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Tu1335 European Registry on H. pylori Management (HP-EuReg) in Spain: Interim Analysis in First and Second Line Therapies
Tu1335 European Registry on H. pylori Management (HP-EuReg) in Spain: Interim Analysis in First and Second Line Therapies Maria Caldas, Angeles Perez Aisa, Manuel Castro-Fernandez, Luis Bujanda, Luis Rodrigo, J Hinojosa, Jorge Perez-Lasala, Angel Lanas, Javier Molina-Infante, Manuel DomínguezCajal, Pedro Almela, Jesús Barrio, Josep M. Botargues, Luis Fernandez Salazar, Ines Modolell, Alfredo J. Lucendo, Juan Ortuño, Rafael Ruiz-Zorrilla, Cristobal De la Coba, M Barenys, J Alcedo, Monica C. Perona, J Gómez, F Bermejo, R. Pajares, Liliana Pozzati, Manuel Rodríguez-Téllez, Blas-Jose Gomez-Rodriguez, Enrique Medina, José María Huguet, Luis Ferrer Barceló, Mercedes Ramas, Colm A. O'Morain, Adrian G. McNicholl, Javier P. Gisbert INTRODUCTION: H. pylori is still a major burden in Spain, infecting around 50% of adults. The high prevalence of antibiotic resistance ( »20% clarithromycin, »30% metronidazole), compromises many eradication treatments; therefore, a specific analysis of its clinical practice outcomes must be performed in the context of the European Registry on H. pylori management (Hp-EuReg). AIM: To systematically register Spanish gastroenterologist's clinical routine management of H. pylori infected adult patients. METHODS: Systematic, prospective, multicenter study, carried out in 41 Spanish hospitals as part of the "European Registry on H. pylori management". Clinical information is being registered by clinicians through an electronic clinical research file (e-CRF) created on AEG-REDCap. RESULTS: 6,665 patients have been included so far and 3,766 have finished follow up. 61% of the patients were women and the medium age was 50 years old. 5% of the patients had drug allergies (87% to penicillin). 74% of the patients received a first-line therapy, being the most prescribed treatments the standard triple therapy (PPI + amoxicillin + clarithromycin; in 45% of patients) and the non-bismuth quadruple concomitant therapy (triple + metronidazole; 42%). Overall efficacy with triple therapy was suboptimal (ITT analysis, 80%; 95%CI=78-81%). The evaluation of the role of the PPI prescribed in triple therapy showed better efficacy when using esomeprazole rather than omeprazole (88% vs. 77%; p<0.001), but no differences could be found when extending the treatment from 10 to 14 days (82% vs. 79%; p=0.14). Overall efficacy with non-bismuth quadruple concomitant therapy was better than the one with triple therapy (ITT analysis, 88%; 86-89%). When separate analysis was made, efficacy was improved extending the length of concomitant treatment (10 days 87% vs. 14 days 90%; p=0.03) and using different PPIs (omeprazole 87% vs. esomeprazole 91%; p=0.002). 20% of the patients included received a second-line therapy, 54% requiring a triple therapy with a PPI, levofloxacin and amoxicillin and 15% a quadruple therapy (adding to the previous one, bismuth salts). Overall efficacy obtained with levofloxacin triple therapy was inadequate (ITT analysis, 78%; 74-81%). Efficacy was improved extending the length of treatment (10 days 70% vs. 14 days 93%; p<0.001), using different PPIs (omeprazole 70% vs. esomeprazole 90%; p<0.001) and adding bismuth salts (triple 78% vs. quadruple 92%; p<0.001). CONCLUSIONS: In Spanish patients, the best efficacy rates with first-line regimens were obtained with non-bismuth quadruple concomitant therapy (around 90%). In second-line therapies, the commonly used triple treatment with levofloxacin and amoxicillin achieves a relatively low efficacy rate (78%), but extending treatments to 14 days or adding bismuth salts increases its success to more than 90%.
Tu1333 Dual Therapy With Vonoprazan and Amoxicillin Is as Effective as Standard PPI-Based Triple Therapy With Amoxicillin and Clarithromycin or Metronidazole in Japan Takahisa Furuta, Shu Sahara, Hitomi Ichikawa, Takuma Kagami, Takahiro Uotani, Mihoko Yamade, Mitsushige Sugimoto, Yasushi Hamaya, Moriya Iwaizumi, Satoshi Osawa, Ken Sugimoto Backgrounds/Aims: Vonoprazan is the first clinically available potassium competitive acid blocker (P-CAB). This class of agents provides faster and more potent acid inhibition than PPIs [check]. We hypothesized that dual therapy with a P-CAB and amoxicillin would provide sufficient eradication rates for H. pylori infection. To evaluate this, we compared the eradication rate with dual vonoprazan/amoxicillin therapy with those with the standard triple PPI/amoxicillin/clarithromycin or metronidazole therapies. Methods: A total of 81 patients infected with H. pylori were randomly assigned to the dual therapy or triple therapies. Forty-one had failed in eradication with standard first-line therapy. Patients assigned to dual therapy were treated with vonoprazan 20 mg bid + amoxicillin 500 mg tid for 1 week, and those assigned to triple therapy with esomeprazole 20 mg or rabeprazole 10 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg for first-line therapy, or metronidazole 250 mg bid for second-line therapy for 1 week. Successful eradication was diagnosed using the 13C-urea breath test at 1 month after eradication therapy. Results: Eradication rates with dual vonoprazan/amoxicillin therapy for first- and second-line therapies were 95% (19/20) and 90% (18/20), respectively, versus 81% (17/21) and 85% (17/20), respectively, with PPI-based triple therapies. There were no differences in the incidence of adverse events related to the study regimens. Conclusion: Vonoprazan-based dual therapy (vonoprazan 20 mg bid + amoxicillin 500 mg tid for 1 week) provides acceptable eradication rates of H. pylori infection without the need for second antimicrobial agents, such as clarithromycin and metronidazole.
Tu1334 Evaluation of the Accuracy of DK14-HP-001, a Novel H. pylori Stool Antigen Test, for the Diagnosis of H. pylori Infection Takahisa Furuta, Mitsushige Sugimoto, Shu Sahara, Hitomi Ichikawa, Takuma Kagami, Takahiro Uotani, Mihoko Yamade, Yasushi Hamaya, Moriya Iwaizumi, Satoshi Osawa, Ken Sugimoto Backgrounds/Aims: Detection of H. pylori antigen in the stool has been widely used for the diagnosis of H. pylori infection. However, there have been several cases diagnosed to be falsely negative with this test. Recently, the new, a novel H. pylori stool antigen test, DK14HP-001, was developed for the diagnosis of H. pylori infection. We compared the sensitivity, specificity and validity of this new kit with those of the existing kits used in Japan. Methods: A total of 143 patients who underwent the gastroscopy and 13C-urea breath test were enrolled. Gastric biopsy specimens were obtained for rapid urease test (RUT) and culture test. Gastric juice sample was obtained for the detection of H. pylori by the PCR method. Patients with a negative result of RUT, culture test, PCR and 13C-urea breath test were considered as H. pylori-negative. Any one of the three tests was positive, patients were diagnosed to be infected with H. pylori. The patients simply collected a stool samples using the falcon tube with the spoon inside of a cap and brought them in a clean, dry, leak-proof container which contained the ice pack within 48 hours. The stool samples were subjected to the three H. pylori stool antigen test kits, DK14-HP-001, Testmate Rapid Pylori Antigen (Rapid TPAg) and ImmunoCard STAT HpSA (ImmunoCard) according to the each of manufacture's protocols. Results: Of 143 patients, 77 were infected with H. pylori and 66 were negative for H. pylori infection. Sensitivity, specificity and validity of DK14-HP-001 were 88.3%, 100.0% and 93.7%, while those of the Rapid TPAg were 92.2%, 100.0% and 95.8%, respectively and those of ImmunoCard were 83.1%, 98.5% and 90.2%, respectively. Conclusion: As whole, the sensitivity, specificity and validity of DK14-HP-001 were equal to those of the existing kits widely used in Japan.
Tu1336 Surveillance of Helicobacter pylori Resistance to Antibiotics in France in 2014 Francis Megraud, Astrid Ducournau, Lucie Bénéjat, Elodie Sifré, Emilie Bessède, Philippe Lehours The outcome of Helicobacter pylori eradication therapies is very much dependent on the antimicrobial susceptibility of the strains. Given the difficulty of offering tailored treatments in some areas, it is important to have accurate knowledge of the prevalence of H. pylori resistance which is evolving over time. Our aim was to perform a survey of antimicrobial resistance in France in 2014. Gastric biopsy specimens obtained from patients during upper digestive endoscopy were sent to a central laboratory for H. pylori culture and antimicrobial susceptibility testing. A real-time PCR detecting the bacterium and the mutations leading to clarithromycin resistance was also performed. Seventy-five gastroenterologists, distributed throughout the different regions of France, enrolled 984 patients. Among the 783 patients with no previous eradication treatment, 266 (33.9%) were H. pylori positive. The strains showed high resistance to clarithromycin (22.2%), moderate to levofloxacin (15.4%), high to metronidazole (45.9%), very low to amoxicillin and rifamycin (<1%), and nil to tetracycline. There were 187 patients who received a previous H. pylori treatment, of which 115 were H. pylori positive with very high resistance to clarithromycin (73.9%) and metronidazole (78.3%). None of the patients having received Pylera®-proton pump inhibitor developed resistance to tetracycline. Real-time PCR detected all H. pylori patients for whom culture was positive and 30 others. The mutations found were essentially A2142/2143G (151) while there were five A2142C and two A2142T. A double population (mutants + wild type) was observed in 21 cases. This study shows that H. pylori resistance to clarithromycin is still increasing and already above the threshold indicating an abandon of its use. However, the
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AGA Abstracts
IHC, 64 were positive for HP (9.6%). Off 363 patients undergoing TZAM 56 were positive for HP (15.7%)(p<0.0001). Of 30 patients who underwent both tests TZAM was positive in one additional patient who was negative for IHC, none of the patients were positive for IHC who were negative for TZAM. Subgroup analysis showed that for PCR, there was no statistically significant difference between gender nor different racial groups. FOR IHC there were statistically significant difference across racial groups for test positive. Compared to Caucasians, Hispanics and African Americans were more likely to test positive. Cost comparison showed that TZAM costed between $45-$150, average $97.5 (various payer's allowance), and IHC $190 (including general, professional and technical component fees). Conclusions: TZAM detected more cases of H Pylori at a lower cost. No significant diagnosis would have been missed if only TZAM was used to detect H Pylori. A prospectively done study with both tests done in tandem would better answer the question.
Tu1333 Dual Therapy With Vonoprazan and Amoxicillin Is as Effective as Standard PPI-Based Triple Therapy With Amoxicillin and Clarithromycin or Metronidazole in Japan Takahisa Furuta, Shu Sahara, Hitomi Ichikawa, Takuma Kagami, Takahiro Uotani, Mihoko Yamade, Mitsushige Sugimoto, Yasushi Hamaya, Moriya Iwaizumi, Satoshi Osawa, Ken Sugimoto Backgrounds/Aims: Vonoprazan is the first clinically available potassium competitive acid blocker (P-CAB). This class of agents provides faster and more potent acid inhibition than PPIs [check]. We hypothesized that dual therapy with a P-CAB and amoxicillin would provide sufficient eradication rates for H. pylori infection. To evaluate this, we compared the eradication rate with dual vonoprazan/amoxicillin therapy with those with the standard triple PPI/amoxicillin/clarithromycin or metronidazole therapies. Methods: A total of 81 patients infected with H. pylori were randomly assigned to the dual therapy or triple therapies. Forty-one had failed in eradication with standard first-line therapy. Patients assigned to dual therapy were treated with vonoprazan 20 mg bid + amoxicillin 500 mg tid for 1 week, and those assigned to triple therapy with esomeprazole 20 mg or rabeprazole 10 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg for first-line therapy, or metronidazole 250 mg bid for second-line therapy for 1 week. Successful eradication was diagnosed using the 13C-urea breath test at 1 month after eradication therapy. Results: Eradication rates with dual vonoprazan/amoxicillin therapy for first- and second-line therapies were 95% (19/20) and 90% (18/20), respectively, versus 81% (17/21) and 85% (17/20), respectively, with PPI-based triple therapies. There were no differences in the incidence of adverse events related to the study regimens. Conclusion: Vonoprazan-based dual therapy (vonoprazan 20 mg bid + amoxicillin 500 mg tid for 1 week) provides acceptable eradication rates of H. pylori infection without the need for second antimicrobial agents, such as clarithromycin and metronidazole.
Tu1334 Evaluation of the Accuracy of DK14-HP-001, a Novel H. pylori Stool Antigen Test, for the Diagnosis of H. pylori Infection Takahisa Furuta, Mitsushige Sugimoto, Shu Sahara, Hitomi Ichikawa, Takuma Kagami, Takahiro Uotani, Mihoko Yamade, Yasushi Hamaya, Moriya Iwaizumi, Satoshi Osawa, Ken Sugimoto Backgrounds/Aims: Detection of H. pylori antigen in the stool has been widely used for the diagnosis of H. pylori infection. However, there have been several cases diagnosed to be falsely negative with this test. Recently, the new, a novel H. pylori stool antigen test, DK14HP-001, was developed for the diagnosis of H. pylori infection. We compared the sensitivity, specificity and validity of this new kit with those of the existing kits used in Japan. Methods: A total of 143 patients who underwent the gastroscopy and 13C-urea breath test were enrolled. Gastric biopsy specimens were obtained for rapid urease test (RUT) and culture test. Gastric juice sample was obtained for the detection of H. pylori by the PCR method. Patients with a negative result of RUT, culture test, PCR and 13C-urea breath test were considered as H. pylori-negative. Any one of the three tests was positive, patients were diagnosed to be infected with H. pylori. The patients simply collected a stool samples using the falcon tube with the spoon inside of a cap and brought them in a clean, dry, leak-proof container which contained the ice pack within 48 hours. The stool samples were subjected to the three H. pylori stool antigen test kits, DK14-HP-001, Testmate Rapid Pylori Antigen (Rapid TPAg) and ImmunoCard STAT HpSA (ImmunoCard) according to the each of manufacture's protocols. Results: Of 143 patients, 77 were infected with H. pylori and 66 were negative for H. pylori infection. Sensitivity, specificity and validity of DK14-HP-001 were 88.3%, 100.0% and 93.7%, while those of the Rapid TPAg were 92.2%, 100.0% and 95.8%, respectively and those of ImmunoCard were 83.1%, 98.5% and 90.2%, respectively. Conclusion: As whole, the sensitivity, specificity and validity of DK14-HP-001 were equal to those of the existing kits widely used in Japan.
Tu1336 Surveillance of Helicobacter pylori Resistance to Antibiotics in France in 2014 Francis Megraud, Astrid Ducournau, Lucie Bénéjat, Elodie Sifré, Emilie Bessède, Philippe Lehours The outcome of Helicobacter pylori eradication therapies is very much dependent on the antimicrobial susceptibility of the strains. Given the difficulty of offering tailored treatments in some areas, it is important to have accurate knowledge of the prevalence of H. pylori resistance which is evolving over time. Our aim was to perform a survey of antimicrobial resistance in France in 2014. Gastric biopsy specimens obtained from patients during upper digestive endoscopy were sent to a central laboratory for H. pylori culture and antimicrobial susceptibility testing. A real-time PCR detecting the bacterium and the mutations leading to clarithromycin resistance was also performed. Seventy-five gastroenterologists, distributed throughout the different regions of France, enrolled 984 patients. Among the 783 patients with no previous eradication treatment, 266 (33.9%) were H. pylori positive. The strains showed high resistance to clarithromycin (22.2%), moderate to levofloxacin (15.4%), high to metronidazole (45.9%), very low to amoxicillin and rifamycin (<1%), and nil to tetracycline. There were 187 patients who received a previous H. pylori treatment, of which 115 were H. pylori positive with very high resistance to clarithromycin (73.9%) and metronidazole (78.3%). None of the patients having received Pylera®-proton pump inhibitor developed resistance to tetracycline. Real-time PCR detected all H. pylori patients for whom culture was positive and 30 others. The mutations found were essentially A2142/2143G (151) while there were five A2142C and two A2142T. A double population (mutants + wild type) was observed in 21 cases. This study shows that H. pylori resistance to clarithromycin is still increasing and already above the threshold indicating an abandon of its use. However, the
S-877
AGA Abstracts
AGA Abstracts
IHC, 64 were positive for HP (9.6%). Off 363 patients undergoing TZAM 56 were positive for HP (15.7%)(p<0.0001). Of 30 patients who underwent both tests TZAM was positive in one additional patient who was negative for IHC, none of the patients were positive for IHC who were negative for TZAM. Subgroup analysis showed that for PCR, there was no statistically significant difference between gender nor different racial groups. FOR IHC there were statistically significant difference across racial groups for test positive. Compared to Caucasians, Hispanics and African Americans were more likely to test positive. Cost comparison showed that TZAM costed between $45-$150, average $97.5 (various payer's allowance), and IHC $190 (including general, professional and technical component fees). Conclusions: TZAM detected more cases of H Pylori at a lower cost. No significant diagnosis would have been missed if only TZAM was used to detect H Pylori. A prospectively done study with both tests done in tandem would better answer the question.