-- Data Presented Includes a Comparative Analysis of Clinical Recovery and Mortality Outcomes from the Phase 3 SIMPLE Trial Versus Real-World Cohort of Severe COVID-19 Patients Receiving Standard of Care --

-- Traditionally Marginalized Racial/Ethnic Groups Treated with Remdesivir Had Similar Clinical Outcomes as Overall Patient Population --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today 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 3 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 3 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 2/3 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.

Due to the current public health emergency, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for remdesivir for the treatment of hospitalized patients with severe COVID-19; please see below for additional important warnings and information about the authorized use of remdesivir in the United States. In the United States, remdesivir is an investigational drug that has not been approved by the FDA, and the safety and efficacy of remdesivir for the treatment of COVID-19 has not been established.

“We are working to broaden our understanding of the full utility of remdesivir. To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These data presented at the Virtual COVID-19 Conference shed additional light on the use of remdesivir in specific patient populations, including those that may be susceptible to higher rates of COVID-19 infection, as well as others that are particularly vulnerable, including children and pregnant and postpartum women.”

Comparative Analysis of Phase 3 SIMPLE-Severe Study and Real-World Retrospective Cohort of Patients Diagnosed with Severe COVID-19 Receiving Standard of Care

This comparative pre-planned analysis included 312 patients treated in the Phase 3 SIMPLE-Severe study and a separate real-world retrospective cohort of 818 patients with similar baseline characteristics and disease severity who received standard of care treatment in the same time period as the SIMPLE-Severe study. Patients were primarily located in North America (92 percent, remdesivir cohort vs. 91 percent, standard-of-care cohort), Europe (5 percent vs. 7 percent) and Asia (3 percent vs. 2 percent). The analysis demonstrated that remdesivir treatment was associated with significantly improved clinical recovery and a 62 percent reduction in the risk of mortality compared to standard of care. Findings from the comparative analysis showed that 74.4 percent of remdesivir-treated patients recovered by Day 14 versus 59.0 percent of patients receiving standard of care; recovery was defined as improvement in clinical status based on a 7-point ordinal scale. The mortality rate for patients treated with remdesivir in the analysis was 7.6 percent at Day 14 compared with 12.5 percent among patients not taking remdesivir (adjusted odds ratio 0.38, 95% confidence interval 0.22-0.68, p=0.001).

“This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone,” said Susan Olender, MD, Columbia University Irving Medical Center. “While not as vigorous as a randomized controlled trial, this analysis importantly draws from a real-world setting and serves as an important adjunct to clinical trial data, adding to our collective understanding of this virus and reflecting the extraordinary pace of the ongoing pandemic.”

The results of this comparative analysis add to the previously presented National Institute of Allergy and Infectious Disease (NIAID) randomized, double-blind, placebo-controlled study in hospitalized patients with COVID-19, which showed that remdesivir shortened time to recovery by an average of four days as compared to placebo (11 vs. 15 days; p