Remdesivir Is Not An Effective Treatment For COVID-19, WHO Says
The antiviral drug has been used on hospitalized COVID-19 patients since May, but the World Health Organization now says there is no evidence remdesivir is effective.
The World Health Organization is advising against using the antiviral drug remdesivir as a COVID-19 treatment, citing that there is no evidence of the drug improving patients’ recovery.
On Thursday, a WHO panel released new guidelines in the medical journal, The BMJ on treatments that have been used on COVID-19 patients. The panel analyzed remdesivir, hydroxychloroquine, and lopinavir-ritonavir used on hospitalized COVID-19 patients and wrote that “the role of these drugs in clinical practice has remained uncertain.”
The organization cautioned against using remdesivir “in hospitalized patients, regardless of disease severity, as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”
The new guideline came from analyzing data from four randomized international trials with 7,000 patients hospitalized for COVID-19. The trials showed the drug had “no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement,” according to the WHO. The panel also said the high-cost and difficulty of administering the drug (intravenously) were also factors in its recommendation.
The guideline comes as COVID-19 surges worldwide, particularly in the U.S., where hundreds of thousands of new cases have been reported daily over the last several weeks. The U.S. has reported more than 11.7 million COVID-19 cases, including at least 252,000 deaths as of Friday, according to Johns Hopkins University.
The pharmaceutical company that manufactures remdesivir, Gilead, released a statement on Thursday saying that it is “disappointed” in the WHO’s latest guideline.
“[Remdesivir] is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations,” the statement read. “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 [remdesivir] as the first and only approved antiviral treatment for patients with COVID-19.”
The Food and Drug Administration issued emergency use authorization (EUA) for remdesivir in May but revised the approval in late October and limited the treatment to hospitalized patients only. When President Trump contracted COVID-19 in early October, doctors gave him a “cocktail” of treatments including remdesivir.
The WHO panel also reiterated that the recommendation of using common corticosteroids on severe COVID-19 patients has not changed.
The treatments for COVID-19 have evolved in the months since the virus first emerged in late 2019. Hydroxychloroquine was once thought to be a viable treatment option, but the FDA later advised against using the drug and revoked its EUA.
The WHO announcement comes as pharmaceutical giant Pfizer announced Friday it would submit its COVID-19 vaccine candidate produced in part with BioNTech to the FDA. The company said the promising vaccine was shown to be 95% effective at preventing COVID-19 in clinical trials. Moderna announced its own vaccine candidate earlier this week and said it would be submitting for EUA from the FDA in the coming weeks.