July 13, 2020 -- Remdesivir, an antiviral drug being used to treat severe COVID-19, may help patients recover sooner and reduce the risk of dying from the coronavirus, according to a news release.by the drug’s manufacturer.
The pharmaceutical company Gilead released more data on Friday from its phase 3 trial. Notably, the trial wasn’t designed to answer the question of whether the drug reduces the risk of dying, but the company said that it does as compared with a group of “real world” hospitalized patients who didn’t receive the drug.
“Remdesivir was associated with an improvement in clinical recovery and a 62% reduction in the risk of mortality compared with standard of care — an important finding that requires confirmation in prospective clinical trials,” according to the statement.
The FDA issued an emergency use authorization on May 1 for remdesivir to be used for hospitalized patients with severe COVID-19. The drug is still considered an investigational treatment that hasn’t been approved by the FDA, and clinical trials are testing the safety and efficacy of the drug as a treatment for COVID-19, the company wrote.
The analysis included 312 patients in the company’s phase 3 study and 818 patients in a separate “real-world” cohort who received standard treatment in hospitals. According to the findings announced in the news release, 74% of patients who received remdesivir recovered in 14 days, as compared with 59% of the hospitalized cohort. About 7.6% died among those who received remdesivir as compared with 12.5% who didn’t receive the drug.
In additional analyses of the company’s trial, researchers found that traditionally marginalized racial or ethnic groups had similar outcomes to the overall patient group. In addition, about 83% of children under age 18 and 92% of pregnant and postpartum women recovered, and the research team didn’t identify any additional safety precautions needed for these groups.
Patients who were Black, under age 65 and required no oxygen support or only low-flow oxygen were more likely to improve in 14 days, the company said. Those who were treated with both remdesivir and hydroxychloroquine, rather than remdesivir alone, were more likely to have adverse events. The company recommended against giving both remdesivir and hydroxychloroquine or chloroquine to patients “due to a risk of reduced antiviral activity.”
“We are working to broaden our understanding of the full utility of remdesivir,” Merdad Parsey, MD, Gilead’s chief medical officer, said in the statement. “To address the urgency of continuing pandemic, we are sharing data with the research community as quickly as possible.”
The data were presented at the International AIDS Society’s Virtual COVID-19 Conference on Friday. Gilead has also studied the effects of remdesivir on COVID-19 patients who require a ventilator, and those results are pending, the company said in the statement.