Gilead’s Covid-19 drug remdesivir appeared to reduce hospitalizations by 87% in high-risk patients diagnosed early in the disease in a new study, the company said Wednesday.
The new results, which were issued in a press release, could help shore up the perception that the medicine is effective. They also could boost hopes for the use of oral antiviral drugs being developed by drug companies including Pfizer and Merck to treat people in the early stages of Covid-19.
The administration of remdesivir remains challenging. It must be given intravenously, and in the study it was given in three infusions over three days — a logistical hurdle for patients who are not hospitalized.
Remdesivir, under the brand name Veklury, has full approval from the Food and Drug Administration to treat Covid-19 and is widely used, but there has still been controversy about its effectiveness. A study conducted by Gilead and the National Institutes of Health showed that it helped patients recover faster. But a second large trial, conducted by the World Health Organization, failed to show any benefit for the drug in reducing Covid deaths.
One challenge of using antiviral drugs like remdesivir is that they tend to work better early in the course of the disease. Currently, in part because it is an IV drug, remdesivir is used to treat patients who are already in the hospital.
The study was meant to test whether giving remdesivir earlier could have a bigger effect on Covid-19. But Gilead stopped it in April 2021 when it had only enrolled about half of the expected number of patients. The company said that this was because of the “changing epidemiology” of Covid-19 and “additional treatment options of the time,” likely meaning data about monoclonal antibody cocktails from Regeneron and Eli Lilly that could be given to outpatients in a single infusion.
But Gilead continued to analyze the data from the 562 patients who were enrolled in the study and who were randomly assigned to receive either remdesivir or placebo. The company said there was an 87% reduction in hospitalization. This means that two patients were hospitalized or died in the remdesivir group, compared to 15 in the placebo group.
There was also an 81% reduction in medical visits due to Covid-19. (Twenty-one patients in the placebo group sought a medical visit compared to four in the remdesivir group.)
Gilead said there was one death in the study, in the placebo group, but that it occurred after the day 28 cutoff for the main analysis.
Full results of the study will be presented at IDWeek, a medical conference. Gilead did not immediately provide information on the demographics of the patients in the trial. The company said side effects were similar to those seen in previous studies. The most common side effects were nausea and headache.
A Gilead spokesman said that the company had shared the results with the FDA.
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