A lab technician shows the drug “Remdesivir” for the Coronavirus disease (COVID-19).
Amr Abdullah Dalsh | Reuters
The World Health Organization (WHO) panel advised doctors on Thursday not to use Gilead’s anti-viral drug remdesivir as a treatment for hospitalized patients. Covid-19, Saying there is currently no “evidence” that it improves survival or shortens recovery time – in stark contrast to US regulatory directives on the drug.
The WHO Guidelines Development Group, a panel of international experts who advise the agency, said its recommendation is based on new data comparing the effects of several drug treatments, including data from four international randomized trials involving more than 7,000 hospitalized patients with the disease. . .
“After a comprehensive review of this evidence, the WHO’s GDG expert panel, which includes experts from around the world including four patients with covid-19, concluded that remdesivir has no appreciable effect on mortality or other important outcomes for patients , Such as needing mechanical ventilation or time for clinical improvement, ”the team wrote in a press release.
The recommendation was published in the British medical trade journal The BMJ on Friday in the UK
In an emailed statement, Gilead said that Remsphere is “recognized as the standard of care for treating hospitalized patients with COVID-19 in guidelines from many authoritative national organizations, including the US National Institutes of Health and Infectious Diseases Association of America and Japan, the United Kingdom and Germany” “.
“We are disappointed that the World Health Organization’s guidelines ignore this evidence at a time when cases are increasing dramatically around the world and doctors are relying on PhyClure as the first approved antiviral treatment only for COVID-19 patients in nearly 50 countries,” Gilead spokesperson Chris Ridley said in a statement.
Remdesivir, under the brand name Veklury, is given in a hospital via an IV. Gilead said the medicine should only be given in a hospital or in a healthcare environment that can provide acute care similar to inpatient care.
The majority of patients treated with Remdesivir receive a five-day course using six vials of the drug. The company is also working on developing an inhaled version of the drug, and it will administer it through a nebulizer, which is a delivery device that can convert liquid medications into an aerosol.
The drug received global attention as a potential effective treatment for the coronavirus earlier in the year after a study funded by the National Institutes of Health found that it slightly reduced recovery time in some patients hospitalized with Covid-19. It was one of the drugs used to treat President Donald Trump, who tested positive for the virus last month.
On October 22ndThe Food and Drug Administration has officially approved the drug for adults and pediatric patients 12 years of age or older who require hospitalization due to Covid-19. It is now the first and only drug approved in the United States to treat the Coronavirus, which has infected nearly 56.4 million people worldwide and killed about 1.4 million.
Dr. Anthony Fauci, the country’s leading infectious disease expert, praised the drug, saying it was It will set a “new standard of care” for COVID-19 patients.
Some medical experts note that the data on the drug’s effectiveness has been mixed. In October, a study coordinated by the World Health Organization indicated that the drug contains: Little or no effect On mortality rates among hospitalized patients. The study was conducted in 405 hospitals in 30 countries on 11,266 patients, with 2,750 administered remdesivir.
Gilad publicly questioned the results of the WHO study, To Reuters In October, further trials showed that the treatment reduces recovery time. “Emerging data (WHO) appears inconsistent with stronger evidence from multiple randomized controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir,” Gilead told Reuters.
The WHO panel acknowledged that the evidence so far does not prove that remdesivir “has no benefit”.
But she added that, given the potential for harm as well as the high cost and resources required to administer the drug, it is an “appropriate recommendation”. The group said it supports continuous enrollment in trials that evaluate the drug.