FLC | Army partner Gilead reports positive effects of compassionate-use remdesivir

Army partner Gilead reports positive effects of compassionate-use remdesivir

April 11, 2020

Army partner Gilead Sciences, Inc. on April 10 announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis.

The majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with remdesivir treatment. The detailed results of this analysis were published on April 10 by the New England Journal of Medicine.

Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for the treatment of COVID-19. In early March, the US Army Medical Research and Development Command signed an agreement with Gilead for the company to provide the investigational drug for troops confirmed to have the COVID-19 virus.

In the NEJM study, nearly two thirds of patients (64%) were on mechanical ventilation at baseline, including four patients also on extracorporeal membrane oxygenation (ECMO). Treatment with remdesivir resulted in an improvement in oxygen support class for 68% of patients over a median follow-up of 18 days from the first dose of remdesivir. More than half of patients on mechanical ventilation were able to discontinue its use (57%) and nearly half of all patients (47%) were discharged from the hospital following treatment with remdesivir.

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%. Clinical improvement was less frequent among patients on invasive ventilation versus noninvasive ventilation and among patients at least 70 years of age.

“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," said Jonathan D. Grein, MD, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, and lead author of the journal article. “We look forward to the results of controlled clinical trials to potentially validate these findings.”

The overall mortality rate in this cohort was 13%. Deaths were more common among patients on invasive ventilation (18%) than those on noninvasive oxygen support (5%). Factors associated with an increased risk of mortality included age greater than 70 years and worse baseline kidney function.

Compassionate use data have limitations due to the small size of the cohort, the relatively short duration of follow-up, potential missing data due to the nature of the program and lack of a randomized control group. Multiple Phase 3 studies are ongoing to more closely study the safety and efficacy of remdesivir for the treatment of COVID-19.

“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 in countries with high prevalence of COVID-19. Data from patients with severe disease are expected this month, followed by data from patients with moderate disease in May.

In addition, Gilead is supporting multiple clinical trials led by other organizations, including two studies conducted in Hubei Province, China. Gilead has been informed that the study in China in patients with severe disease was terminated early due to low enrollment; the company awaits the publication of these data to enable an in-depth review of the results. The study in China in patients with mild-to-moderate disease is ongoing.

A global study of remdesivir led by the National Institute of Allergy and Infectious Diseases continues to enroll patients and data from this study are anticipated in May. Finally, additional studies of remdesivir and other investigational treatments for COVID-19, based on a master protocol by the World Health Organization, have also begun to enroll patients in countries around the world.