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Aandeel Gilead Sciences OTC:GILD.Q, US3755581036

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Remdesivir

136 Posts
Pagina: «« 1 2 3 4 5 6 7 »» | Laatste | Omlaag ↓
  1. [verwijderd] 22 april 2020 09:00
    HIV And Flu Drugs Prove Futile In Fight Against Coronavirus

    Updated Apr 21, 2020, 03:42pm EDT

    In a small randomized control study, researchers in China found that HIV drug Kaletra and influenza drug Arbidol have no effect on patients with mild to moderately severe COVID-19 infections.

    The trial, published by the journal Med by Cell Press, included 86 patients: 34 received Kaletra (lopinavir/ritonavir), 35 received Arbidol (umifenovir), and 17 patients received only supportive care and oxygen if needed.

    The researchers found no significant difference in the length of time that patients had the disease or the severity of their symptoms based on which medication they took; in fact, several participants who took Kaletra had worse gastrointestinal side effects compared to the control group.

    The news follows another study of Kaletra, an HIV drug produced by AbbVie, published in the New England Journal of Medicine in March that also found the drug ineffective.

    Despite these studies, black markets for the drug have emerged around the world, including in Russia.

    www.forbes.com/sites/leahrosenbaum/20...
  2. [verwijderd] 23 april 2020 19:01
    Gilead antiviral drug remdesivir flops in first trial

    23 april 2020

    A potential antiviral drug for the 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.

    A potential antiviral drug for the 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.”

    Until now, evidence from the use of Gilead’s remdesivir in Covid-19, the disease caused by the new coronavirus, 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 enrol in the near future.

    finanz.dk/gilead-antiviral-drug-remde...
  3. [verwijderd] 23 april 2020 19:47
    Eerder vandaag:

    NIAID strategic plan details COVID-19 research priorities

    Thursday, April 23, 2020

    Urgent public health measures are needed to control the spread of the novel coronavirus (SARS-CoV-2) and the disease it causes, coronavirus disease 2019, or COVID-19. Scientific research to improve our understanding of the virus and how it causes disease, and to develop strategies to mitigate illness and death, is of paramount importance. A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

    The NIAID Strategic Plan for COVID-19 Research has four key priorities. The first involves improving fundamental knowledge of SARS-CoV-2 and COVID-19, including studies to characterize the virus and better understand how it causes infection and disease. This research includes natural history, transmission and surveillance studies to determine why some individuals experience mild symptoms of infection while others become critically ill. The role of asymptomatic individuals in viral spread and the potential seasonality of viral circulation also need to be explored, according to the report. Additionally, small and large animal models that can recapitulate COVID-19 disease seen in humans must be developed.

    IAID’s second research priority is the development of rapid, accurate diagnostics and assays to identify and isolate COVID-19 cases and track the spread of the virus. Molecular assays can detect low levels of SARS-CoV-2 and differentiate it from other related viruses. Researchers will work to improve the speed and accuracy of these diagnostic assays to mitigate the spread of the disease during the current outbreak and any future ones. Additionally, new and improved serologic assays to detect antibodies to the virus must be developed to enhance surveillance efforts and identify individuals who may have resolved a previous COVID-19 infection.

    The third research priority is characterizing and testing potential treatments for COVID-19. These efforts will include identifying and evaluating drugs already approved for other conditions that could be repurposed to treat COVID-19 and testing novel broad-spectrum antivirals, such as remdesivir; virus-targeted antibody-based therapies; monoclonal antibodies; and host-directed strategies to target an individual’s immune response to the virus. To optimize findings during the pandemic, multiple clinical trials will be conducted in parallel among various patient populations, including hospitalized people and outpatients.

    NIAID’s fourth research priority is to develop safe and effective vaccines to protect individuals from infection and prevent future SARS-CoV-2 outbreaks. NIAID researchers and their collaborators are adapting vaccine candidates and approaches previously employed to address the related Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) coronaviruses and applied them to the current pandemic. For example, NIAID recently launched a Phase 1 clinical trial using a vaccine platform initially developed to target MERS. NIAID will use its broad clinical trial infrastructure to advance experimental vaccines through Phase 1 safety and dosing testing and simultaneously plan for advanced clinical testing of the most promising candidates. The institute will work with government partners to ensure that any safe and effective vaccine will be manufactured in sufficient quantities to allow expedient distribution to those at highest risk for infection.

    To achieve its four priorities, NIAID will build on its current resources, research programs, clinical trials networks and collaborations with other U.S. government agencies and other key U.S. and global partners. The new strategic plan aligns with priorities set by the White House Coronavirus Task Force and represents a comprehensive and coordinated effort to develop effective biomedical tools to combat COVID-19.

    www.nih.gov/news-events/news-releases...

  4. [verwijderd] 24 april 2020 19:45
    Mesoblast’s remestemcel-L drug could boost COVID-19 survival rates

    April 24, 2020

    Mesoblast’s (ASX: MSB; Nasq: MESO) advanced remestemcel-L drug could potentially boost the survival rate of critically ill COVID-19 patients who have developed acute respiratory distress syndrome, with initial results revealing an 83% survival rate for patients treated with the drug compared to 12%.

    According to Mesoblast, 10 out of 12 COVID-19 ventilator-dependent patients with acute respiratory distress syndrome survived after being treated with Mesoblast’s allogeneic mesenchymal stem cell product remestemcel-L.

    Under emergency compassionate use protocols, the patients were treated with remestemcel-L at the Mt Sinai hospital in New York City between March and April.

    Early success

    Of the treated patients, 75% successfully came off ventilator support within an average of 10 days.

    In comparison, untreated ventilator-dependent COVID-19 patients at two major New York hospitals had a 12% survival rate during the same period.

    Of the non-treated patients, only 9% were able to come off ventilators.

    Mesoblast noted the poor outcomes in patients that only received standard care was consistent with earlier data from China, which showed mortality rates exceeding 80% in COVID-19 patients presenting with moderate and severe respiratory distress syndrome.

    “The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 acute respiratory distress syndrome,” Mesoblast chief executive officer Dr Silviu Itescu said.

    “We intend to rapidly complete the randomised placebo-controlled phase 2/3 trial in COVID-19 acute respiratory distress syndrome patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients,” he added.

    Meanwhile, Mesoblast chief medical officer Dr Fred Grossman said the company has implemented the US FDA’s recommended robust statistical analyses to maximise the company’s ability to evaluate whether remestemcel-L provides a survival benefit in COVID-19 patients.

    Today’s results follows Mesoblast’s receival of FDA Investigational New Drug clearance for treating COVID-19 patients with acute respiratory distress syndrome at the start of the month.

    smallcaps.com.au/mesoblast-remestemce...
  5. Cu Chulainn 30 april 2020 17:45
    25 feb Resultaten Gilead-medicijn tegen coronavirus eind april

    WUHAN (AFN/BLOOMBERG) - De eerste resultaten van een proef met een medicijn van biotechnoloog Gilead tegen het nieuwe coronavirus worden 27 april bekendgemaakt. Voor de test wordt het middel remdesivir toegediend aan 761 patiënten in Wuhan, het epicentrum van de virusuitbraak.
  10. [verwijderd] 1 mei 2020 22:43
    Remdesivir lijkt op veel fronten zwaar tegen te vallen. Als je dan toch voor een anti-viral wil gaan, neem dan Galidesivir van BCRX.

    Galidesivir is een pil, absorbeert beter aan cellen, veiliger en minder giftig, kan daarmee in hogere dosis gebruikt worden.

    Maar BCRX heeft natuurlijk niet de power van Gilead. Als aandeelhouder van Galapagos heb ik meer en meer het gevoel dat we Faust achterna zijn gegaan :(.

    fc
  12. [verwijderd] 2 mei 2020 11:05
    I am truly sorry to say, Remdesivir is probably worthless, and we are seeing some fascinating drug company shenanigans, a thread.

    First, the pretest probability that an infused, small-molecule inhibitor of a virus would improve mortality in symptomatic patients was already pretty low. Unfortunately, antivirals work poorly in acute disease. This has to do with their mechanism@of action, and host response.

    Antivirals usually target some aspect of viral replication/assembly/transmission. Remdesivir is a clever pharmacologic prodrug that inhibits a key piece of RNA viruses that mammals don’t have - the RNA-dependent RNA polymerase, and inhibits viral replication.

    Unfortunately, by the time you are symptomatic with a virus, you are usually already high/peak viral load. So, when you give an antiviral to someone who is already ill, the damage from the virus is largely done. It’s there in big numbers and in the cells.

    Consistent with this, the Lancet paper on the remdesivir trial in China shows no impact on viral load clinically.

    threadreaderapp.com/thread/1256242036...
  13. [verwijderd] 2 mei 2020 13:42
    Government researchers changed metric to measure coronavirus drug remdesivir during clinical trial

    Death rate was eliminated as a primary outcome measure, replaced with the time it took patients to recover.

    May 1, 2020 at 10:29 p.m. GMT+2

    Government clinical trial investigators changed the primary metric for measuring the success of Gilead’s experimental drug remdesivir as a coronavirus treatment two weeks before Anthony S. Fauci’s announcement that the drug would be the new “standard of care.”

    Instead of counting how many people taking the drug were kept alive on ventilators or died, among other measures, the National Institute of Allergy and Infectious Diseases said it would judge the drug primarily on a different outcome: how long it took surviving patients to recover.

    Death and other negative outcomes were moved to secondary measure status: They would still be tracked, but they would no longer be the key measure of remdesivir’s performance. The switch — which specialists said is unusual in major clinical trials but not unheard of — was publicly disclosed on the government’s clinicaltrials.gov website on April 16 but did not receive much attention at the time.

    The change reflects evolving scientific understanding of the fast-moving nature of the virus and uncertainties around how the lethal effects reveal themselves in patients, said NIAID, Gilead, and outside specialists. But the change also adds weight to the assessment of government and medical researchers that remdesivir is not a knockout drug that will change the trajectory of the coronavirus pandemic.

    On Friday, as expected, the Food and Drug Administration approved an emergency use authorization for the drug that will allow it to be prescribed for hospitalized patients infected with the coronavirus.

    The newly adopted criteria were a central feature of this week’s declaration by Fauci, NIAID’s director, that remdesivir reduced the time to recovery for surviving patients from 15 days to 11 days, a 31 percent improvement.

    “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,'' Fauci said as he sat in an Oval Office meeting with President Trump and other members of the president’s coronavirus task force. “It’s highly significant.''

    The difference in death rate, one of the original primary measures, was not statistically significant, Fauci said, showing only a marginal reduction from 11 percent in patients given a placebo to 8 percent in patients given remdesivir. Full release of the trial results would be made soon, Fauci said.

    Some medical research specialists questioned the change in the primary outcome measure of the trial, which had 1,063 patients.

    “I think that they thought they weren’t going to win, and they wanted to change it to something they could win on,'' said Steven Nissen, a Cleveland Clinic cardiologist and expert clinical investigator who has led numerous drug trials. “I prefer the original outcome. It’s harder. It’s a more meaningful endpoint.

    En nog veel meer: www.washingtonpost.com/business/2020/...
  14. [verwijderd] 5 mei 2020 22:46
    Gilead's breakthrough coronavirus drug sparks concerns over how much it'll cost

    Anjalee Khemlani - Senior Reporter, Yahoo Finance - May 5, 2020

    With Gilead Science’s (GILD) anti-coronavirus drug now available for hospitalized patients and getting emergency use approval from the U.S. Food and Drug Administration Friday, expectations for related treatments are growing.

    Yet exactly what those treatments will cost — for both health insurers and out-of-pocket for patients— remains to be seen. The subject of drug prices has been a political hot potato for years, and the COVID-19 crisis is putting new pressure on big pharma to contain price inflation related to potential treatments and vaccines.

    The price question is set to take on increasing prominence as new trials show effectiveness, and officials hint at green-lighting more to contain fatalities. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, and a White House coronavirus task force member, said Gilead’s success has opened the door for similar treatments.

    Roche (RHHBY), which has been one of the top testing providers throughout the outbreak, is also working on repurposing a rheumatoid arthritis drug that could compliment the treatment of Gilead’s remdisivir. The drug, Actemra, is already approved by the FDA and on the market.

    Roche is working to ramp up production in order to meet the potential demand if it is proven effective. Already, the company has seen a 30% increase in sales of the drug in the first quarter, according to CEO Severin Schwan, and the company has donated 10,000 vials to the national stockpile.

    Amid rising fears that consumers could be priced out of the market for treatment, Schwan told Yahoo Finance Monday that Roche intends to ensure that “access is not a hurdle” for patients globally.

    With clinical trials set to provide results as early as June, Schwan added that Actemra is currently priced to consider repeated doses for rheumatoid arthritis, compared to only dose being tested to treat coronavirus.

    “So this, in itself will limit the financial burden for societies,” he said. “We will see how the clinical trials read out, how much the demand as a result of that will be, and then we will at any rate make sure this medicine is broadly available for patients in need.”

    Medicare rates show a payment limit of $5 per milligram of the drug. The clinical trial shows patients are being tested with doses that depend on a person’s weight (in kilograms), with a maximum dose of 800 mg. Meanwhile, a previous National Institute of Health study reported the annual cost of 8mg/kg at $17,472.

    Gilead has yet to name a price for its treatment after donating 1.5 million doses to the national stockpile, but a recent report attempted to calculate a reasonable estimate — yet the amount floated was anything but. A study by the Institute for Clinical and Economic Review suggested a ceiling price of $4,500 per treatment course — assuming 10 days—for remdesivir.

    The report considered that R&D costs for the drug would already have been reclaimed in Gilead’s antivirals that have made it to market, and would not need to be included in the pricing considerations.

    Given political sensitivities around pricing, Gilead CEO Daniel O’Day said he has already seen an improvement in sentiment among lawmakers, while Schwan insisted the coronavirus crisis gives the industry an opportunity to prove its value to the public.

    finance.yahoo.com/news/gileads-breakt...
  15. [verwijderd] 8 mei 2020 22:55
    De lamme leidt de blinde.

    Baricitib heeft een black-box waarschuwing tegen VTE. En Remdesivir is de enige anti-viral die de viral load van patiënten niet verlaagd. Je leven zou toch moeten afhangen van dit duo...

    fc

    NIAID to Test Gilead's Remdesivir Together with Lilly's Olumiant for Coronavirus

    Gilead's drug has shown some success in reducing recovery times, and the hope is the combination with Lilly's drug will work even better.

    May 8, 2020

    The National Institute of Allergy and Infectious Diseases announced Friday that it’s testing Gilead Sciences' (GILD) - Get Report Covid-19 treatment drug remdesivir together with Eli Lilly’s (LLY) - Get Report rheumatoid arthritis drug Olumiant to see if the combination works better than remdesivir alone.

    Last week, The Food and Drug Administration gave emergency use authorization for remdesivir, as it has shown evidence of shortening recovery periods for patients seriously stricken with the coronavirus.

    As for the new trial, the NIAID expects it to include 1,000 patients at more than 100 treatment centers.

    “We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with Covid-19,” NIAID Director Anthony Fauci, said in a statement.

    The new trial “will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes,” he said.

    Baricitinib, a product licensed to Lilly by Incyte (INCY) - Get Report and marketed under the brand name Olumiant, is approved in more than 65 countries, including the U.S., as a treatment for adults with moderately to severely active rheumatoid arthritis.

    Some people with Covid-19 experience acute respiratory distress syndrome, in which inflammation of the lungs leads to shortness of breath and rapid breathing. Baricitinib, taken orally, inhibits cytokine signaling in the body that plays a role in causing inflammatory responses, the NIAID said.

    “The putative benefit of baricitinib for Covid-19 has been described in a case series of critically ill patients who recovered from Covid-19.”

    www.thestreet.com/investing/niaid-to-...
  16. [verwijderd] 11 mei 2020 09:01
    White House to direct supply of COVID drug amid access fears

    May 8, 2020

    WASHINGTON (AP) — Trying to head off another chaotic scramble for scarce supplies, the White House said Friday it will step in to help coordinate distribution of the first drug that appears to help some COVID-19 patients recover faster.

    Press Secretary Kayleigh McEnany told reporters that Dr. Deborah Birx, a member of White House Coronavirus Task Force, will become one of the chief consultants on where the intravenous medication remdesivir will be distributed.

    Alarm is growing in the medical community about access to the drug, which was cleared for emergency use last week by the Food and Drug Administration.

    Birx is “the person who’s constantly reviewing the numbers, constantly reviewing the data,” McEnany said. “And she really has the best grasp as to how that should be distributed.” McEnany provided no additional detail.

    As has happened with personal protective gear and coronavirus tests, the availability of remdesivir could become another foreseeable debacle in the nation’s response to the coronavirus pandemic.

    “Understandably, hospitals with COVID-19 patients are desperate to access the product,” the head of a national organization that represents hospitals pharmacists wrote Vice President Mike Pence earlier this week.

    “The process for hospitals to access the drug remains unclear,” wrote Paul Abramowitz, CEO of the American Society of Health-System Pharmacists.

    The company that makes the antiviral drug, California-based Gilead Sciences, has said it is donating its entire current stockpile to help in the U.S. pandemic response.

    But Abramowitz said that initial supply will be “very limited,” 1.5 million doses that translate to 5 to 10 days of treatment for 140,000 patients.

    “It is clear that the majority of current COVID-19 patients will not receive it,” Abramowitz wrote to Pence.

    A leading hospital in Michigan was denied doses of remdesivir, Rep. Debbie Dingell, D-Mich., said Friday. Michigan Medicine at the University of Michigan has treated more than 500 COVID-19 patients, including more than 80 currently hospitalized, she said.

    “If leading educational hospitals don’t have access to doses, it indicates there may be a problem,” Dingell said in a statement calling the situation “deeply concerning.”

    A senior Michigan Republican also has concerns.

    “We know remdesivir has shown promising results for those severely infected by COVID-19, but we now we need to know if it is getting into the hands of those who need it most,” Rep. Fred Upton said in a statement.

    It’s unclear how the Trump administration will address the growing concern about access.

    “We urge the administration to take immediate action to ensure transparent and orderly allocation of remdesivir to our nation’s hospitals,” Abramowitz, of the pharmacists’ group, wrote Pence.

    He raised potentially troublesome scenarios, such as one hospital in a region getting a supply, and then another hospital in the state being overwhelmed by a spike in severe cases.

    “Hospitals should have the ability to send remdesivir doses where they are most needed,” he wrote.

    The pharmacists’ group is asking for the allocation process to be made public, with as much information as possible on how remdesivir will be distributed. Gilead is ramping up production.

    The eventual price of the drug is also a question mark, since Gilead’s promise to donate the medication applies only to its current stockpile. President Donald Trump was hoping to sign major legislation to rein in the price of prescription drugs ahead of the November elections, but that effort was overtaken by the coronavirus pandemic.

    Gilead said Friday it began shipping remdesivir on May 2 to drug wholesaler AmerisourceBergen, which has been designated the sole distributor for the drug.

    “Initial supplies were distributed within days to a first set of hospitals identified by the government,” Gilead’s statement said. “Hospitals with intensive care units and other hospitals that the government deems most in need will receive priority.”

    AmerisourceBergen said it’s distributing remdesivir under the direction of the Federal Emergency Management Agency, which is choosing which facilities get the drug and how much.

    Only a week ago, Trump had announced at the White House that remdesivir had received an emergency use authorization from the FDA.

    The FDA acted after preliminary results from a government-sponsored study showed that the drug shortened the time to recovery by 31%, or about four days on average, for hospitalized COVID-19 patients.

    Those given the drug were able to leave the hospital in 11 days on average vs. 15 days for the comparison group. The drug may also help avert deaths, but that effect is not yet large enough for scientists to know for sure.

    Scientists want to see more studies, but for now remdesivir has provided a glimmer of hope. It works by blocking an enzyme the virus uses to copy its genetic material.

    No drugs are currently FDA-approved for treating COVID-19, and remdesivir will still need formal approval. The drug does have side effects, including potential liver inflammation.

    Nonetheless, the National Institutes of Health’s Dr. Anthony Fauci has said remdesivir would become a new standard of care for severely ill COVID-19 patients.

    buzzingmarkets.com/white-house-to-dir...
  17. [verwijderd] 22 mei 2020 00:08
    U.S. doctors call for remdesivir data to guide coronavirus treatment

    May 21, 2020

    May 21 (Reuters) - U.S. doctors and others in the scientific community are calling for the release of data that convinced health regulators to authorize emergency use of Gilead Sciences Inc's antiviral drug remdesivir to treat COVID-19, so they can direct limited supplies on the right patients.

    Vanda Pharmaceuticals Inc Chief Executive Mihael Polymeropoulos on Wednesday published an open letter asking for a full download of the trial findings that led to emergency use authorization by the U.S. Food and Drug Administration.

    "What if the drug is best suited to people early in the infection cycle? If we give it to people with severe disease - out of natural compassion - we may have wasted the drug," the CEO told Reuters.

    He said Vanda, which is developing an anti-inflammatory drug for COVID-19, is looking to "lend our expertise."

    The FDA approved emergency use of remdesivir on May 1 based on preliminary results from a National Institute of Allergy and Infectious Diseases (NIAID) trial showing that the drug cut hospital stays by 31%, or about four days, compared with a placebo.

    No other details of the 1,063-patient trial have been released. The Institute said by email that a report on the trial will be published in a few weeks. Gilead has not said when.

    "We want to direct the drug to those most likely to benefit and least likely to be harmed," Dr. Helen Boucher, chief of infectious diseases at Tufts Medical Center in Boston, told Reuters.

    There are no formally approved treatments for COVID-19 - the sometimes deadly illness caused by the novel coronavirus - and remdesivir is the first drug to show benefit in a large placebo-controlled trial.

    Hospitals say they are concerned about distribution of limited supplies and are establishing ethical guidelines to ration remdesivir, without having seen the full trial data.

    Katherine Perez, a pharmacy specialist in infectious disease at Houston Methodist Hospital, said her institution was prioritizing patients based on the drug trial's enrollment protocol, but needed more data to make better informed treatment decisions.

    Gilead's trials close by the end of the month and the NIAID plans to study remdesivir in combination with an anti-inflammatory compound.

    finance.yahoo.com/news/u-doctors-call...
  19. forum rang 5 Endless 23 mei 2020 03:51
    email.seekingalpha.com/news/3577303/t... oxygen%3Fsource%3Demail_2900%3Atitle%26utm_medium%3Demail%26utm_source%3Dseeking_alpha%26mail_subject%3Dgild-study-shows-gilead-drug-helped-only-patients-on-oxygen%26utm_campaign%3Drta-stock-news%26utm_content%3Dlink-1
    email.seekingalpha.com/news/3577307/t...
  20. [verwijderd] 23 mei 2020 07:55
    Remdesivir alone is not enough, researchers conclude in first major Covid-19 trial of the drug

    May 23, 2020

    Researchers have finally published the data that led the federal government to recommend the use of the antiviral drug remdesivir in very ill coronavirus patients, and they say the drug alone will not be enough to help patients.
    The data, published in the New England Journal of Medicine, show the drug shortened the course of illness from an average of 15 days to about 11 days.
    "Preliminary results of this trial suggest that a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with Covid-19," the researchers wrote. But it was not a cure and it did not act quickly.

    "These preliminary findings support the use of remdesivir for patients who are hospitalized with Covid-19 and require supplemental oxygen therapy," the researchers, led by a team at the National Institute of Allergy and Infectious Diseases, wrote.
    "However, given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient," they added. "Future strategies should evaluate antiviral agents in combination with other therapeutic approaches or combinations of antiviral agents to continue to improve patient outcomes in Covid-19."
    Other teams are already combining antiviral drugs, including remdesivir, with immune modulating drugs in coronavirus patients. The NIAID says it has started a trial that compares remdesivir alone to remdesivir combined with the anti-inflammatory drug baricitinib, used to treat rheumatoid arthritis.
    The study also showed that it's important to start treatment early.
    "Our findings highlight the need to identify Covid-19 cases and start antiviral treatment before the pulmonary disease progresses to require mechanical ventilation," NIAID'S clinical research leaders Dr. John Beigel, Dr. Clifford Lane and their team wrote.

    Late last month, the federal government announced that the drug was helping and the US Food and Drug Administration gave remdesivir an emergency use authorization to treat Covid-19.
    "Even though the trial was ongoing, the data and safety monitoring board made the recommendation to unblind the results to the trial team members from the NIAID, who subsequently decided to make the results public," the researchers wrote.
    "Given the strength of the results about remdesivir, these findings were deemed to be of immediate importance for the care of patients still participating in the trial as well as for those outside the trial who might benefit from treatment with remdesivir."

    The study's findings were considered significant because it was the first double-blind, placebo-controlled trial to test the drug in patients. That means some patients got no drug, and neither patient nor doctors knew who was getting the real treatment.
    But some critics complained that the data were not published and worried the federal government was rushing the results.
    The team tested 1,063 patients. They found those who got the infused drug recovered after an average of 11 days. Those who got placebo treatment took 15 days on average to recover. As previously reported, 7% of patients who got remdesivir died, compare to 11.9% given placebo infusions. But those results were not statistically significant.

    Patients who needed oxygen appeared to benefit the most from the drug, the researchers reported.
    "These findings support the use of remdesivir in this population, with the largest benefit observed among individuals who required oxygen supplementation but were not mechanically ventilated," Gilead Sciences, which makes the drug, said in a statement.
    "We anticipate that results from our Phase 3 SIMPLE-Severe study, which is evaluating remdesivir in a similar population of COVID-19 patients requiring oxygen but not on mechanical ventilation, will be published in the near future. These data from the SIMPLE-Severe study support treatment of some patients for 5 days rather than 10 days, depending on clinical status."

    Adverse events

    Remdesivir did not cause an excess of side-effects and appeared safer than placebo, they added.
    "Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13 patients)," the team wrote.
    "Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group," the researchers wrote.

    It was a serious challenge to launch a clinical trial in the middle of a pandemic, the research team said.
    "The trial was implemented during a time of restricted travel, and hospitals restricted the entrance of nonessential personnel," they wrote.

    "Training, site initiation visits, and monitoring visits often were performed remotely. Research staff were often assigned other clinical duties, and staff illnesses strained research resources. Many sites did not have adequate supplies of personal protective equipment and trial-related supplies, such as swabs. However, research teams were motivated to find creative solutions to overcome these challenges."
    The study is still ongoing. "Our preliminary report is intended to help inform clinicians considering the use of remdesivir," the researchers wrote. "We are awaiting final visits, data entry, monitoring, and data lock for the last of the 1,063 patients enrolled, after which an update of the results will be provided."

    edition.cnn.com/2020/05/22/health/rem...
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