US-run trial of Gilead coronavirus therapy demonstrates ‘significant positive effect’
The US government’s leading infectious disease fighter said a new drug developed by Gilead Science had a “clear-cut, significant positive effect” in speeding up recovery in coronavirus victims, giving hope scientists may be able to develop a therapy to combat the pandemic.
Anthony Fauci, a leading member of the White House’s coronavirus task force, cautioned the trial results for the antiviral drug remdesivir were not a “knockout”. But he compared it to the early anti-HIV drug AZT, which became the basis of future treatments for that virus.
The findings from the study led by the US National Institute for Allergy and Infectious Diseases were announced on the same day a paper in a prestigious medical journal showed a different picture, however. It found remdesivir had failed to help patients in its first randomised clinical trial. The World Health Organization accidentally published results of the more sceptical study last week.
The endorsement by Dr Fauci and Gilead’s own statement that it had been notified of “positive data” from the study run by the US NIAID sent Wall Street sharply higher, with the S&P 500 ending the day 2.6 per cent higher.
The NIAID trial, which has yet to be peer reviewed, showed a 31 per cent improvement in patients taking the drug compared with a placebo, Dr Fauci said, with victims recovering in 11 days on average rather than 15 days for the control group. Some 8 per cent of the group taking remdesivir died, compared with 11 per cent in the control group.
“It is a very important proof of concept because what it is proving is that a drug can block this virus,” Dr Fauci said.
The results from a trial in Wuhan, China showed treatment with remdesivir did not speed recovery or reduce deaths from Covid-19.
“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said Bin Cao, a professor from the China-Japan Friendship Hospital and Capital Medical University in China, who led the research. But the Chinese trial of 237 patients did not finish enrolling, as there were not enough Covid-19 patients to study.
Gilead said last week that the summary of the trial that was published early in error included “inappropriate characterisations” and noted that some data suggested there might be a “potential benefit for remdesivir, particularly among patients treated early in the disease”.
Dr Fauci said the NIAID data were announced before it had been fully peer reviewed because there was an ethical obligation to notify all patients of the positive results so that those in the control group could take advantage of the therapy.
“Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately allow the people in the placebo group know so they can have access,” he said. “We would have normally waited several days until the data gets further — dot the Is and cross the Ts . . . But the conclusion will not change.
which a study by Gilead appeared to show patients did just as well after a five-day course of the drug as after 10 days. However, the study did not have a control arm comparing patients on remdesivir to patients who were not taking it and it was not peer-reviewed. The company said it intended to submit the study for peer-review by other scientists.
Merdad Parsey, Gilead’s chief medical officer, said its trial “complements” the placebo-controlled study by NIAID. If patients did not require a 10-day course of the drug, “it could significantly expand the number of patients who could be treated with our current supply of remdesivir”, he said.
Brian Abrahams, an analyst at RBC Capital Markets, said the picture on remdesivir was becoming clearer — but that it was still imperfect.
“The bottom line here is it is increasingly likely that this is an active drug with some benefits,” he said. “The magnitude is not overly dramatic but it will probably be made available more broadly and become one of several potential future tools in physicians’ arsenal.”
Gilead originally developed remdesivir as a drug for Ebola, but it was never approved. Many hoped the antiviral could work in a similar way against Covid-19 — and so there are trials all over the world to test it against the virus.
Umer Raffat, analyst at Evercore, thought the positive signs from the NIAID study meant Gilead was headed towards obtaining regulatory approval for remdesivir, especially because the trial was run by Dr Fauci.
“That’s the most important update,” he said.
NIAID : National Institute of Allergy and Infectious Diseases