Live biotherapeutics may be paradigm shift inC. difficileGIs have been waiting for

Nearly half a million Americans are diagnosed withClostridioides difficileinfection each year. Although often treated with antibiotics,C. difficilerecurrence is possible. However, recently developed therapies may change this paradigm.

Within the past year, the FDA has approved live biotherapeutics, Rebyota and Vowst, for the prevention of recurringC. difficileinfection in patients who failed treatment with antibiotics. Additionally, Zinplava (zalutumumab, Merck), a fully humanized, monoclonal antibody, is being compared with fecal microbiota transplantation for the prevention ofC. diffin patients with inflammatory bowel disease.

These preventative strategies are being studied in other gastrointestinal and non-GI conditions as well as how they interact with medications. Healio has closely followed these clinical trials throughout the year, reporting on breakthroughs and setbacks alike. In case you missed any of it, Healio recaps the latest on these preventative therapies and what clinicians should know about them.

VIDEO: ‘Robust’ data analysis establishes safety of Rebyota for recurrentC. difficile

In a Healio video exclusive,Lindy Bancke, PharmD,outlines results from the “largest safety evaluation to date” for Rebyota, the first FDA-approved, microbiota-based treatment for prevention of recurrentClostridioides difficileinfection.

“There is a significant patient, health care provider and financial burden to address the continued dysbiosis, or disruption of the gut microbiome, and to reduce the associated risks that come with that,” Bancke, vice president of global clinical operations in the U.S. at Ferring Pharmaceuticals, said. “Rebyota is the first and only single-dose FDA-approved microbiota-based treatment for the prevention of recurrence ofC. diffinfection in individuals 18 years of age and older following antibiotic treatment.”Watch video.

VIDEO: Low risk for congestive heart failure exacerbation with Zinplava forC. difficile

In this Healio video exclusive,Paul Feuerstadt, MD, FACG, AGAF,recaps results from a real-world analysis of Zinplava for prevention of recurrentClostridioides difficileinfection in patients with congestive heart failure.

“C. difficileis a major problem in the United States,” Feuerstadt, assistant clinical professor of medicine at Yale University School of Medicine and attending gastroenterologist at PACT Gastroenterology Center, said. “It is estimated about a half a million people will be diagnosed with this infection on an annual basis.Watch video.

VIDEO: No change in concomitant medications after Rebyota for recurrentC. difficile,IBD

Treatment with Rebyota did not affect concurrent medication use in patients with inflammatory bowel disease and recurrentClostridioides difficileinfection,Jessica R. Allegretti, MD, MPH,explains in this Healio video.

Allegretti presented data at Digestive Disease Week on safety outcomes and concomitant medication changes after treatment with Rebyota (fecal microbiota, live-jslm/RBX2660, Ferring Pharmaceuticals) — the first microbiota-based, live biotherapeutic product approved by the FDA to prevent recurrentC. difficileinfection in adults after antibiotic treatment.Watch video.

VIDEO: Rebyota safe, effective when given via colonoscopy for recurrentC. difficile

In a Healio video exclusive,Paul Feuerstadt, MD, FACG, AGAF,discusses data showing consistent safety and efficacy of Rebyota when administered via colonoscopy for prevention of recurrentClostridioides difficileinfection.

“C. difficileis a major problem for people in the United States; it is the most common health care-associated infection,” Feuerstadt, assistant clinical professor of medicine at the Yale University School of Medicine and attending gastroenterologist at the PACT Gastroenterology Center, said. “If we treat patients with totally correct antimicrobials, up to 35% of them will recur after initial infection. After that, up to 45% and thereafter up to 60%. This is where treatments called microbiota restoration therapies fit in.”Watch video.

FDA approves Vowst as first oral microbiota biotherapeutic for recurrentC. difficile

The FDA has approved Vowst, the first orally administered fecal microbiota product indicated for the prevention of recurrentClostridioidesdifficileinfection in adultsfollowing antibacterial treatment. With this approval, Vowst (SER-109, Seres Therapeutics)becomes the second microbiota-based live biotherapeutic approved for recurrentC. difficileinfection following the approval of Rebyota (fecal microbiota, live-jslm; Ferring Pharmaceuticals) in 2022.Read more.

C. difficileFMT高于之前后感染复发sly reported in IBD

More than 20% of patients with inflammatory bowel disease experienced recurrentClostridioides difficileinfection 1 year after fecal microbiota transplantation, according to data presented at Digestive Disease Week.

“While there are data on the short-term efficacy of FMT for eradicatingC. diffinfections in patients with IBD, there is less known about longer-term outcomes,”Edward V. Loftus Jr., MD,the Maxine and Jack Zarrow Family Professor of Gastroenterology at the Mayo Clinic, told Healio. “We assessed our experience with longer follow-up time, focused our attention on patients with moderate to severe colonic IBD activity and found that the recurrence rate ofC. diffinfection was higher than previously reported, and that about one-third of patients ultimately required colectomy.”Read more.

Bezlotoxumab, fecal microbiota transplant similarly effective in preventing recurrent CDI

Bezlotoxumab and fecal microbiota transplantation were similarly effective at preventing both early and late recurrentClostridioides difficileinfection, according to a study published inOpen Forum Infectious Diseases.

“This study was prompted by the idea of knowing the current status (indications, therapeutic success) of the treatment (bezlotoxumab and/or fecal microbiota transplantation) that we administer to our patients,”Sofia de la Villa, MD,infectious disease specialist at the Hospital General Universitario Gregorio Marañón, told Healio.Read more.

Novel alternative to fecal microbiota therapy prevents recurrent CDI in study

A novel oral microbiome-directed therapy called VE303 successfully prevented recurrentClostridioides difficileinfection in adults at high risk for recurrence, researchers found.

“C. difficileis a leading nosocomial pathogen, with considerable morbidity and mortality,”Jeffrey L. Silber, MD,chief medical officer of Vedanta Biosciences, told Healio. “Despite initial improvement with a course of antibiotics, at least 20% of patients with [C. difficileinfection (CDI)] suffer a recurrence within a few weeks. Once someone suffers a recurrence, the probability of additional recurrences is 40% or higher.”Read more.

FDA approves fecal microbiota biotherapeutic for recurrentC. difficileinfection

美国食品和药物管理局已批准Rebyota microbiota-based live biotherapeutic indicated for the prevention of recurrentClostridioides difficileinfection in adults after antibiotic treatment, Ferring Pharmaceuticals announced in a press release. The approval comes after an FDA panel voted in favor of Rebyota (fecal microbiota, live-jslm; Ferring Pharmaceuticals) in September 2022, with the Vaccines and Related Biological Products Advisory Committee voting 13-4 in favor of the availability of adequate data supporting effectiveness and 12-4, with one abstention, in favor of the availability of adequate data supporting safety.Read more.