Christian John Lillis, cofounder and executive director of the Peggy Lillis Foundation for C difficile Education & Advocacy, explained how FDA-approved microbiome-based therapeutics help to treat and prevent C difficile infection.
Amid National C. Diff Awareness Month, Christian John Lillis, cofounder and executive director of the Peggy Lillis Foundation for C. Diff Education & Advocacy (PLF), explains how recent FDA-approved microbiome-based therapeutics help to treat and prevent infection from Clostridioides difficile.
PLF, which was founded in response to the death of 56-year-old Peggy Lillis from an infection caused by C difficile, is the leading national organization dedicated to combating C difficile infections by educating the public, shaping policy, and empowering advocates.
How has the FDA approval of microbiome-based therapeutics impacted C difficile treatment and prevention?
It's early. The first one that got approved became available in January, so it's been 10 or 11 months; the other one became available in June. We are seeing some really optimistic signs. I think the most important thing for C diff patients, our community, and our movement is that it had been 12 years since any new treatment for C diff had been approved by the FDA. And so, the approval of not just 1, but 2 new treatments, which were a completely new paradigm for treating this disease and preventing recurrence, I think has really restored hope for a lot of us and made us think fighting for the past 20 years has been worth it, and feeling like we're going to get to a place where people don't suffer.
What we really want to change with these new therapies, or preventatives, is when patients are battling recurrent C diff, often they're given endless rounds of antibiotics. You might get vancomycin, and then you fail vancomycin, or vancomycin fails you, I should say. Then you're put on a vancomycin taper, and that doesn't work. So then you're given fidaxomicin. So, at this point, we're talking you've been sick for 2 months already. If you're somebody who works and has a family, that's incredibly disruptive. Then, for a time, people were getting a fecal microbiota transplant [FMT], or a stool transplant. But the FDA always considered that experimental, so it really limited the number of people that were able to access that; there's probably about 180,000 people who get recurrent C diff every year, and maybe 10% or 20% of them were able to access an FMT. So, now that we have FDA-approved products, what we hope is that everyone will get that preventative to stop them from getting a recurrence.
I think they're also beginning to not just help people who are getting them right now, but also beginning to change practice guidelines. Prior to this, the standard was the antibiotics had to fail 3 times before you'd even be considered for an FMT. Again, depending on the exact prescription, it could be weeks or months of you suffering before you were offered this sort of treatment of last resort with a fecal transplant. What we hope is that with these new therapeutics, you will get this microbiome intervention way sooner, and so you'll have less physical and socioemotional damage than patients that didn't have access to these therapies.
There's definitely been a little bit of sticker shock. These therapies, they are expensive compared to what has been the previous regime, but by interrupting the cycle of recurrence, they will ultimately save us money. The average cost of somebody who's dealing with multiply recurrent C diff, for their treatment is around $40,000. What we ideally would like to see is that when a patient tests positive for C diff that they're given a narrow spectrum of antibiotic to sort of limit the further disruption of their microbiome. Then, if they get a recurrence—and, even with the best antibiotic we have now, about 10% to 15% will—they will then get a microbiome restoration preventative after that first recurrence to hopefully prevent further occurrences.
Another reason why that's really important is because what we know, and there was a recent article about this that came out a few months ago, is that for every time somebody recurs, their chances of recurrence increases. So, you get C diff, you get treated, you have a 20% chance of recurring. You get that recurrence, now you have a 40% chance of recurring. You get a second recurrence, it's a 60% chance of recurring.
Along with that, what we've seen is that every time a person recurs, their chances of going into septic shock increases, their chances of needing a colectomy increase, and their chances of death increase. Of course, all of those treatment interventions after the first recurrence are more and more costly to the patient and to the health care system. So, I feel like by interrupting this, not letting anybody get past a first recurrence, it will drastically improve people's experiences with C diff and also ultimately save us money and resources.