Small group given experimental Gilead treatment under ‘compassionate use’ showed improvement, but clinical trials needed to assess its effectiveness
An experimental drug made by Gilead Sciences Inc. GILD 1.73% showed promising results in a small group of Covid-19 patients, with clinical improvement seen in 84% of recipients within one month of treatment, researchers said Friday.
The results, while encouraging, far from prove the experimental drug’s effectiveness taking on the new coronavirus that causes the Covid-19 respiratory illness. Determination of the treatment’s efficacy will need to wait for results of more scientifically rigorous clinical trials under way.
In a paper published in the New England Journal of Medicine, researchers described the experiences of 53 severely ill patients hospitalized with Covid-19. The patients were treated with Gilead’s remdesivir under “compassionate use,” which allows patients to be treated with unapproved drugs in emergency situations.
The results offered encouragement that larger, controlled clinical trials might prove the drug safe and effective enough to be approved for broader use in sick Covid-19 patients, the study authors said. The drug is being studied in a number of trials in the U.S. and internationally, and initial data from two trials in China are expected in coming weeks.
“We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said study co-author Jonathan D. Grein, director of hospital epidemiology at Cedars-Sinai Medical Center in Los Angeles, in a statement released by Gilead. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
Seven patients died after treatment with remdesivir, or 13% of the total. Nearly half the patients were discharged from the hospital. Of 30 patients using breathing tubes connected to ventilators, 17 had their tubes disconnected after remdesivir treatment. Three of four patients on life-support machines were able to be taken off them, the researchers said.
The study authors cautioned that it was difficult to determine whether remdesivir contributed to the improved outcomes because the data weren’t derived from clinical trials. The lack of a comparison group, such as patients receiving placebo or standard treatment, makes the data difficult to interpret, said Evercore ISI analyst Umer Raffat in a note to clients.
“Overall, hard to draw definitive conclusion, but a ray of hope,” Mr. Raffat said.
The paper was co-written by researchers from Gilead and hospitals treating patients. Gilead collected and analyzed the study data. The initial draft of the paper was written by a writer hired by Gilead and one of the paper’s co-authors, with input from the other co-authors.
Remdesivir is an antiviral drug administered by intravenous infusion over 10 days, and is being considered for treatment of very sick patients hospitalized because of breathing difficulties. Gilead had studied the drug previously as a treatment for Ebola. When the new coronavirus outbreak became public late last year, the company had been working with academic researchers to study the drug’s effectiveness against earlier coronaviruses.
Separately on Friday, Eli Lilly & Co. said its rheumatoid arthritis drug Olumiant would be included in a larger study of multiple drugs, including remdesivir, that is being funded by the National Institutes of Health. Lilly said the drug might have potential to help treat high levels of inflammation observed in some very sick Covid-19 patients.
In addition, Lilly said it would begin testing one of its experimental drugs as a potential treatment for Covid-19 patients with pneumonia in a mid-stage clinical trial later this month.