Remdesivir may not be effective in treating moderate cases of the novel coronavirus, a new study finds.
The antiviral drug was approved for emergency use authorization by the US Food and Drug Administration (FDA) after it was shown to help reduce patients’ hospital stays over a placebo, in a trial from the National Institutes of Health (NIH).
But a report published on Friday from the drug’s California-based maker, Gilead Sciences Inc, says the effects of the medication may only be seen in those with severe infections.
Researchers found a group of patients given the drug for five days saw their conditions improved but a similar group who received the drug for an average of six days had no significant benefit.
Remdesvir is the only drug in the US approved for emergency use in patients with severe cases of coronavirus. Pictured: A vial of remdesivir at the University Hospital Eppendorf in Hamburg, Germany, April 8
In a new study of moderate cases, researchers gave one-third of patients a five-day dose, another one-third a 10-day dose and the last group got standard case. Pictured: Members of the medical staff at United Memorial Medical Center in Houston, Texas, treat a patient in the COVID-19 ICU, July 28
Patients in the five-day group saw their conditions improve compared to the standard care group but the 10-day group, who received the drug for an average of six days, saw no significant benefit (above)
Remdesivir was developed to treat Ebola, the deadly fever that emerged in West Africa in 2014.
While it was unsuccessful in treating Ebola, the drug appears to interfere with the ability of the coronavirus to copy its genetic material.
In April, the NIH released results from a study that found remdesivir helped patients recover 31 percent faster.
Patients being given the drug improved after 11 days, four days faster than those who didn’t receive the medication.
While the NIH study and others have shown the medication’s clinical benefits in those with severe cases, its effect in patients with moderate disease has not been examined.
For the new study, published in JAMA, the team looked at 584 patients with moderate cases of COVID-19, the disease caused by the virus.
One-third of the patients received a five-day course, one-third received a 10-day course and the remaining were given standard care.
The patients were at 105 hospitals in the US, Europe, and Asia, and were followed for a little less than two weeks.
The median length of treatment was five days for patients in the five-day remdesivir group and six days for patients in the 10-day remdesivir group.
Those treated with remdesivir for five days were much better by day 11 than the standard care group, but the authors said this ‘was of uncertain clinical importance.’
However, the group that received the drug for an average of six days did not differ from standard care group
What’s more, death rates didn’t vary between the 10-day group and those who didn’t get the treatment with two percent in each group dying.
Researchers say that patient receiving remdesivir did have fewer severe symptoms of the virus, they had more moderate symptoms and side effects such as headache and nausea.
The team says its not sure why there was such a difference but plant to evaluate these discrepancies in further trials.
‘Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment,’ the authors wrote.
‘Patients randomized to a [five]-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.’
In a linked editorial, physicians from UPMC Health System say there have now been three studies of remdesivir in hospitalized patients – the current study, the NIH study and a study from China – with differing results.
‘[This raises] the question of whether the discrepancies are [due to] study design choices, including patient populations, or whether the drug is less efficacious than hoped,’ Drs Erin McCreary and Derek C. Angus wrote.
In June, Gilead announced it would be charging governments of developed countries $2,340 for a five-day course. McCreary and Angus say the new results suggest remdesivir may not be worth the cost.