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    Doctors told to ration Covid-19 treatment hope remdesivir as NHS ALREADY ‘faces shortages’

    NHS doctors are told to RATION Covid-19 treatment remdesivir amid global scramble for drug after US hospitals bought up most of the world’s supply

    • Remdesivir shortages mean the drug’s use has been restricted by the NHS
    • Trials revealed it could reduce Covid-19 recovery times from 15 to 11 days
    • Daily hospitalisations from the virus have almost doubled in a week to 408 

    The NHS is already rationing remdesivir, a key drug for treating coronavirus patients, because it is in short supply after the US bought up global stocks in the summer.

    Doctors have been told not to give the drugs to the most seriously ill patients and to save it for those who have the ‘greatest capacity to benefit’.

    The instruction comes early on in the UK’s second wave as the number of people being admitted to hospital with Covid-19 is only 10 per cent as high as it was during the peak, and after officials said they were stockpiling the drug. 

    NHS hospitals around the country were yesterday issued an alert titled ‘supply disruption’ which warned of an ‘increased demand against available supply’, which told doctors to be more selective about to whom they give the drug.

    The Department of Health denies there is a shortage of the drug, claiming there ‘remain plenty of supplies’, but said it was being used up faster and more stocks couldn’t be delivered until the end of October

    The American drug was revealed in trials to reduce Covid-19 patients recovery times from 15 to 11 days. Doctors are yet to find evidence that it can reduce mortality rates.

    The US, where remdesivir manufacturer Gilead is based, was criticised in June for buying up the entire global supply of the drug meaning no new orders could be placed for the three months following. As well as this, Gilead donated 1.5million doses of it for clinical trials around the world, further depleting supplies.

    Britain is not alone in feeling the impact of the stocking issue, however, and hospitals in the US are struggling to get hold of the drug, too.  

    American antiviral drug remdesivir has been rationed in NHS hospitals, after shortages were also reported in the US. It can reduce Covid-19 patients’ recovery times. (Stock)

    The decision comes as the rate of daily hospitalisations in the UK almost doubles within a week

    The decision comes as the rate of daily hospitalisations in the UK almost doubles within a week

    Hospitals were advised to ration use of the drug in an emergency alert and were told the restrictions were likely to remain in place until at least the end of this month.

    WHAT IS REMDESIVIR AND DOES IT WORK AGAINST CORONAVIRUS?

    Remdesivir was developed by Gilead Sciences to treat Ebola, the deadly hemorrhagic fever that emerged in West Africa in 2014. 

    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 encouraging results earlier this year when it showed promise for both preventing and treating MERS – another coronavirus – in macaque monkeys. 

    The drug appears to help stop the replication of viruses like coronavirus and Ebola alike. 

    It’s not entirely clear how the drug accomplishes this feat, but it seems to stop the genetic material of the virus, RNA, from being able to copy itself. 

    That, in turn, stops the virus from being able to proliferate further inside the patient’s body.  

    NIH researchers in charge of the macaque study recommended that it move ahead to human trials with the new coronavirus. 

    Scientists have listened, and human trials for remdesivir first began in Nebraska. 

    Most recently, researchers trialing the drug at the University of Chicago reported that most of the 125 COVID-19 patients they’d teated with the drug had been discharged from the hospital, according to Stat News

    Two patients died over the course of the trial. 

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    The alert ordered staff to deny remdesivir to the most seriously ill patients, including those on ventilators, demanding it should only be given to people with the ‘greatest capacity for benefit’. 

    It said: ‘Due to increased demand against available supply, clinicians are now asked to apply the full eligibility criteria … last published on 3rd September 2020…

    ‘Clinicians are also asked to adhere to a standard treatment course of 5 days.’

    It says that for people to be eligible for remdesivir they should be in hospital with Covid-19 and pneumonia but not using a ventilator.    

    When the drug was first given emergency clearance for use with coronavirus patients, the NHS said it could be used for adults and people aged 12 years and over.

    Health officials also said it should be given for up to 10 days to help stave off the worst symptoms of coronavirus.  

    But an advisory note says that in times of ‘limited supply’ patients will only receive the drug if they have ‘the greatest capacity for benefit’.

    Guidance explains it will only be available to ‘patients in the early stages of respiratory failure’ should there be a shortage.

    A Department of Health spokesperson said the UK was expecting more deliveries of remdesivir at the end of this month, implying that if current stocks run out they can’t be replaced for a month.

    The Department said: ‘We are aware of a rise in the use of remdesivir in line with an increase in Covid-19 hospital cases.

    ‘While there remain plenty of remdesivir supplies, we have asked the NHS to temporarily prioritise patients to ensure those most likely to benefit can access it.

    ‘Patients are also receiving other approved treatments, for example dexamethasone or hydrocortisone, which have been proven to save lives and are in good supply.

    ‘The UK is leading the way on research to find and fast-track more potential treatments, including through the landmark RECOVERY trial which brought lifesaving treatment dexamethasone to NHS patients.’

    The alert comes after it emerged in June that the US had bought up three months’ worth of Gilead’s entire supply of remdesivir.

    Scientists hit out at the nation’s decision to hoard all of the drug for its own medics and said other countries were left wanting. 

    The US Department of Health and Human Services (HSS) revealed it had secured more than 500,00 treatment courses of remdesivir for American hospitals, whiich was the global supply for July, and 90 per cent of all stocks for August and September.

    The US president faced accusations of ‘undermining’ the global coronavirus fight by splashing the cash on one of only two drugs known to treat Covid-19 that are available on the NHS.

     Dr Andrew Hill, from Liverpool University, told The Guardian at the time: ‘They’ve got access to most of the drug supply so there’s nothing for Europe.’

    The Government’s Business minister Nadhim Zahawi was among those who criticised the decision of Britain’s closest ally, telling them it was ‘much better to work together’. 

    Now, hospitals in the US have also warned of a shortage of the urgently-needed drug at the beginning of last month.

    A report by the country’s Food and Drug Administration (FDA) found 38 hospitals have experienced critical shortages since July.

    They also noted there was patchy and inconsistent supply of the drug from its manufacturer Gilead.

    Hospitals in Ohio received more courses of the drug than those in Georgia, even though the latter was battling with three times more coronavirus patients.

    Rochelle Walensky, chief of infectious diseases at a hospital in Boston, said at a press conference last month: ‘We do not have enough remdesivir nationally.

    ‘Currently it’s the only antiviral against Covid-19. It can shorten the time to recovery and stave off ICU-level disease. I’m very worried about the fall and winter surge.’

    The chief of disease at the University of Texas, Tom Patterson, has also warned that they only had enough remdesivir to treat a third of patients at the height of the pandemic.

    The Trump administration has faced mounting criticism for failing to address the shortage by licensing other companies to make the drug after Gilead acknowledged in June ‘there is no assurance that we will be able to meet global supply needs for remdesivir’.

    Hospitalisation rates in the UK have risen almost three-fold since the beginning of last month, although hospitals still reportedly have plenty of capacity.

    The drug is manufactured by Gilead, which has been unable to make enough to meet demand

    The drug is manufactured by Gilead, which has been unable to make enough to meet demand

    There were 132 people admitted to hospital on September 1, which had risen to 323 by September 27, the latest date for which data is available.

    The number of patients on ventilators with Covid-19 also currently stands at 332, a tenth of the 3,228 who were using them at the height of the pandemic on April 11.

    Hospital admissions have leapt 58 per cent, according to the seven-day rolling average, with 13 per cent of all those in hospital being on ventilators.

    Calculations reveal this number is up 79 per cent week on week at present, amid mounting concerns it could rise still higher due to a spike in cases. 

    Drug is manufactured by Gilead, which has warned it will not be able to keep up with global demand. (Stock image of their head office in California)

    Drug is manufactured by Gilead, which has warned it will not be able to keep up with global demand. (Stock image of their head office in California) 

    Remdesivir had originally been developed to treat Ebola, but trials later revealed it could also assist coronavirus patients.

    Doctors in Wuhan revealed in February, writing in the prestigious medical journal Nature, that the drug is ‘highly effective’ in the control of infections.

    In March a US woman made a full recovery after being critically ill with Covid-19 when she received the drug.

    Within a day doctors recorded a drop in the quantity of virus in her body as her condition began to improved. They first administered the drug to her 36 hours after she was admitted to hospital.  

    The Department of Health and Social Care said: ‘While there remain plenty of remdesivir supplies, we have asked the NHS to temporarily prioritise patients to ensure those most likely to benefit can access it.’

    HOW HAS REMDESIVIR PERFORMED IN CLINICAL TRIALS?

    Remdesivir, an anti-viral drug first made to try and treat Ebola, has been used experimentally on Covid-19 patients since the outbreak’s early days.

    It is approved for use by doctors in the UK and US based on early data suggesting it might be helpful, but scientific evidence has been mixed. 

    There are claims of miraculous recovery, improved survival odds and shorter illness, but other studies have found it makes no difference to patients in hospital with Covid-19.

    Here is what research has found so far:

    ‘Highly effective’ in Chinese petri dish experiments (February)

    Doctors writing in a study led by the Wuhan Institute of Virology, published in the prestigious scientific journal Nature in February, said: ‘Our findings reveal that remdesivir [is] highly effective in the control of 2019-nCoV infection in vitro.’

    They added that, since the drug is proven to be safe in humans, it ‘should be assessed in human patients suffering from the novel coronavirus disease’.

    Sudden turnaround in critically-ill US hospital patients  (March) 

    George Thompson, an infectious disease specialist at the University of California Davis Medical Center, was part of a team that gave remdesivir to a sickly American woman with Covid-19 in February. 

    ‘We thought they were going to pass away,’ Thompson told Science magazine. But 36 hours after the woman was admitted to hospital, doctors decided to treat her with remdesivir. Within a day, she saw a drop in the quantity of virus in her body and her condition began to improve.  

    Richard Childs, an assistant surgeon general and lung specialist at the National Institutes of Health, told The Wall Street Journal Friday that 14 American patients from the Diamond Princess cruise ship were treated with remdesivir in Japan. 

    ‘Many of them were probably going to die in a short amount of time, and two weeks later nobody has died and more than half of them have recovered. It’s just absolutely amazing,’ he remarked. 

    ‘Encouraging’ results from uncontrolled trial on 53 patients (April)

    A study published in the New England Journal of Medicine in April revealed the effects the drug had on a group of 53 Covid-19 patients in the US, Europe, Canada and Japan.  

    Thirty-four of them were sick enough to require breathing machines. All were given the drug through an IV for 10 days or as long as they tolerated it.

    After 18 days on average, 36 patients, or 68 per cent, needed less oxygen or breathing machine support. Eight others worsened. Four discontinued treatment because of health problems they developed.

    Seven patients died, nearly all of them over age 70. That 13 per cent mortality rate appeared lower than seen in some other report, but comparisons were weak.

    ‘It looks encouraging,’ said Dr Elizabeth Hohmann, an infectious disease specialist at Massachusetts General Hospital. 

    Patients discharged after taking remdesivir in ‘hopeful’ Chicago trial (April)

    University of Chicago Medicine recruited 125 people with COVID-19 as part of global clinical trials. Of those people, 113 had severe disease, STAT news reported in April.

    All the patients were treated with daily infusions of remdesivir. The antiviral medication led to ‘rapid recoveries in fever and respiratory symptoms’, with ‘nearly all patients discharged in less than a week’, the study claimed.

    Most of the patients were discharged after their symptoms eased over a week, and only two patients had died at the time of publication.

    The paper’s author called the findings ‘hopeful,’ but cautioned it is difficult to interpret the results since they did not include comparison to a control group.

    No benefit for patients with Covid-19, major Chinese study finds (April)

    Chinese researchers published results from one of the first randomised controlled studies – the gold standard – of remdesivir in April.

    Professor Bin Cao, from China-Japan Friendship Hospital and Capital Medical University in China, who led the research, said: ‘Unfortunately our trial found that, while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo.’   

    Those on the placebo drug (78 people) had similar outcomes to those given remdesivir (158). It took a shorter time for the remdesivir-treated patients to get better, 21 days compared with 23, but this was not statistically significant.

    There was a one per cent difference in mortality rate between the two groups, meaning it didn’t shower a clear benefit in survival rates. 

    It was also noted that a larger number stopped their treatment because of adverse events while on remdesivir, such as constipation and anaemia. 

    Independent scientists said the trial was too small to write off the drug and that it wasn’t the ‘end of the story’ for remdesivir.

    Death rate cut from 12% to 7% among 1,000 patients (May) 

    A study published in the New England Journal of Medicine saw remdesivir cut the mortality rate of 1,063 hospital patients around the world.

    Patients given remdesivir had a recovery time that was almost a third (31 per cent) faster than those given a placebo – 11 days compared to 14. 

    Results also suggested a survival benefit, with a lower mortality rate of 7.1 per cent for the group receiving the drug, compared with 11.9 per cent for the placebo group. But this is not deemed a significant difference. 

    Recovery rates improved by 65% (May)

    Trial results published by remdesivir’s own manufacturer, Gilead, said it seemed to show improved recovery times for Covid-19 patients. 

    The ‘SIMPLE’ trial involved 600 people and evaluated five-day and 10-day courses of remdesivir plus standard care, versus standard care alone. 

    Each group in the study included around 200 patients who were hospitalised with moderate Covid-19, meaning they were sick but not in intensive care.

    Patients in the five-day remdesivir treatment group were 65 per cent more likely to have clinical improvement at day 11 compared with those in the standard care group. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard care were also 31 per cent higher.

    The statistic is favourable but did not reach statistical significance, Gilead said. 

    It was not clear why those given a longer treatment course did not get better as quickly as those in the five-day group.

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