Remdesivir Associated With Reduction in Mortality Rate in Hospitalized Patients With COVID-19

Three analyses of large, retrospective, real-world data sets have found that remdesivir was associated with a reduction in mortality rates in patients hospitalized with COVID-19, according to a Gilead press release. Remdesivir is indicated for hospitalized adults and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19.

The 3 data analyses include 98,654 patients who were hospitalized with COVID-19. Two of the studies observed treatment trends and outcomes in the United States using the HealthVerity and Premier Healthcare databases, whereas the third analysis compared clinical outcomes in patients receiving a 10-day treatment course of remdesivir in the extension phase of the SIMPLE-Severe study.

“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,” said Robert L. Gottlieb, MD, PhD, a cardiologist at the Baylor University Medical Center, in a press release. “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.”

This reduction in mortality was observed across a spectrum of baseline oxygen requirements, and the results were consistent at different timeframes over the course of the pandemic and across geographies, according to the researchers. Two of the studies also found that patients who received remdesivir had a significantly increased chance of discharge from the hospital by day 28.

The analysis of data from HealthVerity matched 24,856 patients treated with remdesivir 1:1 with matched controls between May 1, 2020, and May 3, 2021. Researchers found that in the overall population, patients receiving remdesivir had a statistically significant 23% lower mortality risk compared with patients in the control arm, regardless of baseline oxygen requirement.

Investigators also observed a significantly greater likelihood of discharge by day 28 in patients who completed a full 5-day course of remdesivir compared with patients in the control arm. This result was most pronounced in patients with lower oxygen requirements at baseline.

Similarly, an analysis of data from the Premier Healthcare Database found that patients treated with remdesivir had a significantly lower risk of mortality at days 14 and 28 compared with patients who did not receive remdesivir. Patients who received remdesivir and either no oxygen, low-flow oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at baseline had a significantly lower risk of 14-day mortality.

A significant reduction in mortality was also seen at day 28 for these same groups of patients, and patients on high-flow oxygen at baseline who received remdesivir also had significantly lower 14-day mortality. At 28 days, the difference in mortality in patients receiving high-flow oxygen at baseline was not statistically significant.

The SIMPLE-Severe study evaluated hospitalized adult patients with severe COVID-19. Investigators found that in the overall population, treatment with remdesivir was associated with a statistically significant 54% lower mortality risk at 28 days compared to patients who were not treated with remdesivir, regardless of baseline oxygen requirements.

Furthermore, patients who completed a full 10-day course of treatment had a significantly shorter time to discharge within 28 days, compared to patients who did not receive remdesivir. The result for time to discharge was not significant for patients receiving mechanical ventilation or ECMO at baseline.

Finally, in the double-blind, placebo-controlled ACTT-1 clinical trial, investigators noted a trend toward reduced mortality at day 29 among patients who were treated with remdesivir compared with placebo, although this result was not statistically significant.

Researchers also conducted a post-hoc analysis with no adjustment for multiple testing and determined that patients who required low-flow oxygen at baseline and who received remdesivir achieved a statistically significant 70% reduction in mortality at day 29, although this reduction was not statistically significant in the other groups.

“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,” Gottlieb said in the press release.

REFERENCE

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. News release. Gilead. June 21, 2021. Accessed July 21, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/6/gileads-veklury-remdesivir-associated-with-a-reduction-in-mortality-rate-in-hospitalized-patients-with-covid19-across-three-analyses-of-large-ret