WHO tells doctors don’t use Gilead’s remdesivir, splitting with FDA


A lab technician shows coronovirus disease (COVID-19) treatment drug “Remedisvir”.

Amr Abdullah Dalsh | Reuters

A panel of the World Health Organization on Thursday advised doctors to use Gilead Sciences’ antiviral drug Remedisvir as a treatment for patients hospitalized with Kovid-19, saying that currently “there is no evidence” that it Improves Survival or Reduces Recovery Time – Unlike the US. Regulatory guidance on medicine.

The WHO Guideline Development Group, a panel of international experts that provide advice to the agency, said its recommendation is based on new data comparing the effects of new drug treatments, including data from four international randomized trials , Involving more than 7,000 patients. .

“After a thorough review of this evidence, the WHO GDG Expert Panel, consisting of experts from around the world, including four patients who have Kovid-19, concluded that Remedisvir had a higher rate of mortality or on patients. There is no meaningful impact on other important outcomes, such as mechanical ventilation or clinical improvement requiring time, ”the group wrote in a press release.

The recommendation was published in Britain in the British Medical Trade Journal The BMJ on Friday

In an emailed statement, Gilead stated that Remedisvir was set up as a standard for the treatment of hospitalized patients with COVID-19 under the guidelines of several trusted national organizations, including the US National Health and Infectious Diseases Society of America, Japan. Is recognized as. UK and Germany. “

“We are disappointed that WHO guidelines appear to ignore this evidence at a time when cases are increasing dramatically worldwide and doctors are the first and only approved antiviral treatment for patients with COVID-19 in nearly 50 countries. I am trusting Vekleri, “Gilead spokesman Chris Ridley said in a statement.

Remedswear, under the brand name Vecleri, is administered in a hospital setting through an IV. Gilead has stated that the drug should only be administered in a hospital or in a health care setting that can provide acute care with inconsistent hospital care.

Most patients treated with Remedisvir receive a five-day course using six vials of medicine. The company is also developing an inhaled version of the drug, which it will administer via a nebulizer, a delivery device that can transform liquid drugs into gauze.

The drug garnered worldwide attention as a potentially effective treatment for coronovirus early in the year following a study funded by the National Institutes of Health, which found that it has been found in some patients hospitalized with Covid-19 Reduced recovery time. It was one of the drugs used to treat President Donald Trump, who tested positive for the virus last month.

On October 22, the Food and Drug Administration formally approved the drug for adults 12 and older, and pediatric patients who require hospitalization for Kovid-19. It is now the first and only drug approved in the US for the treatment of coronovirus, which has infected approximately 56.4 million people worldwide and killed about 14 million people.

The country’s leading infectious disease specialist, Dr. Anthony Fauci praised the drug, saying it would set “a new standard of care” for Kovid-19 patients.

Some medical experts mix data on drug effectiveness. In October, a study coordinated by the WHO indicated that the drug has “little or no effect” on mortality in hospitalized patients. The study was conducted on 11,266 patients in 405 hospitals in 30 countries, with 2,750 given.

Gilead has publicly questioned the findings of the WHO study, telling Reuters in October that other tests indicate treatment reductions. “Emerging (WHO) data appears to be inconsistent,” Gilead told Reuters, with more detail than studies published in several randomly controlled, peer-reviewed journals.

The WHO panel acknowledged that the evidence so far does not prove that remedisvir “is of no avail.”

But it added the possibility of harm as well as higher costs and the need to medicate resources, a “reasonable recommendation”. The group said it supports continued enrollment in trials evaluating the drug.



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