Current trends in the treatment of H. pylori infection in Ukraine: results of the European Registry on Helicobacter pylori Management (Hp EuReg)

Current trends in the treatment of H. pylori infection in Ukraine: results of the European Registry on Helicobacter pylori Management (Hp EuReg) The European Registry on Helicobacter pylori Management (Hp EuReg) was established to evaluate the efficacy and safety of the different eradication H. pylori treatments, as well as to audit H. pylori infection consensus and clinical guidelines implementation. The current study presents data from a sample of patients from Ukraine who were registered in the Hp EuReg until February 2022. The aim was to assess the frequency, effectiveness and safety of treatment against H. pylori infection in Ukraine. Materials and methods. The Hp EuReg, an international multicenter prospective non‑interventional registry, was launched in 2013 and is promoted by the European Helicobacter and Microbiota Study Group (www.helicobacter.org). The Hp EuReg protocol was approved by the Ethics Committee of La Princesa University Hospital (Madrid, Spain) and registered with Clinical Trials.gov under the code NCT02328131. The effectiveness analysis included mainly a modified intention‑to‑treat (mITT) analysis, aiming to mimic the clinical practice outcomes and including all records with a confirmatory test after the eradication treatment, regardless of compliance. Given that some treatment regimens were used only in a small number of patients, only regimens with a relevant number of patients were selected for analyses. Results. Overall 841 patients (54 % women, 46 % men), whose average age (SD) was 48.35 (± 15.52) were included in the register. The main method for diagnosing on‑going H. pylori infection was histology, and the use of urea breath tests and stool antigen tests was low — (approximately 6 % of cases). Assessment of bacterial antibiotic resistance was performed in 13 % of patients, with less than 1 % reporting a positive result. More than half of the patients received quadruple therapy and 40 % triple therapy. Over 90 % of patients were treatment‑ naïve. Almost all patients received low‑dose proton pump inhibitors (PPIs), and a smaller proportion received standard (7.2 %) or high‑dose PPIs (1.2 %). Low‑doses PPI prescriptions negatively affected the effectiveness of therapy: in treatment‑naïve patients’ overall effectiveness was below 85 %, while the use of standard‑ and high‑doses of PPIs achieved 100 % eradication rates in all patients. Despite the fact that the duration of therapy in the vast majority of patients was at least prescribed for 10 days, there were cases (12 %) of administration of 7‑day therapy with the reported suboptimal (< 90 %) effectiveness. In those prescribed with a first‑line treatment of 7 — 10 days, the eradication rate was 82 %, while therapy for 14 days provided 100 % treatment eradication success. In the overall mITT analysis, the use of therapy in naïve patients resulted in the eradication of H. pylori in more than 90 % of patients. It is noteworthy that effectiveness with PPI+ amoxicillin + levofloxacin was below 84 %, suboptimal according to the most up‑to‑date consensus. The administered therapy was well tolerated, which allowed to complete the treatment of more than 90 % of patients, and the incidence of adverse events was less than 4 % in naïve patients, while in patients with repeated courses of therapy it was more than 3 times higher. Conclusions. In Ukraine, the frequency of use of validated non‑invasive methods (urea breath tests and stool antigen test) to detect H. pylori infection is very low. However, Ukrainian doctors often use methods to assess the antibiotic resistance of Helicobacter pylori, which certainly helps to increase the rate of therapy‑guided eradication. The vast majority of eradication therapies administered to patients in the Ukrainian population corresponds to the current guidelines, but very often PPIs were administered in low doses and there were still some cases of regimens lasting 7 days, even in those patients receiving a second‑line therapy, which reduced the treatment effectiveness. Even though overall effectiveness of eradication therapy was over 90 %., there is a need to closely monitor treatment management. Prescribed first‑line therapy was well tolerated by patients — more than 98 % of patients completed treatment.