Treatment with remdesivir was associated with an improvement in clinical recovery and a 62% reduction in the risk of mortality in patients with severe coronavirus disease 2019 (COVID-19), according to new data presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference.
To investigate the clinical benefits of the investigational antiviral, an analysis was conducted comparing outcomes from 312 patients treated with remdesivir plus standard of care in the phase 3 SIMPLE-Severe study to a separate real-world retrospective cohort of 818 patients with similar baseline characteristics and disease severity who only received standard of care in the same time period.
Results from the analysis showed that 74.4% of patients treated with remdesivir recovered (defined as an improvement in clinical status based on a 7-point ordinal scale) by day 14 compared with 59% of patients who only received standard of care. Additionally, the mortality rate at day 14 was found to be 7.6% for the remdesivr group and 12.5% for the standard of care group (adjusted odds ratio 0.38; 95% CI, 0.22-0.68; P =.001).
“This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone,” said Susan Olender, MD, Columbia University Irving Medical Center. “While not as vigorous as a randomized controlled trial, this analysis importantly draws from a real-world setting and serves as an important adjunct to clinical trial data, adding to our collective understanding of this virus and reflecting the extraordinary pace of the ongoing pandemic.”
Additional analysis of the SIMPLE-Severe study showed that clinical outcomes were similar across different racial and ethnic patient populations. Rates of clinical improvement (defined as a ≥2-point improvement on a 7-point ordinal scale) at day 14 were 84% in Black patients (n=43), 76% in Hispanic White patients (n=17), 67% in Asian patients (n=18), 67% in non-Hispanic White patients (n=119) and 63% in patients who did not identify with any of these groups (n=32).
As for pediatric patients, data from a compassionate use program of remdesivir showed that 83% of the 77 patients treated recovered by day 28. Additionally, among 86 pregnant and postpartum patients treated with remdesivir, 92% recovered by day 28. An open-label phase 2/3 trial investigating the safety, tolerability and pharmacokinetics of remdesivir in pediatric patients has been initiated to further understand clinical outcomes in patients less than 18 years of age.
Gilead also announced that an analysis comparing clinical outcomes in patients treated with concomitant remdesivir and hydroxychloroquine to those treated with just remdesivir showed that the rates and likelihood of recovery were lower in the group that received concomitant therapy (57% vs 69%, respectively; hazard ratio 0.61 [95% CI, 0.45-0.83]; P =.002); concomitant use of hydroxychloroquine also led to higher rates of adverse events, however an increased mortality rate at day 14 was not observed. The Food and Drug Administration recently issued a safety alert recommending against the concomitant use of remdesivir and hydroxychloroquine.
In the US, remdesivir is permitted for use under an Emergency Use Authorization for the treatment of patients with suspected or laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and severe COVID-19.
For more information visit gilead.com.