Objective To date, no randomised trials have compared the efficacy of vonoprazan and amoxicillin dual therapy with other standard regimens for Helicobacter pylori treatment. This study aimed to investigate the efficacy of the 7-day vonoprazan and low-dose amoxicillin dual therapy as a first-line H. pylori treatment, and compared this with vonoprazan-based triple therapy. Design This prospective, randomised clinical trial was performed at seven Japanese institutions. Patients with H. pylori–positive culture test and naive to treatment were randomly assigned in a 1:1 ratio to either VA-dual therapy (vonoprazan 20 mg+amoxicillin 750 mg twice/day) or VAC-triple therapy (vonoprazan 20 mg+amoxicillin 750 mg+clarithromycin 200 mg twice/day) for 7 days, with stratification by age, sex, H. pylori antimicrobial resistance and institution. Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment. Results Between October 2018 and June 2019, 629 subjects were screened and 335 were randomised. The eradication rates of VA-dual and VAC-triple therapies were 84.5% and 89.2% (p=0.203) by intention-to-treat analysis, respectively, and 87.1% and 90.2% (p=0.372) by per-protocol analysis, respectively. VA-dual was non-inferior to VAC-triple in the per-protocol analysis. The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048). The incidence of adverse events was equal between groups. Conclusion The 7-day vonoprazan and low-dose amoxicillin dual therapy provided acceptable H. pylori eradication rates and a similar effect to vonoprazan-based triple therapy in regions with high clarithromycin resistance. Trial registration number UMIN000034140.

中文翻译：

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为期 7 天的沃诺拉赞和低剂量阿莫西林双重治疗作为幽门螺杆菌的一线治疗：日本的一项多中心随机试验

目的 迄今为止，还没有随机试验比较过vonoprazan和阿莫西林双重治疗与其他标准方案治疗幽门螺杆菌的疗效。本研究旨在调查 7 天沃诺拉赞和低剂量阿莫西林双重治疗作为幽门螺杆菌一线治疗的疗效，并将其与基于沃诺拉赞的三联疗法进行比较。设计 这项前瞻性随机临床试验在七家日本机构进行。幽门螺杆菌培养试验阳性且未接受治疗的患者以 1:1 的比例随机分配至 VA 双联治疗（沃诺拉赞 20 mg+阿莫西林 750 mg 两次/天）或 VAC-三联治疗（沃诺拉赞 20 mg+阿莫西林 750 毫克 + 克拉霉素 200 毫克两次/天）共 7 天，按年龄、性别、幽门螺杆菌耐药性和机构分层。在治疗后至少 4 周通过 13C-尿素呼气试验评估根除成功。结果 2018 年 10 月至 2019 年 6 月期间，筛选了 629 名受试者，随机分配了 335 名受试者。根据意向治疗分析，VA 双联疗法和 VAC 三联疗法的根除率分别为 84.5% 和 89.2% (p=0.203)，根据方案分析分别为 87.1% 和 90.2% (p=0.372)，分别。在符合方案分析中，VA-dual 不劣于 VAC-triple。VA-dual 对克拉霉素耐药菌株的根除率显着高于 VAC-triple（92.3% 对 76.2%；p=0.048）。组间不良事件的发生率相等。结论 7 天沃诺拉赞和小剂量阿莫西林双重治疗提供了可接受的 H. 幽门螺杆菌根除率和在克拉霉素高耐药地区与基于沃诺拉赞的三联疗法相似的效果。试用注册号 UMIN000034140。