GILEAD: Data on 53 Patients Treated with investigational antiviral Remdesivir through the compassionate use program published in New England Journal of Medicine

ID 103246793 © Anton Skavronskiy | Dreamstime.com

PRESS RELEASE

Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine

April 10, 2020 at 3:31 PM EDT

— Remdesivir treatment resulted in clinical improvement in 68 percent of patients in this limited data set —

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 10, 2020– Gilead Sciences, Inc. (Nasdaq: GILD) today 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. 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.

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.

Nearly two thirds of patients (64 percent, n=34/53) in this cohort 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 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. 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. Clinical improvement was less frequent among patients on invasive ventilation versus noninvasive ventilation (HR: 0.33 [95 percent CI 0.16, 0.68]) and among patients at least 70 years of age (HR vs < 50 years: 0.29 [95 percent CI 0.11, 0.74]). 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.

To read the full release, please click here.

More about Extracorporeal Membrane Oxygenation (ECMO) here.