AWaRe-aligned doxycycline-based bismuth quadruple therapy achieves high Helicobacter pylori eradication rates and supports antimicrobial stewardship.

OBJECTIVE: Helicobacter pylori infects a large proportion of the global population. The World Health Organization (WHO) developed the Access, Watch and Reserve (AWaRe) classification to promote rational antibiotic use and reduce antimicrobial resistance. The aim of this study was to evaluate the efficacy of a doxycycline-based bismuth quadruple therapy aligned with this strategy, as a potential alternative for Helicobacter pylori eradication in settings with limited availability of tetracycline. PATIENTS AND METHODS: A prospective observational study was conducted (October 2023-October 2024) in adults with confirmed H. pylori infection. Patients received a 14-day regimen with esomeprazole, bismuth, amoxicillin, and doxycycline. Eradication was assessed ≥4 weeks after treatment using a urea breath test or histology. RESULTS: A total of 138 patients were included in the ITT population and 118 in the PP/mITT populations (mean age 51.3 years; 66.1% female). Overall eradication rates were 77.5% in the ITT analysis and 90.7% in the PP/mITT analyses. In the PP/mITT populations, eradication reached 94.5% in treatment-naïve patients, 85.7% after one prior treatment failure, and 61.5% after two or more prior treatment failures. Adverse events were mild (7.6%), and 92.4% of patients reported symptomatic improvement. CONCLUSIONS: This AWaRe-aligned doxycycline-based quadruple therapy achieved an acceptable eradication rate in the PP/mITT populations, with good tolerability. However, the lower ITT eradication rate warrants cautious interpretation of its overall effectiveness.