WHO recommends against using remdesivir for Covid ‘because there’s no proof it works’
- Officials at WHO said there is ‘no evidence’ it has any benefit on Covid patients
- Recommending against its use after reviewing four trials of over 7,000 patients
- Described the £1773 treatment as an expensive ‘gamble’ with no sign of pay off
The antiviral showed early promise in pre-clinical Covid-19 trials and has been used around the world to treat people with severe disease, including in the UK.
But officials at the WHO have now said there is ‘no evidence’ it boosts people’s chances of surviving the disease or stops them falling ill enough to need mechanical ventilation.
Scientists at the global health body are officially recommending against its use after reviewing evidence from four international trials of over 7,000 patients.
They have warned there is the ‘possibility of important harm’ when using the experimental Ebola drug – it can sometimes cause kidney and liver damage in some patients.
The WHO Guideline Development Group (GDG) described the drug as an expensive ‘gamble’ – a five-day course of treatment for one patient costs around £1,773 ($2,340).
For comparison, the steroid dexamethasone costs just £5 ($6.60) per patient and has been scientifically proven to improve survival in the most ill Covid patients.
Writing in the British Medical Journal, they said: ‘Paying a high price for remdesivir without good evidence of mortality benefits a gamble.’
However, the WHO admits the certainty of evidence from the studies is low and has encouraged more studies to dig into the drug’s benefit.
Doctors should not treat coronavirus patients with remdesivir ‘regardless of how ill they are’, the World Health Organization (WHO) has warned
Remdesivir, sold under the brand name Veklury, was developed by California-based Gilead Sciences to treat Ebola, the deadly hemorrhagic fever that emerged in West Africa in 2014.
It works by blocking an enzyme that helps the coronavirus make copies of itself and, in turn, spread throughout the body.
WHAT IS REMDESIVIR AND DOES IT WORK AGAINST CORONAVIRUS?
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.
The FDA issued an emergency use authorization for the drug on May 1, in response to the preliminary results of a notable study that was released at the end of April.
It was also given the green-light for use on the NHS in Britain at the same time.
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.
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.
In cell and animal models, studies showed the drug blocked the activity of Severe Acute Respiratory Syndrome (SARS) and MERS (Middle East Respiratory Syndrome), which are cousins of Covid-19. The early results raised hopes it could be effective on the new virus.
There have been 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.
Remdesivir is given intravenously in a five-day treatment course using six vials of the medication.
The WHO’s recommendation is part of a living guideline to help doctors make better decisions with their patients.
Living guidelines are useful in fast moving research areas like Covid-19 because they allow researchers to update previously vetted and peer-reviewed evidence summaries as new information becomes available.
Remdesivir has received worldwide attention as a potentially effective treatment for severe Covid-19 and is increasingly used to treat patients in hospital. But its role in clinical practice has remained uncertain.
Today’s recommendation is based on a new evidence review comparing the effects of several drug treatments for Covid-19.
It includes data from four international randomised trials involving over 7,000 patients hospitalised for Covid-19.
After reviewing the evidence, the WHO GDG expert panel concluded that remdesivir has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement.
The panel acknowledged that the certainty of evidence is low and said the evidence did not prove that remdesivir has no benefit.
Rather, they said there is no evidence based on currently available data that it does improve important patient outcomes.
But given ‘the remaining possibility of important harm’, as well as the relatively high cost and resource implications associated with remdesivir, it must be given intravenously, they judged this to be an appropriate recommendation.
They also support continued enrolment into trials evaluating remdesivir, especially to provide higher certainty of evidence for specific groups of patients.
In May, after two studies showed remdesivir could shorten hospital stays, the Medicines and Healthcare products Regulatory Agency and Food and Drug Administration (FDA) authorised the drug to be used in emergencies on patients in Britain and the US.
It was also one of among a cocktail of drugs used to treat President Donald Trump when he contracted the virus earlier this month.