The efficacy and safety of high‐dose amoxicillin‐bismuth‐potassium competitive acid blocker therapy for <i>Helicobacter pylori</i> infection—A pilot study

Abstract Recent developments in Helicobacter pylori ( H. pylori ) treatment have highlighted the rising resistance to clarithromycin. Conversely, amoxicillin resistance remains relatively low in both first‐line and rescue treatments. Evidence has shown that the effectiveness of high‐dose amoxicillin/proton pump inhibitor dual therapy varies in different countries. The effectiveness of combining high‐dose amoxicillin with potassium‐competitive acid blocker (PCAB) and bismuth as a mono‐antibiotic strategy for H. pylori eradication remains to be determined. To assess the efficacy and safety of a 14‐day regimen combining bismuth, high‐dose amoxicillin, and PCAB (Bap therapy) as both first‐line and rescue treatment for H. pylori infection, and to identify the factors that affect the outcome of this novel therapeutic approach. We conducted a retrospective cohort study of patients with H. pylori infection treated with Bap therapy from January 2021 to March 2024 across four hospitals in Taiwan. The regimen consisted of tripotassium dicitrato bismuthate (300 mg four times daily), high‐dose amoxicillin (750 mg four times daily), and vonoprazan (20 mg twice daily) for 14 days. Patients returned in the second week to assess drug adherence and adverse events. Post‐treatment H. pylori status was assessed at least 4 weeks following Bap therapy. Fifty‐one patients receiving Bap therapy as either first‐line ( n = 45) or rescue treatment ( n = 6) were analyzed. Eradication rates in first‐line treatment were 95.6% (95% confidence interval [CI]: 89.6%–100.0%), 97.7% (95% CI: 93.3%–100.0%), and 100.0% in intention‐to‐treat, modified intention‐to‐treat, and per‐protocol analyses, respectively. For rescue therapy, the corresponding eradication rates were all 100%. Adverse event rates were 6.7% for first‐line and 0% for rescue treatments, with adherence rates of 95.6% and 100%, respectively. Univariate analysis indicated significantly lower eradication rates in patients with poor drug adherence (50% vs. 100%; p = .040), while factors such as smoking, alcohol consumption, clarithromycin, and metronidazole resistance did not influence outcomes. The 14‐day Bap therapy demonstrates high efficacy and safety for both first‐line and rescue treatments of H. pylori infection, making it a potential standard treatment option for H. pylori eradication. This study underscores the importance of adherence to therapy and warrants further research to validate the effectiveness of this mono‐antibiotic approach across different lines of treatment for H. pylori infection.