Gilead’s Remdesivir Significantly Reduces Risk of Hospitalization in High-Risk COVID-19 Patients, Finds Study

Gilead Sciences (Foster City, CA, USA) has announced positive results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury (remdesivir) for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression.

In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 compared with placebo. Results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury compared with placebo. In the study, no deaths were observed in either arm by Day 28. These results complement positive results from ACTT-1 and other studies in hospitalized patients in which Veklury helped patients recover significantly faster and reduced the likelihood of disease progression.

Gilead continues to study the efficacy and safety of Veklury in hospitalized patient populations with ongoing unmet needs, such as patients with renal impairment, children and pregnant women, as well as through the support of a number of externally sponsored trials. Gilead is also developing novel oral treatment options for non-hospitalized patients with COVID-19 and hopes to file investigational new drug applications (IND) with the Food and Drug Administration (FDA) by early next year.

“Antiviral medications provide maximal benefit when used early in the disease course. Last summer, data from clinical trials demonstrated the benefit of remdesivir in patients hospitalized with COVID-19, even when not yet requiring oxygen. These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” said Robert L. Gottlieb, MD, PhD, Cardiologist and Principal Investigator at Baylor University Medical Center and Baylor Scott & White Research Institute. “We are seeing very high numbers of hospitalized patients as new COVID-19 infections surge, placing increased demands on already over-burdened healthcare systems. Remdesivir, also known as Veklury, is an effective antiviral for the treatment of hospitalized patients with COVID-19 and an essential tool to help reduce disease progression.”

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