WHO on Friday issued formal guidelines recommending against the use of remdesivir for COVID-19 patients, based on a  lack of evidence that the antiviral drug, developed by Gilead, significantly improves patient outcomes.

The recommendation followed publication of trial results on the drug in the The BMJ  involving more than 7,000 patients who had been hospitalized with COVID-19.

Reviewing data obtained from 4 international randomised-controlled  trials, the WHO Guideline Development Group (GDG) concluded that remdesivir had no meaningful effect on mortality or other significant outcomes, like the need for mechanical ventilation.

Four patients who have had COVID-19 were among the panel of leading experts to review the data.

WHO did clarify, however, that further evidence would be needed to write-off the treatment completely, and encouraged continued enrolment into ongoing remdesivir trials, to provide higher certainty of evidence for specific groups of patients.

The authors of the paper wrote: “Considering the low or very low certainty of evidence for all outcomes, the panel interpreted the evidence as not proving that remdesivir is ineffective; rather, there is no evidence based on currently available data.”

The authors also said: “The unprecedented volume of planned and on-going studies for COVID-19 interventions … implies that more reliable and relevant evidence will emerge to inform policy and practice.”

“The solidarity results are available in preprint and those are publicly available. And that provided some of the largest evidence source for the guideline that we publish and the recommendation we made today that is currently under peer review in a journal and from what I know, will be available shortly,” said Janet Diaz, WHO Head of Clinical Care in Health Emergencies, in a WHO press conference Friday just after the negative WHO recommendation was announced.

Due to the negative results, WHO’s plans to “pre-qualify” remdesivir for bulk procurement and sale to developing countries have also been put on hold, said WHO’s Mariangela Simao, who oversees the prequalification process.

Gilead Sciences Ignored WHO Evidence In US FDA Submission For Drug’s Approval

The formal recommendation against remdesivir’s use followed upon statements made in October by WHO’s chief scientist to the effect that WHO’s evidence, drawn from WHO co-sponsored “Solidarity” trials of the drug, had not shown significant benefits for the drug.

The WHO Chief Scientist, Soumya Swaminathan, spoke just after the United States Food and Drug Administration had approved the drug, in a review that failed to consider the results of WHO trial findings.

At the time, Swaminathan, noted that Gilead had not included the WHO data that had provided to them in their FDA submission for drug approval. Speaking at a press conference, Swaminathan said that results had been provided for its Solidarity Trial weeks before the submission, “but it appears that the Solidarity results were not considered, were not provided to the FDA”.

She also said: “What we understand from the FDA decision yesterday was that it was based on data submitted to them from Gilead, which did not include the Solidarity Trial results.”

In a press conference on Friday, Swaminathan said that despite the negative recommendation for remdesivir, to date, the results released are still interim. And the remdesivir arm of the Solidarity Trial would continue until the sample size that had been planned originally is reached.

“The results of the solidarity trial that were released on October 15th were interim results. So the trial is continuing with the Remdesivir arm until the sample size is reached,” said Swaminathan. “We had an agreement with Gilead for a certain number of doses, and we will continue to enroll until we complete that.”

Once the trial is completed, she said that the data base would also be shared with Gilead, Swaminathan added.  But already,  a peer reviewed publication on the findings so far will be published.  Said Swaminathan: “What will be available very soon is the peer reviewed publication that should be out in the next couple of days. But it’s almost the same as what had been released in the pre-print. So most of the data is already out there.”

Image Credits: Gilead, Gilead.