remdesivir seems to work better if given early – as suggested by the NIH trial, such as the SIMPLE trial that Gilead runs – so one theory is that Chinese patients received the drug too early.
Although encouraging the results of these early threads, experts around the world are cautious that the studies should be done and interpreted thoroughly and carefully.
It comes after research showed that remdesivir, created by California-based Gilead Sciences, helped patients to rely on oxygen to leave in two weeks.
Fauci added that the trial was evidence & # 39; that a drug can block this virus & # 39; and compare the finding with the arrival of & # 39; the first antiretrovirals that & # 39; worked against HIV in the 1980s, though at first with modest success.
This would make remesivir of the third drug approved under the EUA by the FDA after the agency approved anti-malaria drugs chloroquine and hydroxychloroquine. The drug is often used to treat Ebola patients.
A separate trial from Gilead Sciences based in California showed that the drug helped patients go from relying on oxygen to hospital in two weeks. Pictured: A five-day view of Gilead shares shows sharply increasing shares at the open on Wednesday
Remdesivir has been one of & # 39; s top proponents of existing drugs that & # 39; are being investigated for coronavirus treatment, although the & # 39; e World Health Organization last week suggested it was unable to help patients recover in a trial of more than 200 people.
Gilead defended the trial, saying it believed the leaked data was a & # 39; mischaracterization & # 39; of & # 39; results were.
On Wednesday, Gilead said he had the study produced & # 39; positive data & # 39; for the treatment of coronavirus patients.
Half of the 397 patients, who were ill enough to need extra oxygen but not placed on ventilators, improved within 10 days of a five-day treatment course and those who did not. on a 10-day regimen, were better by the eleventh day.
More than half of patients were discharged from the hospital within two weeks, Gilead announced in a press release.
The announcement of promising provisional results from remdesivir sent the Dow up by more than 500 points, though Gilead's own shares were halted for trading, in order not to announce results of the trial.
WHAT IS REMDESIVIR AND DOES IT WORK WITH CORONAVIRUS
Remdesivir was developed by Gilead Sciences to treat Ebola, the deadly hemorrhagic fever that originated in 2014 in West Africa.
Ebola, like COVID-19, is caused by a virus, and scientists are now testing remdesivir to treat coronavirus patients, but it's too soon to know if the drug works or not.
Remdesivir produced promising results earlier this year when it promised to both prevent and treat MERS – another coronavirus – in macaques.
The drug seems to stop the replication of viruses such as coronavirus and ebola.
It is not entirely clear how the drug completes this performance, but it seems to stop the genetic material of the virus, RNA, from copying itself.
This, in turn, stops the virus from proliferating in the patient's body.
NIH researchers responsible for the macaque study recommended that progress to human trials with the new coronavirus.
Scientists have listened, and human trials for remdesivir first began in Nebraska.
Most recently, researchers reporting & # 39; drug testing at the University of Chicago reported that most of & # 39; E 125 COVID-19 patients who had the drug with them were discharged from the hospital, according to Stat News.
Two patients died in the & # 39; course of & # 39; a trial.
The NIH also studies remdesivir in a randomized controlled trial of 400 patients, which means that about half of the group would take antiviral Ebola, and the others would receive a placebo drug.
Gilead's trial did not have a placebo arm, which makes it impossible to know whether the drug helped patients or improved them on their own.
In a statement, Gilead Sciences said it was & # 39; aware of positive data that & # 39; s coming from & # 39; it from the National Institute of Allergy and Infectious Diseases, which Dr Fauci turns.
& # 39; We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing, & # 39; read the statement.
The NIAID said patients on & # 39; drug had a 31 percent faster time to recover than those on a placebo.
Fauci said although the results do not & # 39; knock out 100 percent & # 39; were, it was an important proof of concept.
& # 39; The data shows that remdesivir has a clear cut, significant, positive effect in reducing & # 39; e time for recovery, & # 39; he told reporters at the White House.
& # 39; This is very optimistic, mortality counted for better words in & # 39; a sentence of minor deaths in a REM-designated group. Eight percent versus eleven percent in the placebo group.
& # 39; So bottom line. You will hear more details about this, this will be submitted in a peer reviewed journal, and will be peer reviewed. & # 39;
He added that the trial was proof & # 39; a drug can block this virus & # 39; and compare the finding with the arrival of & # 39; the first antiretrovirals that & # 39; worked against HIV in the 1980s, though at first with modest success.
For the Phase 3 trial announced Wednesday, Gilead treated 397 seriously ill patients with his antiviral medication.
The company's press release Wednesday did not specify the locations of & # 39; patients. However, in March, it announced the initiation of two trials of the drug, one of which would be 400 patients studying in & # 39; Hubei Province of China, where & # 39; first appeared coronavirus.
The ages and genders of those patients were not disclosed.
The company tried two different treatment regimens for severely ill coronavirus patients – a five-day and 10-day course – but did not include a control arm of patients who did not receive the drug.
COVID-19 is considered & # 39; heavy & # 39; if a patient is in the hospital and requires additional oxygen.
Among those who were treated for five days, 60 percent could go home by day 14.
In the 10-day group, 52 percent were fired within two weeks.
Complete recovery was achieved on the same timeline by 53.8 percent of the & # 39; treatment group of 10 days, and by 64.5 percent of & # 39; e people in the group of five days of treatment.
& # 39; These data are encouraging, to indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement than patients who did not receive a 10-day course. treatment received, & # 39; said Dr. Aruna Subramanian, a Stanford infectious disease professor who helped guide the study.
Gilead expands on & # 39; study by testing & # 39; a drug in a further 5,600 patients at 180 locations for the next stage of his SIMPLE trial.
It will be tested around & # 39; including in & # 39; e FS, the United Kingdom, China, France, Germany, Hong Kong, Italy, Japan Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, and Taiwan.
These tests will include patients who do not need mechanical ventilation to survive, and will compare the two treatment regimens (five- and 10-day courses) with those that do not receive the standard of care support.
Gilead said it expects to report results on the first 600 patients not involved by the end of May.
& # 39; Although additional data is still needed, these results help to gain a clearer understanding of how therapy with remdesivir can be optimized, as proven to be safe and effective. & # 39;
That is not to say that there were no patients who walked poorly.
Seven percent of patients with coronaviruses outside Italy were treated. It is unclear how many patients were treated in Italy versus outside the hard-hit nation.
Timing also mattered.
People who were treated early – within 10 days of their first symptoms – fared better, with 62 percent being discharged from the hospital within 14 days.
Patients with severely ill coronaviruses, such as those treated in the Remdesivir trial, require oxygen to keep them alive, including mechanical ventilation (pictured). Safe treatments for these people are badly needed, as an estimated 80% of those who put on ventilators will not survive (file)
Gilead Sciences was hit last week when leaked data suggested that remdesivir did not help coronavirus patients, but this week's trial results suggest otherwise
A table from Gilead shows that more than half of patients were in each treatment group and were discharged from the hospital, although a total of 37 patients died
But the results of the trial suggest that the drug can still be beneficial, even if relatively late. About half of those who did not receive remdesivir for 10 or more days after they developed symptoms were also released from the hospital on day 14.
In general, the drug appeared safe in & # 39; e trial, despite the duration of & # 39; treatment course.
More than 10 percent of patients treated with the antiviral became ill, and six percent of the & # 39; five-day treatment group and 10.7 percent of & # 39; e 10-day treatment group were in acute respiratory failure (also a complication of & # 39; infection itself).
The greatest risk posed to the coronavirus patients treated with remdesivir was liver damage.
Lab work showed enzyme buildup in 7.3 percent of patients. the risk of liver damage was large enough that three percent were removed from the trial.
Dow jumps 550 points after Gilead & # 39; positive data & # 39; reported for its experimental coronavirus treatment
DOW JUMPS 53O POINTS OF GILEAD TRANSPORTED & # 39; POSITIVE DATA & # 39; FROM THE EXPERIMENTAL CORONAVIR TREATMENT
By Keith Griffith for DailyMail.com
US stock indexes jumped Wednesday after Gilead Sciences said its experimental antiviral drug met the main goal of a trial that's not tested in COVID-19 patients.
At closing, the Dow Jones Industrial Average was down by 532.31 points, or 2.21 percent, at 24,633.86. The S&P 500 was up more than two percent and Nasdaq composite more than three percent.
Markets have kept a close eye on any signs of when Americans can be back to work, and immediately rose as the result of an effective treatment for the virus that has shaken the economy.
Trading in shares in Gilead was halted during the trade prior to & # 39; the market, in order to & # 39; t issue the company its press release.
Gilead's share shot on the news, with 6.75 percent in midday trading.
Meanwhile, new data showed that the US economy contracted at its sharpest pace since the Great Recession in the first quarter, ending with the longest expansion in history.
Data from the & # 39; Commerce Department said gross domestic product fell at an annual rate of 4.8 percent in & # 39; e period from January to March, while economists expect a 4 percent contraction in a Reuters survey.
. (tagsToTranslate) dailymail (t) health (t) Ebola (t) Coronavirus (t) Breaking News