Introduction
Amoxicillin alone achieves only ~22% eradication. The eradication rate of amoxicillin-vonoprazan (AV) dual therapy for Helicobacter pylori (H. pylori) infection varies by region and is below 90% in the United States, Europe and Taiwan. We recently added bismuth to this regimen, and the resulting bismuth-amoxicillin-vonoprazan (BAV) triple therapy achieved eradication rates ≥95% in Taiwan.
Aims & Methods
Aims: To compare the efficacy and safety of 14-day BAV triple therapy with AV dual therapy and clarithromycin-amoxicillin-rabeprazole (CAR) standard triple therapy as first-line regimens for H. pylori eradication.
Methods: In this multicenter, randomized, open-label trial, adults with H. pylori infection were randomized (1:1:1) to receive one of the following 14-day regimens: BAV triple therapy (tripotassium dicitrato bismuthate 300 mg four times daily, amoxicillin 750 mg four times daily, and vonoprazan 20 mg twice daily), AV dual therapy (vonoprazan 20 mg twice daily and amoxicillin 750 mg four times daily), or CAR standard triple therapy (rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily. Eradication was assessed by the 13C-urea breath test. The primary endpoint was eradication in the intention-to-treat population.
Results
Between November 2023 and June 2025, 390 patients were enrolled. Intention-to-treat eradication rates were 93.8% with BAV therapy, 83.8% with AV therapy, and 83.1% with CAR therapy. BAV therapy was superior to both AV therapy (95% CI, 2.4–17.6%; P = 0.010) and CAR therapy (95% CI, 3.0–18.4%; P = 0.007). Per-protocol eradication rates were 97.5%, 88.3%, and 88.0%, respectively; BAV therapy remained superior to AP therapy (P = 0.010) and CAR therapy (P = 0.05). Overall adverse event rates (10.8%, 8.5%, and 13.8%) were comparable. Amoxicillin resistance and clarithromycin resistance were identified as risk factors for eradication failure with BAV and CAR therapies, respectively.
Conclusion
Enhancing an amoxicillin-based mono-antibiotic therapy by incorporating bismuth and vonoprazan can increase eradication efficacy from ineffectiveness to innovation. To minimize unnecessary antibiotic exposure and curb the development of multidrug-resistant strains, clarithromycin-based triple therapy should be replaced by BAV or AV regimens as first-line treatment for H. pylori infection.
References
- Hsu PI, Yamaoka Y, Chuah SK, Wu DC. Future direction of Helicobacter pylori infection treatment. Lancet 2025;406(10500):232.