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Original title: WHO clinical data shows Remdesivir is ineffective
On Friday, the World Health Organization (WHO) released supportive data on a clinical trial of Gilead Sciences’ antiviral drug Remdesivir, showing the impact of Remdesivir on the death rate and length of stay in patients with new crowns. . Little or no impact.
The results of this study appear to be significantly different from the results of Gilead’s own clinical trials. Although Gilead Sciences questioned the precision of the study, experts believe that the conclusions of the two studies are not contradictory in nature. Gilead Sciences shares closed down 1.5% on Friday.
No effect on survival
The Solidarity trial is the world’s largest randomized clinical trial of potential new corona drugs conducted by WHO. In this trial, 405 hospitals in 30 countries studied four different possible drugs for the treatment of COVID-19 in more than 11,000 patients.
Data shows that three other drugs, including the antimalarial drug hydroxychloroquine, the anti-AIDS drug lopinavir / ritonavir, and the interferon combination, which are being tested in patients with the new crown, have little benefit.
WHO hired independent statistician Richard Peto (Richard Peto) to verify the results of its clinical trials. Peto believes that the scale and design of the test are very reliable. “In terms of getting reliable randomization and reliable follow-up, the quality of these data is excellent, this is real-world evidence,” Peto said.
A clinical expert also told a China Business News reporter that WHO clinical research data has added the weight of long-term follow-up and evidence to show whether Remdesivir is effective in treating new crowns and under what circumstances. .
“The WHO trials are larger and, more importantly, the results are neutral.” Another expert on anti-Ebola drugs told the China Business News reporter: “Gilead’s own data is controversial in terms of fairness.”
According to the WHO, Gilead learned of the results of the Solidarity clinical study on October 6. However, Gilead disagrees with this result. Gilead told the media that the company received a “large number of abbreviated manuscripts” from the WHO in late September, some of which differed from the latest research results published by the WHO. WHO has not yet responded to this.
Gilead also stated that it will not adjust the price of remdesivir drugs in developed countries due to the results of WHO clinical trials. The company said that clinical trials, including a randomized controlled trial of 1,026 patients published last week, have shown that Remdesivir can shorten the recovery time for patients with new coronary disease.
On October 8, Gilead published the final results of the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 phase III clinical study in the New England Journal of Medicine (NEJM). On evaluation of the results, remdesivir showed consistent and clinically significant patient benefits compared to placebo.
“The final results of the trial showed that patients treated with Radixivir had a faster recovery time than previously reported. Data from day 29 showed that Radixivir was more effective than placebo in hospitalized patients receiving standard treatment. Gilead said in a statement to a China Business News reporter: “Overall, compared to the placebo group, the patients’ recovery time on remdesivir was shortened by 5 days and the progression of the disease could slow down.”
EU review10Orders of billions of euros
Regarding the seemingly contradictory results from the two clinical trials, experts believe it is due to different sample sizes and different lengths of follow-up. Andrew Hill, a pharmacologist at the University of Liverpool in the UK, said: “The Gilead trial initially reported only short-term data. However, when results from long-term follow-up are added, the mortality rate of patients using remdesivir begins to increase.. “
Professor Hill believes that the EU should reconsider the price paid for Remdesivir. “Why spend a billion euros to buy drugs that have no effect on survival?” He questioned.
Martin Landray, professor of medicine and epidemiology at the University of Oxford in the UK, also said: “The results of the WHO clinical trial are very clear and Redecive has no effect on overall survival.”
Peter Galle, professor at the Teaching Hospital of the University of Mainz in Germany, said: “WHO clinical trials have provided further evidence that remdesivir is not a specific drug.”
Remdesivir is currently the only new crown therapy to have received an emergency use authorization (EUA) from the US FDA.In August this year, the FDA approved Remdesivir for the treatment of all hospitalized patients with new crowns. . On October 16, in a letter to Gilead, the FDA stated that it would re-authorize the emergency use of remdesivir. The FDA said, “Redcivir may be effective, and the known and potential benefits outweigh the risks in treating hospitalized patients with COVID-19.”
However, the European Union said after the publication of the WHO clinical trial results that it is reconsidering the € 1 billion purchase contract with Gilead. On October 8, the European Union announced that it had signed the largest contract to date with Gilead, which will offer 500,000 Redecive courses in 6 months at a price of 2,070 euros per course.
Yannis Natsis, Director of the European Medicines Agency (EMA) on behalf of the patient organization, said: “The EU should state the reasons for signing the latest contract with Gilead and re-examine it based on the results of the clinical trial of the WHO to determine if you need to change the way the drug is used. . “
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