Vonoprazan-based dual and quadruple therapy with varying duration for Helicobacter pylori eradication: A multicenter, randomised controlled trial.

OBJECTIVES

The study was conducted to assess the effectiveness and safety of two simplified dual and quadruple therapies compared with the guideline-recommended 14-day dual therapy for first-line Helicobacter pylori treatment.

METHODS

This randomised controlled trial (RCT) enrolled treatment-naïve patients across six clinical centres. The study randomly allocated participants equally to one of three regimens: VA-14 (vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days), VA-10 (same drugs with VA-14 but for 10 days), and VBAT-7 (vonoprazan 20 mg twice daily, tetracycline 500 mg three times daily, amoxicillin 1000 mg twice daily, and bismuth potassium citrate 220 mg twice daily for 7 days). The 13C-urea breath test was conducted to confirm eradication at least six weeks after treatment.

RESULTS

Out of 387 patients who were eligible, 330 were assigned randomly. The VBAT-7 group exhibited non-inferior efficacy to the VA-14 group, with the eradication rates of 90.0% (99/110) and 91.8% (101/110) in intention-to-treat (ITT) analysis (P = 0.017), 92.5% (99/107) and 94.4% (101/107) in modified ITT analysis (P = 0.008), and 93.3% (98/105) and 95.2% (100/105) in per-protocol (PP) analysis (P = 0.006). However, the non-inferiority of efficacy between VA-10 and VA-14 was not established. The groups did not show significant variations in adverse events or compliance.

CONCLUSIONS

VBAT-7 demonstrated non-inferiority to VA-14 and represents a potential first-line option for first-line H. pylori treatment. The VA-10 regimen achieved acceptable eradication in PP analysis but did not statistically meet the non-inferiority criterion.

TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06723197.