Gilead’s promising COVID-19 drug remdesivir shows benefit in 68% of hospitalised patients
pharmafile | April 14, 2020 | News story | Manufacturing and Production, Research and Development | COVID-19, Gilead, coronavirus, pharma, remdesivir
Gilead has provided an update on its ongoing efforts against the novel coronavirus, revealing data from a cohort analysis of its antiviral therapy remdesivir, one of the most promising treatments for patients hospitalised by COVID-19.
The findings, published in The New England Journal of Medicine, were drawn from 53 participants hospitalised due to severe complications with COVID-19, 34 of which were being treated with mechanical ventilation at baseline, including four patients who were also receiving extracorporeal membrane oxygenation. The patients received remdesivir through individual compassionate use.
The results of the study showed that 68% of participants receiving remdesivir experienced an improvement in oxygen support class over a median follow-up of 18 days from the first dose. Following treatment, 57% of patients were extubated and 47% were discharged.
Ultimately, after 28 days of follow-up, it was found that 84% of all participants had shown clinical improvement, either achieving hospital discharge or an improvement of at least two points from baseline on a predefined six-point scale.
Those patients at least 70 years old or who were receiving invasive ventilation were less likely to show clinical improvement. Unfortunately, 13% of participants died during the study, with mortality concentrated in those over 70 and with higher baseline serum creatinine levels; this broke down into 18% of patients on invasive ventilation compared to 5% of those on non-invasive ventilation.
“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” remarked Dr Jonathan D Grein, lead author of the study and Director of Hospital Epidemiology at the Cedars-Sinai Medical Center in Los Angeles. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
Gilead is busy conducting a range of ongoing Phase 3 studies into remdesivir for the treatment of COVID-19 patients.
“While the outcomes observed in this compassionate use analysis are encouraging, the data are limited,” explained Dr Merdad Parsey, Chief Medical Officer t Gilead. “Gilead has multiple clinical trials underway for remdesivir with initial data expected in the coming weeks. Our goal is to add to the growing body of evidence as quickly as possible to more fully evaluate the potential of remdesivir and, if appropriate, support broader use of this investigational drug.”
Matt Fellows
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