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October 9, 2020

Remdesivir's final clinical trial results are in. Here's what you need to know.

Daily Briefing

    Final clinical trial data on Gilead Sciences' antiviral drug remdesivir shows the drug reduced Covid-19 hospitalized patients' recovery time by five to seven days when compared with patients who received a placebo—and the drug may have decreased the risk of death among Covid-19 patients who required oxygen.

    How Covid-19 is changing the future of the health care industry

    US new coronavirus cases surpass 7.6M, deaths near 213K

    The findings come as U.S. officials as of Friday morning reported a total of 7,639,600 cases of the novel coronavirus since the country's epidemic began—up from 7,582,200 cases reported as of Thursday morning.

    According to data from the New York Times, the rates of newly reported coronavirus cases are "staying high" in Guam and 27 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Alaska, Arkansas, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, North Carolina, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Wisconsin, and Wyoming.

    Washington, D.C., and 14 states that have had comparatively low case rates are now seeing those rates "going up," according to the Times. Those states are Connecticut, Delaware, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Vermont, and Washington.

    In the 11 remaining U.S. states and territories, rates of newly reported coronavirus cases are "staying low," according to the Times' analysis.

    U.S. officials as of Friday morning also reported a total of 212,778 deaths linked to the coronavirus since the country's epidemic began—up from 211,750 deaths reported as of Thursday morning.

    Final clinical trial data shows remdesivir quickens Covid-19 recovery times

    As the numbers of novel coronavirus cases and related deaths continue to rise, researchers have been scrambling to discover a treatment for Covid-19, the disease caused by the virus. Gilead's remdesivir quickly emerged as one of the most promising experimental treatments for Covid-19, and FDA earlier this year issued an emergency use authorization allowing providers to use the drug to treat patients with severe cases of the disease.

    Preliminary data published in May from a clinical trial led by the National Institute of Allergy and Infectious Diseases (NIAID), which focused on a treatment period of 15 days, showed that remdesivir was associated with faster recovery times among some patients. In addition, an analysis released by Gilead in July showed that Covid-19 patients treated with remdesivir recovered sooner and were 62% less likely to die when compared with data from a historical control group.

    The new clinical trial data, published Thursday in the New England Journal of Medicine, had similar findings, showing that remdesivir quickened recovery times among certain Covid-19 patients.

    The new data comes from a double-blind clinical trial led by NIAID that involved 1,062 patients and focused on a treatment period of 29 days. According to the data, hospitalized Covid-19 patients who received remdesivir recovered from the disease in an average of 10 days—which was five days faster than patients who received a placebo. The researchers also found that remdesivir reduced recovery times by an average of seven days among hospitalized Covid-19 patients who were on oxygen when they first received the drug, when compared with patients who received a placebo.

    The researchers noted that remdesivir appeared to produce the greatest benefits among patients who received the drug early in their course of illness, who were hospitalized and receiving supplemental oxygen but were not on ventilators. In addition, the researchers said the data suggested that remdesivir may prevent Covid-19 patients from developing more severe cases of the disease and requiring more oxygen or ventilation.

    Gilead CEO Daniel O'Day in an open letter published Thursday wrote, "For patients who are hospitalized with Covid-19, the importance of speeding up recovery by five to seven days cannot be underestimated. This represents a significant benefit in a disease where every day counts."

    Analysis suggests remdesivir may reduce risk of death among certain Covid-19 patients

    While the study did not find a statistically significant decline in mortality risk overall, a post-hoc analysis did find a statistically significant decline among one sub-set of patients.

    Specifically, data from the subsequent analysis, which used "a proportional-odds model with an eight-category ordinal scale," suggested that remdesivir decreased the risk of death among Covid-19 patients who required oxygen—representing about 40% of the overall patient population in the study—by 72% at day 15 of treatment and by 70% at day 29 of treatment, Reuters reports. The researchers wrote, "The Kaplan–Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29." However, the researchers also noted that their confidence interval for those findings ranged from 0.52 to 1.03.

    Still, Andre Kalil, an infectious disease expert at the University of Nebraska Medical Center and the study's principal investigator, said, with that analysis, "we now have data suggesting that giving remdesivir to patients on oxygen may significantly reduce their chances of death compared to other subgroups"  (Rosenbaum, Forbes, 10/8; Steenhuysen, Reuters, 10/8; Beigel et al., NEJM, 10/8, New York Times, 10/9).

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