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Bismuth-Amoxicillin-Vonoprazan Triple, Amoxicillin-Vonoprazan Dual, and Clarithromycin-Based Triple Therapies for
Ping-I Hsu1, Ming-Jen Sheu2, Chien-Lin Chen3
1Division of Gastroenterology, Department of Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan.
Background:
The eradication rate of amoxicillin-vonoprazan (AV) dual therapy for Helicobacter pylori (H. pylori) infection varies by region and is below 90% in both the United States 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:
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.
Conclusions:
BAV triple therapy demonstrates superior efficacy compared with AV dual therapy and CAR triple therapy as first-line treatment for H. pylori infection in Taiwan. This regimen represents a promising first-line option that may obviate the need for routine clarithromycin-resistance testing in regions where AV dual therapy yields suboptimal eradication rates.
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