Vonoprazan and amoxicillin dual therapy for 14 days as the first‐line treatment of Helicobacter pylori infection: A non‐inferiority, randomized clinical trial

Abstract Background We previously optimized the duration and dose of vonoprazan and amoxicillin dual therapy in China. The efficacy of vonoprazan with b.i.d. amoxicillin in comparison with vonoprazan‐containing quadruple therapy as the first‐line treatment of Helicobacter pylori infection has not been adequately evaluated. Methods In a non‐inferiority, randomized clinical trial, H. pylori infected and treatment‐naïve patients were randomly assigned to receive 14 days of either vonoprazan dual (vonoprazan 20 mg and amoxicillin 1 g twice daily) or quadruple therapy (vonoprazan 20 mg + amoxicillin 1 g + furazolidone 100 mg + bismuth potassium citrate 600 mg twice daily). H. pylori status was confirmed using 13 C‐urea breath tests or fecal antigen test. The primary outcome was the H. pylori eradication rate following vonoprazan dual and quadruple therapy at 4–12 weeks. We also compared drug compliance to either regimen and documented their side effect. Results A total of 190 subjects were randomized. The eradication rate of vonoprazan dual and quadruple therapy were 87.4% and 92.6% ( p = 0.23) by intention‐to‐treat analysis, respectively, and 96.5% and 97.7% ( p = 0.63) by per‐protocol analysis, respectively. The efficacy of vonoprazan dual therapy was non‐inferior to vonoprazan‐containing quadruple therapy in per‐protocol analysis ( p < 0.001; difference: −1.2%; 90% confidence interval: −5.4% to 3.0%). Conclusion Vonoprazan with b.i.d. amoxicillin for 14 days provided similar satisfactory efficacy with vonoprazan‐containing quadruple therapy as a first‐line H. pylori treatment in China.