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.
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