Results may help optimize treatment with remdesivir, says lead investigator Aruna Subramanian.
As the world looks for a cure for coronavirus, a new study led by an Indian-American scientist has demonstrated the efficacy of investigational antiviral remdesivir drug in treating patients with severe covid-19.
Announcing the results of Phase 3 trial of the drug Wednesday, Gilead Sciences, a California-based biopharmaceutical company said the study demonstrated similar efficacy with 5- and 10-day dosing durations of remdesivir.
In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms.
Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.
“These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, MD, one of the lead investigators of the study, in a statement issued by Gilead.
RELATED: American Bazaar’s Covid-19 coverage
“While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective,” added Subramanian, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine.
No new safety signals were identified with remdesivir across either treatment group, Gilead said. It now plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
Describing the results of the trial as “quite good news,” White House health advisor Dr. Anthony Fauci said it sets a new standard of care for covid-19 patients.
In a White House briefing, Fauci said he was told data from the trial showed a “clear-cut positive effect in diminishing time to recover.”
The median time of recovery for patients taking the drug was 11 days, Fauci said, compared with 15 days in the placebo group. He said the mortality benefit of remdesivir “has not yet reached statistical significance.”
“This will be the standard of care,” Fauci, director of the National Institute of Allergy and Infectious Diseases, added.
“When you know a drug works, you have to let people in the placebo group know so they can take it.”
“What it has proven is a drug can block this virus,” he said.
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
“Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for covid-19 and how to best utilize the drug,” he said.
Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of covid-19.
This study sought to determine whether a shorter, 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir, Gilead said.
Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups.
The ongoing study is being conducted at 180 trial sites around the world, including sites in the US, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom.