Rifabutin‐based 10‐day and 14‐day triple therapy as a third‐line and fourth‐line regimen for Helicobacter pylori eradication: A pilot study

Background and aim This prospective randomized study was designed to assess the efficacy of 10‐day and 14‐day rifabutin‐based triple therapy as a third‐ or fourth‐line rescue therapy. Methods Patients who failed first‐ and second‐line eradication therapy were enrolled. H. pylori was isolated from gastric biopsy specimens and the rpoB mutation status, a factor of resistance to rifamycins, and minimum inhibitory concentrations (MICs) of rifabutin and amoxicillin were determined. Enrolled patients were randomly assigned to receive 10‐day or 14‐day eradication therapy with esomeprazole (20 mg, 4 times a day (q.i.d.)), amoxicillin (500 mg, q.i.d.), and rifabutin (300 mg, once a day (q.d.s.)). Poor compliance was defined as intake of <80% of study drugs. Successful H. pylori eradication was confirmed using a [13C] urea breath test or a stool antigen test, 12 weeks after the end of therapy. Results Twelve patients were assigned to the 10‐day group, and 17, to the 14‐day group. Intention‐to‐treat and per‐protocol analyses of eradication rates were 83.3% and 81.8% for the 10‐day group and 94.1% and 91.7% for the 14‐day group, respectively. All patients with rpoB mutation‐positive strains ( n  = 3) showed successful eradication, irrespective of the regimen received. Therapy was stopped due to adverse events in 8.3% and 29.3% of patients in the 10‐day and 14‐day groups, respectively. Conclusion Both the 10‐day and 14‐day therapies were effective as rescue regimens. In particular, the 14‐day therapy resulted in successful eradication in over 90% of patients, but the 10‐day treatment may be enough to obtain a successful eradication rate, considering the tolerability of therapy.