Remdesivir Averts Hospitalization in High-Risk COVID Patients

An international phase III trial presented at the 2021 virtual IDWeek conference found that a 3-day course of intravenous remdesivir (Veklury) in COVID-19 outpatients at high risk of progression to severe disease significantly reduced the risk of hospitalization by 87% versus placebo.

In this exclusive MedPage Today video, study author Joshua Hill, MD, of the Fred Hutchinson Cancer Research Center in Seattle, discusses the study, its limitations, and the further potential of remdesivir in COVID-19 treatment.

Following is a transcript of his remarks:

My name is Josh Hill. I am a transplant infectious disease physician at the Fred Hutchinson Cancer Research Center at the University of Washington in Seattle. And we were one of the sites participating in a large international global trial, looking at remdesivir for treatment of patients with COVID-19 early in the course of their infection. So these are patients who are outpatient, infected in the last 7 days, and symptomatic due to COVID-19.

And the high level findings here from this study was that 3 days with intravenous remdesivir reduced the incidence of hospitalization or death in the following month by 87%. So that was really a striking finding, which was really nice to see. This was placebo-controlled, randomized, double-blinded -- about 550 patients or so total enrolled in the trial. Half of them got remdesivir half of them got placebo.

And that was a really exciting finding. It's basically on par with what we're seeing with monoclonal antibodies. Granted, this is a 3-day intravenous dose and compared to the monoclonals, which is a single day. So that's one potential drawback of remdesivir. The nice thing about remdesivir is that it's readily available, it's available internationally, which is nice, while the monoclonals aren't. It targets the RNA polymerase as opposed to the spike protein, so theoretically it's less likely to be affected by mutations in the spike protein like we're seeing with some of the new variants that are coming out. So that's all really reassuring.

The safety looked fine. The safety profile was similar to placebo and is in line with what we've seen with other studies of remdesivir. So really quite well tolerated. So that was really encouraging as well.

So it certainly provides another tool in our tool belt for therapies that we can offer our patients. It will be challenging to implement for patients that aren't established at a clinic that can offer outpatient infusions. So that might be a challenge. But for patients at cancer centers and other areas of practice where patients are routinely getting infusions or have access to that, I think it'll really offer another tool that we can use for patients. Ultimately we want an oral therapy, there's some kinds of new drugs that are in the pipeline there. We recently heard about fluvoxamine, and molnupiravir in a press release, we haven't seen data yet. So that's exciting.

They have been able to generate an oral formulation of remdesivir and that shows efficacy in a preclinical model, which is great. So that's going to continue to move through into human studies as well. So this is great proof-of-concept study that early intervention with a direct acting antiviral therapy, or along with the monoclonal antibody data, certainly can be effective and will help improve outcomes for our patients.

The trial was stopped early for administrative reasons. Basically there were fewer patients available to enroll because vaccinations were rolling out, and monoclonals, and rates were going down at the time. So we enrolled about half as many as patients as we initially proposed, but the data remained blinded and were unmanipulated in any way. So once the data were unlocked, we saw this large effect, which was great, which met statistical significance. And so now I don't think any additional studies are being done. This will move forward and has been submitted to the FDA for consideration. Right now remdesivir is restricted to use in hospitalized patients. But hopefully this will get approved by the FDA for this indication. And I think we'll make therapies more available for people globally at places where monoclonals aren't available and where people are quite comfortable now using those drugs. So, that's the goal.

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