Efficacy and safety of vonoprazan as a component of the first- and second-line eradication regimens for Helicobacter pylori: a real-life Egyptian study
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.
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