Regional multi-center randomized trial of three vonoprazan-amoxicillin dosing regimens for Helicobacter pylori eradication in Sichuan Province, China.

BACKGROUND

Helicobacter pylori (H. pylori) infection is highly prevalent worldwide, and rising antibiotic resistance has reduced the efficacy of standard therapy, underscoring the need for simplified and better-tolerated regimens.

AIM: To evaluate the efficacy, safety, and optimal dosing of vonoprazan (VPZ)-amoxicillin (AMO) dual therapy in a non-inferiority randomized trial for H. pylori eradication.

METHODS

In this multi-center, randomized trial conducted at 17 hospitals in Sichuan Province, China, 1717 adults with confirmed infection were assigned (1:1:1) to 14-day regimens: (1) VPZ 20 mg BID + AMO 0.5 g QID; (2) 0.75 g QID; or (3) 1.0 g TID. The primary endpoint was the eradication rate based on intention-to-treat (ITT) and per-protocol (PP) analyses; secondary endpoints included adverse events (AEs) and treatment compliance.

RESULTS

Eradication rates were consistently high (92.35%-97.43%). In the 0.5 g QID group, ITT and PP eradication rates were 93.3% (95%CI: 91.2-95.1) and 97.4% (95%CI: 95.7-98.5), respectively, with no significant differences among groups (P > 0.05). Compliance ranged from 98.1% to 98.3%, and AEs were infrequent (5.2%-7.5%), predominantly mild gastrointestinal symptoms, which occurred least often in the 0.5 g QID group.

CONCLUSION

VPZ-AMO dual therapy achieved excellent eradication, safety, and patient compliance. All regimens were similarly effective, whereas the 0.5 g QID dosing strategy offered the most favorable balance of efficacy and tolerability, supporting its use as a first-line option in high-prevalence settings.