Remdesivir has little to no effect on Covid-19 patients’ chances of survival, a WHO study on the anti-viral drug has found.
The WHO’s Solidarity clinical trial evaluated four potential medications for Covid-19, including hydroxychloroquine and remdesivir.
Remdesivir was among the first to be used to treat Covid-19, and was recently given to President Donald Trump when he was in hospital.
The company manufacturing the anti-viral drug, Gilead Sciences Inc., rejected the findings of the trial.
In a statement, Gilead said the findings of the study were “inconsistent” with others, and that it was “concerned” that the results have yet to be reviewed.
For the Solidarity clinical trial, the WHO tested the effects four potential treatments – remdesivir, an Ebola drug, was one, but they also looked at malaria drug hydroxychloroquine, auto-immune drug interferon, and the HIV drug combination of lopinavir and ritonavir.
Dexamethasone, a low-cost steroid now widely used on Covid patients in intensive care in many countries, was not included in this study.
The four drugs were tested with 11,266 adult patients in total, across 500 hospitals in more than 30 different countries.
The results, which are yet to be peer-reviewed, suggest that none of these treatments has a substantial effect on mortality or on the length of time spent in hospital, the WHO said on October 15.
On October 14, WHO chief scientist Soumya Swaminathan said that their trials on hydroxychloroquine and lopinavir/ritonavir were stopped in June because they had already proven ineffective. However, the other trials continued.
The study’s results appear to contradict a previous study from earlier this month, conducted by Gilead, which concluded that treatment with remdesivir cut Covid recovery time by five days compared to patients given a placebo. About 1,000 patients took part in that trial.
Gilead dismissed the findings, saying in a statement: “The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir.
“We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”
Remdesivir was given emergency use authorization in the US from the FDA on May 1and has since been authorized for use in several other countries.
The FDA has authorized emergency use of the Ebola drug remdesivir for treating the coronavirus.
The authorization means the anti-viral drug can now be used on people who are hospitalized with severe Covid-19.
A recent clinical trial showed remdesivir helped shorten the recovery time for people who were seriously ill.
However, the drug did not significantly improve survival rates.
Experts have warned remdesivir – which was originally developed to treat Ebola, and is produced by Gilead pharmaceutical company in California – should not be seen as a “magic bullet” for coronavirus.
Remdesivir interferes with the virus’s genome, disrupting its ability to replicate.
During a meeting with President Donald Trump in the Oval Office, Gilead Chief Executive Daniel O’Day said the FDA authorization was an important first step.
Gilead would donate 1.5 million vials of the drug, he said.
FDA Commissioner Stephen Hahn also said at the meeting: “It’s the first authorized therapy for Covid-19, so we’re really proud to be part of it.”
Emergency FDA authorization is not the same as formal approval, which requires a higher level of review.
Remdesivir did not cure Ebola, and the producing company says on its website: “Remdesivir is an experimental medicine that does not have established safety or efficacy for the treatment of any condition.”
Gilead also warns of possible serious side-effects.
However, President Trump has been a vocal supporter of remdesivir as a potential treatment for the coronavirus.
In its clinical trial, whose full results are yet to be released, the US National Institute of Allergy and Infectious Diseases (NIAID) found that remdesivir cut the duration of symptoms from 15 days down to 11.
The trials involved 1,063 people at hospitals around the world – including the US, France, Italy, the UK, China and South Korea. Some patients were given the drug and others were given a placebo (dummy) treatment.
Dr. Anthony Fauci, who runs NIAID, said that remdesivir had “a clear-cut, significant, positive effect in diminishing the time to recovery”.
However, although remdesivir may aid recovery – and possibly stop people having to be treated in intensive care – the trials did not give any clear indication whether it can prevent deaths from coronavirus.
As much remains uncertain about the treatment regime, Gilead suggests a 10-day dosing duration for patients on ventilators and five days for patients who are not.
The FDA’s jurisdiction does not stretch overseas so the authorization only applies to US. Experts also stressed that the emergency use is not the same as full approval.
Scientists warn the H5N1 bird flu virus could change into a form able to spread rapidly between humans.
Researchers have identified five genetic changes that could allow the virus to start a deadly pandemic.
Writing in the journal Science, they say it would be theoretically possible for these changes to occur in nature.
A US agency has tried unsuccessfully to ban publication of parts of the research fearing it could be used by terrorists to create a bioweapon.
According to Prof. Ron Fouchier from the Erasmus Medical Centre in the Netherlands, who led the research, publication of the work in full will give the wider scientific community the best possible chance to combat future flu pandemics.
“We hope to learn which viruses can cause pandemics and by knowing that we might be able to prevent them by enforcing strict eradication programmes,” he said.
He added that his work might also speed the development of vaccines and anti-viral drugs against a lethal form of bird flu that could spread rapidly among people.
The H5N1 virus has been responsible for the deaths of tens of millions of birds and has led to hundreds of millions more being slaughtered to stop its spread.
The virus is also deadly to humans but can only be transmitted by close contact with infected birds.
Scientists warn the H5N1 bird flu virus could change into a form able to spread rapidly between humans
It is for this reason that relatively few people have died of bird flu. Latest World Health Organization (WHO) figures indicate 332 people have died of the illness since 2003.
Health officials are concerned though that the H5N1 virus could one day mutate into a form that could be spread between humans through coughs and sneezes through the air.
This could, they fear, result in a lethal pandemic that could spread rapidly across the world killing tens of millions of people.
It is only now that a study has confirmed that the emergence of such a deadly virus is theoretically possible.
A group led by Prof. Ron Fouchier wanted to find out which genetic changes were required to enable the H5N1 virus to mutate into a form that could be transmitted from person to person through the air.
His team compared the genetic structure of the bird flu virus with those responsible for earlier human flu pandemics.
The researchers found five key differences, which they reasoned could be the mutations required for airborne transmission of the virus.
They confirmed their theory was correct by genetically engineering those changes into the H5N1 virus which they found could then be spread between ferrets through coughing and sneezing.
A team from Cambridge University then looked to see whether such a mutation could emerge naturally and if so its likelihood.
The researchers studied the genetic structure of 3,000 bird viruses and 400 that occur in humans.
They found some of these viruses had two of the key changes needed to become airborne. Mathematical modeling suggested it was indeed possible for a virus to develop the three further changes required during the course of an epidemic.
It is the first time it has been shown that it is possible for bird flu to become airborne, but the research team was unable to determine precisely how likely this was to happen.
Prof. Derek Smith, who led the analysis, said more information was needed.
He said researchers required a better understanding of how flu viruses were transmitted between people in order to develop a clearer idea of the likelihood of the emergence of an airborne strain of bird flu.
“These are difficult things to find out,” said Prof. Derek Smith.
“What this work enables us to do is to prioritize particular experiments to obtain this information.”
It is clear though that the emergence of an airborne mutation of H5N1 is unlikely. Were it not it would have emerged already.
But researchers want to be able to calculate the risk of such a virus emerging more precisely in order to help public health officials in their contingency planning.
News of Prof. Ron Fouchier’s work, and another similar study by Yoshihiro Kawaoka published this May in the journal Nature, prompted the US National Security Advisory Board for Biotechnology (NSABB) to ask both journals last November to redact some sensitive parts of the research.
The NSABB believed the information could be used by terrorists to create a bioweapon.
The scientists who carried out the research, and the journals concerned, considered suggestions as to how the results could be redacted in the journals, but distributed to bona fide researchers who urgently needed the information.
But they concluded such a system was unworkable.
“You can’t share information with so many people in the field and keep it confidential,” according to Prof. Ron Fouchier.
Editor in chief of the journal Science, Dr. Bruce Alberts, said the publication of the research in both Science and Nature had “shone a spotlight” on the need to deal more effectively with research that could be misused by terrorists – so called “dual use research of concern” (DURC).
“It has become clear that we will need to work toward the establishment of a comprehensive, international system for assessing DURC, one that includes transparent procedures to allow selected access to any information omitted from a scientific publication to those with a need to know.”
But Prof. Ron Fouchier questioned whether a system of asking scientific journals to censor DURC work is ever workable or even appropriate.
“The general mode should be that science should be freely available so that the wider scientific community can build on the research,” he said.
“I have a hard time identifying research papers that you shouldn’t publish. So I’m not sure whether we should ever go down this alley.”
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