Low-dose Rifabutin Triple Therapy for H. pylori is Efficacious in Patients With Obesity and Diabetes

Background: The overall US prevalence of Helicobacter pylori (H. pylori) infection is ~35% but higher among non-Hispanic Black and Mexican Americans. H. pylorieradication has become more challenging due to rising antibiotic resistance. Obesity and diabetes may further complicate the successful treatment of the infection. We aimed to assess if the efficacy of RHB-105 (low-dose rifabutin triple therapy; 50 mg rifabutin, 1000 mg amoxicillin, 40 mg omeprazole, Q8H) for H. pylori infection was affected by demographics, obesity, or diabetes. Methods: We conducted a post hoc analysis of pooled, modified intention-to-treat data from 293 subjects in the Phase 3 trials (NCT01980095/ NCT03198507) analyzing the efficacy and safety of RHB-105 for H. pylori infection. We compared H. pylorieradication rates, safety, demographics, and body mass index (BMI) in patients with and without diabetes. Results: Of the 293 subjects, 84% were WHITE; 68% were Hispanic; 59% were women. Average BMI was 30.5 kg/m2. Patients with diabetes (n=48) were older (54 vs. 45 years), were more often Black or African American (21% vs. 12%) and had higher BMI (33 vs. 30 kg/m2) compared to patients without diabetes (n=245). Pooled eradication rates for RHB-105 were 91.7% (N=44) and 84.1% (N=206) (p=0.175) in subjects with vs. without diabetes, respectively. Eradication rates were also high irrespective of BMI and demographics. The most frequently reported adverse events were diarrhea, headache, and nausea; no cases of hypoglycemia were reported. Conclusions: Low-dose rifabutin triple therapy for 14 days produced high eradication rates and displayed favorable tolerability across all subjects. Despite higher mean age and BMI, and a different racial and ethnic distribution in patients with vs. without diabetes, eradication rates with RHB-105 remained high. This study supports the efficacy and safety of low-dose rifabutin triple therapy as empiric first-line treatment for H. pylori infection in patients with obesity or diabetes.