EMPIRICAL SECOND-LINE THERAPY FOR HELICOBACTER PYLORI INFECTION: DATA FROM THE ITALIAN REGISTRY ON HELICOBACTER PYLORI TREATMENT (HP-ITAREG)

Aims/Purpose: We aimed to assess the patterns and effectiveness of empirical second-line treatment of Helicobacter (H.) pylori infection in clinical practice in Italy. Methods: The “Italian Registry on H. pylori treatment” (Hp-ItaReg) is a prospective multicenter study that registers adult patients who have received at least one H. pylori treatment in 18 centers in Italy. All patients who received second-line H. pylori therapy were assessed for effectiveness using modified intention-to-treat (mITT) and per-protocol (PP) analyses. Results: A total of 884 patients received an empirical second-line treatment. Of these, 380 (43%) received single-capsule bismuth quadruple therapy (BQT), 217 (24.5%) levofloxacin and amoxicillin triple therapy, 105 (11.9%) rifabutin and amoxicillin triple therapy, 71 (8%) sequential therapy, and 111 (12.6%) other therapies. 111 patients were lost to follow-up; thus, 773 patients were included in the mITT analysis and 752 in the PP analysis. According to mITT and PP analyses, eradication rates were 88.5% (299/338) and 90.5% (296/327) with single-capsule BQT, 76.5% (143/187) and 78% (142/ 182) with levofloxacin and amoxicillin triple therapy, 68.9% (62/90) and 68.5% (61/89) with rifabutin and amoxicillin triple therapy, 63.6% (42/66) and 63.1% (41/65) with sequential therapy, and 81.5% (75/92) and 83.1% (74/89) with other regimens. Conclusion: Single-capsule BQT and triple therapy with levofloxacin and amoxicillin are the regimens most frequently prescribed for the second-line treatment of H. pylori in Italy. However, only single-capsule BQT provided good eradication rates.