Efficacy and Safety of Vonoprazan-Amoxicillin Dual Regimen With Varying Dose and Duration for Helicobacter pylori Eradication: A Multicenter, Prospective, Randomized Study

Abstract

Background & AimsPrevious studies confirm vonoprazan-amoxicillin effectiveness for Helicobacter pylori. This study aims to investigate vonoprazan with varying amoxicillin dose and duration. MethodsThis multicenter, prospective, randomized,controlled, noninferiority trial enrolled patients with treatment naive Helicobacter pylori infection from five clinical centers. Eligible participants were randomly assigned to H-VA-10 (vonoprazan 20mg b.i.d + amoxicillin 750mg q.i.d, 10 days), L-VA-10 (vonoprazan 20mg b.i.d + amoxicillin 1000mg b.i.d, 10 days) and H-VA-14 (vonoprazan 20mg b.i.d + amoxicillin 750mg q.i.d, 14 days) in a 1:1:1 ratio. The eradication rate was assessed using the 13C-urea breath test at least 28 days after treatment. ResultsOf the 623 eligible patients,516 patients were randomized. In both the intention-to-treat and pre-protocol analyses, eradication rates were comparable between H-VA-10 and H-VA-14 groups (86.6% vs 89.5%and 90.9% vs 94.5%, P=.021 and .013 for noninferiority, respectively). However, eradication rates were significantly lower in the L-VA-10 group than the H-VA-14 group (79.7% vs 89.5% and 82.0% vs 94.5%, P=.488 and .759, respectively). Rates of study withdrawal, loss to follow up and adverse events were similar across study groups. ConclusionsH-VA-10 and H-VA-14 regimens provide satisfactory efficacy for Helicobacter pylori infection, while the L-VA-10 regimen was inferior..