Three real-world analyses show that in patients hospitalised with COVID-19, Veklury® (remdesivir) significantly lowers the risk for mortality and significantly increased likelihood of discharge from the hospital by Day 28, compared with matched controls. The data from 98,654 patients hospitalised with COVID-19 will be presented by Gilead Sciences Inc. will be presented at the World Microbe Forum (WMF).
Two of the studies are retrospective and 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. Real-world evidence (RWE) analyses of Veklury from other sources are ongoing and may vary in their results or conclusions.
“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,” commented Dr Robert Gottlieb, Cardiologist at Baylor University Medical Center and Baylor Scott & White Research Institute, both US. “These real-world analyses provide clinicians with additional data on the efficacy of remdesivir (Veklury) in patients hospitalised with COVID-19, including its effect on mortality and likelihood of discharge from the hospital.”
HealthVerity Analysis
iPoster #WMF21-2970
This retrospective, real-world comparative analysis assessed mortality and likelihood of discharge in hospitalised COVID-19 patients who were treated with Veklury (n=24,856) versus matched controls (n=24,856) between 1 May 2020 and 3 May 2021 using US-based claims data from HealthVerity.
This analysis found that in the overall population, patients receiving Veklury had a statistically significant 23 percent lower mortality risk compared with controls (, regardless of baseline oxygen requirement. Those treated with a full five-day course of Veklury had a significantly greater likelihood of discharge by Day 28, compared with controls. This result was most pronounced in patients with lower oxygen requirements at baseline.
Premier Analysis
iPoster #WMF21-2507
This retrospective, real-world comparative analysis of data from the Premier Healthcare Database assessed mortality in hospitalised patients who were treated with Veklury (n=28,855) versus matched patients who were not (n=16,687) between August and November 2020.
In this analysis, patients overall who were treated with Veklury had a significantly lower risk of mortality both at Day 14 (Hazard Ratio [HR]: 0.76) and at Day 28 (HR: 0.89) compared with patients who did not receive Veklury. Patients who were treated with Veklury and received either no oxygen (HR: 0.69), low-flow oxygen (HR: 0.68) or invasive mechanical ventilation/ECMO (HR: 0.70) at baseline had a significantly lower risk of 14-day mortality. A significant reduction in mortality was also noted at 28 days for these same groups of patients, no oxygen (HR: 0.80), low-flow oxygen (HR: 0.77) or invasive mechanical ventilation/ECMO (HR: 0.81).
SIMPLE-Severe Analysis
iPoster #WMF21-2969
The SIMPLE-Severe study was a randomised, open-label, multi-centre, Phase III study in hospitalised adult patients with severe COVID-19 (oxygen saturation of ≤94 percent on room air or receiving supplemental oxygen and radiological evidence of pneumonia. The retrospective real-world analysis compared mortality outcomes of hospitalised patients with COVID-19 who received Veklury in the open-label extension phase of the SIMPLE-Severe study (n=1,974) versus propensity...
(All Rights Reserved)