By Dr. Keith Crawford, BDO HIV/AIDS Expert
Remdesivir was first developed by Gilead Pharmaceuticals and studied for treating Ebola infections. Since then, studies in the laboratory showed that it had potent activity against Sars-2 coronavirus.
Remdesivir can block viral replication because it prevents the virus from making copies of itself. So now the big question is whether these observations in the lab translate into patient benefits in the clinic. We are starting to get some results that may help answer that question.
In a study published April 10 in the New England Journal of Medicine, hospitalized patients requiring some oxygen support or assisted breathing (ventilator-assisted) were given 10 days of Remdesivir intravenously. Overall, two-thirds (36/53) of the study participants improved whereas 15% (8/53) got worse. By the date of last follow-up 47% of subjects had been discharged.
Most subjects who received oxygen support without requiring invasive oxygen support (placed on a ventilator) experienced recovery (71%) and all subjects able to breathe on their own recovered. Patients who required a ventilators and those over 70 years of age had less improvement that those younger than 50 years.
The overall mortality rate was 13% in this group of seriously ill COVID-19 patients. This appears to be a lower rate that what is usually seen among advanced patients. This study is referred to as a “compassionate use” study which is a mechanism whereby sick people with no treatment options may gain access to a medication or procedure that might help them, but has not be proven to be effective.
Just a week after this report appeared, some information regarding a Remdesivir trial was released from the University of Chicago. This is an ongoing study of individuals with severe COVID-19 disease. In this study, there were some pretty encouraging results. Many patients quickly experienced their fevers improve and came off ventilators. Many of these very sick patients recovered enough to be discharged from the hospital. But there are some important considerations here.
While the second clinical trial is still ongoing, neither that study or the other trial had a control group included in the study. All the study participants received Remdesivir.
Without a group of individuals diagnosed with COVID-19 who didn’t get Remdesivir (a control group) to compare with, it becomes difficult to determine if the drug actually has any benefit. This is particularly true for a disease, like COVID-19, where the majority of subjects are likely to recover without any drug.
To make that case, one physician from a different hospital researching Remdesivir noted that she had seen some remarkable recoveries with Remdesivir , but had equally seen remarkable recoveries without Remdesivir! So where does that leave us? Even if the drug may be effective, there still remain questions like, what dose of drug? For how long? When is the best time to start treatment? Which patients could the drug potentially harm? Certain types of clinical evaluations could help us determine the potential effectiveness, for example, testing the blood to see if the drug actually reduced the amount of SARS-CoV-2 coronavirus. This was not done for the first study (not sure about the second one). The bottom line is we need well-designed clinical studies to figure out if any of the drugs of interest are truly effective, and we need solid answers NOW!
Emphasizing the importance of having a control group, a study was just completed (reported 4/21/20) among COVID-19 patients treated at Veteran’s Administration hospitals. Comparing outcomes between patients getting standard care or receiving the drug hydroxychloroquine, showed more than twice as many deaths among those getting hydroxychloroquine (see my article posted on April 15 on Chloroquine/Hydroxychloroquine). A similar study of patients in France also showed no benefit of hydroxychloroquine over those who didn’t receive it. There are still many trials on going with better study designs to tell us if there is a benefit. Stay tuned!
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