Gilead publishes data for antiviral remdesivir in treating COVID-19 patients

Pharma News: Gilead Sciences announced results from a cohort analysis of 53 patients hospitalised with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir.

The majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with remdesivir treatment. Compassionate use data have limitations and multiple Phase 3 studies are ongoing to determine the safety and efficacy of remdesivir for the treatment of COVID-19. The detailed results of this analysis were published today in The New England Journal of Medicine.

Nearly two thirds of patients (64 percent, n=34/53) in this cohort were on mechanical ventilation at baseline. Treatment with remdesivir resulted in an improvement in oxygen support class for 68 percent of patients (n=36/53) over a median follow-up of 18 days from the first dose of remdesivir. More than half of patients on mechanical ventilation were extubated (57 percent, n=17/30) and nearly half of all patients (47 percent, n=25/53) were discharged from the hospital following treatment with remdesivir.

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After 28 days of follow-up, the cumulative incidence of clinical improvement, defined as discharge from the hospital and/or at least a two-point improvement from baseline on a predefined six-point scale, was 84 percent according to Kaplan-Meier analysis.

“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalised patients who received remdesivir are hopeful,” said Jonathan D. Grein, MD, Director of Hospital Epidemiology, Cedars-Sinai Medical Centre and lead author of the journal article.

“While the outcomes observed in this compassionate use analysis are encouraging, the data are limited,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “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.”

Gilead is conducting two Phase 3 clinical trials of remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19. Data from the SIMPLE study in patients with severe disease are expected this month, followed by data from the SIMPLE study in patients with moderate disease in May.

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