Here’s my bias on 8/22/2020. I don’t think that Remdesivir is a game-changer by any stretch of the imagination. This is subject to change with future studies. I could be wrong. To me, it is a pharmacologic agent looking for an indication. Gilead has spent $2.45 million dollars lobbying (per NPR) Congress in the first 3 months of 2020. Who knows how much more they’ve spent since. On April 11th, I wrote about one study about Remdesivir. On April 30th I wrote about another study about Remdesivir. Had I mentioned that the 5-day course of this therapy is $3120 in the United States? Yea, it’s not cheap. And you all know how much I like my cheap, non-toxic, affordable therapies. So far, the only benefit found in a clinical trial is that it has shortened the time to recovery from 15 days down to 11 days. No mortality benefit.
On August 21th, 2020 a new study in JAMA was published by Spinner, et al. The trial took place between March and April of 2020 for historical context. What I mean by that is that dexamethasone hadn’t been shown to improve mortality in oxygen requiring patients yet.
Did they start Remdesivir early?
Yes they did. This is a common theme with all COVID trials. Finding the right starting point is key. In this trial, they started on patients who had positive COVID tests within 4 days of randomization. They also had moderate COVID pneumonia which they defined as O2 sats >94% on room air. In other words, these patients haven’t reach the cytokine release/inflammatory stage yet. They excluded patients with renal failure and liver failure.
Design and Dosing of Remdesivir
This is a randomized-open label trial where they compared on a 1:1:1 ratio between a 5 day course, a 10 day course, and standard care. They were trying to get 200 people into each arm. They ended with a total of 584.
The dosing was 200mg IV of Remdesivir on day 1, followed by 100mg IV daily for the subsequent days to either complete a 5-day course or a 10-day course.
If the liver enzymes or renal function went to crap, they stopped the Remdesivir in those patients. If the patients got well enough that they could go home before finishing the trial, they just stopped the study drug.
Other factors to consider include that patients were receiving concomitant medications which could muddy the waters. Those include steroids, hydroxychloroquine, lopinavir-ritonavir, tocilizumab, and azithromycin. As a comical aside, to all those who state that HCQ kills people, well 58% of the patients in the control arm received HCQ and there was no increase in death.
Clinical Status Endpoint
The primary outcome was clinical status on day 11. This is on a 7 point scale. Spoiler alert: although this was a statistically significant outcome for the 5-day course, the authors state that this is of “uncertain clinical importance”. Why is that? The clinical status was ultimately based on whether the patient was dead (which only happened in 6 patients out of the almost 600) hospitalized with a different O2 modality, or discharged. We are looking at a 1% mortality rate for all comers. That’s not as bad as it could be.
There was also no difference in improvement of clinical status, time to recovery, time to modified recovery, and weaning off of O2.
What this tells us, in my opinion.
The 10-day course of Remdesivir should not be in our arsenal. Overall this medication is not as efficacious was we all need it to be. Let’s do some math because at the end of the day, resources are not unlimited. Let’s say that they did this trial that is not industry sponsored. They gave a therapy that costs $3120 to 384 people. The total cost is almost $1.2 MILLION DOLLARS. They spent $1.2 million dollars for an “uncertain clinical effect”. At our facilities, we are prescribing this like candy in our “do everything” approach. Is this the correct was to practice medicine? Should we cut the cord on this drug like we have for others?
Check this out on my Podcast!
Citation
Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA. Published online August 21, 2020. doi:10.1001/jama.2020.16349
Link to Article and FULL FREE PDF
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