Vonoprazan-based therapy versus standard regimen for Helicobacter pylori infection management in Egypt: an open-label randomized controlled trial

Abstract

As antibiotic resistance continues to rise, the development of novel H. pylori treatment regimens, combined with regular assessment of existing treatment regimens, is imperative. The study evaluates the efficacy, safety, and compliance of vonoprazan dual and triple therapy (VDT and VTT) both consisting of vonoprazan 20 mg twice daily and amoxicillin/clavulanate 875 mg/125 three times daily plus clarithromycin 500 mg twice daily added in VTT versus standard triple therapy (STT), in which vonoprazan 20 mg in VTT is replaced by PPI standard or double dose all for 14 days, along with investigating factors influencing compliance, treatment response, and symptoms severity. By per-protocol analysis, the eradication rates of the STT, VDT, and VTT groups were 70%, 76.2%, and 79.2%, respectively (p = 0.777) indicating suboptimal efficacy of the three treatment regimens. This necessitates the optimization of dosage and frequency of available treatment regimens as well as the development of new regimens with higher eradication rates. Interestingly, the VDT group demonstrated a better safety profile but with no statistically significant difference in cure rate. No difference in compliance with treatment was found between the groups. Gender, frequency of COVID-19 vaccination, height, and BMI were the only factors assessed influencing infection symptoms severity. ClinicalTrial.gov ID identifier: NCT05614934, first posted date (07/11/2022).