Seven-Day Vonoprazan-Based Triple Therapy as First-Line Helicobacter pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial.

Vonoprazan, a potassium-competitive acid blocker, has demonstrated greater potency and a longer duration of acid suppression when compared to the proton pump inhibitors. However, data regarding the comparison between vonoprazan-based triple therapy with standard treatment for first-line Helicobacter pylori treatment are limited. This study aimed to compare the efficacy between 7-day vonoprazan-based triple therapy with high-dose amoxicillin (VAC-7) and 14-day extended sequential therapy (S-14). This was a single-center prospective randomized controlled trial following a noninferiority design. Subjects over 20 years old with confirmed H. pylori infection were enrolled prospectively from Fu Jen Catholic University Hospital. They were randomly assigned to the VAC-7 or S-14 group. The primary endpoint was the eradication rate in first-line treatment, evaluated by urea breath test, with noninferiority determined using the Farrington-Manning method. The secondary outcome included adverse effect rates and compliance, assessed through self-administered questionnaires. Between December 2021 and June 2023, a total of 628 patients were recruited. The eradication rates by per-protocol analysis and intention-to-treat analysis were 88.6%/81.8% for VAC-7 and 90.3%/81.4% for S-14, respectively. The VAC-7 was non-inferior to S-14 in terms of ITT analysis. Subjects experienced fewer incidences of nausea, anorexia, dizziness, fatigue, and any severe adverse events in the VAC-7 group. Compliance was higher in the VAC-7 group, with 94% taking all the pills correctly. Our findings supported the use of 7-day vonoprazan triple therapy with high-dose amoxicillin as the standard first-line treatment for H. pylori infection. ClinicalTrials.gov identifier: NCT05371249.

Chiu YT ，Lee FJ ，Kuo CY ，Chen YT ，Lin YC ，Liang KS ，Wu CY ，Lin RT ，Lin JT ，Chang CY ... -  《-》

Randomized clinical trial: 7-day vonoprazan-based versus 14-day omeprazole-based triple therapy for Helicobacter pylori.

Vonoprazan has more potent and sustained acid inhibitory effects than proton pump inhibitors; therefore, Helicobacter pylori eradication rates are expected to improve with the use of vonoprazan-based regimens. To date, no randomized trial has compared the efficacy of 7-day vonoprazan-based triple therapy (7-VAC) with 14-day omeprazole-based triple therapy (14-OAC). This study aimed to compare the H. pylori eradication rates of 7-VAC and 14-OAC. This randomized clinical trial was performed at a tertiary hospital in Bangkok. Patients with active H. pylori infection who were naive to treatment were included and randomized (1:1) into either a 7-VAC group (vonoprazan 20 mg bid. pc., amoxicillin 1000 mg bid. pc., and clarithromycin 500 mg bid. pc.) or a 14-OAC group (omeprazole 20 mg bid. ac., amoxicillin 1000 mg bid. pc., and clarithromycin 500 mg bid. pc.). Eradication success was evaluated by urea breath test 4-6 weeks after completion of treatment. A total of 122 subjects were randomized to receive 7-VAC (n = 61) or 14-OAC (n = 61). The H. pylori eradication rates of the 7-VAC and 14-OAC groups were 96.7% and 88.5% (P = 0.083), respectively, by intention-to-treat analysis and 98.3% and 93.1% (P = 0.159), respectively, by per-protocol analysis. All treatment-related adverse events were mild and not significantly different between the two groups. Common side effects included bitter taste, nausea, and dizziness. The 7-VAC regimen was well tolerated and achieved similar eradication rates and side effects to those of 14-OAC; therefore, 7-VAC may be considered an alternative regimen for H. pylori treatment with the benefit of shorter duration.

Bunchorntavakul C ，Buranathawornsom A 《-》

Seven-day vonoprazan and low-dose amoxicillin dual therapy as first-line Helicobacter pylori treatment: a multicentre randomised trial in Japan.

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. 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. 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. 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. UMIN000034140.

Suzuki S ，Gotoda T ，Kusano C ，Ikehara H ，Ichijima R ，Ohyauchi M ，Ito H ，Kawamura M ，Ogata Y ，Ohtaka M ，Nakahara M ，Kawabe K ... -  《-》

Vonoprazan-based triple therapy is effective for Helicobacter pylori eradication irrespective of clarithromycin susceptibility.

Okubo H ，Akiyama J ，Kobayakawa M ，Kawazoe M ，Mishima S ，Takasaki Y ，Nagata N ，Shimada T ，Yokoi C ，Komori S ，Kimura K ，Hisada Y ，Iwata E ，Watanabe K ，Yanagisawa N ，Shiroma S ，Shimomura A ，Okahara K ，Cho H ，Uemura N ... -  《-》

Vonoprazan Dual or Triple Therapy Versus Bismuth-Quadruple Therapy as First-Line Therapy for Helicobacter pylori Infection: A Three-Arm, Randomized Clinical Trial.

We compared efficacy of vonoprazan-dual or triple therapies and bismuth-quadruple therapy for treatment-naive Helicobacter pylori (HP) infection in Southern China, where primary resistance rates of clarithromycin and levofloxacin are >30%. This was an investigator-initiated, three-arm, randomized clinical trial in Southern China. Between March 2022 and August 2023, treatment-naïve HP-infected adults were randomly assigned to receive one of three 14-day regimens (1:1:1 ratio): vonoprazan-dual (VA-dual; vonoprazan 20 mg twice daily and amoxicillin 1 g thrice daily), vonoprazan-triple (VAC-triple; vonoprazan 20 mg/amoxicillin 1 g/clarithromycin 500 mg twice daily), or bismuth-quadruple therapy containing bismuth, esomeprazole, tetracycline, and metronidazole. Primary outcome was noninferiority in HP eradication, evaluated by UBT 4-6 weeks post-treatment by intention-to-treat (ITT) and per-protocol (PP) analysis (based on subjects who completed 14-day treatment and rechecked UBT). Bonferroni-adjusted p-value of <0.017 was used to determine statistical significance. A total of 298 subjects (mean age: 35.7 ± 8.4 years; male: 134 [45.0%]; VC-dual: 100, VAC-triple: 98, bismuth-quadruple: 100) were enrolled, and 292 (98.0%) had UBT rechecked. ITT analysis showed that both VA-dual (eradication rate of 96.0%) and VAC-triple therapies (95.9%) were noninferior to bismuth-quadruple therapy (92.0%) (difference: 4.0%, 95% CI: -2.9% to 11.5%, p < 0.001; and 3.9%, 95% CI: -3.1% to 11.5%, p < 0.001, respectively). PP analysis also revealed noninferiority (96.7% or 96.7% vs. 97.4%, with difference: -2.9% and -2.9%, p = 0.009 and 0.010, respectively). The frequency of adverse events was 39.0%, 56.1%, and 71.0% in VA-dual, VAC-triple, and bismuth-quadruple therapies, respectively. VA-dual and VA-triple therapies are highly effective and noninferior to bismuth-quadruple therapy in Southern China. Given the lower adverse effects and fewer antibiotic use, VA-dual therapy is the preferred first-line treatment for HP infection. Chinese Clinical Trial Registry (No. ChiCTR2200056375). Registered on February 4, 2022, https://www.chictr.org.cn/showproj.aspx?proj=14131.

Cheung KS ，Lyu T ，Deng Z ，Han S ，Ni L ，Wu J ，Tan JT ，Qin J ，Ng HY ，Leung WK ，Seto WK ... -  《-》