Gilead’s Remdesivir should not be used in patients hospitalized with COVID-19, regardless of the patient’s condition because there is no evidence that the drug improves survival or reduces the need for ventilation. “The panel found a lack of evidence that Remdesivir improved outcomes that were important to patients,” the guidelines said.
“Particularly considering the impact of the costs and resources associated with Remdesivir, the panel felt that it was responsible for demonstrating evidence of efficacy not established by currently available data.” This advice is another frustration with the drug, which has garnered worldwide attention as a potentially effective treatment for COVID-19 in the summer, when early clinical trials showed little promise.
Antiviral drugs, known under the brand name Veklury, are currently one of only two drugs approved worldwide to treat COVID-19 patients. However, a large WHO-led trial, known as a solidarity trial, has shown little or no effect on the 28-day mortality or length of stay in COVID-19 patients last month.
This drug was one of the drugs used to treat US President Donald Trump’s coronavirus infection, and previous studies have shown it to reduce recovery times. Approved or approved for use as a treatment for COVID-19 in more than 50 countries. Gilead questioned the results of the solidarity trial and said in a statement Friday that he was “disappointed” by the new WHO guidelines.
“Veklury is recognized as the standard of care for the treatment of patients hospitalized with COVID-19 by the guidelines of numerous trusted national institutions.” WHO’s advice raises the question of whether the European Union will need a 500,000 course of antiviral drugs, worth 1 billion euros ($1.2 billion) ordered last month.
The European Commission has noted on Friday the WHO’s updated guidelines for remdesivir, but said “there are no changes to approval for this drug at this time.” A pharmacy in Europe, a drug regulator in the region, requested full data from the trial and said “we will evaluate the evidence along with other available data to see if a change is necessary.”
AIFA, an Italian drug regulatory authority, said “We have been emphasizing the moderate effects of rem desivir for several weeks.” The spokesman said, “In fact, we are saying that it is not very useful.”
No meaningful effect
The WHO’s Guideline Development Group (GDG) panel said it made recommendations based on a review of evidence that included data from four internationally randomized trials involving more than 7,000 patients hospitalized with COVID-19. After reviewing the evidence, the panel concluded that remdesivir should be administered intravenously, which is expensive and complex to administer, but did not significantly affect the patient’s mortality or other significant outcomes.
Peter Horby, professor of epidemic epidemics at Oxford University in the UK, said the WHO’s new advice should spark “rethinking Rem Desivir’s position in COVID-19.” “Remdesivir is an expensive drug that needs to be injected intravenously for 5 to 10 days, so this recommendation will save money and other medical resources.”
U.S. epidemic doctors say they will continue to use the drug because in a double-blind, placebo-controlled U.S. study, they cut hospitalization for some COVID-19 patients. Dr. Rajesh Gandhi, an infectious disease doctor at Massachusetts General Hospital and Harvard, said, “My point of view, our institution’s point of view, is that this is still a useful drug. It’s not as useful as we would like.” Said the medical school.
Dr. Helen Voucher, director of geography and epidemiology at the Tufts Medical Center in Boston, says he is considering that the Solidari tea trial is an open-label study. This means that doctors and patients know that the drug has been administered. Double-blind, placebo-controlled study. Placebo-controlled studies are generally considered scientifically more rigorous.
This non-binding recommendation is part of the WHO’s so-called “Guidelines for Living” project designed to provide ongoing guidance to physicians. The panel added that it supports continued enrollment in clinical trials evaluating remdesivir in patients with COVID-19. This “should provide greater certainty of the evidence for a specific patient group,” he said.