In this episode, I’ll discuss why I think a recent study about 3 days of outpatient remdesivir is probably not going to catch on.
In the past week, a randomized trial was published in NEJM titled Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. This trial was Placebo vs 3 days of IV remdesivir in nonhospitalized patients with Covid-19 who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression.
The remdesivir group got outpatient therapy with 200 mg on day 1 and 100 mg on days 2 and 3.
The findings were statistically significant in favor of remdesivir with COVID-19 related hospitalization just 0.7% vs 5.3% with placebo. There were no deaths in either group.
However several circumstances surrounding the study make it likely the results will not be implemented on a widespread basis:
1. The trial was halted early by the sponsor in April 2021 because of:
administrative reasons related to a decrease in the incidence of SARS-CoV-2 infections, ethical concerns regarding assigning patients to placebo in the context of increased access to emergency-use–authorized treatments such as monoclonal antibodies, and increasing vaccination rates among high-risk persons.
No interim analysis had been performed and blinding was maintained prior to the study being stopped but the study protocol no longer fit into real-world practice given the widespread use of vaccination and monoclonal antibodies.
2. To implement these results, there would need to be a large number of outpatient visits (3 per patient) during a time that the patient is acutely ill and able to transmit the virus.
An editorial that accompanies this study makes the point that, if developed, new medications that could be administrated orally would be much easier to implement in the outpatient setting compared to a 3 day IV infusion.
It is likely that a new research protocol that does not exclude vaccinated patients or monoclonal antibodies would be needed before outpatient remdesivir becomes established practice.
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