Gilead's Remdesivir Ineffective In COVID-19 Patients, WHO Study Finds

Daniel Fowler
October 18, 2020

Interim results from the WHO's Solidarity Therapeutics Trial show four drugs in a multinational study have little or no effect on 28-day mortality or the in-hospital clinical outcomes of severely ill, hospitalised COVID-19 patients.

The WHO said that the trial, which included 11,000 patients in 30 countries, found that four drugs had little to no effect on survival and on the progression of the disease among hospitalized patients.

Health experts said the findings could come as a jolt to doctors across India who have been prescribing both remdesivir and hydroxychloroquine to Covid-19 patients under guidelines approved by the Union health ministry and the Indian Council of Medical Research (ICMR).

The WHO study called those results into question, said Richard Peto, a statistician at the University of Oxford who reviewed the trial results. "The interim analysis showed no benefits of remdesivir in any groups of COVID-19 (asymptomatic/mild/moderate/severe/critical) patients", ICMR said in a statement on October 16.

"As time is of the essence - we are in a situation of a public health emergency - we have to not only invest up-front in vaccine development but also in access to therapeutics", a spokesman for the European Commission said.

Remdesivir was originally developed to treat Ebola and received emergency use authorization from the U.S. Food and Drug Administration back in May. The NIH now recommends against the use of interferons (alpha or beta) for severe or critical patients with COVID-19, except in the context of a clinical trial.

In the trial, 2,750 participants received remdesivir, 954 received hydroxychloroquine, 1,411 received Lopinavir, 651 received Interferon plus Lopinavir, 1,412 Interferon and 4,088 received placebo.

The Solidarity trial, which has not yet been peer-reviewed, found Remdesivir did not "substantially affect mortality", reduce the need to ventilate patients, or shorten hospital stays.

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In a statement, Gilead said it was "concerned" that the data from the trial had not undergone vigorous review, and that it was unclear whether any "conclusive findings" could be drawn from the results.

The viruses that cause COVID-19, SARS and MERS have common mechanisms that might be promising targets for a treatment that would work against all three, plus future viruses, researchers reported on Wednesday in Science.

But Richard Peto, an independent statistician hired by the World Health Organization to scrutinise the results of its Solidarity trial, dismissed Gilead's criticism.

The SOLIDARITY trial is the largest randomised, controlled study of its kind.

There is a bit of uncertainty in the data, but the study says it "absolutely excludes" the idea remdesivir can save a significant number of lives and says the findings are "comfortably compatible" with the drug having no life-saving effect at all.

The trial analysed the effects of these treatments on overall mortality, initiation of ventilation and duration of hospital stay in hospitalised patients.

Commenting on the findings, Dr. Soumya Swaminathan, WHO Chief Scientist, said, "Personal experiences are valuable". Remdesivir is among medications that US President Donald Trump had received.

"We're looking at monoclonal antibodies, we're looking at immunomodulators and some of the newer anti-viral drugs that have been developed in the last few months", she said.

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