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By Deena Beasley and Vishwadha Chander
(Reuters) – Gilead Sciences Inc has disputed the findings of a World Health Organization (WHO) study that concluded that its COVID-19 drug, remdesivir, does not help patients who have been admitted to hospital. .
The US company told Reuters the data appeared inconsistent, the findings were premature, and other studies had validated the drug’s benefits.
In a blow to one of the few drugs used to treat people with COVID-19, the WHO said Thursday that its “Solidarity” trial had concluded that remdesivir appeared to have little or no effect on the 28-day mortality. or the length of hospitalizations. among patients with respiratory disease.
The antiviral drug was one of the drugs used to treat US President Donald Trump’s coronavirus infection, and previous studies have shown that it has shortened recovery time, although the European Union is investigating it for a possible kidney injury.
The WHO trial was conducted in 11,266 adult patients in more than 30 countries. The evidence was conclusive, the WHO said.
Gilead said that other trials of remdesivir, including 1,062 patients who compared it to a placebo, showed that the treatment reduced recovery time from COVID-19.
“The emerging data (from WHO) appear inconsistent, with stronger evidence from multiple randomized controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir,” Gilead told Reuters.
Gilead said it was “unclear whether conclusive findings can be drawn,” given what it called differences in the way the trial was conducted from site to site and between patients who received the drug.
In April, America’s top infectious disease official, Anthony Fauci, predicted that remdesivir would become “the standard of care.”
Companies like Gilead are racing to find a treatment for COVID-19. Approximately 1.1 million people have died and 39.1 million have been infected in the pandemic, and the world economy has been thrown into chaos.
Remdesivir was developed for Ebola, which causes fever, bleeding, vomiting, and diarrhea and is transmitted between humans through bodily fluids.
It was quickly repurposed and has offered some hope to patients, although the WHO findings may shift the focus of the search for a vaccine to new monoclonal antibodies being developed by companies like Regeneron.
The Solidarity trial also evaluated hydroxychloroquine, the combination of HIV drugs lopinavir / ritonavir, and interferon, and concluded that, like remdesivir, they did little to help patients survive or leave hospital more quickly.
The results of the WHO trial have not yet been reviewed and have been uploaded to the medRxiv prepress server. (https://bit.ly/3nViYIf)
“PREMATURE”
Gilead says that Solidaridad’s conclusions, without the scrutiny of other scientists, were premature.
“We are concerned that the data from this global open-label trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design,” he said.
Remdesivir obtained emergency use authorization from the US Food and Drug Administration on May 1 and has been licensed for use in several countries.
During the Solidarity study, the hydroxychloroquine and lopinavir / ritonavir trials were stopped in June after they proved ineffective, but studies of the drug and Gilead’s interferon continued in more than 500 hospitals and 30 countries.
WHO chief scientist Soumya Swaminathan said this week that the UN health agency was now looking for other emerging treatment options, such as monoclonal antibodies, immunomodulators and some newer antiviral drugs.
Regeneron Pharmaceuticals Inc is developing a monoclonal antibody that Trump received for his COVID-19 infection.
Eli Lilly and Co said Tuesday that the US government had stopped a trial of its COVID-19 antibody treatment due to a safety concern.
(Reporting by Vishwadha Chander, Deena Beasley, Stephanie Ulmer-Nebehay and John Miller in Switzerland, Ludwig Burger in Frankfurt; Edited by Shinjini Ganguli, Devika Syamnath and Timothy Heritage)
