Gilead presents additional data on investigational antiviral remdesivir for the treatment of COVID-19.

Gilead Sciences, Inc. announced additional data on remdesivir, an investigational antiviral for the treatment of COVID-19, adding to the available body of knowledge on treatment outcomes with remdesivir. The data are being presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference (AIDS 2020: Virtual) and include a comparative analysis of the Phase III SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe COVID-19. In this analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care – an important finding that requires confirmation in prospective clinical trials. Separate subgroup analyses from the Phase III SIMPLE-Severe trial, including an evaluation of the safety and efficacy of remdesivir across different racial and ethnic patient subgroups treated in the United States, found that traditionally marginalized racial or ethnic groups treated with remdesivir in this study experienced similar clinical outcomes as the overall patient population in the study. Gilead is also presenting new analyses of the company’s compassionate use program, which demonstrated that 83 percent of pediatric patients (n=77) and 92 percent of pregnant and postpartum women (n=86) with a broad spectrum of disease severity recovered by Day 28 . No new safety signals were identified with remdesivir across these populations. To further the understanding of these results in individual patient cases, Gilead recently announced the initiation of a global, open-label Phase II/III trial to evaluate the safety, tolerability and pharmacokinetics of remdesivir in pediatric patients from birth to less than 18 years of age. Gilead is also collaborating on a study for pregnant women.