Ten-day versus 14-day vonoprazan-amoxicillin high-dose dual therapy for Helicobacter pylori eradication in China: A multicenter, open-label, randomized study.

Only a few studies have investigated the efficacy and safety of different durations of vonoprazan and amoxicillin (VA) high-dose dual therapy for the eradication of Helicobacter pylori. We aimed to compare the efficacy and safety of 10 days versus 14 days of VA high-dose dual therapy for H. pylori eradication. This study was conducted in 14 centers in China. A total of 250 patients infected with H. pylori were randomly assigned to Group VA-10 or VA-14. Both groups received the VA dual therapy (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily). The primary endpoint was the H. pylori eradication rate. Secondary endpoints included adverse events and patient compliance. Group VA-10 achieved eradication rates of 89.60%, 91.06%, and 91.67% as determined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analysis, respectively. The eradication rates were similar to those in Group VA-14: 91.20%, 93.44%, and 93.39%. The difference and 90% confidence interval boundary -1.60% (-7.73% to 4.53%) in the ITT analysis, -2.39% (-8.00% to 3.23%) in the MITT analysis, and -1.72% (-7.29% to 3.85%) in the PP analysis were greater than the predefined noninferiority margin of -10%, establishing a noninferiority of Group VA-10 versus Group VA-14 (noninferiority P = 0.001 in ITT analysis, P < 0.001 in MITT analysis, and P < 0.001 in PP analysis, respectively). No significant differences were observed in adverse events between the two groups. Ten-day VA dual therapy achieves comparable efficacy and safety to the 14-day regimen in Chinese population, providing patients with greater convenience and economic benefits.

Lin A ，Lin Z ，Liu Y ，Chen S ，Shao Y ，Qiu F ，Xiao Z ，Xu Z ，Chen L ，Chen L ，Lin W ，Wang Y ，Huang Z ，Lin Z ，Huang X ... -  《-》

Vonoprazan-Amoxicillin Dual Therapy With Different Amoxicillin Administration Regimens for Helicobacter pylori Treatment: A Randomized Controlled Trial.

The effect of preprandial or postprandial administration of amoxicillin on the efficacy of vonoprazan-amoxicillin dual therapy (VA-dual therapy) for Helicobacter pylori treatment has not been studied. It is also unclear whether amoxicillin dosing four times daily is more effective than three times daily. We aimed to investigate the effect of different amoxicillin administration regimens on the efficacy of VA-dual therapy. H. pylori-infected subjects were randomly assigned to three groups in a 1:1:1 ratio to receive a 14-day dual therapy consisting of vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily before meals (BM-TID) or 1000 mg three times daily after meals (AM-TID) or 750 mg four times daily after meals (AM-QID). H. pylori eradication rates, adverse events rates, compliance, and antibiotic resistance were compared. Between May 2021 to April 2023, 327 subjects were enrolled. The eradication rates of BM-TID, AM-TID, and AM-QID dual therapy were 88.1%, 89.9%, and 93.6% in intention-to-treat (ITT) analysis, 90.6%, 94.2%, and 99.0% in modified ITT (MITT) analysis, and 90.4%, 94.1%, and 99.0% in per-protocol (PP) analysis. Although there was non-inferiority between BM-TID and AM-TID, as well as between AM-TID and AM-QID, AM-QID was significantly more effective than BM-TID. There were no significant differences in adverse event rates, compliance, and antibiotic resistance among the three groups. Postprandial administration and the increased frequency of administration of amoxicillin may contribute to a better efficacy of VA-dual therapy, especially for rescue therapy. All VA-dual therapy in our study could achieve good efficacy for first-line treatment. clinicaltrials.gov: NCT05901051.

Qiu S ，Huang Y ，Chen J ，Guo Y ，Li M ，Ding Z ，Liang X ，Lu H ... -  《-》

Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population: A prospective, multicenter, randomized, two-stage study.

The efficacy of Vonoprazan-amoxicillin dual therapy (VAT) in the treatment of Helicobacter pylori (H. pylori) is controversial. To evaluate the efficacy of VAT in the Chinese population. This prospective, multicenter, randomized, open-label, and two-stage study was conducted at 23 centers in Fujian, China (May 2021-April 2022). H. pylori-infected patients were randomized to bismuth quadruple therapy (BQT), BQT-Vonoprazan (BQT-V), seven-day VAT (VAT-7), ten-day VAT (VAT-10), and fourteen-day VAT (VAT-14) groups. The primary endpoint was the H. pylori eradication rate. The secondary endpoint was the frequency of adverse events. This study was registered with the Chinese Clinical Trial Registry, ChiCTR2100045778. In the first stage, VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were eradicated. In the second stage, the eradication rates for BQT, VAT-10, and VA-14 were 80.2% [95% confidence interval (95%CI): 71.4%-86.8%], 93.2% (86.6%-96.7%), 92.2% (85.3%-96.0%) in the intention-to-treat (ITT) analysis, and 80.9% (95%CI: 71.7%-87.5%), 94.0% (87.5%-97.2%), and 93.9% (87.4%-97.2%) in the per-protocol analysis. The ITT analysis showed a higher eradication rate in the VAT-10 and VAT-14 groups than in the BQT group (P = 0.022 and P = 0.046, respectively). The incidence of adverse events in the VAT-10 and VAT-14 groups was lower than in the BQT group (25.27% and 13.73% vs 37.62%, respectively; P < 0.001). VAT with a duration of 10 or 14 days achieves a higher eradication rate than the BQT, with a more tolerable safety profile in H. pylori-infected patients in Fujian.

Huang XP ，Liu YJ ，Lin SW ，Shao YF ，Qiu F ，Qiu QW ，Xu ZK ，Chen JX ，Chen LH ，Lin ZQ ，Dai WH ，Zhang MQ ，Jiang Q ，Xiao ZQ ，Cheng XX ，Zhang XF ，You WB ，Chen W ，Li LQ ，Lin WX ，Wang YF ，Lai FJ ，Chen LQ ，Huang ZH ，Zheng WQ ，Wei JQ ，Lin ZH ... -  《-》

Real-world evidence on the efficacy and safety of vonoprazan-amoxicillin dual therapy for Helicobacter pylori treatment in elderly patients.

A dual therapy regimen containing amoxicillin is a common treatment option for the eradication of Helicobacter pylori (H. pylori). While substantial research supports the efficacy and safety of vonoprazan and amoxicillin (VA) dual therapy in the general population, there is still a lack of studies specifically focusing on its safety in elderly patients. To evaluate efficacy and safety of VA dual therapy as first-line or rescue treatment for H. pylori in elderly patients. As a real-world retrospective study, data were collected from elderly patients aged 60 years and above who accepted VA dual therapy (vonoprazan 20 mg twice daily + amoxicillin 1000 mg thrice daily for 14 days) for H. pylori eradication in the Department of Gastroenterology at Peking University First Hospital between June 2020 and January 2024. H. pylori status was evaluated by 13C-urease breath test 6 weeks after treatment. All adverse events (AEs) during treatment were recorded. In total, 401 cases were screened. Twenty-one cases were excluded due to loss to follow-up, lack of re-examination, or unwillingness to take medication. The total of 380 included cases comprised 250 who received VA dual therapy as first-line treatment and 130 who received VA dual therapy as rescue treatment. H. pylori was successfully eradicated in 239 cases (95.6%) in the first-line treatment group and 116 cases (89.2%) in the rescue treatment group. The overall incidence of AEs was 9.5% for both groups. Specifically, 9.2% of patients experienced an AE in the first-line treatment group and 10.0% in the rescue treatment group. Five patients discontinued treatment due to AE, with a discontinuation rate of 1.3%. No serious AE occurred. The VA dual therapy regimen as a first-line treatment and a rescue therapy was effective and safe for elderly patients aged 60 and older.

Gao W ，Li JW ，Ye H ，Zhang XZ ，Liu JX ，Cheng H ... -  《-》

Eradication rate and safety of vonoprazan-amoxicillin dual therapy for helicobacter pylori eradication: a randomized controlled trial.

Jiang G ，Luo M ，Zheng P ，Cong Y ，Feng Y ，Zhou F ... -  《-》