Pharmaceutical Gilead responded to the report published by the World Health Organization (WHO) on the effect of the drug remdesivir on mortality. The pharmacist who created the drug criticizes that the report was published before being peer reviewed (independent scientists).
For the company, “the design of this trial gave priority to wide access, resulting in significant heterogeneity in the adoption, implementation, control and sampling (patient populations) and, consequently, it is not clear that it is possible to draw any definitive conclusions from the results“, As explained in a press release, released this Thursday. But it is precisely the broad access that is praised by scientists.
This Wednesday, WHO released preliminary results of the Solidarity Therapeutics Trial project, which aimed to accelerate clinical trials with drugs potentially effective in treating patients with Covid-19. In this case, existing drugs were analyzed, such as remdesivir (developed to combat Ebola), hydroxychloroquine (against malaria), lopinavir / ritonavir (against HIV) and interferons (which affect the virus’s ability to replicate).
The report, published on the medRxiv platform, he concluded that “none of the drugs under study definitively reduced mortality (in unventilated patients or other subgroups), initiation of ventilation or duration of hospitalization”. The trials were conducted in 405 hospitals in 30 countries and involved a total of 11,266 adult patients, of which 2,750 were part of the remdesivir trial.
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Gilead defends itself with an article published in The New England Journal of Medicine, where the clinical trial conducted by the United States’ National Institute for Allergies and Infectious Diseases shows the benefits of remdesivir. In this phase III trial over a thousand Covid-19 patients participated, with mild, moderate or severe disease.
The findings indicate that patients who underwent this treatment recovered more quickly from the disease, especially those who had more serious illness; and that, among ventilated patients, there was a decrease in mortality.
The WHO report, although without formal peer review, nevertheless gathers support among scientists, starting with the fact that it is a trial with many patients and in very different locations.
“The WHO Solidarity trial is a well-designed study,” says Paul Griffin, director of Infectious Diseases at Mater Health Services (Australia).
And it is in agreement with results of previous tests, according to the scientists. “The results of the study have been demonstrated in previous studies, but the important thing is the large number of patients of different ethnicities included in this clinical trial, which makes the findings impactful, ”says Brian Oliver, leader of the Respiratory Molecular Pathogenesis group at Sydney University of Technology.
The researchers agree that, after all hope in remdesivir, the results disappoint, but Phillip Reece, a consultant in the pharmaceutical industry, says the problem may lie in the way the drugs were given.
“Experiences with influenza antivirals have shown that they have to be taken 48 hours after the first symptoms to see a benefit,” he says. “Solidarity trial participants may have had symptoms for several days before being hospitalized and this can reduce the chance of seeing any benefit“.
Phillip Reece also has no data to support his hypothesis, but he leaves an open door for further studies. “Despite the results, I suspect that the trials will continue, at least for some of these drugs,” concludes Paul Griffin.
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