One vial of the drug Remdesivir lies during a press conference about the start of a study with the Ebola drug Remdesivir in particularly severely ill patients at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany on April 8, 2020, amidst the new coronavirus COVID-19 pandemic. (Photo by Ulrich Perrey / POOL / AFP) (Photo by ULRICH PERREY/POOL/AFP via Getty Images)
Remdesivir is an investigational drug that was developed as a way to treat Ebola, but has been undergoing clinical trials in recent months to find out if it could be an option for treating COVID-19 patients. Overall the results have shown promise — but it’s not yet clear whether the side effects will be a hindrance to treatment for some.
In early April the first results came in from one of the several remdesiver clinical trials going on concurrently around the world. Those results showed that 68% of people in that trial had improved symptoms thanks to the drug.
Later in the month, another trial concluded that remdesivir did not work. According to The Guardian, “In the trial, 158 patients were randomly assigned to be given remdesivir, while 79 others had standard care with a placebo instead. There was no difference between the groups with respect to recovery time. Just under 14% of those on remdesivir died, compared with nearly 13% of those not taking the treatment.”
The Guardian said this information came from a report accidentally posted by the World Health Organization that was subsequently taken down. According to that report, the trial was halted early in part because some patients were having negative side effects, though the writers did not elaborate as to what those side effects were.
Yet the clinical trials continue. The company that makes remdesivir, Gilead, released the findings of the latest trial Wednesday. This most recent study looked at whether a five-day treatment course was as effective as 10-day treatment regimen and found that yes, it was as effective. According to a press release by the company, “no new safety signals were identified” in any of the patients regardless of how long they took the medication. The company said it will publish the full results in the coming weeks in a peer-reviewed journal.
According to Merdad Parsey, MD, PhD, Chief Medical Officer at Gilead Sciences, these results mean more patients can be treated faster, possibly saving more lives. He wrote, “The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”
Side Effects of Remdesivir Include Possible Liver Damage & Nausea
GettyA doctor and nurses wear protective, suits, masks, goggles, and gloves as they perform the morning medical checks inside the Intensive Care Unit (ICU) for COVID -19 patients of Krakow’s University Hospital on April 18, 2020 in Krakow, Poland.
According to Gilead, the adverse reactions people had to remdesivir in the latest study were nausea, acute respiratory failure, and elevated liver enzymes. They said while overall the drug was well tolerated, over 10% of patients had one of these adverse reactions. It is not clear in the press release whether the acute respiratory failure was related to having COVID-19 or if they think the drug itself caused that issue.
RxList reported that during trials of remdesivir to treat Ebola they found that it increases liver enzymes which could potentially cause liver damage, and at least three COVID-19 patients involved in clinical trials experienced elevated liver enzyme levels. Another possible side effect is vomiting, which RxList says is a typical side effect of antiviral drugs.
According to BioSpace, though, serious side effects from remdesivir affect a quarter of patients negatively. They report, “About 25% of patients receiving it have severe side effects, including multiple-organ dysfunction syndrome, septic shock, acute kidney injury, and low blood pressure. Another 23% demonstrated evidence of liver damage on lab tests.”
Dr. Fauci Weighed In on the Remdesivir Trials, Saying Treatments Will ‘Get Better & Better’
In the Oval Office, Dr Fauci says “the bottom line” of the drug trial opens the door to having the capability to treating patients with COVID-19. Says treatments will “get better and better.” He said it shows “a drug can block the virus.”
White House Correspondent Mark Knoller tweeted Wednesday that the director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, believes that clinical results for remdesivir are “very important” because they prove that “a drug can block this virus.”
Fauci says Gilead reports the anti-viral reduced duration of COVID-19 from 15 to 11 days. “A drug can block this virus,” said Fauci about the results of the drug trial. He says the mortality rate also fell from 11% to 8%. He calls the improvement “very important.”
Remdesivir is not yet FDA approved and is only available for those who meet the criteria to be part of a clinical trial. However, Dr. Fauci said that the FDA is “moving very expeditiously” to approve the drug, according to Knoller.
Asked when Remdesivir will be available for prescription, Dr Fauci says FDA working on approving the drug for marketing and expects “they’ll be moving very expeditiously.” Cautions that the drug trial was conducted on patients in hospitals.
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