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

This study included 418 naïve adult patients with Helicobacter pylori infection, who were randomly divided into 10 or 14-day VA-DT groups (vonoprazan 20 mg twice daily and amoxicillin 1000 mg thrice daily). 13C-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.