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May 26, 2020

What new data reveals about two much-hyped experimental Covid-19 treatments

Daily Briefing

    On Friday, scientists published long-awaited findings on two closely watched experimental treatments for Covid-19—Gilead's remdesivir and hydroxychloroquine, which is often touted by President Trump—and one study was more promising than the other.

    Covid-19 weekly webinar: What health care leaders need to know

    US Covid-19 cases surpass 1.6M, death toll tops 98K

    The findings come as U.S. officials as of Tuesday morning reported 1,670,100 cases of Covid-19—up from 1,584,800 cases as of Friday morning.

    As of Tuesday morning, officials also had reported a total of 98,191 U.S. deaths linked to the new coronavirus—up from 94,722 deaths reported as of Friday morning.

    Remdesivir speeds recovery among some Covid-19 patients, study shows

    As the numbers of Covid-19 cases and related deaths continue to rise, newly released data on Gilead's remdesivir safety and efficacy shows patients with Covid-19 who took the drug recovered faster than patients who did not take the drug.  

    Remdesivir currently is the only drug to receive FDA's emergency use authorization (EUA) to treat patients with Covid-19.

    NIH last month released preliminary data from the clinical trial suggesting the drug may help patients recover from the disease faster. On Friday, researchers published full data from the clinical trial in NEJM. The clinical trial involved 1,063 patients—538 of whom received remdesivir and 521 of whom received a placebo. Covid-19 severity levels ranged among the patients—with some only requiring hospitalization and others needing ventilation.

    The researchers found Covid-19 patients who received remdesivir recovered in a median of 11 days, while patients who received the placebo recovered in a median of 15 days.

    In addition, the researchers found Covid-19 patients who took remdesivir reported a lower mortality rate than patients who took a placebo. According to the researchers, the patients who received remdesivir had a mortality rate of 7.1%, compared to an 11.9% mortality rate among patients who received a placebo. But the researchers noted the differences in mortality were not statistically significant. The researchers said the different mortality rates could be attributed to the fact that fewer patients had severe symptoms at the start of the clinical trial, which reduced the statistical power, STAT News reports.

    In addition, the data shows the drug offered limited benefits among patients with severe cases of the disease who needed ventilators. Among the patients who required hospitalizations, but did not need oxygen, the researchers found a 38% benefit in the pace of their recoveries. The researchers also found a 47% benefit in recovery time among hospitalized patients who needed oxygen but were not on a ventilator. 

    However, according to the researchers, the benefit was less pronounced among hospitalized patients who needed ventilators. The researchers found a 20% benefit in the speed of recovery among patients who received high-flow ventilation.

    Eric Topol, founder and director of the Scripps Research Translational Institute, said the study's results show the drug is "very safe and effective." He added, "We now have a definite first efficacious drug for Covid-19, which is a major step forward and will be built upon with other drugs, [and drug] combinations."

    However, Topol said the data indicates remdesivir provides no benefits to patients with severe cases of Covid-19.

    But others have raised concerns about the trial's data, noting researchers changed the study's main goal before they analyzed the data, which could lead to skewed results, STAT News reports. Another concern is that the study was stopped after researchers found that remdesivir offered a statistically significant benefit.

    Steven Nissen, a cardiologist at the Cleveland Clinic, said, "It's clear from the publication that the study was stopped prior to the completion of a significant number of patients. By stopping it early the scientific community was deprived of the opportunity to determine whether remdesivir can or cannot reduce mortality."

    Peter Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, also noted that more patients who took the placebo appeared to report more severe symptoms at the beginning of the study, which could mean the drug's overall benefit could be "potentially exaggerated."

    WHO suspends hydroxychloroquine trial as data finds link to increased risk of death

    Meanwhile, the World Health Organization (WHO) on Monday announced it is temporarily suspending a global trial evaluating the safety and effectiveness of hydroxychloroquine, citing a study published Friday in the Lancet showing the drug increased the risk of death among patients.

    Hydroxychloroquine has been widely touted by President Trump as a potential treatment for Covid-19. Last week, Trump announced that he's been taking the drug in the hopes of preventing the new coronavirus despite a lack of evidence the drug can prevent Covid-19.

    While the latest data does not prove whether or not hydroxychloroquine or chloroquine can be used to safely treat Covid-19, STAT News reports that it does offer more insight into the drugs' potential benefits and risks.

    The study found that Covid-19 patients who were treated with the antimalarial drugs hydroxychloroquine or chloroquine, either alone or in combination with a macrolide, were associated with an increased risk of death and increased risk of developing ventricular arrhythmias.

    The study, which involved 96,000 hospitalized patients with Covid-19 from six continents, is the largest study to date to examine the risks and benefits of treating the disease with the antimalarial drugs (Herper [1], STAT News, 5/22; Herper [2], STAT News, 5/22; Beasley, Reuters, 5/22; Walker, MedPage Today, 5/23; Moreno, The Hill, 5/23; Evans/Walker, Wall Street Journal, 5/22; Elfrink, "Morning Mix," Washington Post, 5/26; Subramanian, USA Today, 5/22; Rodriguez, USA Today, 5/22; Walker, MedPage Today, 5/22; Erman/Banerjee, Reuters, 5/22; Eujung Cha/McGinley, Washington Post, 5/22; Morgan, Reuters, 5/22; Kolata, New York Times, 5/23; New York Times, 5/26).

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