Remdesivir Showed 87 Percent Reduction in Hospitalization if Given Early, Study Shows

Gilead Sciences’ antiviral drug Veklury (remdesivir) appeared to reduce hospitalizations and death by 87 percent in patients with new cases of COVID-19, according to data just released by the company.

In a phase 3 study of 562 participants, the company looked at the usefulness of a three-day course of the intravenous drug when administered outside the hospital setting to patients with a new case of COVID-19 who were at high risk for disease progression.

In addition to an 87 percent drop in risk of hospitalization and death by day 28, the results also showed an 81 percent reduction in risk of medical visits due to COVID-19 compared with placebo.

In the study, no deaths were observed in either arm by Day 28. One patient who was on placebo did die on day 59, the company said.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and [to keep them] out of the hospital altogether.” said Robert Gottlieb, cardiologist and principal investigator at Baylor University Medical Center.

The data, not yet peer-reviewed, will be presented next week at the IDWeek 2021 virtual conference, said Gilead, which added that it’s now sharing the data with regulatory agencies.

The company said enrollment for the trial was stopped prior to reaching enrollment targets in April 2021, “reflecting the changing epidemiology and adoption of additional treatment options at the time.” However, Gilead said, the study continued to collect data on enrolled participants.

The results complement positive results from other studies in hospitalized patients in which Veklury helped patients recover significantly faster and reduced the likelihood of disease progression, Gilead said.

“As the pandemic continues to evolve and new viral variants emerge, Veklury is playing a critical role as the antiviral standard of care for hospitalized patients, helping prevent disease progression and speed patients’ recovery,” said Merdad Parsey, Gilead’s chief medical officer.

Gilead said it continues to study the efficacy and safety of Veklury in hospitalized patient populations with renal impairment, children and pregnant women. The company is also developing oral treatments for nonhospitalized patients with COVID-19 and hopes to file investigational new drug applications with the FDA by early next year.

Merck and Pfizer are also developing oral antivirals to treat people with new cases of COVID-19.

Currently, in the U.S., Veklury is indicated for adults and pediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalization. — Suz Redfearn