Efficacy of Potassium Competitive Acid Blockers (P-CABs) versus Proton Pump Inhibitors (PPIs) in the First and Second Line Eradication Regimens forHelicobacter pyloriin Egyptian Patients

Abstract

BACKGROUND: The eradication of _Helicobacter pylori_ (_H. pylori_) infection continues to be a challenge due to the evolution of drug-resistant bacteria. It was hypothesized that a more potent acid suppressant agent, by using Potassium Competitive Acid Blockers (P-CABs) such as Vonoprazan, may help to improve eradication rates. AIM OF THE WORK: The aim of this study is to compare the effectiveness of Vonoprazan-based therapy versus Proton Pump Inhibitor (PPI)-based therapy for the eradication of _H. pylori_ infection in treatment-naïve and treatment-experienced Egyptian patients. METHODS: This prospective, non-randomized, comparative study was conducted on _H. pylori_ positive symptomatic patients admitted to the Tropical Medicine Department at Ain Shams University Hospitals from the 1st of January 2022 to the 1st of June 2023. A total of 232 patients were assigned to Group I (treatment-naïve), which included arm 1 (intervention arm) with 58 patients receiving Clarithromycin 500 mg BID + Amoxicillin 1 gm BID + Vonoprazan 20 mg BID, and arm 2 (comparator arm) with 58 patients receiving Clarithromycin 500 mg BID + Amoxicillin 1 gm BID + Esomeprazole 20 mg BID. Group II (treatment-experienced) included arm 3 (intervention arm), where 58 patients received Levofloxacin 500 mg OD + Vonoprazan 20 mg BID + Nitazoxanide 500 mg BID + Doxycycline 100 mg OD, and arm 4 (comparator arm), where 58 patients received Levofloxacin 500 mg OD + Esomeprazole 20 mg BID + Nitazoxanide 500 mg BID + Doxycycline 100 mg OD. All patients received treatment regimens for 14 days. _H. pylori _eradication was checked 4 weeks after treatment. RESULTS: The successful eradication rate was higher in Arm 1 “58.6%” in relation to Arm 2 “50%” and higher in Arm 3 “50%” in relation to Arm 4 “43.1%”, but without reaching statistical significance with a p-value of 0.455. The response to treatment by Intention To Treat (ITT) analysis was higher in Arm 1 “58.6%” in relation to Arm 2 “50%”, but without reaching statistical significance with a p-value of 0.351. By calculating the Per Protocol analysis (PP), the eradication rate was 64% in Arm 1 vs. 56.9% in Arm 2. No statistical significance could be obtained either, with a p-value of 0.447. For Arm 3, the intention to treat percentage was 50% in comparison to the higher per protocol analysis of 72.5%, with no statistical significance. For Arm 4, the intention to treat percentage was 43.1% in comparison to the higher per protocol analysis of 59.5%, with no statistical significance, with p-values of 0.457 and 0.216, respectively. CONCLUSION: Results of eradication in P-CABs based groups are comparable to that of the PPI-based group. Treatment-experienced groups showed lower eradication rates, which indicates increased _H. pylori_ resistance. _H. pylori_ eradication regimens including P-CABs are tolerable with a low incidence of adverse events.