ObjectiveTo 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.DesignThis 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.ResultsBetween 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.ConclusionThe 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 numberUMIN000034140.
Background and Aim Helicobacter pylori eradication can disrupt the gut microbiome. Here, we investigated the short‐term impact of minimum antibiotic treatment—a 7‐day vonoprazan and low‐dose amoxicillin regimen (VA‐dual therapy)—on gut microbiota and compared it with that of vonoprazan‐based triple therapy (VAC‐triple therapy). Methods Fifty‐nine patients with H. pylori infection were recruited (UMIN000034140) from March to May 2019 and randomly assigned to the VAC‐triple therapy or VA‐dual therapy groups, according to the first‐line H. pylori treatment received. Fecal samples were collected before treatment initiation and 1 and 8 weeks after eradication therapy completion. The composition ratios of the bacterial taxa and the alpha and beta diversities were evaluated in both groups via polymerase chain reaction amplification of the V3–V4 region of the 16S rRNA gene and sequencing using the MiSeq system. Results Nineteen patients were assigned to the VA‐dual group and 24 to the VAC‐triple group. Compared with baseline, the alpha diversity reduced significantly 1 and 8 weeks after VAC‐triple therapy. However, for VA‐dual therapy, the alpha diversities at 1 and 8 weeks after the treatment did not change significantly compared with those at baseline. Additionally, the beta diversity differed significantly between baseline and 1 and 8 weeks after VAC‐triple therapy. VAC‐triple therapy led to significant alteration in the relative abundance of Actinobacteria at the phylum level and Collinsella, Blautia, and Streptococcus at the genus level. Conclusions Compared with VAC‐triple therapy, VA‐dual therapy induced minimal changes in the diversity and relative abundance of gut microbiota.
Background As a first‐line therapy for Helicobacter pylori, dual therapy with vonoprazan and amoxicillin (VA‐dual) provides an eradication rate similar to that of vonoprazan‐based triple therapy. As the factors associated with the eradication rate of H. pylori with VA‐dual are unknown,we investigated them in this study. Materials and Methods Overall, 163 patients diagnosed with H. pylori infection received VA‐dual (vonoprazan 20 mg twice daily and amoxicillin 750 mg twice daily for 7 d). The association between successful H. pylori eradication and the following patient clinical factors was analyzed: sex, age, height, weight, body surface area (BSA), body mass index (BMI), history of early gastric carcinoma and peptic ulcer, comorbidity of cirrhosis, alcohol consumption habit, smoking habit, common use of proton pump inhibitors, and concomitant use of drugs that are substratesof cytochrome P450 (CYP) 3A4. The association between post‐eradication adverse events and clinical factors was analyzed retrospectively. Results Successful H. pylori eradication was associated with a lower BSA (eradication rate: 90.8% in patients with BSA <1.723 vs. 79.6% in those with BSA ≥1.723; p = 0.045). The incidence of adverse events was higher in women than in men (adverse events: 40.0% in women vs. 19.4% in men; p = 0.004). Conclusions Successful H. pylori eradication with VA‐dual was associated with the small body size of patients. This therapy may have to be adjusted per body size.
<b><i>Background:</i></b> <i>Helicobacter pylori</i> eradication treatments are widely performed to improve gastric mucosal inflammation, promote ulcer healing, and reduce the incidence of gastric cancer. However, there are several issues associated with <i>H. pylori</i> eradication treatment. First, various treatment regimens are currently used worldwide, and the standard treatment varies with region and country. Second, the antimicrobial resistance of <i>H. pylori</i> is increasing due to indiscriminate antibiotic use. Finally, gut microbiota dysbiosis is potentially induced by <i>H. pylori</i> treatment. <b><i>Summary:</i></b> Based on current international guidelines and a network meta-analysis comparing the effects of various treatment regimens, nonbismuth quadruple therapies for 10–14 days and vonoprazan-based triple therapy for 7 days are the currently recommended <i>H. pylori</i> treatment regimens. These regimens show good eradication rates of approximately 90%, even in areas where antimicrobial-resistant strains are highly prevalent. However, these regimens still have inherent drawbacks that may promote further increases in antimicrobial resistance and induce gut microbiota dysbiosis because of the empiric use of multiple antibiotics. <b><i>Key Message:</i></b> The ideal concept for the present and future <i>H. pylori</i> eradication treatment involves “a simple, cost-effective strategy that fosters compliance without having a negative impact on the gut microbiota or contributing to future antimicrobial resistance.” One interesting possibility that may fulfill this concept is a dual therapy involving vonoprazan and amoxicillin. This is the simplest treatment regimen that provides acceptable eradication rates, improves safety and tolerability, and minimizes the potential for increasing antimicrobial resistance or causing gut microbiota dysbiosis.
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