The World Health Organization told doctors not to use Gilead’s remdesivir as Covid treatment for hospitalized patients.
According to the agency, there is currently “no evidence” that Gilead’s remdesivir as Covid treatment can increase the chance of survival or lessen the recovery time.
The WHO Guideline Development Group, a panel of international experts, explained that its advice is based on new information that compares the effects of drug treatments, including data from four international randomized trials with more than 7,000 patients hospitalized with Covid-19.
“After thoroughly reviewing this evidence, the WHO GDG expert panel, which includes experts from around the world including four patients who have had covid-19, concluded that remdesivir has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement,” the group wrote in a press release.
The statement was published in the British medical trade journal The BMJ on Friday in the U.K.
Meanwhile, Gilead said in an email that remdesivir “is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations, including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany.”
“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing 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.
The company has questioned the findings of the WHO study. “The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir,” Gilead told Reuters.
The WHO panel stressed that the evidence so far does not confirm that remdesivir “has no benefit.”
However, it noted that given the risk of harm, the high cost, and resources needed to give the drug, it is an “appropriate recommendation.” The group added it supports enrollment in trials assessing the drug.
Approval for Gilead’s remdesivir as Covid treatment
In October, the Food and Drug Administration has approved remdesivir as a coronavirus treatment for patients at least 12 years old.
Gilead Sciences’ antiviral drug is now the first and only fully approved treatment in the US for Covid-19.
Remdesivir will be given to Covid-19 patients who are at least 12 years old and will stay in the hospital, according to Gilead Sciences.
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead CEO Daniel O’Day said in a statement. “It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need.”