Abstract
Background: Vonoprazan, a new potassium competitive acid blocker, offers a rapid onset of action
and a predictable antisecretory profile that is independent of the CYP2C19 genotype or parietal cell
activity. This profile may enhance Helicobacter pylori eradication therapy.
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.
Methods: A prospective, controlled, multicenter, parallel-assignment, and open-label study was
designed to verify the superiority of vonoprazan versus PPI in first-line therapy (with amoxicillin
and clarithromycin) or second-line therapy (with levofloxacin, doxycycline, and nitazoxanide)
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
eradication, while the secondary endpoint is the rate of second-line eradication among individuals
who did not respond to first-line treatment. Safety and tolerability of both first- and second-line
treatments were also assessed.
Results: Of the 1184 patients allocated to the study, 701 naïve patients received first-line therapy
(355 patients received a triple vonoprazan-based regimen; 346 patients received triple PPI-based
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).
The first-line eradication rate was 91% in vonoprazan triple therapy versus 74.6% in PPI triple
therapy (P < 0.001). The second-line eradication rate was 89.7% in vonoprazan quadrable therapy
versus 78.3% in PPI quadrable therapy (P < 0.001). Both first- and second-line therapies were well
tolerated with no remarkable adverse events or safety outcomes.
Conclusion: In both naive and experienced patients, vonoprazan-based treatment was statistically
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
Author affiliation
1Department of Tropical Medicine, Faculty of Medicine, Alexandria University, Alexandria, Egypt
2Department of Internal Medicine,
Hepatogastroenterology Unit, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
3Department of Internal Medicine and
Hepatogastroenterology, Faculty of Medicine, Ain Shams University, Cairo, Egypt
4Department of Internal Medicine, Gastroenterology
Unit, Faculty of Medicine, Cairo University, Cairo, Egypt
5Department of Internal Medicine, Gastroenterology Unit, Faculty of Medicine,
Assiut University, Assiut, Egypt
6Department of Hepatogastroenterology, Faculty of Medicine, Mansoura University, Mansoura, Egypt
7Department Internal Medicine, Gastroenterology Unit, Faculty of Medicine, Tanta University, Gharbia, Egypt
8Department of Internal
Medicine, Hepatology and Gastroenterology Unit, Faculty of Medicine, Menofia University, Menofia, Egypt
9Department of Hepatology and
Gastroenterology, National Liver Institute, Menoufia University, Shebin El-Kom, Egypt
10Department of Tropical Medicine, Faculty of Medicine,
Minia University, Minia, Egypt
11Department of Tropical Medicine and Gastroenterology, Faculty of Medicine, South Vally University, Qena,
Egypt
12Hepatogastroenterology and Infectious Disease Department, Faculty of Medicine, Zagazig University, Sharkia, Egypt
13Department of
Hepatology, Gastroenterology and Infectious Diseases, Benha University, Qalyubia, Egypt
*Corresponding author:
Eman Abdelsameea
Department of Hepatology and
Gastroenterology, National Liver Institute,
Menoufia University, Shebin El-Kom, Egypt
Email: eabdelsameea@liver-eg.org
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