The data includes a comparative analysis of clinical recovery and mortality outcomes from Phase 3 SIMPLE Trial versus a real-world cohort of severe Covid-19 patients
Gilead unveils additional data on Remdesivir. (Credit: Chokniti Khongchum from Pixabay.)
US-based biopharmaceutical firm Gilead Sciences has released additional data on remdesivir, an investigational antiviral drug designed to treat patients with Covid-19.
The new data is the result of a comparative analysis of the results from the company’s Phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe Covid-19.
Gilead Sciences chief medical officer Merdad Parsey said: “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.
“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.”
Remdesivir improved clinical recovery and reduced the risk of mortality in the analysis
The comparative analysis involved 312 patients treated in Phase 3 SIMPLE-Severe study and a separate real-world retrospective cohort of 818 patients with similar characteristics and disease severity who received standard of care treatment at same time-period as the SIMPLE study.
According to the analysis, treatment using remdesivir improved clinical recovery and reduced the risk of mortality by 62% than the standard of care, which needs to be confirmed in future clinical trials.
The comparative analysis demonstrated that 74.4% of patients treated with remdesivir were recovered within 14 days, compared to 59% of patients receiving standard of care, and is said to add value to the existing knowledge on the treatment outcomes with remdesivir
The company said that the new comparative analysis complements the previous National Institute of Allergy and Infectious Disease (NIAID) study in hospitalised Covid-19 patients.
The NIAID study demonstrated that remdesivir reduced time to recovery by an average of four days compared to placebo, and remdesivir showed lower mortality compared to placebo.
Columbia University Irving Medical Center professor Susan Olender said: “This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone.
“While not as vigorous as a randomised 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.”