IDDF2022-ABS-0149 Effectiveness and safety of novel vonoprazan-based regimen for H. Pylori eradication in china: a single-centre, prospective, randomized trial

Background

To date, vonoprazan-based regimens for H. pylori infection in Japan have been shown to achieve acceptable eradication rates. However, its effectiveness is unclear in Chinese. Therefore, this study aimed to evaluate the efficacy and safety of the novel Vonoprazan-based regimen as a first-line treatment for H. pylori and to compare it with bismuth-based quadruple regimen.

Methods

This prospective, randomized clinical trial was performed in China. Patients with H. pylori and naive to treatment were randomly assigned to either VAS group (vonoprazan 20mg twice/day, amoxicillin 750mg three times/day and S. boulardii 250 mg twice/day) for 10 days or PCAB group (Esomeprazole 20mg, amoxicillin 1000mg, clarithromycin 500mg and bismuth 220mg twice/day) for 14 days. Eradication success was evaluated by ¹³C-urea breath test at least 4 weeks after treatment, and adverse events were recorded. Factors associated with eradication success and cost-effectiveness analyses were also performed.

Results

135 subjects were screened and 126 were randomized. The eradication rates of VAS and PCAB groups were 87.3% and 88.9% (p=1.000) by intention-to-treat analysis, and 87.3% and 91.8% (p=0.560) by per-protocol analysis, respectively. The incidence of adverse events in PCAB group was significantly higher than that in the VAS group (17.5% VS 4.8% P = 0.044). In the VAS group, successful H. pylori eradication was associated with small body surface area (BSA) (eradication rate: 92.2% in patients with BSA <1.831 vs. 66.7% in those with BSA ≥1.831, p = 0.037) and non-smokers (eradication rate: 92.9% in non-smokers vs. 42.9% in smokers, p = 0.003). The cost-effectiveness ratio of VAS group was less than that of PCAB group (4.64 vs. 4.79, Chinese Yuan, per percent).

Conclusions

This novel Vonoprazan-based regimen is as effective as a bismuth-based quadruple regimen, with less adverse events and is more cost-effective. This regimen is more suitable for small BSA and non-smoking patients.