Vonoprazan-containing Dual and Triple Therapies are Non-inferior to Bismuth-quadruple Therapy for Helicobacter pylori Eradication: A Single-center, Prospective, Open-label, Real-World Study.

Background and aims: Vonoprazan (Vo) and amoxicillin (Amx) dual therapy has shown promising results for Helicobacter pylori (H. pylori) eradication. However, its efficacy needs to be verified in an area with a high prevalence of both H. pylori and gastric cancer. It is also unknown if the modified Vo-Amx plus bismuth (Bis) regimen might increase the eradication rate. We aimed to investigate the efficacy and safety of Vo-Amx and Vo-Amx-Bis regimens, compared to bismuth-containing quadruple therapy (BQT) for H. pylori eradication, as well as factors that affect the curing rate.

Methods: A total of 342 treatment-naïve H. pylori-infected patients were screened and 255 were enrolled and randomized into Vo-Amx, Vo-Amx-Bis, and BQT groups for treatment. H. pylori infection status was determined by 13C-urea breath test. The eradication rate and incidence of adverse events were assessed, and factors that might affect the curing rate were also analyzed.

Results: In per-protocol (PP) analysis, H. pylori eradication rates in Vo-Amx, Vo-Amx-Bis, and BQT groups were 95.1%, 92.7%, and 90.4%, respectively (p>0.05). In intention-to-treat (ITT) analysis, eradication rates in Vo-Amx, Vo-Amx-Bis, and BQT groups were 91.8%, 89.4%, and 88.2%, respectively (p>0.05). The eradication efficacy of Vo-Amx and Vo-Amx-Bis groups was non-inferior to that of BQT group, and the incidence of side effects (including nausea, vomiting, anorexia, abdominal pain, diarrhea, palpitation, dizziness, and debilitation) was lower than that of BQT group (6.1% and 4.9%, vs 45.8%, respectively, p<0.001). Successful eradication was associated with lower body surface area (BSA) in BQT group (p<0.05), but not in Vo-Amx and Vo-Amx-Bis groups. Gender, cigarette smoking, alcohol drinking, side effects, education level, body mass index, infection status of family members, and the frequency of dining out did not affect the curing rate in all three groups (p> 0.05).

Conclusions: Efficacy of the two Vo-containing regimens was comparable and non-inferior to the BQT in this region, and could serve as the first-line regimen for H. pylori eradication, and reduced use of one antibiotic per each patient treatment in real-world clinical application.