Vonoprazan- vs proton-pump inhibitor-based first-line 7-day triple therapy for clarithromycin-susceptible Helicobacter pylori: A multicenter, prospective, randomized trial.

BackgroundThe eradication rate of vonoprazan-based first-line triple therapy (combined with clarithromycin and amoxicillin) (V-AC) was reported to be 97.6% in patients with clarithromycin (CAM)-susceptible Helicobacter pylori in a phase III study, whereas our real-world, prospective, multicenter cohort study yielded an eradication rate <90%. ObjectiveTo validate the eradication rate of V-AC using CAM-susceptible testing in a multicenter, prospective, randomized trial. MethodsWe included 147 treatment-naive H.pylori-positive patients [41 with CAM-resistant infections and 106 with CAM-susceptible infections]. The CAM-susceptible group patients were randomized to either the V-AC group (vonoprazan 20mg bid, amoxicillin 750mg bid, and clarithromycin 200 or 400mg bid) or PPI-AC group (lansoprazole 30mg, rabeprazole 10mg, or esomeprazole 20mg bid; amoxicillin 750mg bid; and clarithromycin 200 or 400mg bid). All CAM-resistant H.pylori were eradicated by V-AC, as measured by the urea breath test around 8weeks after eradication. Safety was evaluated by patient questionnaires. ResultsThe intention-to-treat and per-protocol eradication rates of V-AC in the CAM-susceptible H.pylori-infected patients were 87.3% (95% confidence interval 75.5%-94.7%) and 88.9% (77.4%-95.8%). The respective eradication rates of PPI-AC were 76.5% (62.5%-87.2%) and 86.7% (73.2%-94.9%). No significant difference was observed between the V-AC and PPI-AC regimes in terms of the intention-to-treat (P=.21) or per-protocol (P=.77) analyses. The questionnaire scores did not differ significantly between the groups. Both the intention-to-treat and per-protocol eradication rates of V-AC in the CAM-resistant patients were 82.9% (67.9%-92.8%). ConclusionThe eradication rate of V-AC treatment in the CAM-susceptible H.pylori-infected patients was <90%, as was that by PPI-AC, thus V-AC is not ideal regimen in CAM-susceptible H.pylori. However, the 82.9% eradication rate of V-AC in the CAM-resistant infections may indicate the potential of V-AC with modified dose, dosing interval, and treatment duration. (UMIN000016337).