FOSTER CITY, Calif. - Gilead Sciences said its anti-viral drug Veklury, also known as remdesivir, has shown promise in lowering the risk of hospitalization among certain COVID-19 patients.
Data from Phase 3 of clinical trials found remdesivir to be 87% effective at reducing hospitalizations in high-risk patients who were diagnosed early.
"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 said.
In a 28-day window, researchers studied 562 patients who were randomly assigned either a placebo or remdisivir. They received their dosage through an IV over the course of three days.
In addition to proving effective, data shows the drug is also safe, Gilead Sciences said. Of the 279 trial participants who received remdesivir, no new safety signals were identified. Nausea and headache were the most comment side effects.
One person died in the trial, but Gilead Sciences said that patient was in the placebo group. They died on Day 59, well beyond the Day 28 primary endpoint of the trial.
Hospitals again became overwhelmed during this summer’s surge, which was driven by the highly infectious delta variant and America’s large unvaccinated population.
A vial of Veklury brand remdesivir anti-viral medication at Salinas Valley Memorial Hospital in Salinas, California, U.S., on Thursday, Sept. 2, 2021. (Photographer: Nic Coury/Bloomberg via Getty Images)
While vaccines are available in surplus and highly effective at preventing hospitalizations and deaths, they are just a preventative measure, meaning they’re not able to treat active infections.
Should trial data be replicated in a real-world application, remdesivir’s ability to lower the hospitalization would be a game-changer, should trial data be replicated in a real-world application.
"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. Dr. Merdad Parsey, Chief Medical Officer at Gilead Sciences.
Before vaccines became available last year, remdesivir emerged as a candidate to combat the novel coronavirus. In May 2020, the U.S. Food and Drug Administration (FDA) granted remdesivir emergency use authorization, then granted it full approval in October.
But last November, the World Health Organization (WHO) issued a conditional recommendation against the use of remdesivir in hospitalized patients. The WHO stated there was no evidence that remdesivir improves survival and other outcomes in such patients. They concluded more research was needed on the drug and encouraged enrollment in clinical trials evaluating it.
When asked about Gilead Science's new findings on Wednesday, the WHO said it's "following the research on remdesivir. As of today, there is no plan to review our guidelines on remdesivir in the immediate future, but that could change."
For the WHO’s recommendations on COVID-19 therapeutics, click here.
Meanwhile, Gilead Sciences is in the process of sharing data with regulatory agencies. They will continue to test remdesivir in hospitalized populations as well as develop 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.
This story was reported from Atlanta.