Gilead’s Veklury (Remdesivir) Associated With a Reduction in Mortality Rate in Hospitalized Patients With COVID-19 Across Three Analyses of Large Retrospective Real-World Data Sets

Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge data for patients treated with Veklury (remdesivir). Presented at the World Microbe Forum (WMF) this week, all three of the real-world analyses observed that, in the overall patient populations, patients who received Veklury treatment had significantly lower risk for mortality compared with matched controls. A reduction in mortality was observed across a spectrum of baseline oxygen requirements. The results were consistently observed at different timeframes over the course of the pandemic and across geographies. Two of the studies also observed that patients who received Veklury had a significantly increased likelihood of discharge from the hospital by Day 28.

The three real-world data analyses presented at WMF include 98,654 patients hospitalized with COVID-19. Two retrospective studies observed treatment trends and outcomes in the U.S. from the HealthVerity and Premier Healthcare databases. A third analysis compared clinical outcomes in patients receiving a 10-day treatment course of Veklury in the extension phase of the global, open-label SIMPLE-Severe study with patients receiving standard of care in a real-world retrospective longitudinal cohort study. All three analyses utilized pre-specified endpoints, best practice methodologies, including robust matching and weighting approaches, and sensitivity analyses, and were conducted in collaboration with independent experts in real-world comparative effectiveness research. Real-world evidence (RWE) analyses of Veklury from other sources are ongoing and may vary in their results or conclusions.

In the double-blind, placebo-controlled ACTT-1 clinical trial of hospitalized patients with COVID-19, there was a trend toward reduced mortality at Day 29 (11% vs. 15%, HR:0.73, 95% CI:0.52 to 1.03) in Veklury-treated patients (n=541) compared with placebo (n=521) in the overall study population; this result was not statistically significant. Given the range of disease severity in the overall study population, a post-hoc analysis with no adjustment for multiple testing was conducted to determine whether there were differences in mortality based on patients’ baseline clinical status. In this analysis, patients requiring low-flow oxygen at baseline who received Veklury achieved a statistically significant 70% reduction in mortality at Day 29 (4% vs. 13%; HR:0.30, 95% CI:0.14 to 0.64). The difference in mortality in other subgroups based on baseline clinical status was not statistically significant. The effect on mortality observed in other published studies has varied, by both result and analysis method.