4 coronavirus treatments, including remdesivir, hydroxychloroquine, flop in large WHO study
Gilead Sciences, drug manufacturer of remdesivir, raised concerns over the data because it has yet to undergo 'rigorous review'
{{#rendered}} {{/rendered}}Four coronavirus drugs were found to have "little or no effect" on hospitalized patients, according to preliminary results from a World Health Organization study.
Anticipated findings from the WHO’s multi-country Solidarity trial were posted ahead of peer review in medRxiv on Thursday, which assessed remdesivir, hydroxychloroquine, interferon and an HIV-drug combo lopinavir-ritonavir.
“The main outcomes of mortality, initiation of ventilation and hospitalization duration were not clearly reduced by any study drug,” according to the study.
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While hydroxychloroquine and lopinavir were dropped from the WHO trial over the summer over futility, the remdesivir findings directly contrast with results from a U.S. NIH-led study, which early data showed to shorten patients' path to recovery by four days. Those results were recently upheld by a final report, which sped recovery by five days; faster than previously reported. John Beigel, associate director of clinical research in the division of microbiology and infectious disease at NIAID, told TIME that “these data reinforce the value of Remdesivir in hospitalized patients.”
The drug manufacturer of remdesivir, Gilead Sciences, released a statement voicing concerns over the WHO trial.
{{#rendered}} {{/rendered}}"The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury® (remdesivir)," company officials wrote. "We are concerned that the data from this openlabel global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design."
Gilead previously ran its own clinical trials on the drug, and found that 65% of moderately ill patients had improvement after 11 days.
The WHO study involved over 11,000 adults across 405 hospitals in 30 countries on multiple treatments tested against a control arm; 2,750 patients were allocated remdesivir. (The NIH study involved 1,062 patients who were randomly assigned remdesivir or a placebo for 10 days.)
{{#rendered}} {{/rendered}}In the company statement sent to Fox News, Gilead pointed to the WHO trial's "significant heterogeneity in trial adoption, implementation, controls and patient populations" because the trial design prioritized broad access.
Dr. Soumya Swaminathan, WHO chief scientist, touted the Solidarity trial on Wednesday, calling it a "wonderful global collaboration" that benefited from preparations and investments made over the last few years, having learned from Ebola and other outbreaks. She said, in approaching the trials for COVID-19, investigators knew how to write protocols quickly, ideas were shared around the clock and drug manufacturers came forward to donate drugs.
She called it a "good experience" all-in-all, and on Wednesday before the data was released, she said next plans will involve monoclonal antibodies, immunomodulators and new antiviral drugs developed within the last few months.
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