Once-daily rabeprazole, levofloxacin, clarithromycin-MR, and bismuth for Helicobacter pylori eradication: A randomized study of 7 or 14 days (ONCE study).

ABSTRACT

OBJECTIVE: Most therapies for Helicobacter pylori eradication utilize multiple drugs given 2-4 times daily. Patient adherence has been an impediment to reliably achieving high success. This study evaluated a once-daily dosing H pylori eradication regimen. METHODS: A prospective randomized pilot study of H pylori eradication compared once-daily treatment regimen containing levofloxacin (750 mg), clarithromycin-MR (1 g), rabeprazole (60 mg), and bismuth subsalicylate (1,048 mg) for a 7 or 14 days. CYP2C19 genotype and antibiotic susceptibility tests were performed. Successful eradication was defined as negative 13C-urea breath test at least 4 weeks after completion of treatment. RESULTS: 100 subjects were randomized (40 men, 60 women with mean age =54 years). The eradication rates were as follows 94% (47/50; 95%CI 0.87-1.01) and 84% (42/50; 95%CI 0.73-0.95) with 14-day and 7-day therapy (OR 0.34; 95%CI 0.08-1.35, P = 0.06), respectively. Resistance rates were as follows 13.0% for clarithromycin, 26.0% for fluoroquinolone, 2.9% for dual clarithromycin-fluoroquinolone resistance, and 62.8% for metronidazole. The 14-day regimen provided 100% eradication in patients with levofloxacin susceptible strain irrespective of the presence of clarithromycin resistance. CYP2C19 genotypes had no effect on cure rates. CONCLUSIONS: The once-daily 14-day rabeprazole-, levofloxacin-, clarithromycin-MR-, and bismuth-containing therapy provided high eradication rate suggested that triple therapies with a PPI, bismuth, and clarithromycin-MR or levofloxacin would be highly effective for once-a-day tailored therapy or as empiric therapy for first-line regimen.