Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy

This multicenter, randomized, open-label, trial will enroll 552 adult patients with H. pylori infection from 12 medical centers or regional hospitals in Taiwan. Using a computer-generated randomization sequence (1:1 allocation; block size of four), participants will be assigned to receive either the 14-day bismuth-amoxicillin-vonoprazan triple therapy or the 14-day bismuth-rabeprazole-tetracycline-metronidazole quadruple therapy. Follow-up at week 2 will assess treatment adherence and adverse events. H. pylori status will be evaluated at week 6 using the C13-urea breath test. Eradication and adverse event rates will be compared between groups using the chi-square test. The impact of H. pylori antibiotic resistance and host CYP3A4, CYP2C19, and IL-1B -511 genotypes on treatment efficacy will be analyzed using multivariate models.

Inclusion criteria

• Subjects with Helicobacter pylori infection

Exclusion criteria

• Subjects with known hypersensitivity to the study drug.
• Subjects with a history of gastric surgery.
• Subjects with severe liver cirrhosis or uremia.
• Subjects with a history of malignancy within the past five years.
• Pregnant or breastfeeding women.
• Subjects currently receiving treatment with atazanavir sulfate or rilpivirine hydrochloride.