Gilead Releases Additional Data on COVID-19 Antiviral, Remdesivir

Gilead recently  reported additional data on remdesivir, an investigational antiviral for the treatment of COVID-19.

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The additional data, including the comparative analysis of Gilead’s Phase 3 SIMPLE clinical trial and a real-world retrospective cohort of patients with severe COVID-19, will be presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference.

At the beginning of June, Gilead announced the positive Phase 3 trial results.

Researchers found that patients in the five-day remdesivir treatment group were 65 percent more likely to see clinical improvement at day 11, versus individuals receiving standard care.

There was also a 62 percent reduction in the risk of mortality compared with standard care.

Additionally, separate subgroup analyses from the clinical trial found that some marginalized racial groups treated with remdesivir in the study experienced similar clinical outcomes as the overall patient population in the study.

Gilead noted that these findings are important and require confirmation in prospective clinical trials.

“This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone,” Susan Olender, MD, Columbia University Irving Medical Center, said in the recent announcement.

“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.”

Gilead is also presenting new analyses of its compassionate use program, which previously showed safety and efficacy results in 53 patients hospitalized with severe COVID-19 who were receiving remdesivir treatment as part of the program.

Additionally, 83 percent of pediatric patients and 92 percent of pregnant and postpartum women with a broad spectrum of disease severity recovered by Day 28.

No new safety signals were identified with remdesivir across these populations.

“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, in a statement.

“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,” he added.

Due to the current pandemic, FDA issued an Emergency Use Authorization (EUA) for remdesivir for the treatment of hospitalized patients with severe COVID-19 back in May.

The EUA allowed for the drug to be distributed in the US and administered intravenously by healthcare providers, as appropriate, to treat COVID-19 in patients.

The EUA was based on data from two global clinical trials, the National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19 and Gilead’s global Phase 3 study.

Several other clinical trials are currently ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19. But the EUA opened the way for Gilead to start offering the drug as a COVID-19 treatment, Daniel O’Day, chairman and chief executive officer of Gilead said in the announcement.

The company also noted that its donation of 1.5 million doses of remdesivir equals more than 140,000 treatment courses, which will be provided at no cost to patients following potential emergency authorizations and regulatory approvals, including the EUA.