NHS gets green light to treat coronavirus patients with Ebola drug remdesivir

Coronavirus patients in Britain can now be treated with remdesivir, the Ebola drug which has shown promise in battling the infection. 

The Department of Health announced today that adults and teenagers with severe COVID-19 will be allowed to be treated with remdesivir if they fit specific criteria.

This makes the drug, which destroys a part of the virus in order to stop it reproducing, the closest thing doctors have to a cure or treatment for the disease. 

The criteria for who will get it have not been laid out by the Government but doctors will be expected to decide on a case-by-case basis who is most likely to benefit.

Early trials of remdesivir, which must be injected by a qualified medic, suggest it could speed up people’s time to recovery by four days, British officials said.  

Although the approval of remdesivir has been welcomed by scientists, it has come more than three weeks after the FDA in the US approved it on May 1, putting the UK weeks behind once again. It was also slower to increase testing capacity.

And Japan’s ministry of health approved the drug on May 8. Britain is now following suit in the face of growing scientific evidence.

Remdesivir is expected to be available immediately to patients across England, Wales, Scotland and Northern Ireland. 

Remdesivir may be the closest thing doctors currently have to a cure for the coronavirus, after trials showed it can shave days off patients’ recovery times

Lord James Bethell, Government minister for innovation, said: ‘This shows fantastic progress. 

‘As we navigate this unprecedented period, we must be on the front foot of the latest medical advancements, while always ensuring patient safety remains a top priority.

‘The latest, expert scientific advice is at the heart of every decision we make, and we will continue to monitor remdesivir’s success in clinical trials across the country to ensure the best results for UK patients.’

Remdesivir, which is produced by the California-based company Gilead Sciences, has been approved under the Early Access to Medicines Scheme (EAMS).

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) gave the go-ahead for NHS doctors to use it on people who are seriously ill with COVID-19. 

Officials said: ‘Allocation of the drug will be based on expert clinical advice and will take into consideration the situation where it is most likely to provide the greatest benefit.’

The MHRA’s green light means the drug can be used before it has been officially licensed for prescription.

WHAT TREATMENTS ARE AVAILABLE FOR COVID-19 PATIENTS?

Until today there were no drugs that had been approved specifically for the purpose of treating patients with COVID-19.

Doctors have been trying to save people with serious infections by giving them oxygen therapy – such as through masks, or ventilators for the most sick – and generic attempts to manage the infection.

This may include trying to calm down the immune system if it is over-reacting, treating the symptoms such as pain and difficulty breathing, and using antibiotics, antiviral or antifungal drugs to prevent secondary infections and to try and boost the immune system.

For many, it is a case of experimenting and hoping for the best. 

Usually, drugs have to go through lengthy testing and approval processes which take into account large amounts of scientific evidence and cost-effectiveness.  

Remdesivir is the first medication to get approval for use outside of a clinical trial in the UK.

It is an anti-viral drug that works by crippling an enzyme called RNA polymerase, which is vital for the virus to reproduce and spread. By damaging this, the drug may be able to stop the coronavirus in its tracks.

Dr Stephen Griffin, a medicine professor at the University of Leeds, welcomed the news that it was now available and said it is ‘perhaps the most promising direct-acting antiviral drug’.

He said: ‘The drug mimics the building blocks used by both our own cells and SARS-CoV2 to build new genomic material, yet it is only recognised by the viral machinery concerned with this process, so causing profound disruption to this essential viral process.

‘Rolling out remdesivir… will likely mean that the most severe COVID-19 patients will receive it first. 

‘Whilst this is clearly the most ethically sound approach, it also means that we ought not to expect the drug to immediately act as a magic bullet. 

‘We can instead hope for improved recovery rates and a reduction in patient mortality, which we hope will benefit as many patients as possible. 

‘More pronounced benefit is likely to be seen when treating patients with less severe disease, ideally before they require invasive respiratory support, but this will only follow once the drug is more widely available and will be guided by the final outcomes of ongoing placebo-controlled trials.’

Dr Griffin added that the fact remdesivir must be injected means it will probably never be used by the general public to prevent infection. 

Other drugs which work against the coronavirus in different ways are being used on NHS patients are part of clinical trials, but these are much less available.

WHAT OTHER DRUGS ARE BEING TESTED? 

Only limited numbers of people can be enrolled in trials and only certain people – usually otherwise healthy patients – are eligible for them. 

For those who do make it onto trials there is often still a 50/50 chance that they get a placebo – a fake drug – anyway. 

These are some of the medicines being trialled on COVID-19 patients in the UK:

  • Lopinavir-Ritonavir (normally used to treat HIV) 
  • Dexamethasone (a steroid)
  • Azithromycin (pneumonia; Lyme disease; chlamydia)
  • Tocilizumab (rheumatoid arthritis) 
  • Hydroxychloroquine (malaria prevention; lupus; rheumatoid arthritis)
  • Convalescent plasma (blood from a recovered patient)
  • Bemcentinib (cancer)
  • MEDI3506 (chronic pulmonary obstructive disease; diabetic kidney disease)
  • Acalabrutinib (cancers lymphoma and leukaemia)

Only limited numbers of people can be enrolled in trials and only certain people – usually otherwise healthy patients – are eligible for them. 

For those who do make it onto trials there is often still a 50/50 chance that they get a placebo – a fake drug – anyway. 

The two major clinical trials under way in Britain are named Recovery and REMAP-CAP.

On Recovery, which is being led by the University of Oxford but taking place across the country, patients may be given one of the following drugs:

  • Lopinavir-Ritonavir (normally used to treat HIV) 
  • Dexamethasone (a steroid)
  • Azithromycin (pneumonia; Lyme disease; chlamydia)
  • Tocilizumab (rheumatoid arthritis) 
  • Hydroxychloroquine (malaria prevention; lupus; rheumatoid arthritis)

Doctors are also testing whether people benefit from a treatment called convalescent plasma, in which patients are given part of the blood of someone who has already recovered from the virus.

This, it is hoped, could introduce the antibodies – disease-fighting substances – needed to fend off the disease and bypass the body’s own process of developing them, which takes weeks after infection. 

It is less clear which medicines are being used in the REMAP-CAP trial, which is described as an ‘adaptive’ trial meaning the treatments used change over time.

Britain’s good news comes alongside a blow to global hopes of finding a cure after the World Health Organization announced it was suspending a trial of chloroquine.

The anti-malarial drug, which has caused a storm since US President Donald Trump revealed he is taking it regularly to try and protect himself, was one of the first to show promise.

But it is known to cause heart problems in large doses, and appears to be ineffective against COVID-19 in small doses. 

Director of the WHO Dr Tedros Adhanom Gebreyesus announced the suspension yesterday after a study published in The Lancet suggested COVID-19 patients might be more likely to die if given the drug.

Professor Trudie Lang, at the University of Oxford, said: ‘The WHO temporarily halting the use of chloroquine in COVID-19 clinical trials highlights why we need to run carefully designed clinical trials during outbreaks. 

‘This enables us to learn as quickly as possible about whether potential therapies can tackle the virus and are safe. Properly designed and managed clinical trials are the only way we can see whether drugs might also cause harm. They are designed to assess the safety of the drug relative to the ability to bring any benefit.’ 

NHS WILL HAVE EARLY TRIAL RESULTS ‘BY JUNE’

The NHS will ‘have answers’ about the effectiveness of promising coronavirus drugs in June, health bosses said earlier this month.

Stephen Powis, NHS England’s national medical director, claimed the first results of clinical trials into the medicines were expected in ‘five to seven weeks’ in a letter he sent at the start of May.  

In a letter sent to GPs, public health directors and Clinical Commissioning Groups (CCGs), Mr Powis encouraged clinicians to continue to recruit COVID-19 patients to speed up the trials.

More than 9,000 virus sufferers are taking part in the Recovery trials, testing five drugs earmarked as potential therapies on patients in NHS hospitals around the country.

Among the medicines being trialled are the anti-malarial hydroxychloroquine and HIV drug lopinavir-ritonavir.

Mr Powis said if recruitment for the trial remains high ‘this will allow us to move successful drugs into routine care’.

The letter, seen by the Health Service Journal, said: ‘As new admissions fall due to the success of social/physical distancing measures it will become even more important that a high proportion of patients with COVID-19 are enrolled on to trials if we are to improve future treatment

‘If we can keep recruitment for Recovery high, above 1,000 patients per week, we could have answers on some treatments in five to seven weeks. 

‘This will allow us to move successful drugs into routine care.’

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