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1. Deep-sequencing reveals broad subtype-specific HCV resistance mutations associated with treatment failure

Author

Javier Fernández-Fernández, Concepción Gimeno, Maria Saumoy, María Eugenia Soria, Pau Gilabert, Gasshan Mereish, Helena Masnou-Ridaura, Federico Sáez-Royuela, Javier Salmerón, Raúl Rodríguez, Imma Ocaña, Juan Buenestado, José Francisco Macías-Sánchez, Xavier Forns, Elisabet Deig, Silvia Montoliu, José Castellote, Maria Isabel Costafreda, Ramiro Macenlle, Ildefonso Quiñones, David Tabernero, Jordi Niubó, Silvia Fábregas, Xavier Pamplona, Qian Chen, Maria Carlota Londoño, Juan Turnes, Mercè Barenys, Javier García-Samaniego, Agustín Albillos, Javier Crespo, Juan Manuel Pascasio, Joana Villaverde, B. Sacristan, Silvia Sauleda, Mar Riveiro-Barciela, Judit Carbonell, Silvia Salord, Oscar del Río, Leticia González-Moreno, Doroteo Acero-Fernández, Martín Prieto, A. Estebanez, Manolo Romero-Gómez, Arkaitz Imaz, Xavier Torras, María José López-de-Goicoechea, Jordi Navarro, Manuel Delgado-Blanco, Rosa Maria Morillas, Yolanda Real, Gemma Olivé, Rosa M Lopez, Salvador Augustin, Joan Carles Quer, Angels García-Flores, Nuria Margall, Leonardo Nieto-Aponte, Ángeles Castro-Iglesias, Ariadna Rando-Segura, Verónica Saludes, Rosa Durández, Elena Vargas-Accarino, Mireia Cairó, María Luisa García-Buey, Carme Mora-Moruny, Álvaro Mena-de-Cea, Paloma Sanz-Cameno, Lluis Castells, Miguel Miralbés, Francisco Suárez, Rosa Roca, Joaquín Cabezas, Carlos González-Portela, Albert Bernet, Pilar Castillo-Grau, Juan García-Costa, Mercedes Guerrero-Murillo, R. Quiles, Martin Bonacci, Juan Arenas, Juan Ignacio Esteban, Xavier Xiol, Silvia Viroles, Antonio Madejón, Sabela Lens, Maria Buti, María Silvan di Yacovo, Francisco Rodriguez-Frias, Manuel Rodríguez, Damir Garcia-Cehic, Esteban Domingo, Alejandra Otero, Elisa Martró, Manuel Hernández-Guerra, Inmaculada Fernández, Alba Cachero, Pilar Vázquez-Rodríguez, Carmen García-Martin, José A. Carrión, Miguel Angel Simón, Soledad López-Calvo, Gloria Sánchez-Antolín, Fernando Lázaro, J. Llaneras, Montserrat Forné, Meritxell Llorens-Revull, Maria Juana Gomez-Alonso, Francisco José Martínez-Cerezo, Isabel Conde, Maria Francesca Cortese, Silvia Blanch, Blau Camps, David Vieito, Sofía P. Ruzo, Moisés Diago, Marta Vila, Matilde Trigo-Daporta, Mercè Rosinach, Irati Fernandez-Alonso, Carme López-Núñez, María José Ferri, Georg von Massow, Jose Luis Calleja, Rafael Esteban, Sofía Pérez-del-Pulgar, Rafael Medina, Carme Baliellas, Ángeles Vázquez, Josep Quer, Mercè Roget, Angel Rubín, Celia Perales, Jose Antonio delCampo, María Dolores Ocete, T. Casanovas, J.J. Sanchez-Ruano, Lluís Force, A Martín-Cardona, R.J. Andrade, Angelina Cañizares, Víctor Vargas-Blasco, Marta Bes, Zoe Mariño, Josep Gregori, and Raquel Baluja-Pino

Subjects
0301 basic medicine, Genotype, Hepatitis C virus, 030106 microbiology, Failure, Hepacivirus, medicine.disease_cause, Direct-acting antivirals, Antiviral Agents, Deep sequencing, Antiviral treatment, Direct-acting antivirals, Failure, HCV, NGS, RAS, Cohort Studies, 03 medical and health sciences, chemistry.chemical_compound, Drug Resistance, Multiple, Viral, Interferon, Virology, Medicine, Humans, Treatment Failure, NS5A, NS5B, Pharmacology, business.industry, Ribavirin, High-Throughput Nucleotide Sequencing, Hepatitis C, Subtyping, 030104 developmental biology, chemistry, Antiviral treatment, Spain, NGS, HCV, Mutation, Drug Therapy, Combination, business, medicine.drug, RAS
Abstract

[Abstract] A percentage of hepatitis C virus (HCV)-infected patients fail direct acting antiviral (DAA)-based treatment regimens, often because of drug resistance-associated substitutions (RAS). The aim of this study was to characterize the resistance profile of a large cohort of patients failing DAA-based treatments, and investigate the relationship between HCV subtype and failure, as an aid to optimizing management of these patients. A new, standardized HCV-RAS testing protocol based on deep sequencing was designed and applied to 220 previously subtyped samples from patients failing DAA treatment, collected in 39 Spanish hospitals. The majority had received DAA-based interferon (IFN) α-free regimens; 79% had failed sofosbuvir-containing therapy. Genomic regions encoding the nonstructural protein (NS) 3, NS5A, and NS5B (DAA target regions) were analyzed using subtype-specific primers. Viral subtype distribution was as follows: genotype (G) 1, 62.7%; G3a, 21.4%; G4d, 12.3%; G2, 1.8%; and mixed infections 1.8%. Overall, 88.6% of patients carried at least 1 RAS, and 19% carried RAS at frequencies below 20% in the mutant spectrum. There were no differences in RAS selection between treatments with and without ribavirin. Regardless of the treatment received, each HCV subtype showed specific types of RAS. Of note, no RAS were detected in the target proteins of 18.6% of patients failing treatment, and 30.4% of patients had RAS in proteins that were not targets of the inhibitors they received. HCV patients failing DAA therapy showed a high diversity of RAS. Ribavirin use did not influence the type or number of RAS at failure. The subtype-specific pattern of RAS emergence underscores the importance of accurate HCV subtyping. The frequency of “extra-target” RAS suggests the need for RAS screening in all three DAA target regions. Ministerio de Economía y Empresa; IDI-20151125 Ministerio de Ciencia, Innovación y Universidades; SAF SAF 2017-87846-R

Published
2020

2. Lack of almagate interference in breath test results for Helicobacter pylori diagnosis (Almatest study)

Author

Mercè Barenys, Carles Pons, Modesto Varas, Francisco Javier Fernández, Javier P. Gisbert, Francesca Pajuelo, UAM. Departamento de Medicina, and Enfermedades Inflamatorias Esófago-Gastro-Intestinales

Subjects
Hepatology, Helicobacter pylori, business.industry, Medicina, Gastroenterology, Test de aliento de urea, 03 medical and health sciences, 0302 clinical medicine, Diagnòstic, Almagate, Diagnosis, Medicine, Almagato, 030211 gastroenterology & hepatology, 030212 general & internal medicine, Antacids, UBT, Antiácidos, Dyspepsia, TAU, business, Humanities, Dispepsia, Urea breath test
Abstract

Objetivo El test del aliento con 13C-urea (TAU) es la prueba no invasiva más utilizada para diagnosticar Helicobacter pylori (H. pylori). La posible interferencia de la toma de antiácidos en su resultado es aún controvertida. El estudio se dirige a confirmar la no interferencia del almagato en la determinación de H. pylori mediante el TAU. Pacientes y métodos Estudio observacional, multicéntrico, en pacientes adultos en tratamiento con almagato y a los que se indicó un TAU (TAUKIT®). Cuando el resultado del TAU fue negativo, se suprimió la toma de almagato durante 30 días y se repitió un segundo TAU. En los pacientes cuyo resultado fue positivo, no se realizaron más determinaciones. La variable principal a estudio fue el porcentaje de pacientes que teniendo resultado negativo en la primera prueba de aliento, tras suprimir la toma de almagato y repetirla, ésta se positivizó (falsos negativos del TAU, posiblemente atribuibles a almagato). Resultados De los 167 pacientes evaluables, 59% fueron mujeres, la media de edad fue de 49 años y 97% de los casos presentaban sintomatología digestiva. El resultado del primer TAU fue negativo en un 71% de casos. De éstos, en la segunda prueba de TAU tras suprimir almagato, este resultado se confirmó en el 97,5%. El porcentaje de falsos negativos sobre el total de casos evaluados fue del 1,8%. Conclusiones La toma de almagato tiene una interferencia mínima o nula en el resultado del TAU para el diagnóstico de la infección por H. pylori; por tanto, se puede utilizar en las semanas previas a la realización del TAU, Objective The 13C-urea breath test (UBT) is the most widely used non-invasive diagnostic test for Helicobacter pylori. Debate continues to surround the possible interference of antacid intake on its result. This study aims to confirm the non-interference of almagate in the determination of H. pylori by UBT. Patients and methods Observational, multicentre study in adult patients treated with almagate in whom a UBT (TAUKIT®) was indicated. When the UBT result was negative, use of almagate was stopped for 30 days and the UBT was repeated. When the result was positive, no further determinations were made. The primary endpoint was the percentage of patients who, having had a negative result in the first breath test, were positive in the second after having stopped taking almagate (UBT false negatives, possibly attributable to almagate). Results Of the 167 evaluable patients, 59% were female, average age was 49 and 97% had gastrointestinal symptoms. The result of the first UBT was negative in 71% of cases. Of these, in the second UBT test after stopping the almagate, the negative result was confirmed in 97.5%. Out of the total number of cases evaluated, the rate of false negatives was 1.8%. Conclusions Taking almagate has minimal or no interference in the result of UBT for the diagnosis of H. pylori infection. It can therefore be used in the weeks prior to a UBT, El presente trabajo ha sido financiado por Almirall, S.A., Barcelona y también ha sido posible gracias a la aportación gratuita de los test de urea por parte de Isomed Pharma (kit TAUKIT 100 mg de 13C).

Published
2020

3. Comprehensive analysis of copy number aberrations in microsatellite stable colon cancer in view of stromal component

Author

Elisabet Guinó, Rebeca Sanz-Pamplona, Javier de Oca, Gabriel Capellá, Ramon Salazar, Mercè Barenys, David Cordero, Victor Moreno, Susanna Aussó, M. Henar Alonso, Adriana Lopez-Doriga, Xavier Solé, and Universitat de Barcelona

Subjects
Male, 0301 basic medicine, Cancer Research, Cancer cells, Colon, Colorectal cancer, Gene Dosage, Gene Expression, Biology, Genetics & Genomics, Genome, Gene dosage, 03 medical and health sciences, 0302 clinical medicine, Càncer colorectal, Gene expression, stroma, medicine, Chromosomes, Human, Humans, Variació en el nombre de còpies, Gene, Aged, Genetics, molecular subtypes, Copy number variation, copy number aberrations, medicine.disease, Expressió gènica, 030104 developmental biology, colon cancer, Oncology, 030220 oncology & carcinogenesis, Colonic Neoplasms, Mutation, Cancer cell, Female, Cèl·lules canceroses, Ploidy, Microsatellite Repeats, SNP array
Abstract

Background: Somatic copy number aberrations (CNAs) are common acquired changes in cancer cells having an important role in the progression of colon cancer (colorectal cancer, CRC). This study aimed to perform a characterisation of CNA and their impact in gene expression. Methods: Copy number aberrations were inferred from SNP array data in a series of 99 CRC. Copy number aberration events were calculated and used to assess the association between copy number dosage, clinical and molecular characteristics of the tumours, and gene expression changes. All analyses were adjusted for the quantity of stroma in each sample, which was inferred from gene expression data. Results: High heterogeneity among samples was observed; the proportion of altered genome ranged between 0.04 and 26.6%. Recurrent CNA regions with gains were frequent in chromosomes 7p, 8q, 13q, and 20, whereas 8p, 17p, and 18 cumulated losses. A significant positive correlation was observed between the number of somatic mutations and total CNA (Spearman’s r=0.42, P=0.006). Approximately 37% of genes located in CNA regions changed their level of expression and the average partial correlation (adjusted for stromal content) with copy number was 0.54 (interquartile range 0.20 to 0.81). Altered genes showed enrichment in pathways relevant for CRC. Tumours classified as CMS2 and CMS4 by the consensus molecular subtyping showed higher frequency of CNA. Losses of one small region in 1p36.33, with gene CDK11B, were associated with poor prognosis. More than 66% of the recurrent CNA were validated in the The Cancer Genome Atlas (TCGA) data when analysed with the same procedure. Furthermore, 79% of the genes with altered expression in our data were validated in the TCGA. Conclusions: Although CNA are frequent events in microsatellite stable CRC, few focal recurrent regions were found. These aberrations have strong effects on gene expression and contribute to deregulate relevant cancer pathways. Owing to the diploid nature of stromal cells, it is important to consider the purity of tumour samples to accurately calculate CNA events in CRC.

Published
2017

4. Dietary flavonoids, lignans and colorectal cancer prognosis

Author

Mercè Barenys, Carmen Vidal, M. Henar Alonso, Antonio Soriano, Victor Moreno, Elisabeth Guino, Raul Zamora-Ros, and Universitat de Barcelona

Subjects
Oncology, Male, medicine.medical_specialty, Pronòstic mèdic, Colorectal cancer, Article, Lignans, Food composition database, chemistry.chemical_compound, Risk Factors, Càncer colorectal, Internal medicine, Epidemiology, medicine, Overall survival, Humans, Flavonoides, Aged, Neoplasm Staging, Proportional Hazards Models, Lignan, Flavonoids, Multidisciplinary, Proportional hazards model, business.industry, Middle Aged, medicine.disease, Prognosis, Confidence interval, Surgery, Diet, chemistry, Spain, Neoplasm staging, Female, Dieta, Neoplasm Recurrence, Local, business, Colorectal Neoplasms, Follow-Up Studies
Abstract

Flavonoids and lignans are polyphenol classes with anticarcinogenic activities against colorectal cancer (CRC). However, very limited epidemiological evidence exists on their effects on CRC prognosis. This study aimed to evaluate the association between flavonoid and lignan intakes with the risk of CRC recurrence and overall survival in CRC patients. The study followed incident histologically confirmed CRC cases in Barcelona (Spain). Validated dietary questionnaires and lifestyle information were collected at recruitment. An ad hoc food composition database on flavonoids and lignans was compiled by using data from the US Department of Agriculture and Phenol-Explorer databases. Adjusted hazards ratios (HR) and 95% confidence intervals (CIs) were estimated using multivariable Cox models. After 8.6 years of mean follow-up, 133 of 409 (32.5%) participants died and 77 of 319 (24.1%) had a CRC recurrence. Total flavonoids were associated neither with CRC recurrence (HR comparing extreme tertiles 1.13, 95% CI 0.64–2.02; P-trend 0.67) nor with overall survival (HRT3vsT1 1.06, 95% CI 0.69–1.65; P-trend 0.78) in the multivariable models. No associations were also observed with either total lignans or any flavonoid subclass intake. In conclusion, the results of the current study do not support a role of flavonoid and lignan intake in the CRC prognosis.

Published
2015

5. Tu1335 European Registry on H. pylori Management (HP-EuReg) in Spain: Interim Analysis in First and Second Line Therapies

Author

J. Gomez, Juan Ortuño, Joaquín Hinojosa, Manuel Castro-Fernandez, Angel Lanas, Maria Caldas, Colm O'Morain, Luis Bujanda, Jorge Perez-Lasala, Josep M. Botargues, Monica Perona, Pedro Almela, Alfredo J. Lucendo, Manuel Rodríguez-Téllez, R. Pajares, Luis Fernández Salazar, F Bermejo, Manuel Domínguez-Cajal, Javier Alcedo, Luis Ferrer Barceló, José María Huguet, Cristobal De la Coba, Javier Molina-Infante, Javier P. Gisbert, Rafael Ruiz-Zorrilla, Enrique Medina, Ines Modolell, Jesus Barrio, Angeles Perez Aisa, Mercedes Ramas, Blas-Jose Gomez-Rodriguez, Liliana Pozzati, Adrian G. McNicholl, Luis Rodrigo, and Mercè Barenys

Subjects
Pediatrics, medicine.medical_specialty, Second line, Hepatology, business.industry, Family medicine, Gastroenterology, medicine, Interim analysis, business
Published
2016
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6. High-dose, ten-day esomeprazole, amoxicillin and metronidazole triple therapy achieves high Helicobacter pylori eradication rates

Author

Javier P. Gisbert, Manuel Castro-Fernandez, Sandra Torra, Xavier Calvet, Felipe Bory, J. Lisozain, Mari M. Calvo, Luis Bujanda, Pilar García-Iglesias, Mercè Barenys, and Jordi Sánchez-Delgado

Subjects
Male, medicine.medical_specialty, Urea breath test, Rapid urease test, Gastroenterology, Drug Administration Schedule, Esomeprazole, Helicobacter Infections, Pharmacotherapy, Anti-Infective Agents, Internal medicine, Metronidazole, medicine, Humans, Pharmacology (medical), Aged, Hepatology, medicine.diagnostic_test, biology, Dose-Response Relationship, Drug, Helicobacter pylori, business.industry, Anti-ulcer Agent, Amoxicillin, Hydrogen-Ion Concentration, Middle Aged, biology.organism_classification, Anti-Ulcer Agents, Breath Tests, Drug Therapy, Combination, Female, business, medicine.drug
Abstract

Summary Background Strong acid inhibition using esomeprazole increases cure rates with triple therapy and 10-day treatments are more effective than 7-day ones. The combination of amoxicillin plus metronidazole at full doses, and using a physiologically-correct schedule three times a day, and has been shown to overcome metronidazole resistance and to achieve good eradication rates. Aims To assess the eradication rate of a new first-line treatment regimen associating strong acid inhibition, amoxicillin and metronidazole and to evaluate tolerance. Methods Patients from eight hospitals were included. Helicobacter pylori status was assessed by at least one of the following: histology, culture, rapid urease test or urea breath test (UBT). Ten-day treatment was prescribed comprising esomeprazole 40 mg twice a day plus amoxicillin 1 g and metronidazol 500 mg both three times a day. Helicobacter pylori cure was assessed by UBT. Results A hundred and thirty-six patients were enrolled. Mean age was 52.6 ± 16 years and 59.6% of patients were men. Main indications for treatment were: uninvestigated dyspepsia (13.6%); functional dyspepsia (18.2%); gastric ulcer (21.8%); and duodenal ulcer (39.8%). Helicobacter pylori eradication was achieved in 112 of the 127 patients who returned for follow-up. Eradication rates were 82.4% (95% CI: 74.7–88.1) by intention-to-treat analysis and 88.2% (95% CI: 81.2–92.8) by per protocol. Treatment was well tolerated and no major side effects were reported. Nine patients complained of mild side effects. Conclusions Cure rates of the combination of esomeprazole, amoxicillin and metronidazole are high and the treatment was well tolerated. This pilot study warrants the comparison of this schedule with current standards.

Published
2012

7. Su1167 European Registry on H. pylori Management (Hp-EuReg): Spanish Detailed Results (Interim Analysis)

Author

Adrian G. McNicholl, Manuel Castro-Fernandez, Pilar Sánchez-Pobre, Javier Alcedo, Angel Lanas, Alain Huerta, Judith Millastre, Blas Jose Gómez Rodríguez, Javier P. Gisbert, Luis Bujanda, Josep M. Botargues, Julio Ducons, Manuel Domínguez Cajal, Xavier Calvet, Miguel Montoro, Pedro Almela, Maria Caldas, Javier Molina-Infante, Luis Rodrigo, Alfredo J. Lucendo, Luis Fernandez Salazar, Ines Modolell, Jesus Barrio, Angeles Perez Aisa, Mercè Barenys, and Cristobal De la Coba

Subjects
medicine.medical_specialty, First line therapy, Hepatology, business.industry, Internal medicine, Cyp2c19 genotype, Gastroenterology, medicine, macromolecular substances, Interim analysis, business
Abstract

was negative effect on eradication rates. Conclusions : Japanese is below Westerners in the ratio of homo-EM. In this study, eradication rate was relatively low(70.2%) because of very high CAM-resistant rate(47.9%) , : the eradication rate of CAM-sensitive was very high(96.8%). In first line therapy, the EPZ based triple therapy is useful for the eradication of H pylori as well as RPZ based triple therapy without relation to CYP2C19 genotype, in Japan. Eradication rates

Published
2014
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10. M1126 Effectiveness of a 10-Day Triple Therapy Combining Potent Acid Inhibition With Amoxicillin and Metronidazole for H. pylori Eradication in Clinical Practice. A Pilot Study

Author

Sandra Torra, Xavier Calvet, Manuel Castro-Fernandez, Mercè Barenys, Jacobo Lizasoain, Felipe Bory, Pilar García-Iglesias, M.J. Martin Calvo, Jordi Sánchez-Delgado, and Luis Bujanda

Subjects
Clinical Practice, Metronidazole, Hepatology, Acid inhibition, business.industry, Gastroenterology, Medicine, Amoxicillin, Pharmacology, business, medicine.drug
Published
2010
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12. European Registry on Helicobacter pylori Management: Effectiveness of First and Second-Line Treatment in Spain

Author

María Caldas, Ángeles Pérez-Aisa, Manuel Castro-Fernández, Luis Bujanda, Alfredo J. Lucendo, Luis Rodrigo, Jose M. Huguet, Jorge Pérez-Lasala, Javier Molina-Infante, Jesús Barrio, Luis Fernández-Salazar, Ángel Lanas, Mónica Perona, Manuel Domínguez-Cajal, Juan Ortuño, Blas José Gómez-Rodríguez, Pedro Almela, Josep María Botargués, Óscar Núñez, Inés Modolell, Judith Gómez, Rafael Ruiz-Zorrilla, Cristóbal De la Coba, Alain Huerta, Eduardo Iyo, Liliana Pozzati, Rosario Antón, Mercé Barenys, Teresa Angueira, Miguel Fernández-Bermejo, Ana Campillo, Javier Alcedo, Ramón Pajares-Villaroya, Marianela Mego, Fernando Bermejo, José Luis Dominguez-Jiménez, Llúcia Titó, Nuria Fernández, Manuel Pabón-Carrasco, Ángel Cosme, Pilar Mata-Romero, Noelia Alcaide, Inés Ariño, Tommaso Di Maira, Ana Garre, Ignasi Puig, Olga P. Nyssen, Francis Megraud, Colm O’Morain, and Javier P. Gisbert

Subjects
Helicobacter pylori, treatment, first-line, second-line, Spain, Therapeutics. Pharmacology, RM1-950
Abstract

The management of Helicobacter pylori infection has to rely on previous local effectiveness due to the geographical variability of antibiotic resistance. The aim of this study was to evaluate the effectiveness of first and second-line H. pylori treatment in Spain, where the empirical prescription is recommended. A multicentre prospective non-interventional registry of the clinical practice of European gastroenterologists concerning H. pylori infection (Hp-EuReg) was developed, including patients from 2013 until June 2019. Effectiveness was evaluated descriptively and through a multivariate analysis concerning age, gender, presence of ulcer, proton-pump inhibitor (PPI) dose, therapy duration and compliance. Overall, 53 Spanish hospitals were included, and 10,267 patients received a first-line therapy. The best results were obtained with the 10-day bismuth single-capsule therapy (95% cure rate by intention-to-treat) and with both the 14-day bismuth-clarithromycin quadruple (PPI-bismuth-clarithromycin-amoxicillin, 91%) and the 14-day non-bismuth quadruple concomitant (PPI-clarithromycin-amoxicillin-metronidazole, 92%) therapies. Second-line therapies were prescribed to 2448 patients, with most-effective therapies being the triple quinolone (PPI-amoxicillin-levofloxacin/moxifloxacin) and the bismuth-levofloxacin quadruple schemes (PPI-bismuth-levofloxacin-amoxicillin) prescribed for 14 days (92%, 89% and 90% effectiveness, respectively), and the bismuth single-capsule (10 days, 88.5%). Compliance, longer duration and higher acid inhibition were associated with higher effectiveness. “Optimized” H. pylori therapies achieve over 90% success in Spain.

Published
2020
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13. European Registry on Helicobacter pylori management (Hp-EuReg): patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients

Author

Nyssen OP, Bordin D, Tepes B, Pérez-Aisa Á, Vaira D, Caldas M, Bujanda L, Castro-Fernandez M, Lerang F, Leja M, Rodrigo L, Rokkas T, Kupcinskas L, Pérez- Lasala J, Jonaitis L, Shvets O, Gasbarrini A, Simsek H, Axon ATR, Buzás G, Machado JC, Niv Y, Boyanova L, Goldis A, Lamy V, Tonkic A, Przytulski K, Beglinger C, Venerito M, Bytzer P, Capelle L, Milosavljević T, Milivojevic V, Veijola L, Molina-Infante J, Vologzhanina L, Fadeenko G, Ariño I, Fiorini G, Garre A, Garrido J, F Pérez C, Puig I, Heluwaert F, Megraud F, O'Morain C, Gisbert JP, Romano M, Universidad Autónoma de Madrid (UAM), AS Loginov Moscow Clinical Scientific Center [Moscow, Russian Federation], A.I. Yevdokimov Moscow State University of Medicine and Dentistry [Moscow, Russian Federation], AM DC Rogaska [Rogaska Slatina, Slovenia], Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), University of Bologna/Università di Bologna, Universidad del Pais Vasco / Euskal Herriko Unibertsitatea [Espagne] (UPV/EHU), Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), Liver Unit, Clínica Universitaria, CIBER-EHD, Østfold Hospital, University of Latvia (LU), Universidad de Oviedo [Oviedo], Henry Dunant Hospital [Athens, Greece], Lithuanian University of Health Sciences [Kaunas, Lithuania], Hospital Universitario HM Sanchinarro [Madrid, Spain], Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Faculty of Medicine [Hacettepe University], Hacettepe University = Hacettepe Üniversitesi, Leeds General Infirmary (LGI), Leeds Teaching Hospitals NHS Trust, Ferencváros Health Centre [Budapest, Hungary], Faculdade de Medicina da Universidade do Porto (FMUP), Universidade do Porto = University of Porto, Tel Aviv University (TAU), Medical University of Sofia [Bulgarie], Timisoara Hospital [Timisoara, Romania], Centre Hospitalier Universitaire de Charleroi, University of Split, Medical Centre for Postgraduate Education [Warsaw, Poland], University Hospital Basel [Basel], Otto-von-Guericke-Universität Magdeburg = Otto-von-Guericke University [Magdeburg] (OVGU), Copenhagen University Hospital, Meander Medical Center [Amersfoort, Netherlands], University of Belgrade [Belgrade], Herttoniemi Hospital [Helsinki, Finland], San Pedro de Alcantara Hospital [Cáceres, Espagne], Gastrocentr [Perm, Russian Federation], Digestive Ukrainian Academy of Medical Sciences [Kyiv, Ukraine], Hospital Clínico Universitario 'Lozano Blesa' [Zaragoza, Spain], Althaia Xarxa Assistencial Universitària de Manresa [Manresa, Spain], Universitat de Vic-Universitat Central de Catalunya [Manresa, Spain] (UVicUCC), Complejo Hospitalario Universitario de Santiago de Compostela [Saint-Jacques-de-Compostelle, Espagne] (CHUS), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Physiopathologie du cancer du foie, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Trinity College Dublin, Hp-EuReg Investigators: Jen Hinojosa, Inmaculada Santaella, Nuria Fernandez Moreno, Ilaria Maria Saracino, Horacio Alonso Galán, Almudena Durán, Jennifer Fernandez Pacheco, Miroslav Vujasinovic, Rinaldo Pellicano Molinette, Zdenko Kikec, Pedro-Luis Gonzalez Cordero, Maia Donday, Polona Lampic, Vid Leban, Aleksander Gruncic Krajnc, Natasa Brglez Jurecic, Galyna Dmytrivna Fadieienko, Lorena Lee, Irene V Barbado, Alfredo José Lucendo, Alfredo José Lucendo, Jesus Barrio RIo Hortega, Tatiana Alekseevna Ilchishina, Irina Voynovan, Luis Ignacio Fernández-Salazar, Jose María Huguet, Pilar Canelles, Aiman Silkanovna Sarsenbaeva, Ines Modolell Consorci, Pedro Almela, Marina Roldán Lafuente, Josep Maria Botargues, Miguel Areia, Luís Elvas, Susana Isabel Alves, Daniel Brito, Ana Teresa Cadime, Sandra Lúcia Madeira Saraiva, Charalampos Tzathas, Vassiliki Ntouli, Alicia C Marin, Cem Simsek, Alba Rocco, Juan Antonio Ortuño, Tommaso Di Maira, Sotirios D Georgopoulos, Stephan Brackmann, Vendel Kristensen Lovisenberg, Blas Jose Gomez-Rodriguez, Perminder Singh Phull, Sergey Alekseyevich, Monica Perona, Rustam Abdulkhakov, Deirdre McNamara, Sinead M Smith, Denise Elizabeth Brennan, Marina Fedorovna Osipenko, Cristobal de la Coba, Pilar Varela, Maria Anatolyevna Livzan, Oleg V Zaytsev, Vladislav Vladimirovich Tsukanov, Alexander Viktorovich Vasyutin, Olga Sergeevna Amelchugova, Spiros Michopoulus, Sergey Gennadievich Burkov, Dan Dumitrascu, Bogdan Ianosi, Ingrid Prytz Berset, Rafael Ruiz-Zorrilla Lopez, Charo Antón, Anne Courillon-Mallet, Natasa Brglez Jurecic, Judith Gomez-Camarero, Manuel Jimenez-Moreno, Ahmet Uygun, Ian Leonard Phillip Beales, Alain Huerta-Madrigal, Javier Alcedo, Mercè Barenys, Francesco Franceschi, Jean-Charles Delchier, Liliana Silvia Pozzati, Monika Augustyn, Maja Seruga, Miriam Hiestand, Patric Mosler, Zaza Beniashvili, Doron Boltin, Hubert Louis, Ramon Pajares, Natalia Valerievna Zakharova, Natalia Nikolaevna Dekhnich, Victor Asparuhov Kamburov, Maria Pina Dore, Lorena Sancho, Oscar Núñez, Katrine Dvergsnes Sørlandet, Peter Malfertheiner, Ana Campillo, Miguel Fernandez-Bermejo, Manuel Domínguez-Cajal, José Luis Domínguez Jiménez, Alicia Algaba, Fernando Bermejo, Borislav Vladimirov, László Czakó, Teresa Angueira, Eduardo Iyo, Ekaterina Yuryevna, Larissa Tarasova, Ludmila Grigorieva, Judith Millastre, Aldis Pukitis, Valeriy Kryvy, Roald Torp, Albert Tomàs, Edurne Amorena, Fermin Estremera, Rossen Nikolov, Asghar Quasim, Yury Aleksandrovich Kucheryavyy, Natalia Baryshnikova, Xavier Calvet, Ariadna Figuerola, Marco Romano, Antonietta Gerarda Gravina, Oscar Núñez, Fazia Mana, Pilar Sánchez-Pobre, Zoya Spassova, Jesús M González-Santiago, Ricardo Marcos-Pinto, F Wolfhagen, Svetlana Cui, Ivonne Leeuwenburgh, Driffa Moussata, Adi Lahat-Zok, Sergii Hryhorovych, Rasmus Goll, Tatyana Vasilyevna, Juris Pokrotnieks, Philippe Émile, Nadiya Byelyayeva, Marta Lozano, Mette Wildner-Christensen, Bengt Odman, Yana Valerieva, Alenka Forte, Antonio Cuadrado, Patrice Pienkowski, Ilze Kikuste, Dag Arne Lihaug Hoff, Jane Moeller Hansen, Konrads Funka, Alla Kononova, Sergey Kolbasnikov, Michael Selgrad, Jolanta Sumskiene, Jonathan Hirsch, Francisco Javier Zozaya Larequi, Alain C Burette, Nora Dancs Petz-Aladar, Janne Rajala Herttoniemi, Christina Reimer, Diogo Libanio, Pedro Pimentel-Nunes, Ivailo Evstatiev, Juozas Kupcinskas, Mikhail Butov, Peter Mensink, T Tang, Andrey Yurevich Baranovsky, Natalya Marchenko, Boris Bastens, Lyudmila Mateva, Dominique Lamarque, Leonardo Henry, Mario Ribeiro, M Ter Borg, Alexander C Ford, Enrique Medina, Manuel Rodriguez-Tellez, Francisco José Rancel, Elisa Martin, Carolina Torres Gonzalez, Lissa Maria Franco, Angel Lanas, Pilar Canelles, Noelia Alcaide, Bruno Richard-Molard, Megraud, Francis, Nyssen O.P., Bordin D., Tepes B., Perez-Aisa A., Vaira D., Caldas M., Bujanda L., Castro-Fernandez M., Lerang F., Leja M., Rodrigo L., Rokkas T., Kupcinskas L., Perez-Lasala J., Jonaitis L., Shvets O., Gasbarrini A., Simsek H., Axon A.T.R., Buzas G., Machado J.C., Niv Y., Boyanova L., Goldis A., Lamy V., Tonkic A., Przytulski K., Beglinger C., Venerito M., Bytzer P., Capelle L., Milosavljevic T., Milivojevic V., Veijola L., Molina-Infante J., Vologzhanina L., Fadeenko G., Arino I., Fiorini G., Garre A., Garrido J., F Perez C., Puig I., Heluwaert F., Megraud F., O'Morain C., Gisbert J.P., Universidad Autonoma de Madrid (UAM), University of Bologna, Università cattolica del Sacro Cuore [Roma] (Unicatt), Universidade do Porto, Tel Aviv University [Tel Aviv], Otto-von-Guericke University [Magdeburg] (OVGU), Nyssen, Op, Bordin, D, Tepes, B, Pérez-Aisa, Á, Vaira, D, Caldas, M, Bujanda, L, Castro-Fernandez, M, Lerang, F, Leja, M, Rodrigo, L, Rokkas, T, Kupcinskas, L, Pérez- Lasala, J, Jonaitis, L, Shvets, O, Gasbarrini, A, Simsek, H, Axon, Atr, Buzás, G, Machado, Jc, Niv, Y, Boyanova, L, Goldis, A, Lamy, V, Tonkic, A, Przytulski, K, Beglinger, C, Venerito, M, Bytzer, P, Capelle, L, Milosavljević, T, Milivojevic, V, Veijola, L, Molina-Infante, J, Vologzhanina, L, Fadeenko, G, Ariño, I, Fiorini, G, Garre, A, Garrido, J, F Pérez, C, Puig, I, Heluwaert, F, Megraud, F, O'Morain, C, Gisbert, Jp, and Romano, M

Subjects
Male, Registrie, Proton Pump Inhibitor, Practice Patterns, 0302 clinical medicine, Clarithromycin, Prospective Studies, Registries, Practice Patterns, Physicians', [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, biology, Gastroenterology, Middle Aged, Anti-Bacterial Agents, 3. Good health, Europe, 030220 oncology & carcinogenesis, Combination, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, medicine.drug, Human, Adult, medicine.medical_specialty, TRIPLE THERAPY, QUADRUPLE THERAPY, CONSENSUS, INFECTION, METAANALYSIS, CLARITHROMYCIN, GUIDELINES, RESISTANCE, ARTICLE, Settore MED/12 - GASTROENTEROLOGIA, First line, Helicobacter Infections, 03 medical and health sciences, Drug Therapy, Internal medicine, Anti-Bacterial Agent, medicine, Humans, Medical prescription, Adverse effect, Aged, Physicians', Helicobacter pylori, business.industry, helicobacter pylori - treatment, Proton Pump Inhibitors, Amoxicillin, biology.organism_classification, Metronidazole, Prospective Studie, Concomitant, helicobacter pylori, business, Helicobacter Infection, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

ObjectiveThe best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care.DesignInternational multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables included demographics, previous eradication attempts, prescribed treatment, adverse events and outcomes. Data monitoring was performed to ensure data quality. Time-trend and geographical analyses were performed.Results30 394 patients from 27 European countries were evaluated and 21 533 (78%) first-line empirical H. pylori treatments were included for analysis. Pretreatment resistance rates were 23% to clarithromycin, 32% to metronidazole and 13% to both. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (39%), achieving 81.5% modified intention-to-treat eradication rate. Over 90% eradication was obtained only with 10-day bismuth quadruple or 14-day concomitant treatments. Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates. Time-trend analysis showed a region-dependent shift in prescriptions including abandoning triple therapies, using higher acid-inhibition and longer treatments, which was associated with an overall effectiveness increase (84%–90%).ConclusionManagement of H. pylori infection by European gastroenterologists is heterogeneous, suboptimal and discrepant with current recommendations. Only quadruple therapies lasting at least 10 days are able to achieve over 90% eradication rates. European recommendations are being slowly and heterogeneously incorporated into routine clinical practice, which was associated with a corresponding increase in effectiveness.

Published
2020
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