NEJM: Outpatient Remdesivir for COVID-19

Written by Clay Smith

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Outpatient IV remdesivir was effective in reducing COVID-related hospitalization in high risk outpatients.

Why does this matter?
Remdesivir was shown to speed recovery in inpatients with COVID-19. Might it work for at risk outpatients?

Come back for your IV infusion 3 days in a row. How hard could that be?
This was a double blinded RCT of 562 unvaccinated outpatients, conducted before the delta variant, age 12 and up, at high risk for adverse outcome from COVID-19 who were randomized to receive IV remdesivir 200 mg day 1, and 100 mg on days 2 and 3 compared to placebo. They had to be enrolled within 7 days of symptom onset and within 4 days of a molecular test confirming COVID-19. The trial was administratively stopped early due to concerns over giving placebo when newer effective agents were coming into use, such as monoclonal antibody infusions, and because there was signal of benefit in the treatment arm. They initially planned to enroll 1,264 patients. For the composite outcome of COVID-related hospitalization or death at 28 days, the remdesivir group did significantly better, with 2 having the composite outcome vs 15 in the placebo group (0.7% vs 5.3%; HR 0.13 95%CI 0.03-0.59). There were also fewer medical visits in the remdesivir group, no deaths in either group, and statistically equal adverse events between groups. There was no difference in upper airway viral load between groups, which makes me wonder how remdesivir is working. Of note, the trial was funded, designed, conducted, and written by Gilead Sciences (maker of remdesivir). The evidence is pretty clear that this works. The problem is logistics, as NPR covered earlier this month. This means a patient has to come into an infusion clinic for an IV drug three days in a row. This is no small feat for health systems, especially when other options are more convenient. Monoclonal antibody requires a single IV infusion, though options are now limited as to which antibodies will help with the omicron variant. And now Paxlovid comes in pill form, though it’s still limited in supply. Though remdesivir works, I am not sure how practical it will be to administer since we have other, simpler effective options.

Source
Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med. 2021 Dec 22;NEJMoa2116846. doi: 10.1056/NEJMoa2116846. Online ahead of print.

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