First- and second-line Helicobacter pylori eradication with modified sequential therapy and modified levofl oxacin-amoxicillin-based triple therapy

Authors Angelo Zullo, Lorenzo Ridola, Cesare Efrati, Floriana Giorgio, Giorgia Nicolini, Claudio Cannaviello, Domenico Alvaro, Cesare Hassan, Luigi Gatta, Vincenzo De Francesco.


Background Helicobacter pylori (H. pylori) treatment remains a challenge for physicians. Although highly effective, the standard sequential therapy fails in a certain number of patients. Moreover, the curerate following a levofloxacin-amoxicillin second-line triple therapy seems to be decreasing. We tested the efficacy of modified 10-day sequential therapy, and an intensified levofloxacin-amoxicillin regimen as first- and second-line therapy respectively.

Methods In this prospective, open label, multicenter, pilot study H. pylori-infected patients received a first-line modified 10-day sequential therapy regimen including rabeprazole 20 mg, and amoxicillin 1 g for the first 3 days, followed by rabeprazole 20 mg, clarithromycin 250 mg, and metronidazole 250 mg, for the remaining 7 days, all drugs given thrice daily. An 8-day therapy regimen with rabeprazole 20 mg, levofloxacin 250 mg, and amoxicillin 1 g, all thrice daily, was administered a second-line therapy.

Results A total of 99 and 15 patients were enrolled for first- and second-line therapy. The eradication rates were 85.9% (95% CI 80-93) and 93.4% (95% CI 88-98) according to ITT and PP analyses following modified sequential therapy, and 60% (95% CI 35-86) and 64.3% (95% CI 39-89) following the intensified second-line therapy.

Conclusion A modified sequential 3- plus 7-day regimen with thrice daily drug administration failed to achieve very high eradication rate at ITT analysis. The intensified second-line  regimen achieved disappointingly low eradication rate. Novel levofloxacin-free second-line therapies are urged in Italy.

Keywords Helicobacter pylori, therapy, sequential therapy, modified sequential therapy, secondline therapy, modified levofloxacin triple therapy

Ann Gastroenterol 2014; 27 (4): 357-361

Original Articles