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Feuerstadt reviews ACG 2023 data showing live microbiota therapy provides consistent protection against rCDI in one of the most vulnerable patient populations.
Post-marketing data from the ongoing open-label PUNCH-CD3-OLS trial—presented earlier this week at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting in Vancouver, BC—showed live fecal microbiota (RBX2660; REBYOTA) provided treatment success of recurrent C difficile infection (rCDI) prevention to two-thirds of adults aged ≥65 years old with ≥1 chronic comorbidity through 8 weeks.
The findings from a Ferring-supported team of investigators supported the maintained efficacy and consistent safety profile of the agent—that which the US Food and Drug Administration (FDA) approved rCDI prevention last November—in a highly vulnerable patient population.
In an interview with HCPLive during ACG 2023, study author Paul Feuerstadt, MD, assistant clinical professor of medicine at Yale University School of Medicine and a gastroenterologist with PACT Gastroenterology Center, discussed the relevance of research into older, vulnerable patients with rCDI risk.
“It's really essential to understand that historically, we have learned that the majority of patients that get C difficile are older (>65 years), and have medical comorbidities. That's the mantra,” Feuerstadt said. “And essentially, those patients are the ones who are piped into the health care system. They're the ones who go to frequent doctor's office visits. They're the ones who are frequently admitted to the hospital. They're the ones who receive antimicrobials.”
Regarding the findings from PUNCH-CD3-OLS, Feuerstadt highlighted the consistency of rCDI prevention across each cohort of older patient comorbidities: cardiac conditions, gastric conditions and chronic kidney disease.
“This is a harder-to-treat population with typically more severe disease. The product is consistent across those groups,” Feuerstadt said. “So as a clinician, you can be comfortable applying this product and giving this product to those patients and knowing that the pivotal data applies to that patient cohort.”
What’s more, Feuerstadt perceives a financial and behavioral benefit for these outcomes; he noted the estimated cost of care for a single CDI episode is approximately $72,000 in 1 year. For patients with ≥3 occurrences, the total exceeds $200,000. Common feedback he receives from these patients is how significantly they’ve changed their diet, or they need to pack extra clothes when they go out in fear of an episode.
“We are looking to allow these people the opportunity to live their life and not be in fear that they're going to have another episode,” Feuerstadt said. “So really impacting that risk, and letting the patients rest more easily knowing that the likelihood that this is going to come back is remarkably lower, can have a huge impact on those individuals.”