Randomized Comparison of Vonoprazan-Amoxicillin Dual Therapy Versus Bismuth Quadruple Therapies for Helicobacter pylori Eradication: A Multicenter Trial Evaluating National Centralized Drug Procurement Antibiotics

Abstract

Background and aim: Increasing antibiotic resistance rates and cost constraints necessitate optimized Helicobacter pylori therapies. This trial compared the efficacy, safety, and cost-effectiveness of vonoprazan-amoxicillin dual therapy versus bismuth quadruple therapy for H. pylori eradication using China's centralized procurement antibiotics.

Methods: In this multicenter, randomized, controlled trial, 534 treatment-naïve H. pylori-infected patients were assessed, with 450 patients ultimately assigned to the VNCDPA-dual (vonoprazan 20 mg BID + amoxicillin 1 g TID), B-quadruple (esomeprazole 20 mg BID + non-procurement amoxicillin 1 g BID + clarithromycin 500 mg BID + bismuth 600 mg BID), or BNCDPA-quadruple group (same as B-quadruple but with amoxicillin obtained via centralized procurement). Eradication rates were assessed using the urea breath test [per-protocol (PP) and intention-to-treat (ITT) analyses]. Adverse events (AEs) and costs were systematically evaluated.

Results: Eradication rates were comparable among groups [92.1% (B-quadruple) vs. 90.7% (BNCDPA-quadruple) vs. 91.7% (VNCDPA-dual) in PP analysis (p = 0.889); 85.3% vs. 84.7% vs. and 88.0% in ITT analysis (p = 0.947)]. VNCDPA-dual demonstrated superior safety, with significantly fewer AEs (6.8% vs. 17.9%-19%; p = 0.003), particularly dysgeusia (1.4% vs. 15.2%-15.6%; p < 0.001). Centralized procurement amoxicillin reduced costs by 44% (¥239 per course vs. ¥315 per course) without compromising efficacy. Compliance was highest in the VNCDPA-dual group (99% vs. 95.9.7%-95.2% in the quadruple groups, p < 0.04).

Conclusion: This study confirms that 10-day vonoprazan-amoxicillin dual therapy (using National Centralized Drug Procurement antibiotics) demonstrates noninferior efficacy to bismuth quadruple therapy while offering superior safety, better compliance, and the advantage of shorter treatment duration. These findings support its adoption as a first-line regimen for large-scale H. pylori eradication programs.

Keywords: H. pylori; National Centralized Drug Procurement; amoxicillin; cost‐effectiveness; dual therapy; vonoprazan.