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Journal of Clinical and Translational Research 2024; 10(6): 317-324




                                       Journal of Clinical and Translational Research

                                              Journal homepage: http://www.jctres.com/en/home


        ORIGINAL ARTICLE

        Efficacy and safety of vonoprazan as a component of the first- and

        second-line eradication regimens for Helicobacter pylori: a real-life

        Egyptian study


        Abdelfattah Hanno , Magdy El-Dahshan , Tarek Youssef , Ali Farag , Hussein Elamin , Magdi Hamed ,
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        Sherief Abdel-Salam , Ehab Abdelatty , Eman Abdelsameea *, Yasser Fouad , Shamardan Ezz-Eldin ,
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        Waleed A. Abd El Dayem , Ebada Said , Mohamed S. Ahmed 1
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        1 Department of Tropical Medicine, Faculty of Medicine, Alexandria University, Alexandria, Egypt,  Department of Internal Medicine,
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        Hepatogastroenterology Unit, Faculty of Medicine, Al-Azhar University, Cairo, Egypt,  Department of Internal Medicine and
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        Hepatogastroenterology, Faculty of Medicine, Ain Shams University, Cairo, Egypt,  Department of Internal Medicine, Gastroenterology
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        Unit, Faculty of Medicine, Cairo University, Cairo, Egypt,  Department of Internal Medicine, Gastroenterology Unit, Faculty of Medicine,
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        Assiut University, Assiut, Egypt,  Department of Hepatogastroenterology, Faculty of Medicine, Mansoura University, Mansoura, Egypt,
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        7 Department Internal Medicine, Gastroenterology Unit, Faculty of Medicine, Tanta University, Gharbia, Egypt,  Department of Internal
        Medicine, Hepatology and Gastroenterology Unit, Faculty of Medicine, Menofia University, Menofia, Egypt,  Department of Hepatology and
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        Gastroenterology, National Liver Institute, Menoufia University, Shebin El-Kom, Egypt,  Department of Tropical Medicine, Faculty of Medicine,
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        Minia University, Minia, Egypt,  Department of Tropical Medicine and Gastroenterology, Faculty of Medicine, South Vally University, Qena,
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        Egypt,  Hepatogastroenterology and Infectious Disease Department, Faculty of Medicine, Zagazig University, Sharkia, Egypt,  Department of
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        Hepatology, Gastroenterology and Infectious Diseases, Benha University, Qalyubia, Egypt
        ARTICLE INFO                       ABSTRACT
        Article history:                   Background: Vonoprazan, a new potassium competitive acid blocker, offers a rapid onset of action
        Received: July 13, 2024            and a predictable antisecretory profile that is independent of the CYP2C19 genotype or parietal cell
        Accepted: October 25, 2024         activity. This profile may enhance Helicobacter pylori eradication therapy.
        Published Online: November 26, 2024  Aim: This research compared vonoprazan and proton-pump inhibitors (PPI) in Egypt’s first- and
                                           second-line H. pylori eradication regimens for effectiveness, safety, and tolerability.
        Keywords:                          Methods: A prospective, controlled, multicenter, parallel-assignment, and open-label study was
        Vonoprazan                         designed to verify the superiority of vonoprazan versus PPI in first-line therapy (with amoxicillin
        Proton-pump inhibitor              and  clarithromycin)  or  second-line  therapy  (with  levofloxacin,  doxycycline,  and  nitazoxanide)
        Helicobacter pylori                for H. pylori eradication. Patients received either vonoprazan- or PPI-based regimens for 14 days
                                           followed by a 4-week follow-up period. The primary efficacy endpoint is the rate of first-line
        *Corresponding author:             eradication, while the secondary endpoint is the rate of second-line eradication among individuals
        Eman Abdelsameea                   who did not respond to first-line treatment. Safety and tolerability of both first- and second-line
        Department of Hepatology and       treatments were also assessed.
        Gastroenterology, National Liver Institute,   Results: Of the 1184 patients allocated to the study, 701 naïve patients received first-line therapy
        Menoufia University, Shebin El-Kom, Egypt.  (355 patients received a triple vonoprazan-based regimen; 346 patients received triple PPI-based
        Email: eabdelsameea@liver-eg.org   regimen), and 483 experienced patients received the second-line therapy (243 patients received
                                           quadrable vonoprazan-based regimen and 240 patients received quadrable PPI-based regimen).
        © 2024 Author(s). This is an Open-  The first-line eradication rate was 91% in vonoprazan triple therapy versus 74.6% in PPI triple
        Access article distributed under the terms   therapy (P < 0.001). The second-line eradication rate was 89.7% in vonoprazan quadrable therapy
        of the Creative Commons Attribution-  versus 78.3% in PPI quadrable therapy (P < 0.001). Both first- and second-line therapies were well
        Noncommercial License, permitting all
        non-commercial use, distribution, and   tolerated with no remarkable adverse events or safety outcomes.
        reproduction in any medium, provided the   Conclusion: In both naive and experienced patients, vonoprazan-based treatment was statistically
        original work is properly cited.   and substantially superior to omeprazole-based therapy in eradicating H. pylori.
                                           Relevance for Patients: This work offers a promising approach for the treatment of Egyptian
                                           patients with H. pylori infection.
                                               DOI: http://doi.org/10.36922/jctr.24.00043
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