WHO defends data after concluding Gilead's remdesivir flopped COVID-19 trial
Gilead, which got the Solidarity data 10 days ago, questioned the findings
Zurich/Geneva: A World Health Organization (WHO) trial that concluded Gilead Sciences Inc.'s remdesivir did not significantly help COVID-19 patients is reliable, a scientist who evaluated the data said on Friday, as the U.S. company criticized its methodology.
"It's a reliable result, don't let anybody tell you otherwise, because they'll try to," Richard Peto, an independent statistician hired by the WHO to scrutinize its Solidarity trial results, told reporters. "This is real world evidence." In a blow to one of the few drugs being used to treat people with COVID-19, the WHO said on Thursday that remdesivir appeared to have little or no effect on 28-day mortality or length of hospital stays among patients with the respiratory disease.
Gilead, which got the Solidarity data 10 days ago, questioned the findings, telling Reuters they appear "inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir." The WHO trial was conducted in 11,266 adult patients in more than 30 countries, and also found that other medicines repurposed since the pandemic began -- malaria drug hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon -- also offered little or no benefit to COVID-19 patients.
The WHO trial's results are yet to be reviewed and were uploaded on the preprint server medRxiv. (https://bit.ly/3nViYIf) While Gilead said other remdesivir trials, including with 1,062 patients that compared it with a placebo, showed the treatment cut COVID-19 recovery time, Peto, a professor emeritus at Oxford University, said the smaller trial's perceived benefit could have been mere "chance." The WHO refrained from making a recommendation for how countries should deploy remdesivir, saying that guidance would come in two or three weeks after a review of Solidarity data.
The European Union just agreed to a 1 billion euros ($1.2 billion) deal for remdesivir.