Part 2: A Conversation on Remdesivir Trial Updates

Drug Topics®: Hi, this is Gabrielle Ientile with Drug Topics®. Today I'm going to be interviewing Dr. Julie Ann Justo, infectious disease clinical pharmacist and associate professor at the University of South Carolina College of Pharmacy.

In our last interview, Dr. Justo highlighted some of the preliminary results supporting remdesivir as a potential treatment for COVID-19. Since then, Gilead has announced their latest phase 3 SIMPLE trial results. Dr. Justo joins again to provide expertise on this data.

Drug Topics®: Dr. Justo, thank you so much for joining me again today to give us an update on the remdesivir trials.

Justo: It's my pleasure.

Drug Topics®: So now that these trials are published, there may be a public outcry for wanting to have more access to these treatments. But what do you see as the next steps?

Justo: So there are rumblings that Gilead is preparing their new drug application to submit to the FDA to hopefully get remdesivir formally approved for use as a treatment for COVID-19. We know that it's already approved in Japan, and we're hopeful that over the next weeks to months, that will hopefully come to fruition for the US market, and that remdesivir will be available for purchase and use in healthcare systems relatively soon. That's the long-term solution for access to remdesivir.

In the short term, we know that approximately 900,000 vials of remdesivir have been donated in total to the US government by Gilead Sciences, and to the US government, the Department of Health and Human Services (HHS), as well. On allocating that limited, but sizable, supply of remdesivir to various states based on their burden of COVID-19 disease, they've been asking hospitals around the country to report their cases of COVID-19 at periodic intervals every 2 to 3 weeks. Based on that, they're doling out certain amounts of these 900,000 vials to various state health departments, who have, at this point, all set up systems to then dole out further vials to the actual healthcare systems in various localities.

A lot of work has been done since we last spoke to help improve access to remdesivir. Based on what I've seen around this donated remdesivir, though the emergency use authorization (EUA) is probably the fastest and easiest way for most patients currently admitted with COVID-19 to gain access to this agent, there are still a couple of other mechanisms through the drug company that we talked about before, but the donated supply via the EUA mechanism is the main one for now.

Drug Topics®: I just wanted to get your opinion, I was talking to an expert yesterday, 1 of their concerns with COVID-19 trials in general is that the media has the potential to derail trials and bring attention to certain drugs that may not warrant so much public attention, and then public outcry for wanting to have that treatment available for COVID-19 patients. What is your opinion on media attention to different treatments that you've seen?

Justo: I think the media and the information that's out there for the general public is impactful and important, and I'll give you an example. Anytime we offer a patient to enroll in a clinical trial - for a study, or even to accept remdesivir EUA supply, we have to get informed consent from the patient. The information that the patients have also received from the media does oftentimes come into the patient's own decision about whether or not they would like to agree to receive the medication or to enroll in a clinical trial. I think media does have a role in educating the public.

That being said, that's part of why infectious diseases experts, and clinicians like myself, are doing interviews such as this will provide up to date and accurate information for patients to make the most educated decision. We will echo that same information right at the point of a conversation with the patient and their loved ones so that they can truly make an informed decision about whether or not to participate in the trials. It takes a lot preparation on our part, but that's part of what we do.

Drug Topics®: What do you see as the most important takeaways that you want our audience to remember on these updated trial results?

Justo: I think at this point, we have good information to suggest that remdesivir has a modest impact on improving the treatment courts of COVID-19, particularly for hospitalized patients, particularly early in their treatment course.

Time is of the essence. If patients feel that they have any symptoms and maybe at risk of having COVID-19, I strongly encourage them to seek medical attention as soon as possible and not wait until they're very severely ill. We have seen some patients that have waited quite a bit of time, and then they come into the hospital and essentially have to go straight into the intensive care unit (ICU), which is a much more difficult situation for remdesivir to actually have some positive effect on the treatment course. That's one thing that I would encourage patients to know: if you feel like you have symptoms and you might have COVID-19 make sure that you isolate yourself, follow good infection control practices, and get medical attention.

The second thing that I would say is for clinicians using remdesivir: the best thing is to provide some benefit. We are incorporating it early in the treatment course for patients that are eligible. There are a couple of criteria - you have to make sure that their kidneys are working well, that their liver is working well. It's not there's not an absolute contraindication if they have some multi organ failure, but it has to be taken in careful consideration with all the information that we know about.

We still have a lot of questions that we have to answer, and so I think as a healthcare system, and medical community, we can't step off the gas in terms of trying to do research. I personally have a lot of questions about whether or not it can be used on patients that are on dialysis. know whether or not remdesivir can be used in combination with other agents. What's the right sequence? Should we be doing 5 days or 10 days for ventilated patients? Should we be abandoning that therapy for that level of severity of illness at all?

So as you can see, there's still a lot of questions that need to be answered when it comes to use of remdesivir, but I'm much more hopeful, I think now than I was even 2 months ago. I think we've started to get a clearer picture about the treatment options that are available for COVID-19.

Drug Topics®: Dr. Justo, thank you so much for joining me again and your continued work as well.

Justo: It was my pleasure.