June 30, 2023

Clostridioides difficile infection (CDI) is one of the most common healthcare-associated infections. 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) as an acceptable alternative [1]. Unfortunately, in approximately 25–35% of cases, CDI recurs within 1–2 months of the initial infection [2–5]. After a first recurrence, patients are substantially more likely to have a subsequent recurrence, with approximately 50–60% of these patients experiencing multiple recurrent CDI (rCDI) [2]. We report our early clinical experience in a multi-center community infectious disease private practice setting with the initial five patients who received the live biotherapeutic product, REBYOTA (RBL). Methods: Five patients who had experienced multiple recurrent episodes of C difficile infection and had failed the standard antibiotic therapy were prescribed the live biotherapeutic product REBYOTA (RBL). The product was administered as a single dose via the rectum. The patients were followed for eight weeks for clinical response and adverse events. Results: Patients included three males and two females, aged 20–86 years with recurrences ranging from 3 to 6 in the previous 18 months. Four patients received standard vancomycin, two patients had vancomycin taper, two had fidaxomicin and one had bezlotoxumab (Zinplava). RBL was administered easily and in less than 10 minutes. No new symptoms occurred within seven days. No recurrence was reported at eight weeks. No adverse events were reported, including no bacteremia or fungemia. No patient incurred expenses other than deductible costs. Conclusion: In a real-world setting, our initial five patients found that RBL was easy and convenient to administer with normalization of formed stools and an excellent overall clinical response at eight weeks. Furthermore, no adverse events were reported.