Rifabutin-based 10-day and 14-day triple therapy as a third-line and fourth-line regimen forHelicobacter pylorieradication: A pilot study

Abstract

Background and aim: This prospective randomized study was designed to assess the efficacy of 10-day and 14-day rifabutinbased 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 ¼ 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.

Reply to letter to the editor: “The dosage of rifabutin in H. pylori eradication regimen should be appropriately determined in each area of the world”

“…2 We agree with them in terms of the importance of confirming tuberculosis status before starting rifabutin therapy, including the regimen, and the assurance of empirical rescue regimens especially in third-or fourth-line treatment.…”

Rifabutin-based 10-day and 14-day triple therapy as a third-line and fourth-line regimen forHelicobacter pylorieradication: how should rifabutin be managed in rescue regimens?

“…QuantiFERON-TB Gold In-Tube test), since its use could imply the onset of antibiotic resistance, thus precluding its effectiveness against Koch's bacillus. Further, H. pylori resistance to rifabutin is low, as confirmed in the paper of Mori et al 1 Indeed, genotypic resistance revealed by mutations in the rpoB gene (a factor of resistance to rifamycins) has been found only in 3 out of 29 patients, despite phenotypic resistance to rifabutin being observed only in one patient at culture. This disagreement suggests that, at the moment, a valid genotypic marker for rifabutin resistance may not be available yet.…”

“…8,9 In this regard, Mori et al showed that the 29% of patients in the 14-day and the 8.3% in the 10-day arm stopped the treatment due to adverse events. 1 In our experience, 10 Finally, the ideal combination of antibiotics with rifabutin should be guided by the previous treatment failures. This detail has not been reported by Mori et al, 1 even if they found that 16 strains (55%) were resistant to amoxicillin.…”

“…1 In our experience, 10 Finally, the ideal combination of antibiotics with rifabutin should be guided by the previous treatment failures. This detail has not been reported by Mori et al, 1 even if they found that 16 strains (55%) were resistant to amoxicillin. This value is unexpectedly high compared to that reported worldwide.…”

“…1 The increasing incidences of antibiotic resistance are a clinical dilemma in this setting, with increasing failure rates of conventional eradication regimens. 2 Therefore, novel strategies are needed to achieve successful H. pylori eradication.…”