Efficacy of Fexuprazan-based Concomitant Therapy for Helicobacter pylori Infection.

INTRODUCTION: Fexuprazan is a novel potassium-competitive acid blocker that provides rapid and potent acid suppression and may serve as an alternative to proton pump inhibitors for Helicobacter pylori eradication. We prospectively evaluated the efficacy and safety of a 10-day fexuprazan-based non-bismuth quadruple (concomitant) therapy regimen as first-line treatment for H. pylori eradication. METHODS: This prospective, single-center, single-arm exploratory study enrolled H. pylori eradication-naïve patients. Participants received fexuprazan 40 mg, clarithromycin 500 mg, amoxicillin 1,000 mg, and metronidazole 500 mg twice daily for 10 days. Clarithromycin resistance was assessed by dual-priming oligonucleotide-based multiplex polymerase chain reaction for 23S rRNA point mutations, and cytochrome P450 2C19 genotyping was performed for subgroup analysis. RESULTS: A total of 93 patients were enrolled, and 88 completed the eradication therapy. The eradication rates were 90.3% (84/93) in the intention-to-treat analysis and 92.0% (81/88) in the per-protocol analysis. Among the 89 patients who underwent dual-priming oligonucleotide-based multiplex polymerase chain reaction, point mutations were identified in 25 patients, of whom 80.0% (20/25) achieved successful eradication. Eradication rates did not differ significantly according to cytochrome P450 2C19 genotype (p = 0.686). No severe adverse events occurred, and no liver function abnormalities were observed during the study. CONCLUSIONS: Ten-day fexuprazan-based concomitant therapy showed favorable efficacy and tolerability as first-line treatment for H. pylori eradication. As this is the first clinical study to evaluate fexuprazan for H. pylori eradication, further comparative studies are needed to confirm these findings.