WHO supported Solidarity trial finds remdesivir ineffective but WHO prequalifies it anyway

Even as WHO supported Solidarity Therapeutics Trial found remdesivir to be ineffective in reducing mortality and duration of hospital stay, the global body prequalified the drug the same day the results of the trial were posted on the preprint server. And Gilead Sciences, which was aware of the Solidarity trial results, signed a $1 billion deal with European Commission a week before the results were posted.

On October 15, a preprint published in medRxiv server noted that the WHO supported Solidarity Therapeutics Trial found all four repurposed drugs — remdesivir, interferon, hydroxychloroquine and lopinavir/ritonavir regimes — were not effective for the treatment of COVID-19. These are interim results from the Solidarity trial.

“Remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalised COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” says the preprint.

The WHO too posted on its website the highlights of the trial saying that the interim results show that none of the four repurposed drugs were found to effective in either reducing mortality or hospital stay. WHO also said: “Other uses of the drugs, for example in treatment of patients in the community or for prevention, would have to be examined using different trials”.

The Solidarity Therapeutics Trial is the largest randomised, controlled trial carried out during the pandemic on over 11,200 adults in 405 hospitals in 30 countries.

WHO still prequalifies remdesivir

But even as the WHO supported trial found all four drugs, including remdesivir, ineffective in reducing mortality, initiation of ventilation and duration of hospital stay, the drug was prequalified by the WHO on the same day (October 15) the preprint was posted.

It’s not clear why WHO prequalified remdesivir despite knowing that the Solidarity Therapeutics Trial finding the drug “not effective” in reducing mortality and duration of hospital stay. 

Gilead signs $1 billion deal with European Commission 

According to Science, Gilead received the manuscript about Solidarity trial on September 28. On 8 October, the day the results of NIH’s ACTT-1 trial of the drug was published in the New England Journal of Medicine (NEJM), Gilead Sciences signed a $1 billion deal with the European Commission for a six-month supply of the drug. The deal, according to Reuters, will allow its 27 member states and 10 partner countries, including Britain, to order up to 500,000 remdesivir courses over the next six months.

The deal was signed just a week before the results of the Solidarity Trial were posted on the preprint server, and when the company was already aware of the trial results.

According to the results published in NEJM, those who received remdesivir had a “median recovery time of 10 days as compared with 15 days among those who received placebo”. The ACTT-1 trial also found that mortality was 6.7% with remdesivir and 11.9% with placebo by day 15, and 11.4% with remdesivir and 15.2% with placebo by day 29.

FDA issues EUA in May

The U.S. FDA had issued an Emergency use authorisation for remdesivir on May 1. The authorisation was for use of the drug to treat hospitalised patients with severe COVID-19 disease. For the purpose of EUA, severe disease was defined as patients with oxygen saturation less than 94% or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation.

On August 28, 2020, the FDA expanded the authorisation of the drug by no longer limiting its use to the treatment of patients with severe disease. It said: “The FDA has determined that it is reasonable to believe Veklury [remdesivir] may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalised adult and paediatric patients. The Agency’s review has also concluded that the known and potential benefits outweigh the known and potential risks for these uses.” 

India approves the drug

India approved remdesivir on June 1 under restricted emergency use as part of DCGI’s accelerated approval process.