Leaked data show Gilead’s remdesivir allows severe COVID-19 patients to be discharged after six days
pharmafile | April 17, 2020 | News story | Medical Communications, Research and Development | COVID-19, Gilead, coronavirus, remdesivir
The clinical benefit of Gilead’s promising antiviral therapy Remdesivir has been touted in the treatment of severe cases of COVID-19 after anecdotal reports of its success were obtained from a trial conducted at the University of Chicago Medicine.
Many have high hopes for the therapy, which was originally trialled as an Ebola treatment and has pulled to the front of the pack in the race for an effective treatment in the short term for severe cases of COVID-19.
The University trialled daily infusions of remdesivir in 125 participants with COVID-19, 113 of which were suffering from a severe form of the disease, as part of two Gilead-sponsored Phase 3 studies.
It was reported that almost all of the patients were ultimately able to be discharged from hospital in less than a week. Excitement around the new report sent Gilead shares up by 14%.
“Certainly when we start [the] drug, we see fever curves falling,” explained Kathleen Mullane, the University of Chicago infectious disease specialist who oversaw the trial. “Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.
“Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she added.
She made the comments in a video discussing the findings with other University staff, obtained by STAT News.
Gilead refrained from commenting on the results directly, only teasing at what may be to come: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”
However, despite the promise these results suggest, it is important to note that the study did not feature a control group, making it more difficult to definitively determine that drug is causing patient recoveries.
Gilead advised that we manage our expectations at this stage, telling CNN: “The totality of the data need to be analysed in order to draw any conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for Covid-19.”
Full results from the study’s first 400 patients are expected to be released later this month.
Matt Fellows
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