Due to increasing resistance to commonly used antibiotics, the World Health Organization and Food and Drug Administration have advocated the development of new therapeutic regimens for Helicobacter pylori (H. pylori). This phase three, double-blind study (ERADICATE Hp) randomized (2:1) treatment-naïve adults with H. pylori infection and dyspepsia to RHB-105 (an all-in-one combination of omeprazole 40 mg, amoxicillin 1000 mg, and rifabutin 50 mg) or an identically-appearing placebo, both administered every 8 h for 14 days. The H. pylori eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28–35 days post-completion of therapy, was compared (one-sample Z-test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures. The mITT H. pylori eradication rate (95% CI) with RHB-105 of 89.4% (82.0–96.8%) was greater than both the literature-derived comparator rate (P < 0.001) and the standard-of-care rate of 63.0% (44.8–81.1%) (P = 0.006). Adverse events with an incidence ≥5% for RHB-105 were diarrhea (12.7%), headache (11.9%), chromaturia (9.3%), abdominal tenderness (6.8%), and dizziness (5.1%). No leukopenia was noted. RHB-105 (Talicia^®) proved to be a safe and effective empiric therapy for H. pylori eradication.

中文翻译：

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含利福布丁的三联疗法 (RHB-105) 根除幽门螺杆菌：随机根除 Hp 试验

由于对常用抗生素的耐药性不断增加，世界卫生组织和食品药品监督管理局提倡针对幽门螺杆菌（H. pylori）开发新的治疗方案。这项三期双盲研究 (ERADICATE Hp) 将患有幽门螺杆菌感染和消化不良的未接受治疗的成年人随机 (2:1) 接受 RHB-105（奥美拉唑 40 毫克、阿莫西林 1000 毫克、和利福布丁 50 mg）或外观相同的安慰剂，每 8 小时给药一次，持续 14 天。RHB-105 的幽门螺杆菌根除率，使用改良的意向治疗 (mITT) 人群，受试者接受≥1 剂量的研究药物，并在治疗完成后 28-35 天进行根除测试，与文献得出的 70% 的比较率以及医生选择的安慰剂失败护理标准的成功率进行了比较（单样本Z检验）。RHB-105 的mITT幽门螺杆菌根除率 (95% CI) 为 89.4% (82.0–96.8%)，高于文献得出的比较率 ( P < 0.001) 和标准护理率 63.0 %（44.8–81.1%）（P = 0.006）。RHB-105发生率≥5%的不良事件为腹泻（12.7%）、头痛（11.9%）、色尿（9.3%）、腹部压痛（6.8%）和头晕（5.1%）。未发现白细胞减少症。RHB-105 (Talicia ^® ) 被证明是一种安全有效的根除幽门螺杆菌经验疗法。