Helicobacter pylori eradication by low-dose rifabutin triple therapy (RHB-105) is unaffected by high body mass index

GastroHep Pub Date : 2021-09-28 DOI:10.1002/ygh2.494
John Y. Kao, June S. Almenoff, Dana D. Portenier, Kely L. Sheldon
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Abstract

Background

Helicobacter pylori infection affects ~35% of Americans and may lead to serious sequelae if left untreated, including gastric cancer. Obesity is a significant risk factor for antibiotic treatment failure; however, little work has been done to understand the influence of high body mass index (BMI) on the success rates of H pylori eradication regimens in treatment-naïve and refractory adult patients.

Aim

This analysis evaluated the association of subject obesity on overall H pylori eradication rates for RHB-105 (rifabutin, amoxicillin, and omeprazole magnesium; Talicia®) and its comparators using data from two Phase 3 clinical trials.

Methods

A post hoc analysis of the eradication rates of RHB-105 vs comparators in a total of 269 subjects who tested positive for H pylori was conducted. Comparators in the two studies included placebo (placebo comparator) and amoxicillin and omeprazole (active comparator). Subjects were treated for 14 days and returned for follow-up test-of-cure at 28-59 days post-therapy using urea breath testing.

Results

Subjects receiving RHB-105 with 30 ≤ BMI < 40 or BMI ≥ 40 had pooled modified intent to treat (mITT) eradication rates of 88.1% (95% CI: 81.1-92.8) and 90.9% (95% CI: 72.2-97.5) [P = .707], respectively, compared to active comparator rates of 62.9% (95% CI: 52.5-72.2) and 31.8% (95% CI: 16.4-52.7) [P = .008].

Conclusions

Obese patients treated with RHB-105 were associated with efficacy rates comparable to the overall study population. This supports further evaluation of the efficacy of RHB-105 in obese populations, where H pylori is prevalent. ClinTrials.gov # NCT01980095 & NCT031985070.

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低剂量利福布丁三联疗法(RHB-105)根除幽门螺杆菌不受高体重指数影响
背景幽门螺杆菌感染影响约35%的美国人,如果不治疗可能会导致严重的后遗症,包括癌症。肥胖是抗生素治疗失败的重要危险因素;然而,很少有研究了解高体重指数(BMI)对治疗幼稚和难治性成年患者的幽门螺杆菌根除方案成功率的影响。目的本分析使用两项3期临床试验的数据评估了受试者肥胖与RHB-105(利福布汀、阿莫西林和奥美拉唑镁;Talicia®)及其对照品的幽门螺杆菌总根除率的关系。方法对269名幽门螺杆菌检测呈阳性的受试者中RHB-105与对照组的根除率进行事后分析。两项研究中的对照品包括安慰剂(安慰剂对照品)和阿莫西林和奥美拉唑(活性对照品)。受试者接受了14天的治疗,并在治疗后28-59天通过尿素呼气测试返回进行治愈随访测试。结果接受RHB-105治疗的受试者BMI<30;40或BMI≥40的患者的改良意向治疗(mITT)根除率分别为88.1%(95%CI:81-19.2.8)和90.9%(95%CI:72-2-97.5)[P=.707],与62.9%(95%CI:52.5-72.2)和31.8%(95%CI:16.4-52.7)的活性对照率相比[P=.008]。结论接受RHB-105治疗的肥胖患者的有效率与整个研究人群相当。这支持进一步评估RHB-105在幽门螺杆菌流行的肥胖人群中的疗效。ClinTrials.gov#NCT01980095&;NCT031985070。
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