The World Health Organization on Friday addressed criticism from drugmaker Gilead over the group’s interim finding that the antiviral remdesivir has “little or no effect in preventing death from COVID-19 or reducing time in hospital.”
WHO’s interim trial results, which it said would be published soon in a peer-reviewed journal, sparked pushback from Gilead, which said in a statement that the data appears inconsistent with evidence from other studies of the drug.
“We are concerned that the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design,” the company said in a statement.
Remdesivir, which was given to President Donald Trump when he contracted COVID-19, has been administered to thousands of patients in the U.S. following its emergency use authorization from the Food and Drug Administration.
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Gilead contends that because the trial prioritized broad access, which resulted in “significant heterogeneity in trial adoption, implementation, controls and patient populations,” it is unclear if the study’s findings are conclusive.
But WHO Director General Tedros Adhanom Ghebreyesus defended the so-called Solidarity Trial, which was launched to study the effectiveness of remdesivir and three other drugs in treating COVID-19, as the largest trial in the world. It included more than 11,000 coronavirus patients across 30 countries, with more than 2,700 participants given remdesivir.
“For the moment, the corticosteroid dexamethasone is still the only therapeutic shown to be effective against COVID-19, for patients with severe disease,” Tedros said at a press conference.
The organization reported “factually on what we found,” WHO’s Chief Scientist Soumya Swaminathan said, adding that “we believe that the results are very robust.”
WHO’s guideline development group will examine the data and possibly update their policy on the use of remdesivir in a couple weeks.