Gilead Sciences said Wednesday that its late-stage trial of a three-day intravenous course of the antiviral remdesivir significantly reduced the risk of non-hospitalized Covid-19 patients becoming sicker and dying.
In this trial, remdesivir, also known by its brand name, Veklury, was tested on 562 people considered high-risk for severe Covid-19 based on their health conditions and age. Half received the drug and the other half received a placebo.
The group that got the drug saw an 87% reduction in risk of hospitalization by day 28, and an 81% reduced risk of dying compared with the group that got a placebo.
The company had stopped enrolling people in the trial in April, it said, “reflecting the evolution of the Covid-19 landscape and changing patient needs.” At that time, the National Institute of Allergy and Infectious Diseases had decided to start giving remdesivir to patients who had been receiving standard care, since NIAID found that the drug had showed a small effect against Covid-19. The company said it continued to collect data on the patients in its trial so that it was able to produce the results of this latest trial.
The data has not yet been peer-reviewed or published, and Gilead said it will be presented at the IDWeek 2021 virtual conference.
“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,” Dr. Robert L. Gottlieb, a cardiologist and principal Investigator at Baylor University Medical Center and Baylor Scott & White Research Institute, said in a company news release. “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.”
What's next: Gilead said it plans to continue to study how safe the drug is and how well it works in patients who are hospitalized. In November, the World Health Organization had updated its ongoing guidance on medication to advise against using the antiviral drug to treat hospitalized patients. However, it is approved for temporary use in 50 countries and has been provided to 127 middle and low income countries.
In October, the antiviral was the first drug to be approved by the US Food and Drug Administration to treat Covid-19; it’s approved for treatment of hospitalized adult and pediatric patients age 12 and older, and has emergency use authorization for treatment of younger children. It is approved for use only in a hospital or health care setting and needs to be administered by IV over 30 to 120 minutes.