Gilead Sciences remdesivir has shown, in several studies, that it can decrease the hospital stays of patients who contract COVID-19. However, a new World Health Organization (WHO) clinical trial indicates that Gilead’s remdesivir does not have a particular effect on a patient’s survival.
The Financial Times reported that the Solidarity Trial evaluated remdesivir and three other drugs in hospitalized COVID-19 patients, finding that none of the drugs “substantially affected mortality” or decreased the need to ventilate patients.
“These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little effect on in-hospital mortality,” stated the study.
The WHO’s Solidarity Trial demonstrated that the drugs did not affect hospital stays, which seems to contradict previous studies. WHO scientists said that was not the focus of the trial, which was meant to evaluate the in-hospital mortality impact; the study was not peer-reviewed.
Veklury, the brand name for remdesivir, is the only antiviral drug in the U.S.A. that is authorized to treat COVID-19. Emergency authorization was granted in the U.S.A. and Europe after a National Institute of Allergy and Infectious Diseases (NIAID) test trial in April proved promising.
An infectious disease doctor at the University of Alberta, Canada, Ilan Schwartz, told the New York Times, “This puts the issues to rest – there is certainly no mortality benefit.”
Although some infectious disease researchers don’t have as negative an outlook. Peter Chin-Hong at the University of California, San Francisco, noted that the size of the conducted trial in several countries and healthcare systems is difficult to analyze.
Chin-Hong told The New York Times, “So much goes into care. The drug is only part of it.”
Reuters reported that Gilead Sciences said the data seems inconsistent, the results were premature, and other studies had already validated remdesivir’s benefits, including a placebo trial demonstrating the drug decreased recovery time.
“The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir,” Gilead Sciences told Reuters.
During the Solidarity Trial, the drugs hydroxychloroquine and lopanivir/ritonavir were halted after they were proven ineffective. Remdesivir and interferon, however, continued being used in more than 30 countries.
The WHO indicated the Solidarity Trial had “generated conclusive evidence” on the effectiveness of drugs repurposed for treating COVID-19, and that “the progress achieved by the Solidarity therapeutics trial shows that large international trials are possible, even during a pandemic, and offer the promise of quickly and reliably answering critical public health questions concerning therapeutics.”
Gilead Sciences indicated it was “unclear if any conclusive findings can be drawn” because of the inconsistencies in how the study was conducted from site to site. Gilead also noted, “We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”
The Solidarity Trial continues with new drugs added and removed at any time. So far, the four drugs in the study appear to cover March to October.
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