Gilead’s Remdesivir Reduced Mortality in Hospitalized COVID-19 Patients, Shows Real-World Data Analyses

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 include 98,654 patients hospitalized with COVID-19. Two retrospective studies observed treatment trends and outcomes in the US 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.

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.

While randomized clinical trials (RCTs) remain the best tool for assessing the efficacy and safety of a medicine, RWE provides important data on a treatment’s use in clinical practice that can complement data from RCTs. These studies take on greater incremental importance in a pandemic, where clinical management of a disease continues to evolve and can outpace the initiation of new clinical trials, and where frontline healthcare workers are eager for RWE to guide and reinforce treatment decisions in real time.

“Clinical trials help us understand the efficacy and safety profile of a treatment, but their size can limit our ability to assess all potential aspects of a treatment’s effect due to low event rates in the trials. Large real-world datasets with greater sample sizes and robust methodologies can be helpful to assess treatment effects in both the overall patient population and in clinically relevant subsets of patients,” said Robert L. Gottlieb, MD, PhD, Cardiologist at Baylor University Medical Center and Baylor Scott & White Research Institute. “These real-world analyses provide clinicians with additional data on the efficacy of remdesivir (Veklury) in patients hospitalized with COVID-19, including its effect on mortality and likelihood of discharge from the hospital.”

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