WHO urges medical doctors to not use Gilead’s remdesivir as a coronavirus therapy as they’re separating from the FDA
A laboratory technician shows the drug “Remdesivir” used to treat coronavirus disease (COVID-19).
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A panel from the World Health Organization advised doctors Thursday against using Gilead Sciences’ antiviral drug Remdesivir to treat patients with Covid-19. Currently, there is “no evidence” that it improves survival or reduces recovery time – in stark contrast to US approval guidelines for the drug.
The WHO Guideline Development Group, a panel of international experts advising the agency, said its recommendation was based on new data comparing the effects of multiple drug treatments, including data from four international randomized trials of more than 7,000 patients with the disease Hospitalized.
“After carefully reviewing this evidence, the WHO GDG Panel of Experts, made up of experts from around the world, including four patients with Covid-19, concluded that remdesivir did not have a significant impact on mortality or other important outcomes for patients, such as need for mechanical ventilation or time to clinical improvement, “the group wrote in a press release.
The recommendation was published in The BMJ in the UK on Friday
In a statement emailed, Gilead said remdesivir “has been included in guidelines by numerous credible national organizations, including the US National Institutes of Health and the Infectious Diseases Society of America, Japan, as the standard for the treatment of hospital patients with COVID- 19. Great Britain and Germany. “
“We are disappointed that WHO guidelines seem to be ignoring this evidence at a time when cases are increasing dramatically around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 in approximately 50 countries.” Gilead spokesman Chris Ridley said in a statement.
Remdesivir is given via infusion in a hospital under the brand name Veklury. Gilead has said the drugs should only be given in a hospital or health care facility that can provide acute care that is comparable to inpatient hospital care.
The majority of patients treated with Remdesivir receive a five-day course with six vials of the drug. The company is also developing an inhaled version of the drug that is administered via a nebulizer, a delivery device that can turn liquid drugs into mist.
The drug received global attention as a potentially effective treatment for the coronavirus earlier this year after a study funded by the National Institutes of Health found it slightly reduced recovery time in some patients hospitalized with Covid-19. It was one of the drugs used to treat President Donald Trump that tested positive for the virus last month.
On October 22nd, the Food and Drug Administration officially approved the drug for adults and pediatric patients 12 years and older who need to be hospitalized for Covid-19. It is now the first and only drug approved in the United States to treat the coronavirus, which has infected around 56.4 million people and killed around 1.4 million people worldwide.
Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, praised the drug and said it would “set a new standard for care” for Covid-19 patients.
Some medical experts note that the data on the drug’s effectiveness are mixed. In October, a study coordinated by the WHO found that the drug had “little or no effect” on the death rate in hospital patients. The study was conducted on 11,266 patients at 405 hospitals in 30 countries, with 2,750 remdesivir administered.
Gilead has publicly questioned the results of the WHO study, telling Reuters in October that other studies show that the treatment reduces recovery time. “The emerging data (WHO) appear to be inconsistent, with more robust evidence from multiple randomized controlled trials published in peer-reviewed journals confirming the clinical benefits of remdesivir,” Gilead told Reuters.
The WHO panel acknowledged that the evidence to date fails to show that remdesivir “has no benefit”.
However, given the potential for harm and the high cost and resources required to administer the drug, this is a “reasonable recommendation”. The group said it supports continued participation in studies evaluating the drug.