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C Diff Therapy Demonstrates Long-Term Protection After Antimicrobial Usage


A new study published in Open Forum Infectious Diseases demonstrated long-term protection of Rebyota in a patient population that was exposed to non-CDI antibiotic use.

The live biotherapeutic product, fecal microbiota, notably live-jslm (Rebyota) was FDA approved in November 2022 to prevent recurrent Clostridioides difficile infection (CDI) in adult patients who have already completed an antibiotics regimen for recurrent CDI.

Since its approval, there have been a number of studies looking at its efficacy and durability over time.

A new study published in Open Forum Infectious Diseases demonstrated long-term protection of Rebyota in a patient population that was exposed to non-CDI antibiotic use.1

“Across all evaluable time points, 86% (37/43) of participants had treatment response regardless of when non-CDI antibiotic exposure occurred,” the investigators wrote.1

“RBL[ Rebyota] remained efficacious in participants with a history of rCDI after subsequent non-CDI antibiotic exposure,” the investigators wrote.

Learn more: Impact of Live Biotherapeutic Products on Gut Microbiome in Recurrent C difficile Infections

What You Need to Know

Rebyota demonstrated long-term protection in patients exposed to non-CDI antibiotics. Across all time points, 86% of participants had a treatment response, regardless of when non-CDI antibiotic exposure occurred.

Treatment response was sustained for a median duration of 470 days from the first day of initial non-CDI antibiotic use.

Rebyota may restore the gut microbiota to a sufficient threshold protective against recurrent CDI, even after subsequent non-CDI antibiotic use

Study Parameters and Takeaways
Investigators wanted to looking at the durability of the Rebyota in patients who were using non-CDI antibiotics. This subgroup was looked at up to 2 years after administration of the C diff therapy.

“Treatment response was sustained for a median duration of 470 days [interquartile range: 212–648] from the first day of initial non-CDI antibiotic use,” the investigators wrote. “Most participants (5/6) with CDI recurrences received a high-risk antibiotic.”

“These results suggest RBL [Rebyota] may restore the gut microbiota to a sufficient threshold protective against rCDI for many patients despite subsequent non-CDI antibiotic use,” the authors wrote.

C diff is estimated to infect approximately 500,000 patients annually in the US, and of these around 30,000 will die.2

Recurrent C diff infection is associated with even higher rates of morbidity and mortality, treatment options are limited or may worsen the problem by further disrupting the gut microbiome.

References
1. Reveles K, Gonzales-Luna A, Gola Y, et all. Efficacy of Fecal Microbiota, Live-jslm (REBYOTA) Among Patients Exposed to Non-Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Study.
2. Feuerstadt P, Theriault N, Tillotson G. The burden of CDI in the United States: a multifactorial challenge. BMC Infect Dis. 2023;23(1):132. Published 2023 Mar 7. doi:10.1186/s12879-023-08096-0



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