Gilead Sciences has announced positive data from a trio of retrospective studies of real-world treatment of hospitalized COVID-19 patients with Veklury (remdesivir). Presented at the recent online World Microbe Forum event, the findings of the three analyses reportedly indicate patients receiving the treatment experienced significantly lower mortality risk, compared with matched controls.
Robert Gottlieb, a cardiologist at Baylor University Medical Center and Baylor Scott and White Research Institute, said while trials are helpful in determining the effectiveness and safety of a treatment, they can limit researchers' abilities to accurately assess all the potential aspects of a drug’s effect.
“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,” he said. “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.”
According to researchers conducting the analyses, they observed a reduction in mortality across a range of baseline oxygen requirements, with results consistently observed at different timeframes over the course of the pandemic and across geographies. Additionally, in two of the studies, researchers observed that patients who received the remdesivir experienced an increased likelihood from the hospital by the 28th day.
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; the third matched clinical outcomes in patients that received 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.
According to researchers, all of the studies employed 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. Gilead reports that real-world evidence (RWE) analyses of Veklury from other sources are ongoing.
In the US, Veklury is indicated for adults and pediatric patients 12 years of age and older, weighing 40kg (approximately 88 lbs) or more, for treating cases of COVID-19 that require hospitalization. Veklury is not recommended for patients allergic to remdesivir or any of its components.