Seven‐Day Vonoprazan‐Based Triple Therapy as First‐Line Helicobacter pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial

Abstract

ABSTRACTBackgroundVonoprazan, a potassium‐competitive acid blocker, has demonstrated greater potency and a longer duration of acid suppression when compared to the proton pump inhibitors. However, data regarding the comparison between vonoprazan‐based triple therapy with standard treatment for first‐line Helicobacter pylori treatment are limited. This study aimed to compare the efficacy between 7‐day vonoprazan‐based triple therapy with high‐dose amoxicillin (VAC‐7) and 14‐day extended sequential therapy (S‐14).Materials and MethodsThis was a single‐center prospective randomized controlled trial following a noninferiority design. Subjects over 20 years old with confirmed H. pylori infection were enrolled prospectively from Fu Jen Catholic University Hospital. They were randomly assigned to the VAC‐7 or S‐14 group. The primary endpoint was the eradication rate in first‐line treatment, evaluated by urea breath test, with noninferiority determined using the Farrington–Manning method. The secondary outcome included adverse effect rates and compliance, assessed through self‐administered questionnaires.ResultsBetween December 2021 and June 2023, a total of 628 patients were recruited. The eradication rates by per‐protocol analysis and intention‐to‐treat analysis were 88.6%/81.8% for VAC‐7 and 90.3%/81.4% for S‐14, respectively. The VAC‐7 was non‐inferior to S‐14 in terms of ITT analysis. Subjects experienced fewer incidences of nausea, anorexia, dizziness, fatigue, and any severe adverse events in the VAC‐7 group. Compliance was higher in the VAC‐7 group, with 94% taking all the pills correctly.ConclusionsOur findings supported the use of 7‐day vonoprazan triple therapy with high‐dose amoxicillin as the standard first‐line treatment for H. pylori infection.Trial Registration: ClinicalTrials.gov identifier: NCT05371249