Presented at the
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
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.
'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
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. Real-world studies should be interpreted based on the type and size of the source datasets and the methodologies used to mitigate potential confounding or bias. RWE should be considered carefully in context of all available data.
In
Aetion and HealthVerity Analysis (iPoster #WMF21-2970)
This retrospective, real-world comparative analysis of
This analysis found that in the overall population, patients receiving Veklury had a statistically significant 23% lower mortality risk compared with controls (HR:0.77, 95% CI:0.73 to 0.81), regardless of baseline oxygen requirement. Overall, a significantly greater likelihood of discharge by Day 28 was observed in patients completing a full five-day course of Veklury compared with controls (HR:1.19, 95% CI:1.14 to 1.25); 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 hospitalized patients who were treated with Veklury (n=28,855) versus matched patients who were not treated with Veklury (n=16,687) between August and
In this analysis, patients overall who were treated with Veklury had a significantly lower risk of mortality both at Day 14 (HR:0.76, 95% CI:0.70 to 0.83, p
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