In new data released detailing the efficacy of Gilead’s investigational antiviral remdesivir, the drug reduced the risk of death by 62% in severely-ill COVID-19 patients.
The additional remdesivir data, presented at the Virtual COVID-19 Conference last week, includes new comparative analysis from the phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe COVID-19. In this analysis, remdesivir demonstrated an improvement in clinical recovery and an impressive 62% reduction in the risk of death when compared with standard-of-care.
Analyses from separate subgroups investigated in the trial also included an evaluation of safety and efficacy of remdesivir across different racial and ethnic patient subgroups. Results from these analyses found that ‘traditionally marginalised racial or ethnic groups’ treated with remdesivir experienced similar outcomes to the overall patient population in the study.
Gilead also revealed new analyses from its compassionate use programme, which demonstrated that 83% of paediatric patients and 92% of pregnant and postpartum women with a broad spectrum of disease severity recovered by day 28 of treatment.
Some analysts have taken issue with the validity of the data, given that the source of the analysis is not from a randomised, placebo-controlled clinical trial, but rather compares clinical trial data to non-clinical trial data.
However, given the urgency of the pandemic, drug developers are releasing any data which may show a benefit against the disease as the need for treatments grows increasingly critical. This fact has been acknowledged by Gilead – its chief medical officer Merdad Parsey commented on the release of this data last week:
“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,” he said in a statement
“The 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,” he added.
Former US Food and Drug Administration (FDA) commissioner Scott Gottlieb also said that rigorous confirmation is needed to further support the data, tweeting that “this is very encouraging but needs to be confirmed in a prospective trial”.
“It appears to be a retrospective analysis of the phase 3 data using historical matched controls, suggesting a survival benefit in severe COVID-19 patients,” he added.