Efficacy of Rifabutin-based Triple Teraphy as Second-line to Eradicate Helicobacter Pylori Infection

Background: Rifabutin has been found to be effective in multi-resistant patients after various treatment cycles for Helicobacter pylori (HP) infection, but it has not been analysed as a second-line treatment. Therefore, we seek to compare the effectiveness of a treatment regimen including rifabutin versus conventional quadruple therapy (QT). Methods/Design: Open clinical trial, randomised and multi-centre, of two treatment protocols (conventional regime -QTor an experimental one -OARwith omeprazole, amoxicillin and rifabutin), in patients with HP infection for whom an eradication cycle using OCA treatment had failed. Eradication was determined by Urea Breath Test (UBT).Safety, was determined by the adverse events. Results: 99 patients were randomised, QT, n= 54; OAR n=45. The two groups were homogeneous. In 8 cases, treatment was suspended (6 in QT and 2 in OAR). The eradication achieved, analysed by ITT, was for QT, 38 cases (70.4%), and for OAR, 20 cases (44.4%);p = 0.009, OR = 1.58-. Of the cases analysed PP, QT were 77.1%; OAR,46.5%, -p = 0.002-. Adverse effects were described in 64% of the QT patients and in 44% of the OAR patients (p = 0.04). Discussion: The treatment regimen with omeprazole, amoxicillin and rifabutin was not found to be effective as a second-line rescue. The problem with quadruple therapy lies in the adverse side effects it provokes. We believe the search should continue for alternatives that are more comfortably administered and that are at least as effective, but with fewer adverse side effects. The present trial was approved by the Clinical Trials Committee of the Regional (Autonomous) Administration of Andalusia, by the corresponding committee within each of the participating hospitals and by the Spanish Agency of Drug. It is registered at the European Drugs Agency under Eudract Code No. 2004-001320-20.