Background To investigate the effectiveness and safety of vonoprazan-based low-dose amoxicillin dual therapy with different treatment durations for Helicobacter pylori (Hp) eradication.

Methods 150 naive Hp-infected patients were recruited from the Affiliated Changzhou No. 2 People’s Hospital of Nanjing Medical University from December 2022 to November 2023, and randomly allocated to group A (75 cases) and group B (75 cases). Both group A and group B were treated with vonoprazan (20 mg, twice a day) and amoxicillin (750 mg, three times a day); group A received the treatment for 10 days while Group B received the treatment for 14 days. All patients received a ¹³C-urea breath test 4-6 weeks after the treatment. The eradication rate and incidence of adverse effects were compared between the two groups. Factors affecting the eradication rate were explored, and cost-effectiveness analyses were performed.

Results The eradication rates of group A and group B by the intention-to-treat analysis were 86.7% and 90.7% (P = 0.440), and by the per-protocol analysis, were 92.9% and 94.4% (P = 0.965), respectively. The total incidence of adverse events in group A was similar to group B (12.9% vs. 9.7%, P = 0.555). The eradication rate was higher among patients with low body weight (eradication rate: 100.0% when body weight≤63.5kg vs. 82.1% when body weight>63.5kg, P = 0.018) and small body surface area (BSA; eradication rate: 100.0% when BSA≤1.73m² vs. 80.3% when BSA>1.73m², P = 0.009). The cost-effectiveness ratio of the group A was less than that of the group B (3.29 vs. 4.19).

Conclusions The 10-day vonoprazan-based low-dose amoxicillin dual therapy is a safe and effective first-line regimen for Hp eradication. Body weight and BSA are risk factors that can reduce the eradication rate.