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The World Health Organization has advised doctors not to prescribe Gilead’s remdesivir to coronavirus patients in hospital, casting doubt on the efficacy of the only antiviral approved to treat the disease.
Remdesivir was approved by the US Food and Drug Administration (FDA) last month.
But a WHO expert panel wrote in the British Medical Journal on Friday that the drug “was not suggested for patients admitted to hospital with Covid-19, regardless of the severity of their illness, because there is currently no evidence. that improves survival or need for ventilation ”.
The notice is one of the so-called living guidelines, commonly used in areas where research is progressing rapidly. Friday’s recommendation is based on four randomized trials involving more than 7,000 patients.
“Remdesivir does not have a significant effect on mortality or other important patient outcomes, such as the need for mechanical ventilation or the time to clinical improvement,” the WHO said.
The panel noted that the certainty of the evidence was low and said it did not prove that the drug had no benefit. “Rather, there is no evidence based on the currently available data that it improves important patient outcomes,” he said.
But because remdesivir could potentially cause harm, and given the relatively high cost and difficulty of administering it intravenously in hospital, the panel; He said it was an appropriate recommendation. He has recommended more studies.
The health agency has recommended the use of steroids to treat severe patients with Covid-19. Steroids are cheap, taken by mouth, and widely available. Remdesivir costs $ 2,340 per course, or more.
The WHO has also taken steps to suspend remdesivir from its prequalification list, a prerequisite for procurement in developing countries, an official told the Financial Times.
Gilead said remdesivir, now known by its Veklury brand, was recommended by renowned institutions such as the US National Institutes of Health and the Infectious Diseases Society of the United States. The company said there was “strong evidence” from various studies showing that the drug accelerated recovery from Covid-19.
“We are disappointed that the WHO guidelines appear to ignore this evidence at a time when cases are increasing dramatically around the world and Veklury is trusted by physicians as the first and only antiviral treatment approved for Covid-19 patients in approximately 50 countries, “Gilead said. said.
Last month, the WHO published the largest amount of evidence on the drug to date, which showed it had no effect on mortality, hospital stays or the need for ventilation. Gilead claimed that the study was flawed, but WHO insisted its methodology was sound.
The FDA approved remdesivir in full last month, hours before the second US presidential debate.
Gilead reported remdesivir sales of $ 873 million in the third quarter, falling short of analysts’ expectations of about $ 1 billion. The biotech group warned when it announced its earnings in October that there was “significant volatility and uncertainty” surrounding remdesivir sales, with hospitals stockpiling the drug at lower rates than they had predicted.
The drugmaker was aware of the negative results of the trial when it reached an agreement, worth up to one billion euros, to supply the drug to European countries in October. Member states are not required to pay, and the European drug regulator is reviewing available trial data with a view to changing the way the drug is used.
Umer Raffat, an analyst at Evercore, said there were “methodological problems” in how data from the WHO trials were analyzed. He put more weight on the trial by Anthony Fauci’s group at NIH, as well as Gilead’s, which were “adequate large studies with appropriate randomisation and statistical analysis.”
“Also, if someone has Covid, what other antiviral option do we have? None at this time, ”he said.
The WHO disagreed, saying its trial “provides the vast majority of the world’s information on the impact of remdesivir on mortality and the need for ventilation.”
