title: Risk of recurrent Helicobacter pylori infection 1 year after initial eradication therapy in 7 Latin American communities.
abstract: OBJECTIVE
  The long-term effectiveness of Helicobacter pylori eradication programs for preventing gastric cancer will depend on recurrence risk and individual and community factors.
  
  
  OBJECTIVE
  To estimate risk of H. pylori recurrence and assess factors associated with successful eradication 1 year after treatment.
  
  
  METHODS
  Cohort analysis of 1463 randomized trial participants aged 21 to 65 years from 7 Latin American communities, who were treated for H. pylori and observed between September 2009 and July 2011.
  
  
  METHODS
  Randomization to 1 of 3 treatment groups: 14-day lansoprazole, amoxicillin, and clarithromycin (triple therapy); 5-day lansoprazole and amoxicillin followed by 5-day lansoprazole, clarithromycin, and metronidazole (sequential); or 5-day lansoprazole, amoxicillin, clarithromycin, and metronidazole (concomitant). Participants with a positive (13)C-urea breath test (UBT) 6 to 8 weeks posttreatment were offered voluntary re-treatment with 14-day bismuth-based quadruple therapy.
  
  
  METHODS
  Recurrent infection after a negative posttreatment UBT and factors associated with successful eradication at 1-year follow-up.
  
  
  RESULTS
  Among participants with UBT-negative results who had a 1-year follow-up UBT (n=1091), 125 tested UBT positive, a recurrence risk of 11.5% (95% CI, 9.6%-13.5%). Recurrence was significantly associated with study site (P = .03), nonadherence to initial therapy (adjusted odds ratio [AOR], 2.94; 95% CI, 1.31-6.13; P = .01), and children in the household (AOR, 1.17; 95% CI, 1.01-1.35 per child; P = .03). Of the 281 with positive posttreatment UBT results, 138 completed re-treatment, of whom 93 tested UBT negative at 1 year. Among the 1340 who had a 1-year UBT, 80.4% (95% CI, 76.4%-83.9%), 79.8% (95% CI, 75.8%-83.5%), and 77.8% (95% CI, 73.6%-81.6%) had UBT-negative results in the triple, sequential, and concomitant groups, respectively (P = .61), with 79.3% overall effectiveness (95% CI, 77.1%-81.5%). In a single-treatment course analysis that ignored the effects of re-treatment, the percentage of UBT-negative results at 1 year was 72.4% (95% CI, 69.9%-74.8%) and was significantly associated with study site (P < .001), adherence to initial therapy (AOR, 0.26; 95% CI, 0.15-0.42; P < .001), male sex (AOR, 1.63; 95% CI, 1.25-2.13; P < .001), and age (AOR, 1.14; 95% CI, 1.02-1.27 per decade; P = .02). One-year effectiveness among all 1463 enrolled participants, considering all missing UBT results as positive, was 72.7% (95% CI, 70.3%-74.9%).
  
  
  CONCLUSIONS
  One year after treatment for H. pylori infection, recurrence occurred in 11.5% of participants who had negative posttreatment UBT results. Recurrence determinants (ie, nonadherence and demographics) may be as important as specific antibiotic regimen in determining the long-term success of H. pylori eradication interventions. Study findings are relevant to the feasibility of programs for the primary prevention of gastric cancer in high-incidence regions of Latin America.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01061437.
authors: Division of Gastroenterology, Hepatology, & Nutrition, Department of Medicine, Vanderbilt Medical Center, Nashville, TN 37232, USA. douglas.morgan@vanderbilt.edu
authors: Douglas R
authors: DR
authors: Morgan
authors: Javier
authors: J
authors: Torres
authors: Rachael
authors: R
authors: Sexton
authors: Rolando
authors: R
authors: Herrero
authors: Eduardo
authors: E
authors: Salazar-Martínez
authors: E Robert
authors: ER
authors: Greenberg
authors: Luis Eduardo
authors: LE
authors: Bravo
authors: Ricardo L
authors: RL
authors: Dominguez
authors: Catterina
authors: C
authors: Ferreccio
authors: Eduardo C
authors: EC
authors: Lazcano-Ponce
authors: Maria Mercedes
authors: MM
authors: Meza-Montenegro
authors: Edgar M
authors: EM
authors: Peña
authors: Rodolfo
authors: R
authors: Peña
authors: Pelayo
authors: P
authors: Correa
authors: María Elena
authors: ME
authors: Martínez
authors: William D
authors: WD
authors: Chey
authors: Manuel
authors: M
authors: Valdivieso
authors: Garnet L
authors: GL
authors: Anderson
authors: Gary E
authors: GE
authors: Goodman
authors: John J
authors: JJ
authors: Crowley
authors: Laurence H
authors: LH
authors: Baker
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use; D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D001729:Bismuth / Q000627:therapeutic use; D001944:Breath Tests; D017291:Clarithromycin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D064747:Lansoprazole; D007843:Latin America / Q000453:epidemiology; D008297:Male; D055118:Medication Adherence; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D011322:Primary Prevention; D012008:Recurrence; D012306:Risk; D013274:Stomach Neoplasms / Q000382:microbiology / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000890:Anti-Infective Agents; D004791:Enzyme Inhibitors; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D001729:Bismuth
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