One day a study published in the New England Journal of Medicine is picked up by the news media telling us that remdesivir is working in the fight against COVID-19. A few days later, other stories based on research by the World Health Organization say that it is not. So what result contains the truth? Neither? Both?
It’s a trick question. The studies examine two different results.
Remdesivir took to the world stage when it was presented to President Donald J. Trump at Walter Reed National Military Medical Center for treatment for COVID-19. The antiviral drug was developed by US drug maker Gilead Sciences in the hopes of treating viruses like hepatitis, SARS, and Ebola. It was never approved by the FDA.
Then in May 2020, remdesivir received FDA Emergency Approval (EUA) for the treatment of children and adults hospitalized with COVID-19. This EEA has been upgraded to any adult or child hospitalized for COVID-19 symptoms regardless of severity.
The study, published October 8 in NEJM, tracked over 1,000 hospitalized patients with COVID-19 who had a lower respiratory infection, which would be either pneumonia or bronchitis. The patients received either remdesivir or a placebo.
The results showed that the patients who received remdesivir recovered within 10 to 11 days, while those who received the placebo were sick for about 15 days.
As with all drugs, remdesivir can cause adverse events or side effects, and some can be very serious. These include changes in kidney function, anemia, respiratory failure, and increases in blood sugar levels, to name a few.
A total of 131 of the 542 patients who received remdesivir had a major adverse event, as did 163 of the 516 in the placebo group. The most serious was respiratory failure and the patients needed intubation so they could be put on a ventilator. Less serious adverse events occurred in 273 patients in the remdesivir group and 295 in the placebo group.
Despite the shortened duration of the illness, the researchers admitted that the drug did not affect the death rate. In conclusion, the authors wrote: “[G]high mortality [related to COVID-19] Despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is unlikely to be enough for all patients. “
The WHO study
The WHO study, called the SOLIDARITY study, had a different goal. The researchers looked at death rates in patients with COVID-19 who were given remdesivir. The study’s authors wanted to know if more people would stay alive with remdesivir.
The researchers recruited over 11,000 patients who received either remdesivir, hydroxychloroquine, lopinavir, interferon, and lopinavir, or nothing. Hydroxychloroquine is used to treat or prevent malaria. Lopinavir is an antiviral drug used to treat HIV.
The results showed that there were no differences in the death rate in any of the patient groups. The hydroxychloroquine and lopinavir studies were stopped prematurely because there was no evidence that they were beneficial. And of the 2,743 patients who received remdesivir, 11% of them died – about as many as those who received nothing at 11.2%.
The take away
So what is the non-medical person to take this information away from? In terms of face value, the studies aren’t that different – both said remdesivir made no difference in the number of deaths caused by COVID-19. But the first said that it shortened the course of the disease.
Perhaps the drug decision will depend on the hospital’s resources and how quickly patients can be discharged home.
Medical Daily contacted experts for comment. They were not available on the reporting date.