The World Health Organization has now recommended against the usage of Gilead Sciences Inc.’s antiviral medication remdesivir to treat hospitalized COVID-19 patients, as it showed no signs of improving survival or reducing ventilation.
The suggestion against this antiviral medication is coming in less than a month after the US authority has granted the speedy approval of the drug. “The panel found a lack of evidence that remdesivir improved outcomes that matter to patients such as reduced mortality need for mechanical ventilation, time to clinical improvement and others,” the guideline said.
The guideline is a hit for Gilead’s drug, which was one among those drugs thought to offer beneficial treatment against coronavirus, early studies showed it reduced recovery time.
The antiviral drug was one of the medications used to treat U.S. President Donald Trump’s COVID-19 infection and previous studies have also shown that it reduced the recovery time. Currently, Remdesivir is approved for use as a coronavirus treatment in more than 50 countries.
Remdesivir is one of only two medicines that are currently approved to treat COVID-19 patients around the world. But a huge study led by WHO known as the Solidarity Trial showed last month that the antiviral drug had little or no effect on 28-day mortality or duration of hospitalization. The group also reviewed three other trials and concluded that the drug has no visible effect on the time it took patients to clinically improve.
Last month, Gilead Science Inc had reduced its 2020 revenue estimates, due to lower demand than expected and difficulty in predicting sales of remdesivir. The company has questioned the results of the Solidarity Trial by WHO.
“Veklury is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations. 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,” Gilead said in a statement, referring to the drug’s brand name.
The WHO’s Guideline Development Group (GDG) panel stated that the conclusion was derived from evidence that included data from four international randomized trials involving more than 7,000 patients hospitalized with COVID-19.
After reviewing the evidence, the panel concluded that remdesivir, which has to be given intravenously and is therefore costly and complex to administer, has not been able to create any visible changes in death rates or other important outcomes for patients.
“Especially given the costs and resource implications associated with remdesivir, the panel felt the responsibility should be on demonstrating evidence of efficacy, which is not established by the currently available data,” it added.
The guideline by WHO comes following one of the world’s top bodies representing intensive care doctors’ statement which advised not to use antiviral for COVID-19 patients in critical care wards.
However, the panel stated that it supports continued enrolment into clinical trials evaluating remdesivir in patients with COVID-19, to offer higher certainty of proofs for patients under specific groups.
The WHO’s recommendation comes as part of its living guidelines project, designed to guide doctors to make clinical decisions about patients in fast-moving situations like the COVID-19 pandemic.