Reviewing Real-World Cases of C diff Biotherapeutic


Here is a brief report of 5 cases of the use of fecal microbiota, live-jslm (Rebyota) in the management of recurrent Clostridioides difficile infection.

Last fall, the FDA approved fecal microbiota, live-jslm (Rebyota) for use of recurrent Clostridioides difficile infection (rCDI). Since that time, ongoing real-world cases has been ongoing and here is a recent report on a small number of cases.

Van Hise and colleagues in Private Practice Infectious Disease described their experience in a multi-center community infectious disease practice where they treated 5 cases of rCDI with Rebyota.

The current recommended treatment regimen for an initial episode of CDI is fidaxomicin (200 mg twice daily for 10 days) or vancomycin (125 mg, four times daily for 10 days). However, in approximately 25-35% of cases, CDI recurs within 1-2 months of the initial infection. After a first recurrence, patients are substantially more likely to have a subsequent recurrence, with approximately 50-60% of these patients experiencing multiple rCDI.

The 5 patients had experienced multiple recurrent episodes of C difficile infection and had failed several courses of standard antibiotic therapy. The patients were prescribed the live biotherapeutic product Rebyota. The product was administered as a single dose via the rectum.

In this report there were 3 males and 2 females, ages ranged from 20-86 years, recurrences ranged from 3-6 in the previous 18 months. Four patients had previously received standard vancomycin, 2 patients had vancomycin taper, 2 fidaxomicin and 1 bezlotoxumab.

Each course had failed these patients and all of them were administered Rebyota. The procedure took less than 10 minutes to perform, and did not require bowel preparation. Patients did not experience any new symptoms within 7 days, and no recurrence was reported at 8 weeks. The safety profile demonstrated no adverse events including no bacteremia or fungemia. The only expense patients incurred were deductibles.

The authors concluded that in their daily clinical practice that the treatment with the initial 5 patients was easy and convenient to administer with normalization of formed stools and an excellent overall clinical response.

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