Risk of Recurrent Helicobacter pylori Infection 1 Year After Initial Eradication Therapy in 7 Latin American Communities
Authors: Douglas R. Morgan, Javier Torres, Rachael Sexton, Rolando Herrero, Eduardo Salazar-Martínez, E. Robert Greenberg, Luis Eduardo Bravo, Ricardo L. Dominguez, Catterina Ferreccio, Eduardo C. Lazcano-Ponce, Maria Mercedes Meza-Montenegro, Edgar M. Peña, Rodolfo Peña, Pelayo Correa, María Elena Martínez, William D. Chey, Manuel Valdivieso, Garnet L. Anderson, Gary E. Goodman, John J. Crowley, Laurence H. Baker
Journal: JAMA (2013)

<h3>Importance</h3>The long-term effectiveness of Helicobacter pylori eradication programs for preventing gastric cancer will depend on recurrence risk and individual and community factors.<h3>Objective</h3>To estimate risk of H pylori recurrence and assess factors associated with successful eradication 1 year after treatment.<h3>Design, Setting, and Participants</h3>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.<h3>Interventions</h3>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.<h3>Measurements</h3>Recurrent infection after a negative posttreatment UBT and factors associated with successful eradication at 1-year follow-up.<h3>Results</h3>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 &lt; .001), adherence to initial therapy (AOR, 0.26; 95% CI, 0.15-0.42; P &lt; .001), male sex (AOR, 1.63; 95% CI, 1.25-2.13; P &lt; .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%).<h3>Conclusions and Relevance</h3>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.<h3>Trial Registration</h3>clinicaltrials.gov Identifier: NCT01061437