Efficacy and Safety of Keverprazan–Amoxicillin Dual Regimen in Initial Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial

OBJECTIVES: The efficacy of keverprazan-amoxicillin dual therapy (KA) in the treatment of Helicobacter pylori (H. pylori) has not yet been demonstrated. Here, we aimed to compare the eradication rate of the KA regimen with esomeprazole-based bismuth quadruple therapy (EBQT) containing amoxicillin and clarithromycin for H. pylori initial eradication in the Chinese population. METHODS: Patients aged between 18-75 years were randomly assigned into KA group or the EBQT group. The KA group patients received keverprazan 20 mg (b.i.d.) and amoxicillin 1.0 g (t.i.d.) for 14 days. The EBQT group patients took esomeprazole 20 mg (b.i.d.), amoxicillin 1.0 g (b.i.d.), clarithromycin 0.5 g (b.i.d.), and bismuth potassium citrate 220 mg (b.i.d.) for 14 days. The primary outcome was the H. pylori eradication rate 28 days after therapy. Secondary outcomes included compliance and adverse events. RESULTS: A total of 394 patients were enrolled in this study. Eradication rates in the KA group and the EBQT group were 87.88% and 84.18% in intention-to-treat analysis (ITT) (rate difference: 3.70%, 95% CI: -3.14% to 10.53%), 92.55% and 88.24% in modified ITT analysis (rate difference: 4.32%, 95% CI: -1.63% to 10.27%), and 93.99% and 90.56% in per-protocol analysis (PP) (rate difference: 3.43%, 95% CI: -2.05% to 8.92%), respectively. The eradication rates for the KA group were not inferior to those of the EBQT group in ITT, modified ITT, and PP analysis. The incidences of nausea and overall adverse effects in the KA group were significantly lower than those of the EBQT group. CONCLUSIONS: Keverprazan 20 mg twice daily with high-dose amoxicillin demonstrates a noninferior efficacy to bismuth quadruple therapy for initial H. pylori eradication. TRIAL REGISTRATION: Chinese Clinical Trial Registry, registration No: ChiCTR2400092511.