Efficacy of 14-day vonoprazan-amoxicillin dual therapy compared to esomeprazole-amoxicillin dual therapy for eradication of Helicobacter pylori in treatment-naïve patients

Abstract

Abstract Objective: This study was a multicenter, randomized controlled trial that compared the therapeutic efficacies of vonoprazan-amoxicillin (VA) and esomeprazole-amoxicillin (EA) dual therapies for Helicobacter pyloriinfection in China. Methods: A total of 236 patients were randomized to receive either VA dual therapy (vonoprazan 20 mg bid, amoxicillin 1 g tid, 14 days) or EA dual therapy (esomeprazole 20 mg qid, amoxicillin 750 mg qid, 14 days). The success of eradication was assessed using a 13C urea breath test after 4-6 weeks. The study assessed H. pylori eradication rates, incidence of adverse reactions, patient compliance, antibiotic resistance rates, and CYP2C19 gene polymorphisms. Results: Both the intention-to-treat (ITT) analysis and the per-protocol (PP) analysis demonstrated that the eradication rate by the VA group (ITT:96.61%, 95%CI 93.34–99.88%; PP:98.26%, 95% CI 95.87–100.00%)was not inferior to that of the EA group (ITT:93.22%,88.68-97.76%; PP:93.10%, 95% CI 90.80-98.86%) with the one-sided P < 0.0001 for both. The incidence of adverse reactions was 11.30% and 13.79% for the two groups (P=0.568), and compliance rates were 97.46% and 98.3% for the VA and EA groups, respectively, with both exceeding 95% (P = 1.000). Compliance was identified as an independent risk factor for H. pylori eradication (P= 0.002). Conclusions: The 14-day VA and EA dual therapies have comparable efficacies and safeties, and both are recommended as first-line treatment for an H. pylori infection.