What Specialties are Using Live Biotherapeutic Products?


With the FDA approval of 2 of these products, which are indicated for recurrent Clostridioides difficile infection (CDI), a study reviewed which types of clinicians are prescribing them and the protocols in using them.

With any new FDA-approved treatment, it takes time for clinicians to adapt to it, especially if the modality is unfamiliar and one not typically employed by some specialties. This theory bears out in a small, new study which showed gastroenterologists (GI) were more likely to use live biotherapeutic products (LBP) than infectious disease (ID) clinicians for recurrent Clostridioides difficile infection (rCDI). 1

The study was a retrospective chart review presented at the recent IDWeek conference and showed 6 rCDI patients had received the LBP live-jslm (Rebyota, RBL). One patient was treated in an ID practice and the other 5 in GI practices.

“Early experience with RBL administration found more treatment by GI than ID physician practices,” the investigators wrote.

“I think the uptake in the general population of practitioners is going to be slower than you would typically see. But over time, I think anyone that's committed to taking care of patients with C diff is going to want to adopt this to some degree—whether it is adopting it by using it in their office, or being very quick to refer these patients out to someone that they know can provide this therapy,” said Timothy E. Ritter, MD, senior medical research director, GI Alliance, and coinvestigator on the study.

Administration and Treatment Protocol

One area that may be considered a challenge is the modality itself, whereas, specialties outside of GI clinicians are not typically providing rectally administered therapies. However, Ritter explains the treatment does not take long to do.

“It only takes a few minutes—5 to 6 minutes to deliver to the patient—and then they just rest for another 15 minutes and get up and leave,” Ritter said.

He says it's really about getting your staff trained and having a process to administer the treatment. He says it is a short learning curve and that the value behind offering an LBP to patients as another viable treatment to reduce recurrence is significant.

“I think the main thing is just awareness that we now have an option for these patients who get recurrent disease,” Ritter said. “Many patients get one episode of C diff, and they are treated with antibiotics, and they're fine. but when they start getting recurrent episodes, these can be devastating to their health, and then they're very expensive. If we can intervene after that first recurrence, and certainly after subsequent recurrences, we can stop the cycle.”

The study investigators also reviewed the shipping logistics and scheduling of the procedure.

“RBL (Rebyota) was ordered from the distributor and shipped to the practices in a 150mL pre-packaged frozen suspension. RBL was thawed for 24 hours and administered within 5 days. Average time from order to treatment was 18±5 days,” the investigators wrote.

“It's new, and so it requires a little bit more organized logistics, in terms of having a place to store the medication and shipping and timing,” explained Ritter. “You need to have a process in place in your office, so that you hit all the all the markers of getting this done: How you order it, how you get it approved, how you get the medication delivered to the office, how it's stored, how it's the thawed, and how it is scheduled to be delivered at the right time to the patient a couple of days after they finished their previous standard of care antibiotic."

To learn more about FDA-approved LBPs, read this recent article on the treatments.

1. Hengel R, Krishnan S, et al. Early Experience with a Simple Administration of a Novel Fecal Microbiome Replacement for Prevention of Recurrent Clostridioides difficile. Presented at: IDWeek 2023. October 11-14, 2023; Boston, MA. Poster 685.

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