Zinplava should be administered as a single intravenous infusion of 10mg/kg given over 60 minutes during the initial 10 to 14 days of the course of antibacterial therapy for CDI. Zinplava is not a treatment for CDI and has no effect on the current CDI episode.
Bezlotoxumab is a human monoclonal antibody that binds with high affinity to C. difficile toxin B and neutralises its activity. CDI recurrence is prevented through the provision of passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores.
The efficacy of bezlotoxumab was evaluated in the MODIFY I and MODIFY II trials in 1613 adults with a confirmed diagnosis of CDI treated with a 10- to 14-day course of oral antibacterial therapy. Patients were randomised to receive a single infusion of bezlotoxumab or placebo within the first 14 days of antibacterial therapy (median, day 3).
Among the patients included in the full analysis set (bezlotoxumab, n=781; placebo, n=773), the CDI recurrence rate within 12 weeks of the infusion was significantly lower in those who received bezlotoxumab than in those who received placebo (16.5% vs 26.6%, p<0.0001). The clinical cure rates of the presenting CDI episode were comparable between the two groups.
Secondary analysis of the results did not point towards a benefit of Zinplava in patients with no known risk factors for CDI.