702. Efficacy of Fecal Microbiota, Live-jslm After Receipt of Non–Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Trial

BACKGROUND: Live biotherapeutic products (LBPs) are adjunctive therapies to prevent recurrence of Clostridioides difficile infection (CDI). In this post hoc subgroup analysis, the durability of fecal microbiota, live-jslm (REBYOTA™; abbreviated here as RBL, previously known as RBX2660), the first microbiota-based LBP approved by the US Food and Drug Administration for the prevention of recurrent CDI (rCDI) in adults following antibiotic treatment for rCDI, was investigated in a subset of participants who received systemic antibiotics for indications other than CDI following RBL treatment in a phase 2 open-label trial (NCT02589847). METHODS: PUNCH Open Label participants were ≥ 18 years old with either ≥ 2 rCDI episodes treated with standard-of-care antibiotic therapy after a primary CDI episode, or ≥ 2 severe CDI episodes requiring hospitalization. Participants in this analysis all received 2 doses of RBL rectally administered approximately 7 days apart. We report outcomes at various timepoints for participants who were successfully treated with RBL and subsequently received non-CDI systemic antibiotics. RESULTS: A total of 43 participants were included in the analysis; the mean age was 65.9 years, most were male (67.4%), and most (97.7%) had ≥ 3 rCDI episodes before RBL. Most participants were treated with antibiotic monotherapy (n=34/43, 79.1%), received 1 course of treatment (n=28/43, 65.1%), and did not receive CDI prophylaxis (n=38/43, 88.4%). The median time to antibiotic exposure after the second dose of RBL was 155 days (interquartile range [IQR], 55-349), and the median duration of treatment per antibiotic course was 8 days (IQR, 4.5-12.5). Urinary system infections were the most common indication for antibiotic treatment (n=17/43, 40%). Among evaluable participants who received systemic antibiotics within 8 weeks, 6 months, 12 months, and 24 months of RBL administration, 91.6% (11/12), 95.7% (22/23), 90.6% (29/32), and 83.3% (30/36) remained CDI recurrence-free, respectively. A total of 86% (37/43) of participants were recurrence-free at their last evaluable timepoint. CONCLUSION: In this post hoc analysis, RBL remained effective in preventing CDI recurrence in patients with multiple episodes of rCDI after subsequent systemic antibiotic exposure. DISCLOSURES: Kelly R. Reveles, PharmD, PhD, Ferring Pharmaceuticals: Advisor/Consultant|Ferring Pharmaceuticals: Honoraria Anne J. Gonzales-Luna, PharmD, BCIDP, Cidara Therapeutics: Grant/Research Support|Ferring Pharmaceuticals: Personal Fees|Paratek Pharmaceuticals: Grant/Research Support|Seres Therapeutics: Grant/Research Support Yoav Golan, MD, Ferring Pharmaceuticals: Advisor/Consultant|Pfizer: Honoraria|Seres Therapeutics: Advisor/Consultant|Vedanta Bioscience: Advisor/Consultant Carolyn D. Alonso, MD, Academy for Continued Healthcare Learning: Honoraria|AiCuris: Advisor/Consultant|American Society of Healthcare Pharmacists: Honoraria|Cidara Therapeutics: Advisor/Consultant|Clinical Care Options: Honoraria|Merck: Advisor/Consultant|Merck: Grant/Research Support Beth Guthmueller, AS, Rebiotix Inc., a Ferring Company: Employee Xing Tan, PharmD, Ferring Pharmaceuticals: Employee Monique Bidell, PharmD, Ferring Pharmaceuticals: Employee Victoria Pokhilko, PhD, Ferring Pharmaceuticals: Employee Carl Crawford, MD, Ferring Pharmaceuticals: Advisor/Consultant Andrew M. Skinner, MD, Academy for Continued Healthcare Learning: Honoraria|American Society of Healthcare Pharmacists: Honoraria|Ferring Pharmaceuticals: Honoraria|MJH Life Sciences: Honoraria