Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Summary

The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

Timeline

Start

2023-01-20

Primary completion

2024-07-06

Completion

2024-11-05

Outcome

Mixed primary results

paper The efficacy of MVA was noninferior to HVA in ITT analysis (difference: -1.6%, 97.5% CI: -7.0% to 3.8%, p < 0.001) PMID 40481714 ↗

paper LVA's effectiveness was less than HVA in ITT analysis (difference: -6.2%, 97.5% CI: -12.2% to -0.2%, p = 0.076) PMID 40481714 ↗

Publications

• Background Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17.
• Background Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.
• Background Ford AC, Malfertheiner P, Giguere M, Santana J, Khan M, Moayyedi P. Adverse events with bismuth salts for Helicobacter pylori eradication: systematic review and meta-analysis. World J Gastroenterol. 2008 Dec 28;14(48):7361-70. doi: 10.3748/wjg.14.7361.
• Background Gao CP, Zhang D, Zhang T, Wang JX, Han SX, Graham DY, Lu H. PPI-amoxicillin dual therapy for Helicobacter pylori infection: An update based on a systematic review and meta-analysis. Helicobacter. 2020 Aug;25(4):e12692. doi: 10.1111/hel.12692. Epub 2020 Apr 20.
• Background Furuta T, Shirai N, Kodaira M, Sugimoto M, Nogaki A, Kuriyama S, Iwaizumi M, Yamade M, Terakawa I, Ohashi K, Ishizaki T, Hishida A. Pharmacogenomics-based tailored versus standard therapeutic regimen for eradication of H. pylori. Clin Pharmacol Ther. 2007 Apr;81(4):521-8. doi: 10.1038/sj.clpt.6100043. Epub 2007 Jan 10.
• Background Guan JL, Hu YL, An P, He Q, Long H, Zhou L, Chen ZF, Xiong JG, Wu SS, Ding XW, Luo HS, Li PY. Comparison of high-dose dual therapy with bismuth-containing quadruple therapy in Helicobacter pylori-infected treatment-naive patients: An open-label, multicenter, randomized controlled trial. Pharmacotherapy. 2022 Mar;42(3):224-232. doi: 10.1002/phar.2662. Epub 2022 Feb 5.
• Peng R, Cai P, Zhang Z, Lv S, Chen G, Xu Y, He B, Sun M, Dai X, Yan K, Shen L, Wang J, Li W, Yin R, Ge J, Hu D, Hu K, Xu X, Li H, Pan C, Duan Z, Gao X, Zhang Z, Liu W. Efficacy of Three Amoxicillin Doses in Vonoprazan Dual Therapy for Helicobacter pylori Eradication: A Randomized Noninferiority Trial. Helicobacter. 2025 May-Jun;30(3):e70050. doi: 10.1111/hel.70050.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amoxicillin	Other / unclassified	500 mg	—
Subject	Amoxicillin	Other / unclassified	1000 mg	—
Background	Vonoprazan	Other / unclassified	20 mg	—

Indications