In June, the Food and Drug Administration approved the drug Xocova (ensitrelvir) as the very first post-exposure prophylaxis for Sars-CoV-2, and if taken within 72 hours, it could stop a SARS-CoV-2 infection in its tracks. The drug is also being studied as a potential Long COVID treatment and even maybe as a preventative. But how accessible will this drug be?
In this episode of Still Here, Betsy Ladyzhets talks to co-host and Sick Times co-founder Miles Griffis about his reporting on the drug, the manufacturers, the studies behind it, and what it could mean for the disease.
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RSSLinks mentioned:
- FDA approves COVID-19 antiviral Xocova as PEP. But will it be accessible? – The Sick Times
- Research updates, June 23 – The Sick Times
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Intro
Melanie Marich: [00:00:00] Welcome to Still Here, a Long COVID news and commentary podcast from The Sick Times. In this week’s episode, how might the new drug Xocova change how we think about COVID-19?
Miles Griffis: I’m Miles Griffis.
Betsy Ladyzhets: And I’m Betsy Ladyzhets. We’re the co-founders of The Sick Times.
Melanie Marich: And I’m Melanie Marich, the podcast producer for Still Here.
Miles Griffis: Many institutions are ignoring the ongoing COVID-19 pandemic and trying to erase [00:00:30] the Long COVID crisis.
Betsy Ladyzhets: But here at The Sick Times, we’re bringing you the latest news and commentary that matters to the Long COVID community.
Miles Griffis: Without pandemic denial, minimizing, or gaslighting
Melanie Marich: just a short six years into this pandemic, there’s a new medication that has a lot of people talking. If you’ve been exposed to COVID, there’s a new pill that could stop you from getting sick. That is, if you can get it in time. Last month, the FDA [00:01:00] approved the drug XCOVA, also known as ensitrelvir, as the very first post-exposure prophylaxis for SARS-CoV-2 That means if you’ve been exposed to the virus, you can take the pill within 72 hours to try and stop the infection in its tracks.
The drug is also being studied as a potential Long COVID treatment, and even maybe as a preventative, though those studies are still underway. It’s big news, but it’s also complicated news. Our co-host and Sick Times co-founder, [00:01:30] Miles Griffis, has been reporting on this story for the past few weeks, and has spoken to the drug manufacturers, researchers, and patient advocates about what this might mean for public health.
Miles and Betsy sat down to talk about this reporting, the science, the potential access problems, and what this all means for folks trying to prevent reinfection. You can read his full reporting at thesicktimes.org, and as always, links will be in the episode description. Here’s that conversation.
Interview with Miles Griffis
Betsy Ladyzhets: Um, well, Miles, it’s good to be back on the mic with you for Still Here.
First time in a few weeks that [00:02:00] we’re we’re both in a recording. Um, so we’re here to talk about Xokova, I think is how we are pronouncing it, also known as ensitrelvir. This drug was just approved by the US Food & Drug Administration as post-exposure prophylaxis, or PEP, PEP, for SARS-CoV-2. Um, so let’s start with the basics.
Can you explain a little bit about what this drug is and how it is different from Paxlovid and/or other COVID antivirals?
Miles Griffis: It’s good to be back on. Um, [00:02:30] yeah, so we are talking about Xokova or ensitrelvir. It’s different from Paxlovid in that it is a post-exposure prophylaxis drug, or PEP, as you said. So that means that after you are exposed to COVID-19, maybe someone tests positive in your household, um, and then you would take it within 72 hours of that, um, exposure.
This reduces your risk of getting COVID-19. The study that it came from, um, was about [00:03:00] 67%, um, when treatment was started within 72 hours. So this is very significant, um, risk reduction, but of course it is not, um, 100%. In comparing it to Paxlovid now, um, Paxlovid is something that you take after you have tested positive for COVID-19, um, and it helps to reduce the risk of severe complications from COVID-19.
Interestingly, Xokova is actually approved for two things in Japan, um, PEP, [00:03:30] which we have, it was just approved for recently, and it’s been approved since 2024, um, in the same way that Paxlovid is approved here, um, for treating COVID-19, um, after you get COVID-19.
Betsy Ladyzhets: Yeah. So Paxlovid you take after you’ve tested positive or after you have confirmation of an infection as far as that is feasible these days, whereas Xokova you take before you’ve tested positive, and then ideally [00:04:00] it helps lower that risk of you testing positive or developing symptoms, um, just to kinda summarize, right?
Miles Griffis: Yeah, exactly
Betsy Ladyzhets: With this clinical trial that showed efficacy, um, it had kind of an interesting design compared to some other trials that we’ve seen for other antivirals and other COVID treatments. So can you talk about that a little bit and kind of why, uh, researchers find this really promising in terms of the drug’s, uh, potential [00:04:30] effectiveness?
Miles Griffis: Yeah. So it was a very, uh, robust and significant trial, um, in that, A, it’s, uh, it looked at over 2,000 people who had been exposed to COVID-19 with household contacts. So these are people they were living with, um, had prolonged exposures to, not just brief exposures to maybe getting coffee with someone who had COVID-19 or something, like people they lived with.
So, um, the trial found this 67% reduction [00:05:00] of symptomatic COVID-19. The second endpoint found a 34% reduction, um, of transmission. So obviously, of course, not 100%, but, um, also a significant, um, risk reduction. So These were pretty big, uh, bars. To get FDA approval is a very big deal. Um, it has to be reviewed, um, it has to be a very, you know, well put together study.
This was published in the New England Journal of Medicine, which is a really prominent journal, [00:05:30] um, and has a very high bar to clear. And then to get FDA approval, the results came, uh, within weeks after. So this is encouraging to see that, uh, this drug, you know, has a big opportunity for risk reduction of COVID-19, um, and that’s being seen through, like, very rigorous review from multiple, uh, agencies and medical journals.
Betsy Ladyzhets: So I know in your article you were able to get a bunch of comments from Shionogi, which is the manufacturer of this drug. It’s a Japanese-based, [00:06:00] uh, pharmaceutical company, and one striking detail that they provided is that the list price is set at $1,400 in the United States, which is compared to about $310 in Japan, um, where the manufacturer is based.
Um, and then you also reported a little bit on a co-pay assistance program for the drug. So could you talk a little bit more about that and what it might mean for accessibility?
Miles Griffis: Yes. So, uh, this was the first that I had seen, um, from our reporting of this, [00:06:30] uh, list price of 14, um, hundred dollars. Um, so this is pretty similar to what Paxlovid’s li- list price is.
Um, they’re both five-day courses of a drug. Um, but yeah, it’s, it’s quite a contrast when you see the, the price in Japan. One commentator on a recent social post pointed out that you could actually fly round trip to Japan, maybe see a doctor there, and get it prescribed, and it might still be around the same as the list price in the US.
Um, which [00:07:00] kind of is a way of showing how ridiculous, um, these, these sort of pricing disparities are between the two countries. Um, but yeah, so the drug, uh, will hit the market in mid-July. So it seems like Shionogi is still figuring out, um, some… these programs. Um, the, what they’ve told me right now is that you basically have to have commercial insurance through, like, a private healthcare insurance group, um, to qualify [00:07:30] if, if you have a co-payment, um, for their co-pay assistant, assistance program.
So this basically means your insurance m- may cover it, so you might not pay anything. Um, it might not fully cover it, and if it doesn’t fully cover it, there may be, um, opportunities for getting assistance, um, through this co-pay program. However, when it hits the market next month, there will be no um, assistance programs if you do not have insurance or if you’re on, [00:08:00] um, different type of health programs like Medicaid, Medicare, um, VA health programs, et cetera.
Um, so it’s not going to be extremely easy to get. We’ve seen a lot of these issues with Paxlovid as well. Um, because you have to take these drugs in such a small window, um, it makes it much more difficult to get prior authorizations through, through healthcare insurance companies. Um, so access is [00:08:30] definitely a big issue, and I’m, uh, really interested to see how this sort of plays out and how people can, how people are accessing the drug with this time constraint.
Um, and sort of if, what insurance companies will end up wanting to see to approve the drug, whether it’s a positive COVID test from someone in the house, or how sort of they will make the decisions on who gets coverage or not. That’s to say that Shionogi did state that they are working on a [00:09:00] program for people without insurance that they hope to debut in mid-August.
Um, so we’ll look out for more details on that when it comes out.
Betsy Ladyzhets: Yeah. Plus, I guess more details from different insurance companies or from Medicare, Medicaid, other, like, public insurance plans. I think all of that is probably pretty up in the air right now, and what we have in the story is really just comments from the manufacturer on what they’re, they are planning.
But, like, the US healthcare system is so complicated and has so many different [00:09:30] players, so I think it’s important to be clear that, like, a lot of this, a lot of these logistics are probably still a work in progress. So in your story, you also draw a comparison to HIV PEP, um, which in some cases has pretty streamlined access pathways.
So say a little bit more about that and kinda how advocates would like to see things work for Xokova as compared to, or maybe drawing on some of these other kinda similar drugs that are [00:10:00] available for other diseases.
Miles Griffis: Yeah. Um, so PEP, post-exposure prophylaxis, um, exists for, um, a lot of different, um, diseases, so that we have it for HIV, um, mpox, rabies, and I think hepatitis B.
So there are some options. Some are approved and some are not, um, by the FDA. Um, so for HIV, the drugs that you would use for this are not, um, FDA approved [00:10:30] yet, but they are very effective. Um, in this course, they are also taken within 72 hours. Um, they’re taken for much longer than the five-day course of, um, Xokova, so I think they’re usually about, like, 28 days compared to the five.
So these programs have been around for a while. Um- And you can find them in sexual health clinics, you can find them, um, in hospitals, you can find them in, like, urgent cares. It– The mileage will definitely vary on sort of the, [00:11:00] the clinician’s knowledge, um, on all of these, so there’s definitely issues still within this.
Um, but there are programs that are very quick, um, to help you access this drug in a very short amount of time. Um, and sources I spoke with, uh, Gabrielle Senn and Materio at Long COVID Justice told me that, um, sort of like the quickness to accessing these drugs is, is the importance of getting to them, um, because [00:11:30] it’s what makes the difference.
The medication is obviously so groundbreaking, but if you can’t get to it quickly, um, it’s not as effective. So this is something that has really been, I think, shown a good model of how, um, how PEP drugs can be, can be used in the US, um, and made more accessible. There’s a bunch of different programs that you can access, um, with different levels of insurance for HIV PEP.
HIV PEP [00:12:00] drugs are a really good comparison for this, um, because they also have to be taken within 72 hours, um, of an exposure to HIV
Betsy Ladyzhets: And there’s also obviously the dynamic of testing, which I think we are also seeing people talk about in, uh, comments on social media about this story, and I think came up from the experts you talked to as well, um, where it’s like not only do you need to be able to access Xokova quickly, you also would need to know that somebody in your hassle- household, [00:12:30] or a close contact, or someone you’ve been exposed to has COVID-19, um, which is not necessarily an easily thi- an easy thing to quickly learn these days with the decline in PCR testing and the decline in, uh, availability of, like, free rapid tests, um, from government programs and all of this stuff.
Um, obviously a lot of different tests exist, but they tend to be pretty expensive, and you have to pay for them out of pocket. So that’s also kind of a part of the access [00:13:00] dynamic, I guess.
Miles Griffis: Yeah, a lot of the experts I spoke with talked about testing still being a really important part of COVID-19 prevention.
Um, a lot of people talked about this drug as sort of an expansion of the toolkit, but it’s not like this is the end-all, be-all drug that will prevent COVID-19. Um, we need to continue masking, um, cleaning air, testing, isolating, et cetera. Um, so this is just sort of something else to have if you do have a [00:13:30] confirmed exposure.
Um, I think a lot of people, if they’re able to access tests, they can, that it’ll be a helpful tool ’cause they may be able to confirm if someone has COVID-19. Um, but it is a big access issue, and it’s gonna be really difficult, um, since it’s so much harder and more expensive to access COVID-19 tests. And then on top, um, get the drug within 72 hours, um, from informed healthcare providers.
Betsy Ladyzhets: At least I guess there’s no restriction on [00:14:00] who is eligible for it. I know that is also a access barrier for Paxlovid in that you might have to document that you have some kind of like quote unquote preexisting health condition that puts you at higher risk of severe COVID symptoms.
Miles Griffis: Yeah. It’s approved for, uh, people 12 and older, um, and they say that pregnant people should not take it.
Um, and there’s obviously there will be other drug interactions, so you re- would definitely have to check with your provider to see [00:14:30] if it’s a good fit for you
Betsy Ladyzhets: So in addition to the acute COVID treatment aspects of this drug, uh, your article also touches on two ongoing trials that are looking at Xokova as a potential Long COVID treatment.
Um, one looking at its capacity to prevent Long COVID if somebody is taking it, uh, during the acute phase of a SARS-CoV-2 infection, and one for actually treating Long COVID itself. Um, so what, what would you want people to know about these [00:15:00] trials, um, kinda given that we don’t have results for either one yet?
Miles Griffis: Basically, the research is still very ongoing into this drug, um, for Long COVID. I’ve seen the– basically, the results that led to the FDA approval for this as PEP, um, was a really strong clinical trial showing it, that it works exclusively for PEP. Um, there’s been some interpretations that the, the trial also showed that it prevented Long [00:15:30] COVID, um, but the study didn’t look at this, so some experts I spoke with said, um, caution just sort of interpreting it that way.
The company behind the drug, Shionogi, is also looking at one study called Resilience, and that’s sort of to see if you get COVID-19, take this drug, will it prevent post-COVID complications, Long COVID, et cetera. Um, so that is still undergoing, um, study. We’ve seen similar studies [00:16:00] look at this from more of an observational standpoint or retrospective standpoint, um, for Paxlovid, and those studies have kind of shown, um, at least some recent ones, that there’s not a significant reduction or risk.
Um, but this is a different drug and, um, is approved both to treat COVID-19 and as PEP in Japan, so it’ll be interesting to see the results of that study. Uh, the second study, um, is being run at the University of [00:16:30] California, San Francisco. Um, Michael Peluso is one of the co-leads, so I talked with him about that trial.
Uh, it’s a small trial. It’s phase two, and it has about forty people in it, and they’re basically looking at to see if a one-course, you know, five-day Um, trial of the drug basically helped improved any Long COVID symptoms. Um, they are still analyzing the results of that, and we’ll [00:17:00] hopefully have them soon.
They didn’t give me a date, but I definitely look forward to seeing that study. So one interesting part about that trial is they were also looking at, uh, biological markers, um, in research-based laboratory measures potentially related to persistent SARS-CoV-2 or post-COVID inflammation. So they took biospecimens from blood, lumbar punctures, um, and gut biopsies in about half of the participants, and they’ll be able to have more of an [00:17:30] understanding of how the drug impacted those different markers.
So that might be released as a part of that paper or as a separate paper.
Betsy Ladyzhets: Makes sense, yeah. A lot of the, uh, studies looking at Paxlovid as a potential Long COVID treatment have also been doing this kind of thing of, like, not just tracking the more obvious impacts on symptoms, but looking at if there’s any kind of measurable change in underlying biology of people who have Long COVID, uh, when they take an antiviral.
So it’ll be really cool to see that. [00:18:00] Um, and hopefully a precursor to other studies that maybe go more in depth with, like, subgroups or with, uh, a better un- understanding of which biomarkers to use or all of these questions that researchers are trying to figure out.
Miles Griffis: Yeah. Dr. Peluso said that he’s– he would like to see this drug trialed in more Long COVID research in different ways.
Um, he said that the approval is helpful. Um, it’s only approved as PEP But it may open up some doors to make it more accessible for [00:18:30] future trials, but there’s still a lot of obstacles.
Betsy Ladyzhets: Um, obviously, Miles, you and I have been covering COVID-19 and Long COVID for a while now, and I know this, uh, FDA approval kind of felt like big news when it happened a couple of weeks ago.
Um, do you still feel that way after reporting this story, or what, what are you kind of thinking, um, as we continue to cover this space?
Miles Griffis: Yeah, I do still think this is a big milestone in, um, in just the tools that we have. I think, I [00:19:00] think we’ve had to think of COVID-19 prevention as, you know, the Swiss cheese model for a long time, and this is just another layer, um, for that.
I’m very curious to see how sort of access issues play out in the next few months and year, and I guess, yeah, h- how this drug will be used in future research, um, if it’s able to prevent COVID-19, um, in this way. This definitely means that I think that there could be future research that’s even more effective and will have even more effective drugs in the [00:19:30] future.
Um, so it’s definitely, I think, a really positive milestone, um, but only if people can take it.
Melanie Marich: To read more of Miles’ reporting, check out the link in our episode description, or go to thesicktimes.org. Now, here’s this week’s research updates.
Research updates
Miles Griffis: A new study adds to growing evidence that Long COVID can harm your heart.
Researchers looked at health records for more than 8,000 people who had a SARS-CoV-2 infection. They found that people with Long COVID symptoms were more likely to develop [00:20:00] cardiovascular disease, especially angina and heart attacks, compared to people who did not have Long COVID. The authors point to underlying biological mechanisms they say are shared by both conditions, chronic inflammation Problems with blood vessel function and immune system disruption.
In their words, growing evidence suggests Long COVID and cardiovascular disease share underlying biological mechanisms.
Betsy Ladyzhets: Two new studies are giving us a clearer picture of a serious inflammatory condition in children triggered by [00:20:30] SARS-CoV-2. It’s called MIS-C, which stands for Multisystem Inflammatory Syndrome in Children.
The first study, which was shared in the journal Scientific Reports ahead of publication, found specific autoantibody patterns in kids with severe acute COVID-19 and kids with MIS-C. The authors wrote that SARS-CoV-2 acts as both a trigger and an amplifier of autoimmunity. They called it a risk factor for long-term autoimmune complications.
And then the second [00:21:00] study, which was published in the journal Pediatrics, found that MIS-C can persist for at least four and a half years after a SARS-CoV-2 infection and can affect multiple organ systems. The author said that their findings redefine what we should expect for children who have MIS-C.
Miles Griffis: The Veteran Affairs Office is funding another potentially harmful behavioral clinical trial on Long COVID.
The trial will be based in Palo Alto, California, and is looking at water-based exercise and, quote, “cognitive training,” unquote. [00:21:30] Researchers plan to enroll 50 participants. Half will do pool-based exercise three times a week for six months, followed by 10 sessions of cognitive training. The other half will get what is called, quote, “usual care,” unquote, which they define as education on brain health.
Despite extensive research showing Long COVID is not deconditioning and can be made worse by exercise, the clinicaltrials.gov page does not account for post-exertional [00:22:00] malaise, or PEM, which many people with Long COVID experience.
Outro
Betsy Ladyzhets: That’s all for this week’s episode.
Miles Griffis: In the meantime, we’ll continue reporting the information that you need.
Betsy Ladyzhets: Solidarity with everyone still here.
Melanie Marich: This podcast and The Sick Times are supported by you. You can help us keep this work going by donating on our website. Still Here is a production of The Sick Times, a nonprofit newsroom chronicling the ongoing Long COVID crisis. Our theme song for this episode is The Rude Mechanical Orchestra’s rendition of Which [00:22:30] Side Are You On?,
originally by Florence Reece. I’m Melanie Marich, and I produced this episode. Our engagement editor is Heather Hogan. Sophie Dimitriou designed our podcast cover art. And Miles Griffis and Betsy Ladyzhets are your co-hosts and The Sick Times co-founders. Thanks for listening.
