A recent study conducted by a government agency, NIAID, offered preliminary evidence of Remdesivir’s benefit to COVID-19 patients. The drug is heralded as the first antiviral drug to improve COVID-19 patients response to treatment.
According to an article in STAT NEWS, the study represents the first study demonstrating that an antiviral drug has successfully shortened COVID-19 patients’ time to recovery.
Dr. Anthony Fauci, NIAID director, commented that the study has given a reason to be optimistic, although the results were not significant.
Remdesivir, an intravenous (by injection) drug developed by Gilead, reached the primary goal of improving time to recover in eleven days. People taking a placebo took 15 days to recover. The statistics for the mortality difference were insignificant.
Dr. Frederick Hayden, professor emeritus at Virginia’s School of Medicine commented that he believes this can change the standard of care in many countries.
About the NIAID Study
The remdesivir study involved eight hundred COVID patients. It was a double-blind, placebo-controlled study. This means that neither physicians nor patients knew who received the drug or who had been administered a placebo. This removes the possibility of unconscious bias that could affect conclusions.
The primary endpoint of the study is a patient’s time-to-improvement. Various measures of improvement are used to gauge the severity of a patient’s condition at the onset of the study. However, clinicians have been unable to gauge the extent of improvement.
A Chinese study had to be discontinued as the virus curve flattened due to lack of enrollment. China released unspectacular results from its remdesivir study that were published in the Lancet. However, the NIAID study is considered to be the most critically designed test for remdesivir/COVID-19.
Emergency Measures
Several people weighed in with their view of remdesivir.
The FDA former commissioner, Scott Gottlieb, expects to see evidence for the FDA to grant emergency use authorization for the drug. He acknowledged that remdesivir may not be a ‘home run’ but he feels it will lower the nation’s virus burden in the fall.
Commissioner Gottlieb mentioned that hydroxychloroquine received emergency authorization for testing by the FDA. This was despite the fact that some studies claimed the drug was not effective. He said based on that authorization, remdesivir is well ahead in drug performance especially for patients who are critically ill.
Emory University physician, Dr. Aneesh Mehta, said she felt the results were sufficiently robust for preliminary findings. However, she said an analysis of the data is required so that clinicians may fully understand the effects of the drug. She offered that the time to recovery could be longer or shorter than originally thought.
Nahid Bhadelia, special pathogens director in Boston, believes that remdesivir will most likely benefit patients who have been admitted to the hospital. However she acknowledges that the drug will have the most impact on patients who are newly infected. Antiviral medications are most effective when given as soon as possible after the infection is discovered.
Conflicting Reports
STAT had previously reported data from a Chicago hospital trial indicating that remdesivir patients were improving beyond expectations.
Almost immediately after publication, a Chinese study contradicted this announcement.
The STAT headline read:
New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope
The study results were inadvertently sent out via the WHO website, seen by STAT, then deleted. The WHO is waiting for final results of the remdesivir study before issuing comments.
Gilead’s Study
Standard procedure in the pharmaceutical or biotechnology industry is for early release of information associated with the market as soon as the companies receive it.
Gilead released data on the study of remdesivir in three hundred ninety-seven patients just recently. Patients who required ventilators were not included.
The study tested dosing over a five-day or ten-day period with similar results for either dosing schedule. Gilead said that they believe it may be feasible to treat patients on a five-day rather than ten-day schedule as in the NIAID study. Eight percent treated on the five day remdesivir schedule died compared to eleven percent who were on the ten day schedule.
Median time to improvement was ten days. About half of the patients were released from the hospital on day fourteen.
Critics say that since there were no untreated patients in the study it must be concluded that the two treatment schedules (5 day and 10 day) were the same.
Gilead’s spokesperson explained that this study is being conducted under unusual circumstances. The company is attempting to test the drug while under pressure brought on by the global pandemic.
The chief medical officer of Gilead stated because there are a few studies running concurrently they should garner significant data. He said that multiple studies will confirm whether remdesivir is an effective COVID-19 treatment and show its highest and best utilization.
Gilead’s next study will enroll six thousand patients from one hundred fifty-two clinical sites worldwide.
A complete analysis of study results will be available when data has been compiled.
Dr. Hayden was on the investigating team for the China study that had been discontinued. He commented on the similarity of the two test results.
