Rifabutin-Containing Triple Therapy (RHB-105) for Eradication of : Randomized ERADICATE Hp Trial.

Due to increasing resistance to commonly used antibiotics, the World Health Organization and Food and Drug Administration have advocated the development of new therapeutic regimens for . This phase three, double-blind study (ERADICATE Hp) randomized (2:1) treatment-naïve adults with infection and dyspepsia to RHB-105 (an all-in-one combination of omeprazole 40 mg, amoxicillin 1000 mg, and rifabutin 50 mg) or an identically-appearing placebo, both administered every 8 h for 14 days. The eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28-35 days post-completion of therapy, was compared (one-sample -test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures. The mITT eradication rate (95% CI) with RHB-105 of 89.4% (82.0-96.8%) was greater than both the literature-derived comparator rate ( < 0.001) and the standard-of-care rate of 63.0% (44.8-81.1%) ( = 0.006). Adverse events with an incidence ≥5% for RHB-105 were diarrhea (12.7%), headache (11.9%), chromaturia (9.3%), abdominal tenderness (6.8%), and dizziness (5.1%). No leukopenia was noted. RHB-105 (Talicia) proved to be a safe and effective empiric therapy for eradication.