Englewood Hospital has made strides in reducing rates of C. difficile infection over the past year. A critical step included updating our testing algorithm for C. difficile and standardizing our infection prevention recommendations. One issue that continues to be problematic is recurrent disease in high-risk patients.
Bezlotoxumab (Zinplava) is the first fully humanized monoclonal antibody designed to lower risk of bacterial infection by binding to the C. difficile toxin B and neutralizing its effect. It was approved by the FDA in October of 2016 for the prevention of C. difficile infection recurrence in adults (age > 18) at high risk of recurrent disease.
Patients with an initial episode of C. difficile infection have a 20-25% risk of recurrent disease. Patients who suffer a second episode have a 35% risk of subsequent episode, and patients with three or more episodes have a risk of 65% of relapse.
Bezlotoxumab was approved on the basis of two large randomized controlled trials involving 1,554 adult patients with positive stool test for toxigenic C. difficile. The majority had high-risk features for recurrence (age > 65, prior episode of C. difficile infection, immunosuppression, severe C. difficile infection at study entry, renal impairment, and infection with hypervirulent NAP/B1 strain). The recurrence rate in clinical trials for recipients of bezlotoxumab was 19-22% vs 33% for placebo in the 12 weeks following infection.
Bezlotoxumab is administered as a one time intravenous infusion over about an hour. Ideally the infusion is given while the patient is still on therapy for C. difficile infection. It appears to be well tolerated, with main side effects reported as pyrexia, nausea and headache within four weeks of infusion. Heart failure was reported more commonly with Bezlotoxumab in patients with a history of CHF and should be used with caution.
If you have a patient that may be a candidate for this new treatment, please consult with Gastroenterology or Infectious Disease to facilitate arrangements.