Ten‐Day Versus 14‐Day Vonoprazan and Amoxicillin Dual Therapy for the Firstline Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial

BACKGROUND: The optimal duration for vonoprazan and amoxicillin dual therapy (VA-DT) remains unclear, and studies on gastric acid suppression of vonoprazan during eradication are still lacking. OBJECTIVE: This study conducted a multicenter, randomized controlled trial to compare the eradication efficacy between 10 and 14-day VA-DT, and to identify the dynamic changes of gastric pH during treatment. METHODS: C-urea breath tests were conducted at 4-8 weeks after eradication to evaluate the success of treatment. 24-h intragastric pH was monitored in 22 patients. RESULTS: Ten and 14-day VA-DT demonstrated eradication rates of 83.3% vs. 88.0% (rate difference: -4.8%, 95% confidence interval: -11.6% to -2.0%) in intention-to-treat analysis, 87.9% vs. 93.9% (-6.0%, -11.9% to -0.3%) in modified intention-to-treat analysis, and 89.1% vs. 95.3% (-6.1%, -11.8% to -0.7%) in per-protocol analysis, respectively. Vonoprazan showed excellent gastric acid suppression during eradication, with the time percentages of pH > 6 at 75.3% and 97.2% and the median pH levels at 7.4 and 7.8 on the 1st and 7th days, respectively. Furthermore, gastric pH exceeded 6 approximately 4-5 h after the first dose and remained stable at 7-9 thereafter. CONCLUSION: The noninferiority of eradication efficacy between 10- and 14-day VA-DT in the first-line treatment was not established, indicating that 10-day therapy cannot be used as a substitute for 14-day therapy. Vonoprazan exerted excellent gastric acid suppression during eradication. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2200057625.