WHO defends Covid-19 drug study after remdesivir maker Gilead questions methodology

HONG KONG, Oct 19 (SCMP): The World Health Organisation (WHO) has defended a study that sparked a debate about whether the antiviral drug remdesivir is any use in treating Covid-19.

The report was based on a large-scale clinical trial of four drugs that concluded none of them helped reduce mortality or the amount of time patients spent in hospital.

Gilead, the firm that makes remdesivir, has hit back at the study, questioning its methodology. “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,” the company said in a statement.

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The WHO defended the robustness of its findings, saying the scale of the study has made it more representative than previous studies, including those commissioned by the National Institutes of Health (NIH) in the US.

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Oxford University Professor Richard Peto, who was the chief statistician in the trial, told a media briefing on Friday: “It [the number of subjects] is more than three times as big as all the other evidence in the world put together.”

The WHO’s chief scientist Soumya Swaminathan said that although the study only looked at the effect on hospitalised patients did not mean that the drugs had been administered too late, saying: “You cannot conduct trials if the patients are not hospitalised.”

The WHO’s conclusions were based on the interim results of the Solidarity Therapeutics Trial, which looked at the effects of remdesivir, hydroxychloroquine, autoimmune drug interferon, and the HIV drugs lop pinavir and ritonavir on 11,266 adult Covid-19 patients in more than 30 countries.

The WHO has refrained from saying it will recommend that regulators remove the drug from treatment lists.

Ana Maria Henao-Restrepo, a medical officer at the WHO, told the briefing that an independent guideline review committee will make recommendations to regulators after examining all available data about the drug.

The drug was one of the three drugs administered to US president Donald Trump after he was diagnosed with Covid-19.

Speaking in a briefing on Friday, the WHO said the interim findings were given to Gilead in September.

“[The WHO] made a presentation to Gilead and other companies [on the results of the trial] on September 23,” Henao-Restrepo said. She said the draft and graphics of the manuscript were sent to Gilead on September 28.

The study has been submitted to New England Journal of Medicine and a preprint has been published online.

While there was no evidence in previous trials to show that remdesivir, an antiviral originally designed to treat Ebola but never commercialised, could reduce the number of Covid-19 deaths, a previous study commissioned by the US NIH concluded the drug could shorten hospital stays by five days.

The double-blind, randomised, placebo-controlled trial on 1,062 patients published in the New England Journal of Medicine on October 8 was largely in line with earlier study commissioned by the pharmaceutical firm.

Scientists said when patients in the latest trial were given the drugs could be important to the results.

“It can be all about the timing of these therapies,” said Kylie Quinn, a vice-chancellor’s research fellow at RMIT in Melbourne, noting that some antiviral medicines, such as those used to treat cold sores, need to be used earlier in the course of infection to be effective at suppressing the virus.

David Hui Shu-cheong, a respiratory medicine professor in the Chinese University of Hong Kong, said the NIH” is stringent in carrying out research ... I would not play down its findings”.

But Hui added: “For the WHO study, it is difficult for it to monitor the quality of supportive care different hospitals provide and there are a lot of variables.”

Gilead questions WHO study that found remdesivir has little effect on Covid-19 deaths

He expected the study would not have a major impact on regulator decisions for the time being, but it will stimulate more research into the combined use of antivirals.

Despite the WHO report, the US government announced on Friday that it would launch large scale tests on three immune-modulating drugs in combination with remdesivir.

The European Commission has also announced a contract with Gilead to supply 500,000 courses of the antiviral drug at a price of €2,070 (US$2,425) per treatment. - South China Morning Post