Gilead Sciences has announced additional data on remdesivir outcomes in the phase 3 SIMPLE Trial, including a comparative analysis of clinical recovery and analysis of outcomes across ethnic groups.
Findings were announced during the special COVID-19 sessions of the virtual 23rd International AIDS Conference, AIDS 2020.
In the analysis, remdesivir was tied to an improvement in clinical recovery and a reduction in the risk of mortality compared with standard of care – but these results require confirmation in future prospective clinical trials. Remdesivir is an investigational treatment, made available under an Emergency Use Authorization
by the US Food and Drug Administration (FDA) for patients with severe COVID-19.
Gilead also included an analysis of the safety and efficacy of remdesivir across different racial and ethnic patient subgroups treated in the United States. The analysis shows that across these demographics, people treated with remdesivir experienced similar clinical outcomes as the overall patient population.
In Gilead’s compassionate use program, 83% of pediatric patients (n=77) and 92% of pregnant and postpartum women (n=86) with a broad spectrum of disease severity recovered by Day 28. No new safety signals were identified with remdesivir across these populations.
Gilead recently announced the initiation of a further global, open-label Phase 2/3 trial to evaluate pharmacokinetics of remdesivir in pediatric patients from birth to less than 18 years of age. Gilead is also working on another study among pregnant women.
"We are working to broaden our understanding of the full utility of remdesivir. To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "These data presented at the Virtual COVID-19 Conference shed additional light on the use of remdesivir in specific patient populations, including those that may be susceptible to higher rates of COVID-19 infection, as well as others that are particularly vulnerable, including children and pregnant and postpartum women."
The pre-planned comparative analysis included 312 patients treated in the Phase 3 SIMPLE-Severe study along with a separate real-world retrospective cohort of 818 patients with similar baseline characteristics and disease severity who received standard of care during the same study period as SIMPLE-Severe.
Patients were mostly located in North America (92%, remdesivir cohort. 91%, standard-of-care cohort) and Europe. Preliminary analysis indicates 74.4% of remdesivir-treated patients recovered by Day 14 versus 59% of patients receiving standard of care. The mortality rate for patients treated with remdesivir in the analysis was 7.6% at Day 14 compared to 12.5% in patients not taking remdesivir.
An article by Matthew R. Davis, Erin K. McCreary, and Jason M. Pogue with more commentary on the rise of remdesivir was published in The Infectious Disease Therapy Journal
the day before Gilead's announcement. The article raises questions, but ultimately the authors frame remdesivir as safe and worth pursuing.
"Results have been mixed for remdesivir in studies of COVID-19, but it is the first effective therapy for COVID-19 regarding shortening time to recovery," the trio wrote. If the SIMPLE trial results Gilead shared today hold up to confirmation, there may be even less ambivalence about clinical use soon.
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