Helicobacter pylori eradication by low-dose rifabutin triple therapy (RHB-105) is unaffected by high body mass index

Abstract

Background

Helicobacter pylori infection affects ~35% of Americans and may lead to serious sequelae if left untreated, including gastric cancer. Obesity is a significant risk factor for antibiotic treatment failure; however, little work has been done to understand the influence of high body mass index (BMI) on the success rates of H pylori eradication regimens in treatment-naïve and refractory adult patients.

Aim

This analysis evaluated the association of subject obesity on overall H pylori eradication rates for RHB-105 (rifabutin, amoxicillin, and omeprazole magnesium; Talicia^®) and its comparators using data from two Phase 3 clinical trials.

Methods

A post hoc analysis of the eradication rates of RHB-105 vs comparators in a total of 269 subjects who tested positive for H pylori was conducted. Comparators in the two studies included placebo (placebo comparator) and amoxicillin and omeprazole (active comparator). Subjects were treated for 14 days and returned for follow-up test-of-cure at 28-59 days post-therapy using urea breath testing.

Results

Subjects receiving RHB-105 with 30 ≤ BMI < 40 or BMI ≥ 40 had pooled modified intent to treat (mITT) eradication rates of 88.1% (95% CI: 81.1-92.8) and 90.9% (95% CI: 72.2-97.5) [P = .707], respectively, compared to active comparator rates of 62.9% (95% CI: 52.5-72.2) and 31.8% (95% CI: 16.4-52.7) [P = .008].

Conclusions

Obese patients treated with RHB-105 were associated with efficacy rates comparable to the overall study population. This supports further evaluation of the efficacy of RHB-105 in obese populations, where H pylori is prevalent. ClinTrials.gov # NCT01980095 & NCT031985070.