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ANUAL REPORT 2011

CENTRO DE INVESTIGACIÓN BIOMÉDICA EN RED DE ENFERMEDADES HEPÁTICAS Y DIGESTIVAS (CIBERehd)

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REPORT ON ACTIVITIES OF THE CENTRO DE INVESTIGACIÓN BIOMÉDICA EN RED DE

ENFERMEDADES HEPÁTICAS Y DIGESTIVAS (CIBERhd) DURING THE YEAR 2011

1.- INTRODUCTION. General description of the center The ‘Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas’ (CIBERehd) is a research consortium created on November 29, 2006, and funded by the Instituto de Salud Carlos III. It brings together 51 research groups selected by an international peer review process from 30 centres throughout Spain. The CIBERehd is devoted to foster research in the field of liver and gastrointestinal diseases promoting interaction among the best Spanish groups, aimed primarily in translational research, encouraging results transferable to clinical practice and biotechnological applications This is sought through the main objectives of CIBERehd, which are i.- Fostering research excellence in gastrointestinal and liver diseases, in an international context, promoting interaction among the best Spanish groups, ii.- Aimed primarily to translational research, encouraging results transferable to clinical practice and biotechnological applications, iii.- Serve as a mobilizer to invigorate the national level and be an international cooperation model. Through the integration of basic and clinical research we favour synergies and enhance translation in the six research programs of the CIBERehd: i.- Portal hypertension and mechanisms of transition to cirrhosis; ii.- Viral hepatitis; iii.- Cholestasis, metabolic and toxic liver diseases; iv.- Liver transplantation and immunology; v.- Liver and gastrointestinal cancer; and vi.- Gastrointestinal inflammation and motility. Each program incorporates clinical and basic research groups directed by world renowned investigators including Drs V.Arroyo and P.Ginés in “Ascites and disorders of renal function in cirrhosis”; Dr F.Azpiroz in “Gastrointestinal motility”; Drs J.Bosch, JC.García-Pagán, C.Villanueva and A.Albillos in “Portal Hypertension”; Drs J.Bruix, and JM Lobet in “Hepatocellular carcinoma”; Drs R-J Esteban, M Buti and X.Forns in “Hepatitis”; Dr Á.Lanas in “Drug-induced gastric lesions”; Dr JM.Mato in “Liver proteomics and metabolomics” and Dr J.Prieto in “Gene therapy”. Taking advantage of the resources from universities, hospitals and research centres trough the creation of mixed research groups, we integrate basic and clinical investigation to favour synergies and enhance transference, and with an innovative structure that lets us work as an efficient and well coordinated network.

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2.- GROUPS AND INSTITUTIONS THAT FORM THE CIBEREHD

CIBERehd groups

PI incorporation

Institution

Agustín Albillos 2006 Universidad de Alcalá de Henares Vicente Arroyo 2006 Hospital Clínico y Provincial de Barcelona Fernando Azpiroz 2006 Institut de Recerca de l'Hospital Universitari Vall d'Hebron Rafael Bañares 2006 Fundación para la Investigación Biomédica del Hospital Gregorio

Marañón Marina Berenguer 2006 Fundación para la Investigación del Hospital La Fe Jaime Bosch 2006 Hospital Clínico y Provincial de Barcelona Jordi Bruix 2006 Hospital Clínico y Provincial de Barcelona Xavier Calvet 2006 Corporación Sanitaria Parc Taulí José V Castell 2006 Fundación para la Investigación del Hospital La Fe Antoni Castells 2006 Hospital Clínico y Provincial de Barcelona Daniel Closa 2006 Consejo Superior de Investigaciones Científicas (CSIC) Juan Córdoba 2006 Institut de Recerca de l'Hospital Universitari Vall d'Hebron Juan Vicente Esplugues

2006 Universidad de Valencia

Juan Ignacio Esteban

2006 Institut de Recerca de l'Hospital Universitari Vall d'Hebron

Rafael Esteban 2006 Institut de Recerca de l'Hospital Universitari Vall d'Hebron José Carlos Fdez-Checa

2006 Consejo Superior de Investigaciones Científicas (CSIC)

Xavier Forns 2006 Hospital Clínico y Provincial de Barcelona José Juan García Marín

2006 Universidad de Salamanca

Javier García-Samaniego

2006 Fundación para la Investigación Biomédica del Hospital Carlos III

Jordi Gómez 2006 Consejo Superior de Investigaciones Científicas (CSIC) Javier González Gallego

2006 Universidad de León

Carlos Guarner 2006 Instituto de Investigación del Hospital de la Santa Cruz y San Pablo

Francisco Guarner 2006 Institut de Recerca de l'Hospital Universitari Vall d'Hebron Angel Lanas 2006 Instituto Aragonés de Ciencias de la Salud Manuel de la Mata 2006 Fundación Reina Sofía Cajasur José Mª Mato 2006 CICBioGune Juan F Medina 2006 Fundación para la Investigación Médica Aplicada Ricardo Moreno 2006 Fundación para la Investigación Biomédica del Hospital

Universitario La Princesa Julià Panés 2006 Hospital Clínico y Provincial de Barcelona Albert Parés 2006 Hospital Clínico y Provincial de Barcelona Marçal Pastor 2006 Universidad de Barcelona Ramon Planas 2006 Fundación Instituto de Investigación Germans Trias i Pujol Jesús Mª Prieto 2006 Clínica Universitaria de Navarra

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Antoni Rimola 2006 Hospital Clínico y Provincial de Barcelona Manuel Romero 2006 Fundación Valme Fco Javier Salmerón 2006 Fundación de Investigación Biosanitaria en Andalucía Oriental

(FIBAO) José Such 2006 Fundación para la Investigación del Hospital General

Universitario de Alicante Antonio Zarzuelo 2006 Universidad de Granada Luis Bujanda 2007 Fundación Vasca para de Innovación e Investigación Sanitarias Pere Clavé 2007 Fundación Privada Salud del Consorcio Sanitario del Maresme Pascual Parrilla 2007 Fundación para la Formación e Investigación Sanitarias Javier Pérez Gisbert 2007 Fundación para la Investigación Biomédica del Hospital

Universitario La Princesa Ignacio Vicente Sandoval

2007 Consejo Superior de Investigaciones Científicas (CSIC)

Paloma Martín Sanz 2007 Consejo Superior de Investigaciones Científicas (CSIC) Raul Andrade 2008 Fundación Instituto Mediterráneo para el Avance de la

Biotecnología Sanitaria (IMABIS)

María Esteva 2011 Hospital Universitari Mutua de Tarrassa Llorenç Caballería 2011 Instituto de Investigación en Atenciçon Primaria Jordi Gol Mª Rocío Álvarez 2011 Fundación para la Formacion e Investigación Sanitarias de la

Región de Murcia Ana Belén Beltrán 2011 Fundación para la Investigación La Fe de Valencia Carmelo García Monzón

2011 Hospital Santa Cristina

CIBERehd consortium

Instituto de Salud Carlos III (ISCIII)

Consejo Superior de Investigaciones Científicas (CSIC)

Fundación para la Investigación Biomédica de Córdoba (FIBICO)

Fundación de Investigación Biosanitaria en Andalucía Oriental (FIBAO)

Fundación Pública Andaluza para la Investigación en Salud de Sevilla (FISEVI)

Instituto Aragonés de Ciencias de la Salud

Universidad de León

Universidad de Salamanca

Corporación Sanitaria Parc Taulí

Fundación Instituto de Investigación Germans Trias i Pujol

Universidad de Barcelona

Fundación para la Investigación del Hospital General Universitario de Alicante

Fundación para la Investigación del Hospital La Fe

Universidad de Valencia

Universidad de Alcalá de Henares

Fundación para la Formación e Investigación Sanitarias

Hospital Clínico y Provincial de Barcelona

Instituto de Investigación del Hospital de la Santa Cruz y San Pablo

Clínica Universitaria de Navarra

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Fundación para la Investigación Médica Aplicada

Asociación Instituto Biodonostia

Fundación Privada Salud del Consorcio Sanitario del Maresme

Fundación Instituto Mediterráneo para el Avance de la Biotecnología Sanitaria (IMABIS)

Universidad de Granada

CICBioGune

Institut de Recerca de l'Hospital Universitari Vall d'Hebron

Fundación para la Investigación Biomédica del Hospital Universitario La Princesa

Fundación para la Investigación Biomédica del Hospital Carlos III

Fundación para la Investigación Biomédica del Hospital Gregorio Marañón

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3.- SCIENTIFIC STRUCTURE AND ADMINISTRATIVE SUPORT OFFICE. Organization chart The integration of basic and clinical research to favour synergies and enhance translation is what was aimed with the creation of CIBERehd, as well as by most other NBRCs. CIBERehd’s research structure is dividen in Programs of Research, each with a Coordinator (member of the Steering Committee) and several adjuncts. The groups are integrated into the program which better reflected their scientific interests. The Scientific Program for 2010-2013 was elaborated by the Steering Committee and Adjuncts, circulated through the differents programs and approved by the General Assembly of the CIBERehd and its Board of Governors. This common Scientific Program was generated following a translational strategy and developed around the most common medical problems in liver and gastroenterological diseases. Six large research programs are established: 1. Portal hypertension and mechanisms of transition to cirrhosis. 2. Viral Hepatitis 3. Cholestasis, metabolic and toxic liver diseases. 4. Liver transplantation and immunology. 5. Liver and gastrointestinal cancer. 6. Gastrointestinal inflammation and motility. As mentioned, each program has a coordinator who is the representative of the program in the Steering Committee. It also has adjunct coordinators, who along with the group leaders are responsible for defining the area’s scientific program that needs to be submitted and approved by the Steering Committee. The scientific programs are organized in research lines based on objectives defined in the yearly action plans. These objectives are ranked according to scientific risk and execution time. We also have designed technological platforms and strategic actions to encourage the groups to integrate in the CIBERehd’s scientific project. The research structure is designed to promote traslational research, promoting the interaction between basic and clinical groups. It is also designed to encourage the interplay between the components of the different areas, so they don’t become detached. To accomplish this aim, there were designed platforms, common resources and strategic actions. Also, one of the objectives of the training plan is to promote the stay of researches in other groups to facilitate knowledge exchange and joint projects. Regarding the administrative support office, the Managing Director is the position in charge of the general administration of the NBRC, being responsible of the day-to-day operation including the financial and HR management. The administration office itself is divided into 5 main responsibility areas, namely Accounting & Controlling, HR & Occupation Safety, Legal & Projects coordination, Communication & PR, and last but not least Scientific Coordination.

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4.- EXTERNAL SCIENTIFIC ADVISORY BOARD We are very proud of have the following professors as our External Scientific Advisory Board: Prof. Guadalupe Gª-Tsao, Prof. Massimo Pinzani, Prof. Roger Butterworth, Prof. Jean Pierre Vinel, Prof. Sophie Loterszan, and Prof. Hans Vasen.

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5.- SCIENTIFIC REPORT

The scientific activity of CIBERehd is mainly based on its research programs and strategic actions, and is complemented by the training plan, platforms, common resources, and extramural program.

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a) SCIENTIFIC PROGRAMS CIBEREHD is sctructured in 6 research programs:

1. Portal hypertension and mechanisms of transition to cirrhosis

2. Viral Hepatitis

3.Cholestasis, metabolic and toxic liver diseases

4.Liver transplantation and immunology

5.Liver and gastrointestinal cancer

6.Gastrointestinal inflammation and motility

Encompassing 51 research groups:

Program 1: Portal hypertension and mechanisms of transition to cirrhosis

�Dr. Agustín Albillos (Coordinator)

�Dr. Vicente Arroyo

�Dr. Rafael Bañares

�Dr. Jaume Bosch

�Dr. Juan Córdoba (Ass. Coord.)

�Dr. Carlos Guarner

�Dr. Ramón Planas

�Dr. José Such

Program 2: Viral Hepatitis

�Dr. Juan Ignacio Esteban (Coordinator)

�Dr. Rafael Esteban

�Dr. Xavier Forns (Ass. Coord.)

�Dr. Javier García-Samaniego

�Dr. Jordi Gómez

�Dr. Ricardo Moreno

�Dr. Manuel Romero (Ass. Coord.)

�Dr. Javier Salmerón

Program 3: Cholestasis, metabolic and toxic liver diseases

�Dr. Juan Francisco Medina (Coordinator)

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�Dr. José Vicente Castell

�Dr. José Carlos Fernández-Checa (Ass. Coord.)

�Dr. Carmelo García Monzón

�Dr. Javier González Gallego

�Dr. José Mª Mato

�Dr. Albert Parés (Ass. Coord.)

�Dr. Ignacio Vicente Sandoval

�Dr. Paloma Martín Sanz

�Dr. Raúl Andrade

�Dr. Llorenç Caballería

Programa 4: Liver transplantation and immunology

�Dr. Antoni Rimola (Coordinator)

�Dr. Rocío Álvarez

�Dr. Marina Berenguer (Ass. Coord.)

�Dr. Manuel de la Mata

�Dr. Pascual Parrilla

Programa 5: Liver and gastrointestinal cancer

�Dr. Jordi Bruix ((Coordinator)

�Dr. Antoni Castells (Ass. Coord.)

�Dr. José Juan garcía Marín ((Ass. Coord.)

�Dr. Marçal Pastor

�Dr. Jesús Mª Prieto

�Dr. Luis Bujanda

Programa 6: Gastrointestinal inflammation and motility

�Dr. Julián Panés (Coordinator)

�Dr. Fernando Azpiroz (Ass. Coord.)

�Dr. Xavier Calvet

�Dr. Daniel Closa

�Dr. Juan Vicente Esplugues

�Dr. Eduard Cabré

�Dr. Francisco Guarner

�Dr. Ángel Lanas (Ass. Coord.)

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�Dr. Antonio Zarzuelo

�Dr. Pere Clavé

�Dr. Javier Pérez-Gisbert

�Dr. María Esteve

�Dr. Belén Beltrán

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1.-Portal hypertension and mechanisms of transition to cirrhosis

Coordinator: Dr. Agustín Albillos CIBERehd Program num. 1, named “Portal hypertension and mechanisms of transition to cirrhosis”, focuses on collaborative research on the pathogenesis, diagnosis and treatment of liver cirrhosis, portal hypertension and its complications. In particular, the cooperative translational research that holds the Program studies the pathogenic mechanisms of liver fibrogenesis and portal hypertension and seeks to develop drugs and therapeutic strategies to improve portal hypertension and its associated complications (bleeding gastroesophageal varices, ascites and renal failure, bacterial infection, hepatic encephalopathy). Research is systematized in the Program in five lines 1) hepatic fibrogenesis, 2) portal hypertension, 3) ascites / renal function and liver insufficiency, 4) infection and bacterial translocation, and 5) hepatic encephalopathy. The Program is formed by eight groups, five located in Barcelona and led by Drs. Arroyo (Hospital Clinic), Bosch (Hospital Clinic), Córdoba (Hospital Valle Hebron), Guarner (Hospital San Pablo) and Planas (Hospital Germán Trias Pujol), two in Madrid led by Drs. Albillos (Hospital Ramón y Cajal-University of Alcalá) and Bañares (Hospital Gregorio Marañón), and one in Alicante led by Dr. Such (General Hospital). In spite of its clinical origin, all the groups included in the Program have incorporated experimental research. The latter fact enables the Program 1 to cover the whole spectrum of translational research in the field of its competence, including studies of cell and molecular biology, proof of concept in patients with cirrhosis and clinical trials to evaluate different drugs and treatment strategies. The main strategic aim of CIBERehd strategic is to promote clinical and experimental collaborative research. In this sense, the direction of CIBERehd has stimulated the development of collaborative projects among groups of Program 1, as well as with groups in other areas. The collaboration has included multicentered clinical trials, cooperation to evaluate prognostic markers and test and design strategies for diagnosis and treatment with a direct impact on clinical practice. One of the initial goals of CIBERehd was to extend this collaboration towards mechanistic basic research, using the advantages of cell and molecular biology. Cooperation in this sense has also been initiated among CIBERehd groups and is expected to continue rising in coming years. Table describes the topics of research of the 8 groups of Program 1:

Group

Center

Main investigator

Lines of research of each group

Number of members

1 Universidad de Alcalá-Hospital Ramón y Cajal, Madrid

Agustín Albillos

Portal hypertension Infection/Translocation

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2 Hospital Clínic Barcelona

Vicente Arroyo

Fibrogenesis Ascites/renal function /Liver insufficiency Infection/Translocation Hepatic encephalopathy

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3 Hospital Gregorio

Rafael Bañares

Portal hypertension Ascitis/función

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Marañón, Madrid

renal/Insuficiencia hepática

4 Hospital Clínic Barcelona

Jaime Bosch

Portal hypertension Infection/Translocation

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5 Hospital Valle de Hebrón, Barcelona

Juan Córdoba

Ascites/renal function /Liver insufficiency Hepatic encephalopathy

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6 Hospital San Pablo, Barcelona

Carlos Guarner

Portal hypertension Ascites/renal function Infection/Translocation

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7 Hospital Germans Trías, Badalona

Ramón Planas

Portal hypertension Ascites/renal function Infection/Translocation Hepatic encephalopathy

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8 Hospital General Universitario, Alicante.

José Such

Ascites/renal function Infection/Translocation

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Interactions and collaborations among groups of Program 1

Collaborative projects carried out by members of the program during 2011

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Multicenter, randomized, double-blind, placebo-controlled study on the efficacy of beta-blockers to prevent decompensation of cirrhosis with portal hypertension. Clinical Research Project Institute of Health Carlos III EC08/00122. Code: PREDESCI. Year Started: 2008. Hospital / participating institutions: H. Santa Cruz and San Pablo, H. Clinic, H. Trias Pujol, H. Valle de Hebron, H. Ramon y Cajal-University of Alcalá, H. Gregorio Marañón, H. Puerta de Hierro Majadahonda, H. Arnau de Vilanova. Principal Investigator / Coordinator: Candido Villanueva, Hospital Santa Creu i Sant Pau, Barcelona. Phase II study randomized, controlled, multicenter to evaluate the efficacy and safety of ribavirin monotherapy versus prolonged colchicine on the progression of chronic hepatitis C virus advanced fibrosis in patients not responding to conventional antiviral treatment. Code: RIBA-CIR. Year Started: 2008. Hospital / participating institutions: H. Ramon y Cajal-University of Alcalá, H. Gregorio Marañón, H. Puerta de Hierro. Principal Investigator / Coordinator: Agustín Albillos, Ramon y Cajal Hospital, Madrid. Efficacy and safety of self-expanding esophageal prosthesis-balloon catheter versus Sengstaken as emergency hemostatic treatment in patients with acute bleeding from esophageal varices, and failure of medical and endoscopic treatment. Multicenter, prospective, randomized trial. Health Research Project, Instituto de Salud Carlos III PI 080 504. Code: PE08001. Year Started: 2008. Hospital / participating institutions: H. Clinic, H. Santa Cruz and San Pablo, H. Valle de Hebron, H. Trias Pujol, H. Ramon y Cajal-University of Alcalá, H. Gregorio Marañón, H. Puerta de Hierro. Principal Investigator / Coordinator: Angels Escorsell, Hospital Clinic, Barcelona. This project is a strategic action of Ciberehd. Study to assess the efficacy of oral norfloxacin associated with intravenous cefotaxime compared with that demonstrated by intravenous cefotaxime (current standard treatment) in the treatment of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with low and high risk of developing complications. Code: 01.08 CIBERehd-Alicante. Year Started: 2009. Hospital / participating institutions: H. General de Alicante, H. Clinic, H. Santa Cruz and San Pablo, M del Mar, H. Trias Pujol, H. Bellvitge, H. John XXIII, Tarragona, H. Ramon y Cajal-University of Alcalá, H. Gregorio Marañón, H. Tajo, H. General de Elche. Principal Investigator / Coordinator: José Such, General Hospital, Alicante. Effects of albumin infusion in the treatment of an episode of hepatic encephalopathy. Multicenter randomized study in patients with liver cirrhosis. Alpha code. Start year 2009. Hospital / participating institutions: H. H. Valle de Hebrón, H. Clinic, H. Santa Cruz and San Pablo, H. Parc Taulí. Principal Investigator / Coordinator: Juan Cordoba, Hospital Vall d'Hebron, Barcelona. Efficacy of albumin and midodrine in the prevention of the complications of cirrhosis in cirrhotic patients in the transplantation waiting list:: a double-blind, randomized, controlled study. Code: MACHT study. Year Started: 2009. Hospital / participating institutions: H. Clinic, H. Valle de Hebrón. Principal Investigator / Coordinator: Pere Ginés, Hospital Clinic, Barcelona. Efficacy of statins in combination with standard therapy in the prevention of variceal rebleeding in patients with cirrhosis: double-blind, placebo-controlled study. Health and Social Policy Ministery. Year Started: 2010. Code: BLEPS study. Hospital / participating institutions: H. Clinic, H. Santa Cruz and San Pablo, H. Valle de Hebron, H. Trias Pujol, H. Parc Taulí, H. General de Alicante, H. Ramon y Cajal-University of Alcalá, H. Gregorio Marañón, H. Puerta de Hierro. Principal Investigator / Coordinator: Angels Escorsell, Hospital Clinic, Barcelona.. Principal Investigator / Coordinator: Jaime Bosch, Hospital Clinic, Barcelona. Pilot randomized study to evaluate physical exercise in cirrhotic patients and branched aminoacid supplementat.ion. Mapfre Foundation. Year started: 2010. Hospital / participating institutions: H. Santa Cruz and San Pablo, H. Valle de Hebron. Principal Investigator / Coordinator: Germán Soriano, Santa Cruz and San Pablo, Barcelona.

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2.- Viral Hepatitis Coordinator: Dr. Juan Ignacio Esteban Area 2 includes 8 research groups led by Drs. Juan Ignacio Esteban (Hospital Universitari Vall d’Hebron. Barcelona), Rafael Esteban (Hospital Universitari Vall d’Hebron. Barcelona), Xavier Forns (Hospital Clínic de Barcelona), Javier García-Samaniego (Hospital Carlos III. Madrid), Jordi Gómez (CSIC Instituto Lopez Neyra. Granada), Manuel Romero (Hospital Universitario de Valme, Sevilla), Javier Salmeron (Hospital Universitario San Cecilio. Granada) and Ricardo Moreno (Hospital de la Princesa. Madrid). During 2011 the Viral Hepatitis Program groups have consolidated the collaboration efforts previously planned.

1. A Public HBV database named CIBERHEP, owned by Ciberehd, has been developed. CIBERHEP is open to all National Health professionals willing to participate in the Project. The database coordinated by Drs. M. Buti and R. Esteban received approval in the Boletín Oficial del Estado BOE-B-2010-32871 Sept 25th 2010, and was registered in the Agencia Española de Protección de Datos (AEPD), Oct 22nd 2010.

2. The use of new technologies such as GWAS, Ultra-deep pyrosequencing (UDPS) using the 454/Roche platform and structural RNA biosensors using microarrays, have opened new research lines. In vitro HCV RNA transcripts have been generated as molecular controls to quantify minority mutants in HCV viral populations by UDPS and others. Such new technologies will allow the simultaneous study of HCV viral variability and DNA genomic polymorphisms (IL28B, HLA haplotypes, RBV transpoters, etc.) from acute and chronically infected patients and offspring’s of carrier mothers for their potential correlation with spontaneous or treatment-associated outcome. Personalising therapy and defining the bases for new therapies are the main aims of these studies.

3. A CDTI (Centro para el Desarrollo Tecnológico Industrial) project in collaboration with Roche Diagnostics and ABL has been granted by the Spanish Ministry of Science and Innovation. This project entitled “Estudios de quasiespecies de los virus de la hepatitis B y C (VHB y VHC) y de polimorfismos genómicos asociados a la respuesta al tratamiento antiviral por pirosecuenciación” started on March 1st 2010 and will last until April 30th 2013. The Project involves the consortium of four Institutions: Roche Diagnostic Systems, ABL-Therapy Edge, Ciberehd, and VHIR-HUVH.

4. The CDTI project includes the generation of a Public HCV data base owned by Ciberehd that should be fully working in 2013. The core of the database (HepatiC) has already been designed, and the register to include patients should be active during 2011.

5. Another fully collaborative study, sponsored by a Ciberehd platform, still ongoing during 2010 and entitled “Secuenciación a gran escala para el diagnóstico y planificación del tratamiento de hepatitis víricas” has focused on the analysis of the effect of Ribavirin on HCV “in vivo” and “in vitro”. UDPS sequencing data from control HCV subgenomic cell cultures are currently being concluded. Samples from patients treated with Ribavirin monotherapy have been obtained and the NS5A region will be amplified and subject to UDPS analysis.

6. IL28 polymorphism testing in chronic HCV patients has been implemented in practice in all participating Clinical Hospitals.

7. We have also succeeded in using subgenomic and genomic HCV replicons to study HCV infection, replication, including the cloning of a fully replicating full-length HCV genome (Dr. X. Forns’ group), and investigation of the effect of anti-viral drugs on HCV quasispecies dynamics (Drs. J. Gomez and E. Domingo).

8. Non-invasive (ARFI) techniques to characterise hepatic fibrosis, including licensed software to analyse magnetic resonance images have been evaluated.

9. Improvement of viral load detection of HDV has been developed (Dr. Garcia Samaniego). 10. Epidemiological studies focussed in HBV, HCV, HDV and recently in HEV infection has been

reinforced including nosocomial HCV transmission studies thus supporting the National Health

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Spanish System. We are also studying the viral dynamics during antiviral therapy and during post-transplant recurrence and we are also involved in developing cooperative multicentric assays for antiviral treatments.

11. Studies on DNA genomic polymorphisms in Interferon inducible genes (ISGs), have reported its association as independent predictive factors of response to anti-HCV treatment (Peg-IFN & Ribavirin) in chronic HCV (HCC) patients (Dr. R. Moreno). Immune response and levels of expression of host proteins have been implicated in progression to fibrosis/cirrhosis and development of hepatocarcinoma.

12. A three-year multicenter study including all hepatocarcinoma cases occurring on NASH, HCV or cryptogenic cirrhosis, named FLIP (Fatty Liver: Inhibition of Progression) started in 2010 (Dr. M Romero Gomez)

13. Dr. Salmeron’s group participates in the European Project “Fatty liver: Inhibition of Progression. “Prevention and treatment of non-alcoholic fatty liver disease (NAFLD)” that started in 2010.

14. A new collaborative line of research involving three groups of our Area 2 and led by Dr. Garcia Samaniego has started focussing in the study of epigenetic interactions between the host’s genomic DNA and HBV or HCV genomes.

As a summary, the activity developed during 2011 in the Area 2 of Ciberehd has been successful and has increase the competitive research capability of our network.

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3.- Cholestasis, metabolic and toxic liver diseases. Coordinator: Dr. Juan Francisco Medina There is a total of eleven groups included in Programme 3 that carry out research activities in hepatology essentially related to cholestasis, metabolic disorders and hepatotoxicity. Thus, two of the initial groups of the Programme (those of Dr. Albert Parés and Dr. Juan F. Medina) and a recently joined group (Dr. Llorenç Caballería) are mainly focused on basic, clinical and epidemiological studies of cholestasis. These groups maintain a close cooperation for the analysis of bile transporters in primary biliary cirrhosis and other chronic cholestatic diseases. Remaining groups are within a second branch of the Programme dedicated to research on metabolic disorders, and more in particular to the study of steatohepatitis and liver toxicity. Also, they are interested in the subsequent alterations of those disorders such as hepatic fibrogenesis and carcinogegesis. Accordingly, these groups conduct studies related to the mechanisms of oxidative stress and apoptosis in hepatocytes and the role of cytokines and adipocytokines in metabolic, toxicological and infectious liver disorders. Highly relevant in this regard is the activity carried out by the groups of Dr. José M. Mato and Dr. José C. Fernández-Checa. These groups have been awarded a substantial number of projects and carry out multiple collaborations with other groups. Moreover, the groups of Dr. Javier González Gallego and Drs. Carmelo García Monzón and Paloma Martín Sanz collaborate closely in the study of antioxidant therapies in models of hepatitis C. Finally, contributions from the groups of Dr. Jose V. Castell, Dr. Ignacio V. Sandoval and Dr. Raúl Andrade are investigating the molecular mechanisms that cause hepatotoxicity. Projects and Collaborations The groups included in Programme 3 have continue reinforcing collaborative networks among them (intra-Nodal collaborations) and with groups included in other Programmes (inter-Nodal collaborations). This is manifested, for instance, in the enthusiastic participation in the Strategic Action on Alcoholic and Non Alcoholic Steatohepatitis during years 2009-2010. Moreover, the group of Dr. José M. Mato, from CIC BioGUNE, makes available the Platforms of Genomics, Proteomics, Metabolomics and Gene Silencing to the whole Ciberehd. These platforms are already operating and collaborations have been substantiated by the organization of training sessions among other activities. Additionally, several high-impact publications show further the quality of current collaborations.

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4.- Liver transplantation and immunology.

Coordinator: Dr. Antoni Rimola Since the beginning of the CIBEREHD, Program 4 (formerly named Area 4) has been designed to address the current main problems in liver transplantation: 1) the disproportion between the number of patients in need of this therapy and the scarce number of liver grafts; 2) the optimization of immunosuppressive treatment to tailor immunosuppression according to each particular liver transplant recipient, to minimize the side-effects of immunosuppressants and to identify patients who are tolerant to their allografts, and 3) the post-transplant recurrence of the primary disease, particularly hepatitis C. Therefore, the research developed by the investigators of this Program can be grouped into several lines: a) Immune response against the liver allograft. This line mainly involves the investigation of the mechanisms of rejection and their modulation by immunosuppressive treatment, with the final goal to administer the most adequate immunosuppression in each particular liver transplant recipient according to his/her immunological characteristics. b) Long-term extrahepatic complications. These complications are mainly due to the adverse effects of immunosuppressive drugs. This line pays especial attention to risk factors for cardiovascular disease, which is one of the most frequent causes of death in the late post-transplant period. c) Recipient tolerance of the liver graft. The main objectives of this line are the identification of biomarkers of tolerance and the promotion of tolerance status after liver transplantation. Tolerance allows the withdrawal of all immunosuppressive treatment and, therefore, the minimization of adverse events related to this treatment. d) Mechanisms of hepatocellular injury, particularly those related to ischemia-reperfusion damage. The main objective of this line is to improve this type of injury by different interventions, with the final goals of both increasing the viability of liver grafts, especially those which are considered as suboptimal, and thereby expanding the number of grafts for liver transplantation. e) Recurrence of hepatitis C after liver transplantation, one of the most characteristic and severe complications in liver transplant patients and responsible for most graft failures and post-transplant deaths. The aims of this line are to investigate pathogenic mechanisms of post-transplant hepatitis C recurrence, to identify markers of progression of its severity over time, and to address different aspects concerning antiviral treatment. On the other hand, some groups of Program 4 develop part of their research activity on issues other than those mentioned above. Although this activity is, in theory, foreign to the Program, some of these investigations could be of interest due to their possible future applicability in the context of the Program objectives. One example is the research on mechanisms of liver cell damage caused by injuries other than ischemia-reperfusion and on the interventions to improve this damage. Program 4 involves five groups. Two groups are located in the Hospital Virgen de la Arrixaca, in Murcia. The respective leaders of these two groups are Dr. Rocio Alvarez and Dr. Pascual Parrilla. The leaders of the other three groups are Dr. Marina Berenguer, from the Hospital Universitario La Fe, Valencia; Dr. Manuel de la Mata, from the Hospital Universitario Reina Sofía, Córdoba, and Dr. Antonio Rimola, from the Hospital Clínico y Provincial, Barcelona. The research activity of Program 4 is predominantly clinical. Nevertheless, the groups of Dr. Rocio Alvarez, Dr. De la Mata and Dr. Rimola also perform basic research.

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PROJECTS AND COOPERATIVE RESEARCH The five groups of Program 4 participate in the different common lines of research of the Program, as shown in the following table: LINE OF RESEARCH PARTICPATING GROUPS Immune response to liver graft, immunosuppression Alvarez

Berenguer De la Mata Parrilla Rimola

Extrahepatic complications due to immunosuppression Berenguer De la Mata Parrilla Rimola

Tolerance of liver graft Alvarez Berenguer Parrilla Rimola

Hepatic ischemia-reperfusion injury De la Mata Rimola

Hepatitis C recurrence after liver transplantation

Berenguer De la Mata Parrilla

During 2011, all the groups collaborated in different projects. Some of these projects also involved groups of other CIBEREHD Programs and national and international groups outside CIBEREHD. The most relevant of these projects and the most relevant publications by the groups of Program 4 are the following: Relevant projects: Impact of allelic incompatibility and functional HLA-C isomorfisms in the maintenance of tolerance in liver transplantation. Leading group: Dr. R. Alvarez (project principal investigators: Dr. R. Alvarez and A. Minguela). Other participating groups from the CIBEREHD: Dr. P. Parrilla. Influence of HLA-C polymorphisms and their KIR receptor ligands on the risk of rejection in liver transplantation. Leading group: Dr. R. Alvarez (project principal investigator: Dr. M.R. Alvarez). Other participating groups from the CIBEREHD: Drs. M. De La Mata, P. Parrilla, and A. Rimola. Cd28 and Cd95 expression on peripheral CD4 T lymphocytes to differentiate acute rejection from post-transplant HBV/HCV infection recurrence in liver transplant recipients. Leading group: Dr. M. Berenguer. Other participating groups from the CIBEREHD: Drs. R. Alvarez and P. Parrilla.

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Immunosuppression weaning in liver transplant patients with hepatitis C recurrence. Leading group: Dr. A. Rimola (project principal investigator: Dr. A. Sánchez-Fueyo). Other participating groups: Drs. M. Berenguer and X. Forns (from Program 2 of the CIBEREHD). Control of blood pressure in liver transplant patients. Leading group: Dr. A. Rimola. Other participating groups from the CIBEREHD: Drs. M. Berenguer, M. De la Mata, and P. Parrilla. Other participating national groups: Dr. T. Serrano (Zaragoza). Re-treatment after virological relapse in post-transplant hepatitis C recurrence: efficacy, tolerance and viral kinetic response according to the type of maintenance immunosuppressive drugs. Leading group: Dr. M. Berenguer. Other participating groups from the CIBEREHD: Drs. R. Alvarez and Parrilla. Other participating national groups: Drs. T. Serrano, FJ. López-Labrador and JJ. Abellan. Search for the immunological signature of tolerance in liver transplantation. Leading group: Dr. A. Rimola (project principal investigator: Dr. A. Sánchez-Fueyo). Other participating international groups: Drs. G. Tisone (Rome), J. Pirenne (Leuven), HD Volk (Berlin), F. Class (Leyden).

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5.- Liver and gastrointestinal cancer Coordinator: Dr. Jordi Bruix Research in this area is focused on epidemiology, molecular mechanisms, diagnosis and treatment of digestive and liver cancer. It consists of 6 groups whose activity is complementary. Despite sharing field of study, each group focuses on different aspects. Below are shown the different groups and their main lines of research. Group "Regulation of transport systems (U. Barcelona). Principal Investigator. Dr. Marçal Pastor Anglada. This group has long experience in the research of transport systems, particularly those related to the mechanisms leading the resistance to treatment in neoplastic processes. Collaboration with Dr. Juan José García Marín group should result in creation of new tools and markers for determining drug resistance and suggest strategies to reverse it. Group “Experimental Hepatology and vectorization of drugs" (U. Salamanca). Principal Investigator. Dr. Juan José García Marín. The research group focuses on the mechanisms responsible for the delivery of drugs inside the cell and in modulating the cellular toxic response as a result of the incorporation of toxic metabolites. As mentioned before, their collaboration with the group of Dr. Pastor Anglada is very close and should result in the study of the mechanisms that maintain the resistance of the digestive and liver cancer to chemotherapy. Group "Gastrointestinal and Pancreatic Oncology (IDIBAPS). incipal Investigator. Dr. Antoni Castells. is group has excellence activities in molecular epidemiology of colorectal cancer and in the assessment of screening plans for this malignancy. Its research into new genetic abnormalities and their participation in international consortia has enabled the group to update the risk criteria and policy to follow for effective prevention. In addition, investigates new techniques for endoscopic diagnosis of digestive cancer, while also leads the evaluation of surgical treatment of digestive cancer using minimally invasive surgery. It has also led the creation of the EPICOLON for the study of hereditary forms of colorectal cancer and their families in Spain, in collaboration with the Hospital del Mar in Barcelona, Alicante General Hospital, University of Illinois at Chicago, and the National Centre for Genotyping (CeGen) from Santiago de Compostela, and with the participation of more than 20 Spanish centres. Group Oncology Liver "(IDIBAPS). Principal Investigator. Dr. Jordi Bruix. This group operates on two complementary fields. It has an international recognition in the diagnosis and treatment of liver cancer and their contributions have laid the foundation for diagnostic and therapeutic recommendations based on scientific evidence. It has demonstrated the usefulness of the drug sorafenib in the treatment of advanced liver cancer and this has primed an active research in molecular therapiy. Moreover, in recent years the group has engaged an active translational research aimed at establishing a basic molecular classification of liver cancer and elucidate the different signalling pathways involved in tumour progression. The group has led the creation of an international consortium for Genomic Research in collaboration with Mount Sinai Medical School in New York, Harvard University, Institute Nationale di Tumori di Milan and the IDIBAPS in Barcelona. Currently, the group leads international research in phase 1, 2 and 3, evaluating various molecular therapies in first or second line and as adjuvant after surgical resection or chemoembolization. Group Experimental Hepatology and Gene Therapy "(CUN). Principal Investigator. Jesús Prieto. CUN is a reference centre in Spain regarding liver disease and liver cancer in general. In addition to a relevant general activity in hepatology, the group has developed a pioneering gene therapy which obviously has its objectives in the medium - long term. Its dedication to innovative therapies make it a key centre for the development of successful clinical trials. Group "Colorectal Cancer" (San Sebastian). Principal Investigator. Luis Bujanda. This group joined CIBERehd during year 2008. The group previously possessed an established track record in the field of genetics of colorectal cancer and the evaluation of screening programs in the population. Along with the group led by Dr. Castells they are responsible for multiple programs to strengthen state-level cancer screening and at the same time generate a criteria to achieve an optimal cost-effectiveness.

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6.- Gastrointestinal inflammation and motility Coordinator: Dr. Julián Panés A significant strategic achievement of the research program on Gastrointestinal inflammation and Motility achieved during the calendar year 2011 has been the strengthening of the interaction and collaborative efforts among the various groups integrated in this program. This has led to significant achievements in various research areas. The biobanking and genetic initiatives in the field of inflammatory bowel disease has resulted in completion of a GWAS in a sample of 2000 patients with Crohn’s disease and 1000 patients with ulcerative colitis with at least five years of disease duration. This genomic analysis is contributing to the discovery of susceptibility genes, and the well phenotyped cases and long duration of the disease is facilitating the analysis of genetic prognostic factors, and development of diagnostic tools based on genomic analyses. Also in the area of genetics the collaborative effort of this program has led to identification of susceptibility genes to thiopurine toxicity. A landmark study resulting also from join forces of the program has been the characterization of liver dysfunction related to hepatitis B and C in patients with inflammatory bowel disease treated with immunosuppressive therapy. This has led to the generation of new national and international guidelines for the prevention of liver complications in patients with IBD. In this area also a multicenter study established the factors associated with differential therapeutic responses to immunosuppression in patients with ulcerative colitis and Crohn’s disease. All the results of this area of research have been published in first quartile journals. One of the groups of the area acts as a reference center for innovation in cell therapies for inflammatory bowel disease, and is currently offering hematopoietic stem cell transplantation for the treatment for refractory Crohn’s disease. This program is very active with 8 transplants in 2009 (15 overall since the initiation of the transplant program), and 7 patients currently under evaluation. Also innovative forms of cells therapies have started to be investigated anfter obtaining accreditation of facilities and approval of a phase I study design from the Spanish Agencity for Medicines to investigate the potential benefit of tolerogenic dendritic cells in refractory Crohn’s disease. The area of esofagogastric pathology has also had a growing number of ongoing collaborative projects during 2011 that include the identification of genetic and environmental risk factors for development of esofagogastric lesions oriented to development of preventive strategies, various genetic studies related to epigenetic alterations in Barrett’s esophagus and gastric cancer related to H pylori infection, new diagnostic methods for this infection, as well as new treatment strategies. The highly integrated activity of the groups involved in these studies is evidenced by the fact that the majority of the publications of the investigators during 2009 are collaborations within CIBERehd. Five groups participate in initiatives in the area of neurograstrenterology, which are centered in studying the pathophysiology of symptoms and complications of oropharyngeal dysphagia, aiming at validating new diagnostic methods and standardization of clinical practice, development of in vitro models for studying aspects ofesophagogastric and colonic molitity. Various members of area 6 have been involved in the organization and elaboration of international guidelines of treatment of gastrointestinal bleeding, diagnosis and treatment of Crohn’s disease, consensus for the treatment of ulcerative colitis, use of small bowel endoscopy in inflammatory bowel disease, and optimization of the use of cross-sectional imaging techniques for the study of inflammatory bowel diseases.

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b) TRANSVERSAL PROGRAMS

Strategic Actions Program. These actions are decided by each of the programs regarding their own priorities and they have an apart authorized budget for their development. Due to funding constraints, it was agreed to focus the budget of this strategic action on one or two programs each annuity. In 2008 was particularly relevant the Transversal Cancer Action, which received funding of 1,400,000€, and which was developed by the area of Hepatic and Gastrointestinal Cancer of Ciberehd, with performances at the level of a) Research projects (60%) B) Platform to support the diagnosis and therapeutic orientation in patients with liver and gastrointestinal cancers (25%), c) consensus conferences (May 2008) International Symposium on Translational Research in Liver and Digestive Oncology (February 2009) (15%). In 2009 it was carried out a strategic action on the part of Program 2, consisting in the acquisition of a pyrosequencing device, which has benefit many CIBERehd groups, and has been culminated with the obtention of a competitive project and a collaboration agreement within the CIBERehd, Vall d’Hebron Hospital and the industry in 2010. Also approved in 2009 was the Program 3 strategic action: "Study of biomarkers in esteoatohepatitis" which is participated by 13 groups and supported by CIC-bioGUNE technological collaboration, and that was completed in the annuity 2010. In 2010 no new strategic actions were approved due to budget cuts as it was decided to accumulate the amount for the following year.For the same reasons no new strategic actions were approved in 2011.. Training plan CIBER’s Hepatic and Digestive Disease Training Plan is based on “fellowship” stays in CIBERehd’s research groups for post-graduate researchers (post-MIR; post-doctorate; and foreign), abroad with a variable timeframe (fundamentally for a short period for those with few financing options) and Intramural Visiting Professor Program that will last a semester/year, so that one senior researcher from each group will spend one week per year as a visiting professor in another institution subjected to the promotion of staff interaction and the collaboration of scientific researchers from different centers. Similarly, specific support will be provided for programs for invited professors and those who participate in courses and meetings. CIBERehd’s Extramural Program will assign groups with the Linked groups and those in the Outside Collaboration program. Linked Groups do not receive financing or resources from CIBER, but indirectly benefit from their association with it. This comes from its collaboration with their clinical/population studies, by receiving scientific advice or development, through participation in training activities and via educational programs. The Outside Collaboration Program is based on the concept that it is not possible to understand CIBER’s Hepatic and Digestive Disease without locating it within a global context along with positive interaction. In 2011 45 grants have been awarded to researchers for various activities under the program of the Training Plan. Despite the budget cuts we have been able to attend nearly all applications. The beneficiaries of the aid have been 13 investigators from CIBERehd institutions, 32 employees, of whom 9 were doctors, 16 licensed, 1 nursing graduate and 6 technicians. The activities funded were 2 stages of investigators in other centers CIBERehd, 1 short stay abroad (Germany), 1 short stay in Spain, 2 phD, 1 Postgraduate Course, 32 training courses and activities nationwide, and 6 international ones.

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Among these activities we should like to highlight the stays in CIBERehd groups of EUGENIO ROSADO (Dr. BOSCH’s CIBERehd staff) who did a stay in the Liver Research Unit, Hospital Reina Sofía Córdoba, with Dr. De la Mata, and IRENE CRESPO (Dr. GONZALEZ-GALLEGO’s CIBERehd staff) who did a stay in Hospital CIMA, with Dr. PRIETO. In addition the inscriptions for PhD programs were funded to Drs. J PEREZ-GISBERT (PhD in Medicine and Surgery), and R. Esteban (PhD in Biochemistry, Molecular Biology and Biomedicine), to two CIBERehd staff members. External Partnership Program The Ciberehd is situated in a global context with which it must interact positively. This is achieved through actions designed to promote: Participation in EU programs and other (providing bonuses for groups that lead EU projects or involving at least three groups of CIBER). It is expected to encourage and support participation of the CIBER groups at the next convocation of the Seventh Framework Programme. Joint actions with Scientific Associations (national and international) and research centers in other countries. Co-sponsorship of courses, scientific meetings and symposia with the Spanish Association for the Study of the Liver (AEEH), the Spanish Association of Gastroenterology (AEG) and the National Institutes of Health (NIH). In this sense, clinical guidelines have been developed in collaboration with these societies, have co-sponsored meetings and CIBERehd researchers have been directors of courses organized by European and American Societies for the Study of Liver Diseases. International exchange (especially with EU countries and Latin America). This has resulted in the participation of researchers from CIBERehd in the National Congresses of Gastroenterology and Hepatology of different Latin American countries to help develop the field in that countries, and the reception of American doctors as pre and post-doctoral fellows in CIBERehd groups to complete their training. Advising companies, institutions and patient associations. CIBERehd is working with and advising associations such as liver transplant patients, patients with inflammatory bowel disease and relatives of colorectal cancer patients.

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Technological Platforms and common infrastructures Genome Analysis, Proteomics Metabolomics and Gene Silencing Platforms The word “biogune” means a site for biosciences, which is precisely what CIC bioGUNE is: a place that attracts talented researchers from all over the world. By setting up joint projects with other scientific institutions, it has become a center of excellence for biomedical research. With this vision, in 2007, CIC bioGUNE and CIBERehd signed a collaboration agreement that allows researchers, in this research network, access to technology platforms CIC bioGUNE. Genome Analysis Platform The main goal of the Genome Analysis Platform is the optimization of sample processing protocols for a set of sophisticated, state-of-the-art, high-throughput genome analysis technologies. The principal methodologies used deal with the characterization of variants at gDNA sequence level (mainly Single Nucleotide Polymorphisms –SNPs and Copy Number Variations – CNVs), changes at mRNA or smallRNA expression level and epigenetic modifications. Recently, the group has been also establishing appropriate work-flow procedures for the data analysis, as well as developing new bioinformatics tools. Services 1. High-throughput genotyping: standard panels from 10 thousand up to 1 million SNPs and customized

Panels from 96 to 1536 SNPs. 2. High-throughput gene expression analysis: whole genome transcription analysis of human, mouse and rat tissues using standard chips. Customized Panels for up to 700 genes. 3. Characterization of methylation induced epigenetic modifications: 27 000 CpG islands (for human DNA) and customized Panels for up to 1536 CpG islands. 4. Next-generation sequencing: De novo sequencing and resequencing of genomic DNA. � BAC (bacterial artificial chromosome) end sequencing. � Genomic regions of interest. � Complete genes. � Complete chromosomes. � Complete genomes. DNA methylation analysis at the completegenome level. Expression analysis (complete transcriptome). Identification and analysis of microRNA and smallRNA. DNA-protein interactions (ChIP-Seq). 5. Assistance in designing of the customized SNP (for genotyping projects) or gene panels (for differential expression projects). 6. Results can be delivered as raw data or in a processed form: the basic statistical analysis of the data can be performed. Equipment BeadStation 500 GT/GX (Illumina, Inc.), Genome Analyzer II (Illumina, Inc.).

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All the equipment required to perform various molecular biology experiments, such as Experion (BioRad) and Bioanalyzer (Agilent Technologies) systems, EpiMotion (Eppendorf) liquid handling workstation, centrifuges, electrophoresis apparatus, gel imaging systems, etc. Proteomics and Metabolomics Platform Proteomics By analyzing the abundance of proteins under different physiological or experimental conditions, it is possible to identify groups of proteins that are important to those specific conditions. Differential in-gel electrophoresis (DIGE) is nowadays the most powerful technique for gelbased differential proteomic analysis. During the last decade the genomes from many organisms, including human, have been sequenced. The availability of genomic sequences has boosted the proteomic research as the data obtained by analyzing proteins and peptides by mass spectrometry can be directly linked to the genomic information, using bioinformatics methods. Continuous optimization of sample preparation while employing the latest generation of tandem mass spectrometers, with their constantly improving high mass accuracy, high resolution and sensitivity, makes the protein identification process increasingly fast and accurate. The Proteomics Platform provides services to in-house groups and external users and offers joining forces for collaborative research projects. Metabolomics Metabolomics employs the extraction and measurement of multiple small molecules from tissues or biofluids to produce metabolic profiles. The approach derives its success from the fact that disease, drugs or toxins cause perturbations of the concentrations and fluxes of endogenous metabolites involved in key biochemical pathways. Since mammalian metabolic control functions are dispersed across many cell types in topographically distinct locations, the metabolome has no compartmental constraints. The metabolomics techniques may therefore be regarded as a complete systems biology approach where the processes in separate organs and different cell types may be integrated into a holistic view of an organism. Together, proteomics and metabolomics research efforts should help to get a more complete picture and supply the better understanding of the molecular events taking place in the cells. Services Molecular mass determination by MALDI TOF, protein identification by MALDI TOF/TOF, protein identification by liquid chromatography coupled online to tandem mass spectrometry, differential in-gel-electrophoresis (DIGE). The Metabolomics Platform strives to provide a top quality service for cutting-edge research, using strictly controlled analytical procedures and state-of-the-art facilities under expert supervision. On receipt of a request, advice will be provided to choose the right sample collection criteria, sample preparation procedures, analytical methodology and data processing methods for the project under consideration. All procedures are optimized to provide a high quality, fast turnaround, cost efficient final product. Equipment (Proteomics Platform)

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MALDI: Proteineer DP robotic station (Bruker): allows automatic digestion of gel spots. Autoflex III TOF/TOF (Bruker): this mass spectrometer can perform different types of analysis, intact protein molecular mass can be obtained for previously resolved and digested proteins, protein identification by peptide mass fingerprinting (MALDI-TOF) and/or peptide fragment fingerprinting MALDI TOF/TOF). Liquid chromatography coupled to tandem mass spectrometry systems: Nano Acquity UPLC chromatography system coupled on-line to Q-TOF Premier (Waters), agilent 1200 nano flow liquid chromatography system coupled on-line to LTQ-Orbitrap XL (Thermo-Fisher). These two high sensitivity systems have the latest technical features for optimal identification of the proteins from complex protein mixtures. Differential in-gel electrophoresis (DIGE): Typhoon TRIO, spot picker and DeCyder. DIGE is nowadays the most robust approach for gel-based differential proteomic analysis. Equipment (Metabolomics Platform) 1. UPLC coupled to TOF (Waters). 2. UPLC coupled to Q-TOF (Waters). 3. UPLC coupled to Quad-IMS-TOF (Waters). These systems offer selective, sensitive analysis with state-of-the-art ion fragmentation tools; ideal for novel metabolite identification experiments. Gene Silencing Platform The Gene Silencing Platform is a facility to develop and execute cell-based screening using RNAi. It has dedicated staff to manage platform resources and help in assay development and data analysis. The main goal of this platform is to make RNAi-mediated gene silencing as widely accessible as possible. Within collaborative research, we can facilitate silencing of individual genes to elucidate their functions. Upon request, the GSP advises users on customer design of siRNAs to silence specific genes (mostly in cases of targets obtained from point mutations and/or chromosomal rearrangements). Possibilities of collaborative researches: in vitro and in vivo silencing of individual genes, customer design of siRNAs, adapted cell-based screening using sub-libraries targeting requested pathways or families of genes, genome-wide screening using the Drosophila library. Equipments and facilities 1. The Human retroviral shRNAmir library developed by Greg Hannon (CSHL), Stephen Elledge (Harvard) and colleagues. The library includes about 62.500 microRNA30-based hairpin constructs targeting the whole human genome. 2. Silencer®Drosophila RNAi library distributed by Ambion/Applied Biosystem. This library is a collection of 13.071 dsRNAs targeting the bestannotated Drosophila genes. 3. Sciclone ALH 3000 (liquid handling system) + Twister II. 4. Cytomat 2C (CO2 incubator with plate shuttling). 5. Detection systems: • Microplate reader (Synergy HT). • Automated wide-field microscope (ImageXpress) including MetaXpress Analysis Application Modules for cell scoring, translocation, cell cycle, etc.

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Biobank Continuous improvement in the health of European citizens relies on biomedical research and on citizens who participate in that research. Research today needs new, bigger and better resources. BioBanking offers unique solutions to research, assessment and documentation of global diversity. CIBERehd created a BioBankplatform for the management of a tailored facility that collects stores and distributes biological resources related to digestive diseases, and relies on the infrastructure of the IDIBAPS BioBank. This system incorporates an adaptive data model and developed processes for the management of intellectual property, policy issues, services and maintenance. The main objectives of the CIBERehd – IDIBAPS BioBank include

- Offer to the scientific community well standardized and characterized biologic samples of patients with digestive diseases, with high added value, to promote development of biomedical research according to current regulations.

- To obtain large collections of samples of digestive diseases and/or phenotypes of high interest for research

- To distribute samples for the promotion and development of collaborative research projects among CIBERehd centers, and between these centers and other partners, according to current regulations

- To provide technical support to investigators interested in BioBanking, including standards for annotation, designation and procedures, tools to harmonize collections, informatics, support to track samples, associated data, and previously generated data, and current regulations. For fulfilling these objectives the CIBERehd – IDIBAPS BioBank is equipped with:

- Freezers with security systems for -20ºC, -80ºC i -150ºC - Programmable freezer with controlled ramp freezing - Chemagic MSM1® robot for DNA extraction of large volume samples - Tecan EVO150® automated station to aliquot samples - CoulterZ1® cell and particle counter - Chambers for sterile cell isolation - Cell immortalization platform - Informatics for sample and data management.

Outstanding achievements during 2010 relate to strategic and scientific areas. From a strategic perspective the Biobank includes now management of tissue samples, in addition to the fluid samples. From a scientific point of view, the samples and associated information of inflammatory bowel disease have provided a significant contribution to the international consortium for the study of IBD genetics resulting in the publication of meta-analyses and validation of candidate genes for ulcerative colitis and Crohn’s disease (Nat Genet. 2010 Dec;42(12):1118-25; Nat Genet. 2011 Feb 6. [Epub]).In addition, investigators of CIBERehd are coordinating the gastroenterology arm of a national project to discover common susceptibility genes and predictors of disease course in immune mediated inflammatory disorders including inflammatory bowel disease, rheumatoid arthritis, psoriatic arthritis, psoriasis, and lupus. This project will analyze samples of 12000 patients and 3000 controls, and samples from CIBERehd are being used for the validation phase. Results from this project are expected during the 3rd term of 2011 and will likely have a high international impact, similar to the results of the accomplished international consortium for the study of IBD genetics. In addition to investigator initiated studies, samples from Biobank have also been used for collaborations with pharmaceutical industry, in particular in two studies evaluating diagnostic tools for screening of colorectal cancer. Pyrosequencing platform The recent availability of commercial platforms for massive parallel ultra-deep pyrosequencing (UDPS) offer the opportunity to characterize with unprecedented sensitivity the hepatitis C virus (HCV) quasiespecies, which infects 1-2.6 % of the general population in Spain. The UDPS will allow: (i) An accurate and quantitative characterization of the viral population in clinical samples. (ii) To design individualized treatment strategies according to the complexity of the infecting quasispecies and the presence/absence of STAT-C drug-resistant mutants both in treatment-naive and patients with relapse, slow or null-response to previous treatment with Peg-Interferon (those with a higher risk of selecting multi-

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drug resistant mutants). (iii) To identify novel viral or host-related factors influencing resistance to the new STAT-C drugs including minor viral variants present at frequencies below 1% within a complex viral population. Due to the great potential of this technology the Scientic Board of the CIBEREHD endorsed a strategic action to create a UDPS platform for all groups included in the viral hepatitis area 2, and granted 100.000€ for its development, implementation and the hiring of Bioinformatic personnel. The Bioinformatics specialist was given specific training for the handling and interpretation of the huge amount of data which is generated during each UDPS run, and he has recently been hired by the IR-HUVH to continue further development of optimized interpretation algorithms. The granting of over 600.000€ by the Fondo de Investigaciones Sanitarias for the acquisition of a 454-FLX-Roche/Life Sciences equipment by the Institut de Recerca Hospital Universitari Vall d’Hebron (IR-HUVH) finally located at the Unidad Científico Técnica de Soporte (UCTS) of the IR-HUVH, further boosted the Project and the establishment of an official collaboration agreement between the CIBERehd and the IR-HUVH active thorough 2011, for the use of the UDPS service by all investigators belonging the CIBERehd area 2. The Roche company provided free reagents for the initial implementation of the UDPS platform. Recently, The Roche Company, the IR-HUVH and the CIBERehd decided to create a consortium and apply for additional funding through the CDTI program established by the Spanish Ministry of Science and Innovation, which will provide a solid base ground to explore the full potential of the new technology in the field of viral hepatitis. Bioinformatics Platform Principal Investigator: Juanjo Lozano Salvatella Phd The main goal of Bioinformatics Platform is to rpovide biostatistical and bioinformatic support to all CIBEREHD investigators. CIBERehd is a public partnership that aims to promote translational research of the highest calibre by bringing together the best Spanish research groups in gastroenterology, hepatology and liver transplantation. CIBERehd provides its research group members with financial support for research staff and for collaborative projects, and funds strategic key technological platforms to foster collaborative translational research.

Among the many studies in which he has participated at CIBERehd, Dr Lozano has been interested in the field of organ transplantation. In addition, very productive collaborations involving bioinformatics and statistical analyses have been established in the colon cancer área with Dr Gironella (microRNA expression) and Dr Balaguer and Dr Castells (Genome Wide methylation analysis), and in the field of liver cirrosis with Dr Bataller (Alcoholic Cirrhosis), and Dr Clària, Dr Martinez Chantar and Dr Mato (liver steatosis). Additional collaborations with foreign institutions in the field of cancer have resulted in two more patents being filed. Also others relevant collaborations includes importans groups as Dr Julià Panès in the field of the gastroenterology between others.

Services – Bioinformatic tools development and application. – Webserver with different applications for microarray and Real-time RT-PCR data process. – File repository. – Bioinformatic collaborations, consultancy and advisory services for project planning. Collaborations -Most relevant collaborations inside the CIBEREHD are: Liver Transplant (Dr. Alberto Sanchez-Fueyo, Dr. Constantino Fondevila)

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Gastroenterology (Dr. Julià Panés and Dra. Azucena Salas) Colorectal and Pancreatic Cancer (Dr. Antoni Castells, Dr. Meritxell Gironella, Dr. Francesc Balaguer) Alcoholic Hepatitis (Dr. Ramon Bataller) Hepatic Cancer (Dr. Carolina Armengol) Helicobacter Pylori: Consorci Sanitari Parc Tauli (Dr. Xavier Calvet, Dr. Sergi Lario) Intestinal Inflammation: :Hospital Germans Trias i Pujol (Dr. Elisabet Pedrosa) CiC Biogune: (Dr. Mª Luz Martinez Chantar, Dr. Jose Maria Mato, Dr. Ana María Aransay) Cirrosis Hepatica: (Dr. Joan Clarià, Esther Titos) -Established collaborations outside the CIBEREHD: Bladder Cancer: Urology service at Hospital Clinic: (Lourdes Mengual and Dr. Alcaraz) Prostate Cancer: Pathology group (Dr. Pedro L Fernandez, Dr. Timothy Thomson) Kidney Transplant: INSERM (Dr. Sophie Brouard, joint collaboration with Dr.Alberto Sanchez-Fueyo) IDIBAPS Bioinformatic Unit :( Dr. Susana G Kalko) Centre for Genomic Regulation: Alternative Splicing (Dr. Juan Valcárcel). Publicactions: Bohne F, Martínez-Llordella M, Lozano JJ, Miquel R, Benítez C, Londoño MC, Manzia TM, Angelico R, Swinkels DW, Tjalsma H, López M, Abraldes JG, Bonaccorsi-Riani E, Jaeckel E, Taubert R, Pirenne J, Rimola A, Tisone G, Sánchez-Fueyo A. Intra-graft expression of genes involved in iron homeostasis predicts the development of operational tolerance in human liver transplantation. J Clin Invest. 2012 Jan 3;122(1):368-82. doi: 10.1172/JCI59411. Epub 2011 Dec 12. PubMed PMID: 22156196; PubMed Central PMCID: PMC3248302. Baños-González M, Cantú-Brito C, Chiquete E, Arauz A, Ruiz-Sandoval JL, Villarreal-Careaga J, Barinagarrementeria F, Lozano JJ. [Systolic blood pressure and functional outcome in patients with acute stroke: A Mexican registry of acute cerebrovascular disease (RENAMEVASC)]. Arch Cardiol Mex. 2011 Jul-Sep;81(3):169-75. Spanish. PubMed PMID: 21975228. Balaguer F, Moreira L, Lozano JJ, Link A, Ramirez G, Shen Y, Cuatrecasas M, Arnold M, Meltzer SJ, Syngal S, Stoffel E, Jover R, Llor X, Castells A, Boland CR, Gironella M, Goel A. Colorectal cancers with microsatellite instability display unique miRNA profiles. Clin Cancer Res. 2011 Oct 1;17(19):6239-49. Epub 2011 Aug 15. PubMed PMID: 21844009; PubMed Central PMCID: PMC3186834. Lozano JJ, Pallier A, Martinez-Llordella M, Danger R, López M, Giral M, Londoño MC, Rimola A, Soulillou JP, Brouard S, Sánchez-Fueyo A. Comparison of transcriptional and blood cell-phenotypic markers between operationally tolerant liver and kidney recipients. Am J Transplant. 2011 Sep;11(9):1916-26. doi: 10.1111/j.1600-6143.2011.03638.x. Epub 2011 Aug 9. PubMed PMID: 21827613. Patents: Title: "Plasma MicroRNAs for the Detection of Early Colorectal Cancer". Inventors: Meritxell Gironella (Ciberehd), María Dolores Giráldez, Juan José Lozano (Ciberehd), Antoni Castells. Hospital Clínic, CIBERehd, Hospital Clínico y Provincial de Barcelona. 61/550,148. 21-oct-11. Int, US. Title: "MicroRNAa as biomarkers for the identification of familial and non-familial colorectal cancer". Inventors: Ajay Goel, C Robert Boland, Francesc Balaguer, Meritxell Gironella (Ciberehd), Antoni Castells, Leticia Moreira, Juan José Lozano (Ciberehd). BRI, CIBERehd, Hospital Clínic Hospital Clínico y Provincial de Barcelona. 61/391,585. 08-oct-10. Int, US/PCT, Taiwan, Argentina.

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Title: "Method and kit for the diagnosis and prognosis of tolerance in liver transplantation employing liver tissue" Inventors: Alberto Sánchez Fueyo , Félix Bohne, Marc Martínez-Llordella, Antoni Rimola Castella, Juan José Lozano (Ciberehd). Hospital Clínic, Fundació per la Recerca Biomèdica y CIBERehd, Hospital Clínico y Provincial de Barcelona. EP10382224,3. 09-ago-10. Int, EU/PCT. Title: "Method and kit for the diagnosis and prognosis of tolerance in liver transplantation employing liver tissue". Inventors: Alberto Sánchez Fueyo, Félix Bohne, Marc Martínez-Llordella, Antoni Rimola Castella, Juan José Lozano (Ciberehd). Hospital Clínic, Fundació per la Recerca Biomèdica y CIBEReh, Hospital Clínico y Provincial de Barcelona. PCT/EP2011/053127. 09-ago-10. Int, EU/PCT. Clinical database of chronic hepatitis B patients (CIBERHEP) The CIBERHEP platform has been designed as a database, to collect data on the clinical handling of patients with chronic hepatitis B under different antiviral treatments, in Spain. The aims of this database are the following: • Provide anonymous data on the clinical handling of a large number of patients, from different centres, to CIBERehd members who are interested in study the effectiveness and safety of antiviral treatments in order to optimise the hepatitis B treatment. • Make available to its users complete and easy access for monitoring their patients. You can access the platform trough CIBERehd’s website: www.ciberehd.org Clinical database of chronic hepatitis C patients (HEPATIC) Following CIBEREHP's model, the HEPATIC platform has been designed as a database, to collect data on the clinical handling of patients. The main goal is to perform clinical research for the identification of viral factors (treatment resistance mutations present in the genome of HCV and HBV) and specifications of the host genome (IL28 and HLA) to achieve the design of personalized treatments with new drugs. The platform will: • Provide anonymous data on the clinical handling of a large number of patients, from different centres, to CIBERehd members. • Make available to its users complete and easy access for monitoring their patients. You can access the platform trough CIBERehd’s website: www.ciberehd.org REHEVASC (Vascular Liver Disease Registry) NATIONAL COOPERATIVE GROUP STUDY non-cirrhotic portal hypertension (HTPNC) Also following the CIBEREHP’s model, the "National Centers Cooperative Group for the Study of HTPNC" platform has been set up in 2011. The main objectives are: 1. Dissemination of clinical protocols that define uniform criteria for diagnosis, treatment and monitoring of Budd-Chiari syndrome, non-cirrhotic portal vein thrombosis, idiopathic portal hypertension and congenital hepatic fibrosis in the participant centres. 2. Development of a centralized on-line registry using the website of the Biomedical Research Centre Network Liver and Digestive Diseases (CIBERehd) to record the patients with these rare vascular diseases. The consolidation of this national cooperative group with interest in HTPNC will allow estimate the

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incidence of these diseases in Spain. Moreover, it will allow recognize a larger number of patients with these conditions have been diagnosed and treated homogenously. Altogether, this will increase the knowledge of these diseases, their natural history and we will have the ability to perform multicenter randomized trials or cohort studies. The platform is accessible trough CIBERehd’s website: www.ciberehd.org Telematic platforms to support diagnostic in liver cancer and therapeutic guidance and genetic counselling in colorectal cancer: e-CATCH Technologic platform for the support of the diagnosis and therapy of liver cancer. Developed by the Hepatic Oncology Group of CIBERehd, led by Dr. Jordi Bruix. It allows patients at any geographical area to benefit from a clinical management based on expert knowledge derived from the most important clinical studies. Its use is open to every doctor, member of the National Health System, who can consult both specific cases and individual information. The information is provided at evidence-based medicine reports. It also helps to homogenize qualitatively the different preventive, diagnostic and therapeutic strategies as well as the new imaging techniques used in liver’s cancer. On the other hand, it will improve the understanding of the disease and its better management, while incorporating the latest information about ongoing clinical essays. e-ColonRisk CIBERehd makes available to the National Health System its Risk Assessment and Prevention of Colorectal Cancer (e-ColonRisk) Platform, an innovative initiative for the prevention of cancer based on the specific care of people and patients with colorectal cancer risk. e-ColonRisk is the platform for risk assessment and prevention of colorectal cancer. Developed by the Pancreatic and Gastrointestinal Oncology CIBERehd group, led by Dr. Antoni Castells. The aim of this platform is to give the National Health Service a new way of preventing colorectal cancer based on a specific and specialized attention of patients with an increased risk of getting colorectal cancer, either for personal or family factors. Through this initiative is possible the identification of those individuals or patients with an increased risk of suffering from this cancer and suggesting the most appropriate measures to prevent its development. The initiative, pioneered globally, aims to facilitate the work of those centers where there is a lack of assistive device for that purpose, as well as primary care or health workers in the field of prevention, making a recommendation adjusted to the current scientific knowledge. The technical solution integrates, for the first time in the world, the use of a representing solution and analysis of clinical records and genetic studies (Progeny) with an intranet platform based on the CMS Plone/Zope, allowing unlimited users through simple web interface. Platform, user-friendly, is accessible through its website www.colonrisk.org or at the CIBERehd’s website www.ciberehd.org. The exchange of information between agents is possible to do in a safe and confidential environment keeping a valueless archive.

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Functional Genetics Unit In 2008 it was granted funding for the creation of an economic genetics laboratory in two functional groups CIBER liver and digestive diseases of the Institute. The objective of this laboratory was the study of gene expression in digestive diseases using microarray technology. The possible technological interest of this laboratory and by other groups of the Institute have allowed the creation of Functional Genetics Unit in the laboratory located on the ground floor of sharing space with the Institute of Genomics Unit . This unit has an open platform that allows the use of arrays of different shops as well as the assessment not only of expression but also arrays of arrays of DNA arrays CGH, methylation, SNP, CHIP -on-chip, the letter arrays and protein arrays. The technology that makes the unit covers all the procedures necessary for the realization of microarrays: the extraction of nucleic acids and / or proteins using automated robot QIAcube analysis of the integrity and quantification of nucleic acids and / or proteins extracted by capillary electrophoresis with Experion equipment, automated hybridization (TrayMix) or manual (Hybex) sample the array, reading this scanner with a resolution of up to 3µm (InnoScan700) and analyze the results. Functional Genetics Unit aims to advise and provide technical support to all research groups interested in the study of gene expression as well as those interested in further clinical groups in this field, not forgetting the rest of the technological possibilities of the unit. You can access the platform trough CIBERehd’s website: www.ciberehd.org

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c) CIBERehd specific scientific activity. Results as a consortium:

● CIBERehd PROJECTS Regarding the complex legal nature of CIBERehd as a consortium, most competitive research projects are requested from the consortium institutions, and not as CIBERehd, except in cases where the Principal Investigator is appointed by the CIBERehd or type call so dictate (and always in accordance with the institutions that make up the CIBERehd). Annuity 2011 was awarded with the following project: “Endotelial protection during organ cold storage for transplantation: Implicated mechanisms and new therapeutic targets”. PI: Jordi Gracia Sancho ISCIII-FIS PI11/00235. 2012-2014: 51.314,89.-€ Projects active in other annuities were granted: "Development of biomarkers of liver fibrosis and prognosis of patients with advanced liver disease through the use of metabolomic tools. " PI: Jaume Bosch, Juan Caballería and Xavier Forns MICINN Subprogram INNPACTO 2010. 2010-2013: 351,536.80 .-€ "Micro RNAs in pancreatic cancer: evaluation of diagnostic and therapeutic potential. " PI: Meritxell Gironella ISCIII-FIS PI10-02 888. 2011-2013: € 96,800 .-€ "Analysis of expression profiles of microRNAs in the noninvasive diagnosis of colonic neoplastic lesions microRNA." PI: Meritxell Gironella Olga Torres Foundation 2010-2012: 60,000 .-€ "Identification of microRNA expression profiles for prediction of response to 5-fluorouracil and oxaliplatin in colorectal cancer" PI: Meritxell Gironella Mutua Madrilena Medical Research Foundation 2008-2011: 50,000 .-€ → Endotelial protection during organ cold storage for transplantation: Implicated mechanisms

and new therapeutic targets. The research aims to caractherize the hepatic endothelial phenotype during liver storage for transplantation, as well as, to discover new therapeutic treatments to prevent early endothelial dysfunction post-reperfusion, considered the main cause of early graft dysfunction after transplantation. The research is divided in two sub-projects: Sub-project 1: Effects of shear stress stimuli on the hepatic

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endothelial phenotype in liver transplantation. Which is composed by three research avenues, 1.1.- Molecular characterization of shear stress cessation on the hepatic endothelial phenotype and function; 1.2.- Effect of preconditioning on the hepatic endothelial phenotype; 1.3.- Intrahepatic stress stimuli maintenance during cold storage of normal and marginal liver grafts for transplantation. Sub-project 2: Endothelial protection as new therapeutic strategy in liver transplantation. Divide in two main research lines, 2.1.- Generation of a new preservation solutions for normal and marginal liver grafts transplantation; 2.2.- Synergistic effects of preservation solutions and shear stress stimuli combination to maintain organs for transplantation. In 2011CIBERehd has been funded with 51.314,89.-€ to carry out the project. Due to the change of Dr. Gracia’s employer institution to IDIBAPS in 2012, the CIBERehd has trespassed that amount to that entity, as well as all the issues related to the project.

• Analysis of scientific production During 2011, and despite the cut in funding received, the scientific production has been increased and it has been excellent, with 394 articles published in 1st and 2nd quartile journals, with almost 100 of them collaborations CIBER (see list of publications). It have also been continued the training plan actions, the technology platforms and infrastructure, and the signing of agreements with institutions in the consortium and Scientific Societies. There were no significant deviations during the annuity in the development of the Action Plan envisaged.

Publications CIBERehd 2007 2008*

2009* 2010*

2011**

Publications in first quartile of the subject area 189 212 231 277 299 Publications in tenth percentile of the subject area 80 106 130 158 160 Publications in journals with and IF > 15 4 10 9 9 7

Publications with a member of the NBRC as a first author or as corresponding author (+50%)

129 (68%)

165 (77%)

152 (66%)

207 (75%

)

315 (80%)

Publications in collaboration 47 50 50 46 98 * from 2008 only those in which affiliation has CIBERehd are collected ** from 2011 also second quartile is collected as requested by the ISCIII

Program PI

Papers publish

ed

In collaboration with other CIBERehd

groups IF

1st Deci

le

1st Quarti

le

2nd Quarti

le

1 Agustín Albillos 4 1 18,17 1 1 2

1 Vicente Arroyo 18 3 133,429 12 4 2

1 Rafael Bañares 5 1 30,21 3 0 2

1 Jaime 17 5 157,52 15 2 0

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Bosch

1 Juan Córdoba 12 7 84,559 5 6 1

1 Carlos Guarner 5 3 24,664 2 0 2

1 Ramon Planas 7 2 35,943 2 1 4

1 José Such 7 1 47,014 3 4 0

2

Juan Ignacio Esteban 6 5 33,447 1 4 1

2 Rafael Esteban 11 7 117,733 5 5 1

2 Xavier Forns 13 4 87,919 8 4 1

2

Javier García-Samaniego 6 1 21,173 0 4 2

2 Jordi Gómez 10 0 56,013 0 6 4

2 Ricardo Moreno 12 6 46,583 4 2 6

2 Manuel Romero 10 3 45,938 3 2 5

2

Fco Javier Salmerón 7 2 37,338 3 3 1

3 José V Castell 4 0 15,522 1 2 1

3

José Carlos Fdez-Checa 5 3 36,286 4 1 0

3

Carmelo García-Monzón 2 1 8,8999 0 2 0

3

Javier González Gallego 9 4 46,403 3 5 1

3 José Mª Mato 14 0 79,314 5 5 4

3 Juan F Medina 1 0 4,411 0 1 0

3 Albert Parés 3 0 19,897 2 1 0

3

Ignacio Vicente Sandoval 2 0 12,898 1 1 1

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3

Paloma Martín Sanz 6 0 33,622 3 2 1

3 Raul Andrade 7 3 55,996 4 2 1

3

Llorenç Caballería 0 0

4 Mª Rocío Alvarez 5 5 15,69 1 0 4

4

Marina Berenguer 7 0 42,372 4 3 0

4

Manuel de la Mata 10 0 47,475 5 2 3

4 Antoni Rimola 14 6 80,074 8 4 2

4 Pascual Parrilla 6 6 21,725 2 2 2

5 Jordi Bruix 17 2 165,542 14 16 1

5 Antoni Castells 26 13 161,321 13 19 7

5

José Juan García Marín 7 1 46,014 5 6 1

5 Marçal Pastor 4 1 21,819 2 4 0

5 Jesús Mª Prieto 23 6

146,183 11 19 4

5 Luis Bujanda 9 9

47,319 1 7 2

6 Fernando Azpiroz 5 0

39,134 0 4 1

6 Xavier Calvet 15 12

94,735 5 14 1

6 Daniel Closa 1 0 7,274 1 1 0

6

Juan Vicente Esplugues 22 0

117,993

12 20 2

6 Eduard Cabré 11 5

35,526 0 5 6

6 Francisco Guarner 8 5

63,416 1 6 2

6 Angel 15 3 64,023 3 11 4

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Lanas

6 Julià Panés 20 5

149,108 9 16 4

6 Antonio Zarzuelo 7 1

29,342 2 5 2

6 Pere Clavé 13 3 55,871 2 7 6

6

Javier Pérez Gisbert 32 19 124,999 4 21 11

6 Julio Ponce 5 3 24,132 1 4

1

6 María Esteve 14 6

50,127 5 8 6

Total

CIBERehd

• Patents and transfer The results of the research of CIBERehd have led to various actions of transfer, some of which are in operation and others are in the process of licensing. The most important are of four kinds: 1 .-Clinical Knowledge Transfer: These are reflected in the contribution of CIBERehd to clinical guidelines and consensus documents. 2 .- Maintenance and improvement of the two telematics platforms for support the diagnosis and therapeutic approach in hepatic cancer and colorectal cancer genetic counseling. These platforms have been created in collaboration with the Strategic Action Cancer. They are running free on the web (www.ciberehd.org) accessible to all doctors in the NHS. 3 .- Clinical Trials: The CIBERehd has a very intense activity in the field of clinical trials, with 52 initiated in 2011 and more than 150 ongoing. 60% of these trials have been sponsored by industry contracts with pharmaceutical and biotechnology sector. It is also noteworthy that we are conducting several clinical trials without commercial interest sponsored by ISCIII. 4.- Patents: While CIBERehd is not specifically devoted to bring about patents, it is noteworthy that CIBERehd has made as a consortium a total of 12 patents since its constitution.

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It should be noted that four of that patents are the result of a cooperative reserach developed between CIBERehd groups and the CIBERehd’s bioinformatic’s platform. Also we have one of them licensed and another pre-licensed. During the 2011 the following patents were requested: Title:"Plasma MicroRNAs for the Detection of Early Colorectal Cancer" Inventors: Meritxell Gironella (Ciberehd), María Dolores Giráldez, Juan José Lozano (Ciberehd), Antoni Castells . Institutions: Hospital Clínic, CIBERehd Patent: 61/550,148; 21-oct-11. Int US Title: "Células dendríticas telorogénicas y su uso en terapia celular" Inventors: Julián Panés Díaz, Elena Ricart Gómez, Daniel Benítez Ribas (Ciberehd) Institutions: Hospital Clínic, CIBERehd Patent: EP11382174,8; 26-may-11. Int EU Our current patent portfolio: Spanish Office: P200931265 P200931265 (24.12.2009) ES2362770 A1 (13.07.2011) UNIVERSIDAD DE SEVILLA (47,50%) USO DE COMPUESTO N-FENIL-N'-(3-METIL-2-BUTENIL)TIOUREA PARA LA ELABORACIÓN DE MEDICAMENTOS DESTINADOS AL TRATAMIENTO DE LA ENCEFALOPATÍA HEPÁTICA. P200803224 P200803224 (11.11.2008) ES2349970 A1 (13.01.2011) CONSEJO SUPERIOR DE INVESTIGACIONES CIENTÍFICAS (CSIC) USO DE LA RNASA P COMO AGENTE ANTIVIRAL. PCT/ES2010/070855 PCT/ES2010/070855 (21.12.2010) FUNDACIÓN PÚBLICA ANDALUZA PARA LA GESTIÓN DE LA INVESTIGACIÓN EN SALUD DE SEVILLA USO DEL COMPUESTO N-FENIL-N''-(3-METIL-2-BUTENIL)TIOUREA PARA LA ELABORACIÓN DE MEDICAMENTOS DESTINADOS AL TRATAMIENTO DE LA ENCEFALOPATÍA HEPÁTICA PCT/ES2011/070683 PCT/ES2011/070683 (28.09.2011) CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES (CNIC) USO DE INHIBIDORES DE TAK1 EN LA PREVENCIÓN Y TRATAMIENTO DEL FRACASO DE LA MEMBRANA PERITONEAL European Office: 1. USE OF TAK1 INHIBITORS IN THE PREVENTION AND TREATMENT OF PERITONEAL MEMBRANE FAILURE Inventor: DEL POZO BARRIUSO MIGUEL ANGEL [ES] LOPEZ CABRERA MANUEL [ES] (+2) Applicant: CT NAC DE INVESTIGACIONES CARDIOVASCULARES CNIC [ES] CONSEJO SUPERIOR INVESTIGACION [ES] (+5) EC: IPC: Publication info: WO2012042091 (A2) 2012-04-05 Priority date: 2010-09-28

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2. METHOD AND KIT FOR THE DIAGNOSIS AND/OR PROGNOSIS OF TOLERANCE IN LIVER TRANSPLANTATION Inventor: SANCHEZ FUEYO ALBERTO [ES] LOZANO SALVATELLA JUAN JOSE [ES] (+3) Applicant: HOSPITAL CLINIC DE BARCELONA [ES] CT DE INVESTIGACION BIOMEDICA EN RED DE ENFERMEDADES HEPATICAS Y DIGESTIVAS CIBEREHD [ES] (+5) EC: C12Q1/68M4 IPC: C12Q1/68 Publication info: WO2012019786 (A1) 2012-02-16 Priority date: 2010-08-09 3. USE OF THE COMPOUND N-PHENYL-N'-(3-METHYL-2-BUTENYL)THIOUREA FOR PRODUCING MEDICAMENTS FOR THE TREATMENT OF HEPATIC ENCEPHALOPATHY Inventor: BAUTISTA PALOMAS JUAN DIONISIO DIAZ HERRERO MARIA DEL MAR (+5) Applicant: FUNDACION PUBLICA ANDALUZA PARA LA GESTION DE LA INVESTIGACION EN SALUD DE SEVILLA [ES] UNIV SEVILLA (+2) EC: IPC: A61K31/17 Publication info: ES2362770 (A1) 2011-07-13 Priority date: 2009-12-24 4. USE OF RNASE P AS ANTIVIRAL AGENT Inventor: MENA PINEIRO IGNACIO GOMEZ CASTILLA JORDI (+2) Applicant: CONSEJO SUPERIOR INVESTIGACION [ES] CT INVESTIGACION BIOMEDICA EN RED AREA TEMATICA ENFERMEDADES HEPATICAS Y DIGESTIVAS CIBEREHD (+2) EC: C12N15/113A IPC: A61P31/14 C12N15/11 Publication info: ES2349970 (A1) 2011-01-13 ES2349970 (B1) 2011-11-28 Priority date: 2008-11-11 PCT: 1.WOWO/2012/048236 - MICRORNAS (MIRNA) AS BIOMAKERS FOR THE IDENTIFICATION OF FAMILIAL AND NON-FAMILIAL COLORECTAL CANCER12.04.2012 C12Q 1/68 PCT/US2011/055391BAYLOR RESEARCH INSTITUTEGOEL, Ajay

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A technique for the analysis of global miRNA signatures including a larger panel of miRNAs in various roups of well-characterized colorectal cancers (CRCs) is described in the instant invention. The results presented herein provide a large list of miRNAs that are dysregulated in CRC compared to the normal colonic tissue, and, more importantly, the present invention shows for the first time that Lynch syndrome and sporadic MSI tumors exhibit a different miRNA signature that distinguishes them. 2.WOWO/2012/042091 - USE OF TAK1 INHIBITORS IN THE PREVENTION AND TREATMENT OF PERITONEAL MEMBRANE FAILURE05.04.2012 PCT/ES2011/070683CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES (CNIC)DEL POZO BARRIUSO, Miguel Ángel The invention relates to the use of TAK1 inhibitors for the preparation of a drug for the prevention and treatment of peritoneal membrane failure, said use preventing and reversing the mesenchymal-epithelial transition experienced by the mesothelial cells of the peritoneum during peritoneal dialysis treatment. In addition, the invention relates to the use of a TAK1 expression product or of its activity as a biomarker for determining peritoneal fibrosis. The invention further relates to the method for obtaining data that can be used in the diagnosis and/or prognosis of peritoneal fibrosis and to a method for predicting the progression of peritoneal fibrosis. The invention also relates to the use of a kit comprising the sequence that codes for TAK1 or the protein for the diagnosis of peritoneal fibrosis. 3.WOWO/2012/019786 - METHOD AND KIT FOR THE DIAGNOSIS AND/OR PROGNOSIS OF TOLERANCE IN LIVER TRANSPLANTATION16.02.2012 C12Q 1/68 PCT/EP2011/053127HOSPITAL CLINIC DE BARCELONASÁNCHEZ FUEYO, Alberto The invention refers to a method and kit for the in vitro diagnosis and/or prognosis of the tolerant state of a patient to be submitted to liver transplantation, which comprises assessing the level of systemic and/or intra-hepatic iron stores in a biological sample obtained from the patient under investigation, and comparing it either with the level of iron stores of a reference sample, or with a predetermined threshold. 4.EP2418288 - Method and kit for the diagnosis and prognosis of tolerance in liver transplantation employing liver tissue15.02.2012 C12Q 1/68 10382224HOSPITAL CLINIC DE BARCELONASANCHEZ FUEYO ALBERTO 5.ES2362770 - USO DE COMPUESTO N-FENIL-N'-(3-METIL-2-BUTENIL)TIOUREA PARA LA ELABORACION DE MEDICAMENTOS DESTINADOS AL TRATAMIENTO DE LA ENCEFALOPATIA HEPATICA.13.07.2011 A61K 31/17 200931265FUNDACION PUBLICA ANDALUZA PARA LA GESTION DE LA INVESTIGACION EN SALUD DE SEVILLA (47,50%)BAUTISTA PALOMAS JUAN DIONISIO Uso del compuesto N-fenil-N''-(3-metil-2-butenil)tiourea para la elaboración de medicamentos destinados al tratamiento de la encefalopatía hepática.La presente invención se refiere a una composición farmacéutica que comprende el compuesto N-fenil-N''-(3-metil-2-butenil)tiourea y al uso del compuesto N-fenil-N''-(3-metil-2-butenil)tiourea y de dicha composición farmacéutica en la elaboración de medicamentos destinados al tratamiento de enfermedades que cursan con hiperamoniemia, como por ejemplo, pero sin limitarnos, la encefalopatía hepática en general o la encefalopatía hepática provocada por cirrosis en particular. Este compuesto es capaz de inhibir parcialmente la actividad enzimática de la

43

glutaminasa intestinal activada por fosfato (GAP), provocando una reducción en la producción de amonio. 6.WOWO/2011/076967 - USE OF THE COMPOUND N-PHENYL-N'-(3-METHYL-2-BUTENYL)THIOUREA FOR PRODUCING MEDICAMENTS FOR THE TREATMENT OF HEPATIC ENCEPHALOPATHY30.06.2011 A61K 31/17 PCT/ES2010/070855FUNDACIÓN PÚBLICA ANDALUZA PARA LA GESTIÓN DE LA INVESTIGACIÓN EN SALUD DE SEVILLAROMERO GÓMEZ, Manuel The invention relates to a pharmaceutical composition comprising the compound N-phenyl-N'-(3-methyl-2-butenyl)thiourea and to the use of the compound N-phenyl-N'-(3-methyl-2-butenyl)thiourea and said pharmaceutical composition in the production of medicaments for the treatment of illnesses involving hyperammonemia, such as, but not limited to, hepatic encephalopathy in general or hepatic encephalopathy caused by cirrhosis in particular. Said compound can partially inhibit the enzymatic activity of intestinal phosphate-activated glutaminase (PAG), causing a reduction in the production of ammonium. 7.ES2349970 - USO DE LA RNASA P COMO AGENTE ANTIVIRAL.13.01.2011 C12N 15/11 200803224CONSEJO SUPERIOR DE INVESTIGACIONES CIENTIFICAS (CSIC)MENA PINEIRO IGNACIO Uso de la RNasa P como agente antiviral. Uso de la RNasa P de Synechocysitis sp. para inhibir la replicación de virus de RNA, y para la elaboración de medicamentos para el tratamiento de enfermedades provocadas por virus de RNA. 8.WOWO/2010/055187 - USE OF RNASE P AS ANTIVIRAL AGENT20.05.2010 PCT/ES2009/070497CONSEJO SUPERIOR DE INVESTIGACIONES CIENTÍFICAS (CSIC) (34%)GÓMEZ CASTILLA, Jordi Use of the RNase P of Synechocysitis sp. to inhibit replication of RNA virus and for the production of medicaments for the treatment of diseases caused by RNA virus. 9.WOWO/2010/045470 - COMPOSITIONS, KITS, AND METHODS FOR IDENTIFICATION, ASSESSMENT, PREVENTION, AND THERAPY OF HEPATIC DISORDERS22.04.2010 G01N 33/53 CT/US2009/060859DANA-FARBER CANCER INSTITUTE, INC.GOLUB, Todd, R. The invention relates to compositions, kits, and methods for detecting, characterizing, preventing, and treating hepatic disorders such as hepatocellular carcinoma and/or cirrhosis. A variety of informative biomarkers corresponding thereto, are provided, wherein alterations in expression relative to a control is correlated with the presence of a hepatic disorder, likelihood of survival from a hepatic disorder, and likelihood of recurrence of a hepatic disorder.

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PUBLICATIONS RESULT FROM CLINICAL TRIALS CIBERehd 2011 1: Bohne F, Martínez-Llordella M, Lozano JJ, Miquel R, Benítez C, Londoño MC, Manzia TM, Angelico R, Swinkels DW, Tjalsma H, López M, Abraldes JG, Bonaccorsi-Riani E, Jaeckel E, Taubert R, Pirenne J, Rimola A, Tisone G, Sánchez-Fueyo A. Intra-graft expression of genes involved in iron homeostasis predicts the development of operational tolerance in human liver transplantation. J Clin Invest. 2012 Jan 3;122(1):368-82. doi: 10.1172/JCI59411. Epub 2011 Dec 12. PubMed PMID: 22156196; PubMed Central PMCID: PMC3248302. 2: Abulí A, Fernández-Rozadilla C, Alonso-Espinaco V, Muñoz J, Gonzalo V, Bessa X, González D, Clofent J, Cubiella J, Morillas JD, Rigau J, Latorre M, Fernández-Bañares F, Peña E, Riestra S, Payá A, Jover R, Xicola RM, Llor X, Carvajal-Carmona L, Villanueva CM, Moreno V, Piqué JM, Carracedo A, Castells A, Andreu M, Ruiz-Ponte C, Castellví-Bel S; Gastrointestinal Oncology Group of the Spanish Gastroenterological Association. Case-control study for colorectal cancer genetic susceptibility in EPICOLON: previously identified variants and mucins. BMC Cancer. 2011 Aug 5;11:339. PubMed PMID: 21819567; PubMed Central PMCID: PMC3176240. 3: Abulí A, Fernández-Rozadilla C, Giráldez MD, Muñoz J, Gonzalo V, Bessa X, Bujanda L, Reñé JM, Lanas A, García AM, Saló J, Argüello L, Vilella A, Carreño R, Jover R, Xicola RM, Llor X, Carvajal-Carmona L, Tomlinson IP, Kerr DJ, Houlston RS, Piqué JM, Carracedo A, Castells A, Andreu M, Ruiz-Ponte C, Castellví-Bel S; Gastrointestinal Oncology Group of the Spanish Gastroenterological Association. A two-phase case-control study for colorectal cancer genetic susceptibility: candidate genes from chromosomal regions 9q22 and 3q22. Br J Cancer. 2011 Sep 6;105(6):870-5. doi: 10.1038/bjc.2011.296. Epub 2011 Aug 2. PubMed PMID: 21811255; PubMed Central PMCID: PMC3171011. 4: Fernández-Esparrach G, Ayuso-Colella JR, Sendino O, Pagés M, Cuatrecasas M, Pellisé M, Maurel J, Ayuso-Colella C, González-Suárez B, Llach J, Castells A, Ginès A. EUS and magnetic resonance imaging in the staging of rectal cancer: a prospective and comparative study. Gastrointest Endosc. 2011 Aug;74(2):347-54. PubMed PMID: 21802588. 5: Rimola J, Ordás I, Rodriguez S, García-Bosch O, Aceituno M, Llach J, Ayuso C, Ricart E, Panés J. Magnetic resonance imaging for evaluation of Crohn's disease: validation of parameters of severity and quantitative index of activity. Inflamm Bowel Dis. 2011 Aug;17(8):1759-68. doi: 10.1002/ibd.21551. Epub 2010 Nov 8. PubMed PMID: 21744431. 6: Sangro B, Carpanese L, Cianni R, Golfieri R, Gasparini D, Ezziddin S, Paprottka PM, Fiore F, Van Buskirk M, Bilbao JI, Ettorre GM, Salvatori R, Giampalma E, Geatti O, Wilhelm K, Hoffmann RT, Izzo F, Iñarrairaegui M, Maini CL, Urigo C, Cappelli A, Vit A, Ahmadzadehfar H, Jakobs TF, Lastoria S; European Network on Radioembolization with Yttrium-90 Resin Microspheres (ENRY). Survival after yttrium-90 resin microsphere radioembolization of hepatocellular carcinoma across Barcelona clinic liver cancer stages: a European evaluation. Hepatology. 2011 Sep 2;54(3):868-78. doi: 10.1002/hep.24451. Epub 2011 Jun 30. PubMed PMID: 21618574. 7: Lucena MI, Molokhia M, Shen Y, Urban TJ, Aithal GP, Andrade RJ, Day CP, Ruiz-Cabello F, Donaldson PT, Stephens C, Pirmohamed M, Romero-Gomez M, Navarro JM, Fontana RJ, Miller M, Groome M, Bondon-Guitton E, Conforti A, Stricker BH, Carvajal A, Ibanez L, Yue QY, Eichelbaum M, Floratos A, Pe'er I, Daly MJ, Goldstein DB, Dillon JF, Nelson MR, Watkins PB, Daly AK; Spanish DILI Registry; EUDRAGENE; DILIN; DILIGEN; International SAEC. Susceptibility to amoxicillin-clavulanate-

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induced liver injury is influenced by multiple HLA class I and II alleles. Gastroenterology. 2011 Jul;141(1):338-47. Epub 2011 Apr 12. PubMed PMID: 21570397; PubMed Central PMCID: PMC3129430. 8: Lanas A, Garcia-Tell G, Armada B, Oteo-Alvaro A. Prescription patterns and appropriateness of NSAID therapy according to gastrointestinal risk and cardiovascular history in patients with diagnoses of osteoarthritis. BMC Med. 2011 Apr 14;9:38. PubMed PMID: 21489310; PubMed Central PMCID: PMC3101123. 9: Trapero-Marugán M, Mendoza J, Moreno Monteagudo JA, Chaparro M, García-Buey L, González-Moreno L, Borque MJ, Moreno-Otero R. Current antiviral combination therapy for chronic hepatitis C patients who failed to interferon alfa-based treatment. J Clin Pharm Ther. 2011 Dec;36(6):695-703. doi: 10.1111/j.1365-2710.2010.01231.x. Epub 2010 Dec 22. PubMed PMID: 21175705. BUSINESSES CREATED

Although there have been no new in the annuity, continue in operation the ones created in the last years. Renal MD. Partners. CIC bioGUNE, CICbiomaGUNE, Kidney Foundation and Hospital Clínic Barcelona. Spin off created collaboratively by Dr. Mato and Dr. Fernández-Checa CIBERehd groups. Image & Physiology. NIF B63515464. Blanco A, Clave P. Company dedicated to developing and marketing methods to study human gastrointestinal physiology and clinical diagnostic methods based on image analysis. Cytochrome SC. CIF: G-83528505. Luis G. Guijarro www.cytochromesalud.com.

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COLABORATION AGREEMENTS 2011 “Convenio de colaboración entre el Institut de Investigacions Biomèdiques August Pi i Sunyer y Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas” Aim: encouragement of the participation of research professionals in the area of liver, digestive system and metabolism (Program 3) Date: 01/01/2011 “Acuerdo de Colaboración entre la Corporación Sanitària Parc Taulí y el Consorcio Centro de Investigación Biomédica en el área temática de Enfermedades Hepáticas y Digestivas” Aim: establishing the cooperation conditions for the development of the research project "Perfil de expresión de microRNAs en la infección por Helicobacter pylori” carried out in Dr. Xavier Calvet’s Group within CIBERehd-Corporación Sanitaria Parc Taulí Date: 03/01/2011 “Convenio de Colaboración en Investigación en Investigación Científica y Técnica entre CIBERHED y la Compañía GILEAD SCIENCES, SL” Aim: regulate the terms and conditions under which GILEAD will contribute to carry out the activities of Platform for hepatitis B Date: 05/01/2011 “Convenio de colaboración entre el Hospital Clínico y Provincial de Barcelona y el Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd)” Aim: establishing the cooperative conditions for the development of coordination tasks and scientific direction of CIBERehd within the HCPB in relation to the scientific objectives of CIBERehd and the implementation of the directives given by the ISCIII Date: 12/01/2011 “Acuerdo de colaboración entre la Institut d’Investigacións Biomèdiques August Pi i Sunyer y el Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas” Aim: establishing the cooperation conditions for the development of the research project "Molecular predictors of response to Sorafenib as adjuvant therapy after resection in hepatocellular carcinoma, Tissue biomarker study of the STORM randomized trial (BIIO-STORM), carried out in Dr. Bruix’s Group under the supervision as PI of Dr. Llovet. Date: 12/01/2011 “Annex to Convenio de Colaboración entre la Universitat de València y el Consorcio Centro de Investigación Biomédica en el Área temática de Enfermedades Hepáticas y Digestivas” Aim: extend the term of the collaboration agreement dated November 25, 2010 a year Date: 01/02/2011 “License Agreement between el Servicio Andaluz de salud, la Universidad de Sevilla, el Consorcio Centro de Investigación Biomédica en el Área Temática de Enfermedades Hepáticas y Digestivas, y Janus Development, SL”

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Aim: granting exclusive license to use and operation of Patent Date: 23/02/2011 “Acuerdo de colaboración entre la Fundació Clínic per a la Recerca Biomédica y el Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas” Aim: establishing the cooperation conditions for the development of the research project "Cultivo y caracterización de Liver Cancer Stem Cells", carriedn out in Dr. Jordi Bruix’s Group within CIBERehd-FCRB Date: 07/03/2011 “Addenda al Convenio de Colaboración suscrito el 30 de abril de 2010 entre el Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas y la Fundación para la Formación e Investigación Sanitarias de la región de Murcia” Aim: establishment of conditions for the provision of additional funds for development and strengthening of activities in Dr. Pascual Parilla’s group Date: 07/04/2011 “Anexos al Convenio de cooperación educativa entre el Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas y la Universidad de Salamanca” Aim: conditions of work experience in the CIBERehd by students of the Faculty of Biology, University of Salamanca Date: 18/05/2011 “Anexos al Convenio de cooperación educativa entre el Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas y la Universidad de Salamanca” Aim: conditions of work experience in the CIBERehd by students of the Faculty of Biology, University of Salamanca Date: 18/05/2011 “Acuerdo de Colaboración entre la Universidad de Salamanca y el Consorcio Centro de Investigación Biomédica en el área Temática de Enfermedades Hepáticas y Digestivas” Aim: establishing the cooperation conditions for the development of the research project "Predicción y superación de la resistencia a la quimioterapia en tumores hepáticos e intestinales" carried out in Dr. José Juan García Marín’s Group. Date: 01/06/2011 “Acuerdo de Colaboración entre el el Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas y la Universidad de Granada”Aim: establishing the cooperation conditions for the development of the research project "Búsqueda de nuevos productos naturales activos en la enfermedad inflamatoria intestinal" carried out in Dr. Antonio Zarzuelo’s Group. Date: 06/06/2011 “Convenio de Colaboración CIBERehd-Merck Sharp & DOHME DE ESPAÑA, S.A”. Aim: regulating the terms under which Merck Sharp & Dohme SPAIN, SA will help the CIBERehd perform actividadades the group of Dr. Javier Perez Gisbert Date: 16/06/2011

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“Anexos al Convenio de cooperación educativa entre el Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas y la Universidad de Salamanca Aim: conditions of work experience in the CIBERehd by students of the Faculty of Biology, University of Salamanca Date: 28/06/2011 “Acuerdo de Colaboración entre la Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca y el CIBERehd” Aim: establishing the cooperation conditions for the development of the research project "Permeabilidad Intestinal e Inflamación" carried out in Dr. Francisco Guarner’s group Date: 01/07/2011 “Anexos al Convenio de cooperación educativa entre el Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas y la Universidad de Salamanca” Aim: conditions of work experience in the CIBERehd by students of the Faculty of Biology, University of Salamanca Date: 22/07/2011 “Acuerdo de Colaboración entre la Fundació Clínic per a la recerca Biomèdica y el Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas” Aim: establishing the cooperation conditions for the development of the research project "Desarrollo de un test transcripcional de tolerancia en el transplante hepático" carried out in Dr. Antoni Rimola’s Group and under the supervision as IP of Dr. Alberto Sánchez-Fueyo. Date: 27/07/2011 “Acuerdo de colaboración entre el grupo de investigación CIBERehd CSDM-UAB y el Consorcio Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas” Aim: establishing the cooperation conditions for the development of the research project "Diferenciación Mastoctaria en el síndrome de intestino irritable y el ileo postoperatorio", carried out in the grupo Ciberehd CsdM-UAB. Date: 30/09/2011 “Acuerdo específico de cotitularidad entre el Centro de Investigación Biomédica en Red: Enfermedades hepáticas y Digestivas y la Universidad Autónoma de Madrid de la invención titulada: Método para detectar el riesgo a padecer fibrosis hepática en pacientes con hepatitis C crónica”. Aim: ownership agreement of intellectual property Date: 01/09/2011 “Intellectual property agreement” between Baylor Research Institute, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas and Hospital Clínic. Aim: ownership agreement of intellectual property Date: 19/11/2011 “Acuerdo de Colaboración entre la Fundació Clínic per a la Recerca y el CIBERehd” Aim: establishing the cooperation conditions for the development of the research line " lipid mediators of inflammation and liver damage " carried out in Dr. Vicente Arroyo’s Group under the supervision of Dr. Joan Clarià

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Date: 03/10/2011 “Anexos al Convenio de cooperación educativa entre el Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas y la Universidad de Salamanca” Aim: conditions of work experience in the CIBERehd by students of the Faculty of Biology, University of Salamanca Date: 04/10/2011 “Intellectual property agreement” between Baylor Research Institute, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas and Hospital Clínic. Aim: ownership agreement of intellectual property Date: 07/10/2011 “Contrato de cotitularidad y explotación de patente”. Hospital Clínic. Aim: ownership agreement of intellectual property Date: 05/12/2011 “Convenio de Colaboración”. Merck Sharp & Dohme España, SA. Aim: MSD contribution to the activities of CIBERehd Date: 19/09/2011 “Contrato de cotitularidad y explotación de patente”. Hospital Clínic. Aim: ownership agreement of intellectual property Date: 21/12/2011

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Outreach activities Bosch J: “CIBER de Enfermedades hepáticas y digestivas, un modelo de investigación traslacional”. I Foro de Investigadores de la Fundación Pfizer: Grandes retos actuales en la investigación biomédica e instrumentos para el desarrollo de una investigación de vanguardia en España. ISCiii. Madrid, 28 de abril de 2011.

J. Bosch. Participación en calidad de Director Científico del CIBERehd en las Conferencias Científicas Año Dual Rusia España. Russian-Spanish Innovation Bussiness-Forum. May 12-14, 2011. Madrid. Co-organizado por nuestros Ministerios de Ciencia e Innovación y Ministerio de Educación y el Ministerio de Educación y Ciencia Ruso.

J Bosch. Organizador de las V Jornadas Científicas del CIBER de Enfermedades Hepáticas y Digestivas, celebradas en el Hotel Barceló Sants- Barcelona los días 22 y 23 de noviembre de 2011.

Bosch J. Conferencia especial: “Importancia de las estructuras de investigación cooperativa”. I Jornadas de Investigación del Instituto de Investigación Sanitaria Hospital Gregorio Marañón. Madrid, 14 de diciembre de 2011.

Events and activities It is impossible to detail all the news and events in which the CIBERehd is involved in a year. The following are some of the events and activities we have carried out during 2011 which are worth highlighting. All news and events related to the center can be followed on our website: www.ciberehd.org.es

The CIBERehd assists in editing the manual: “Treatment of Gastroenterological Diseases”. Barcelona Clinic Liver Cancer (BCLC) day: the 25th anniversary. 25 years of liver cancer at the Hospital Clínic of Barcelona. The 72nd Nestle nutrition workshop intitute: stepping stones to Living Well with dysphagia II International Course on Oropharyngeal Dysphagia XXII National Day of gastrointestinal ultrasound CIBERHEP is born, the first record with data from patients with hbc (medical journal 21 to 18 | February 27, 2011 V Annual Meeting of CIBERehd Roundtable, Madrid Science Week: Translational research in the service of the patient (Madrid November 15, 2011) Panel, Barcelona Science Week: Translational research in the service of the patient (Barcelona November 24, 2011) Bosch J, Lalleman W. Early Morning Workshop on “Advances in Portal Hypertension”. 46th Annual Meeting of the European Association for the Study of the Liver. Berlin, Germany. March 30-April 3, 2011, Berlin, 02 Abril 2011.

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List of papers published during 2011

1. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med Authors: Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Authors CIBERehd: Elizalde JI 2. Deep resequencing of GWAS loci identifies independent rare variants associated with inflammatory bowel disease. Nat Genet. Authors: Rivas MA, Beaudoin M, Gardet A, Stevens C, Sharma Y, Zhang CK, Boucher G, Ripke S, Ellinghaus D, Burtt N, Fennell T, Kirby A, Latiano A, Goyette P, Green T, Halfvarson J, Haritunians T, Korn JM, Kuruvilla F, Lagacé C, Neale B, Lo KS, Schumm P, Törkvist L; National Institute of Diabetes and Digestive Kidney Diseases Inflammatory Bowel Disease Genetics Consortium (NIDDK IBDGC); United Kingdom Inflammatory Bowel Disease Genetics Consortium; International Inflammatory Bowel Disease Genetics Consortium, Dubinsky MC, Brant SR, Silverberg MS, Duerr RH, Altshuler D, Gabriel S, Lettre G, Franke A, D'Amato M, McGovern DP, Cho JH, Rioux JD, Xavier RJ, Daly MJ. Authors CIBERehd: Panés J 3. Meta-analysis identifies 29 additional ulcerative colitis risk loci, increasing the number of confirmed associations to 47. Nature Genetics Authors: CA Anderson, G Boucher, CW Lees, A Franke, M D'Amato, KD Taylor, JC Lee, P Goyette, M Imielinski, A Latiano, C Lagacé, R Scott, L Amininejad, S Bumpstead, L Baidoo, RNBaldassano, M Barclay, TM Bayless, S Brand, C Büning, JF Colombel, LA Denson, M De Vos, M Dubinsky, C Edwards, D Ellinghaus, RS Fehrmann, JA Floyd, T Florin, D Franchimont, L Franke, M Georges, JGlas, NL Glazer, SL Guthery, A Haritunians, NK Hayward, JP Hugot, G Jobin, D Laukens, I Lawrance, M Lémann, A Levine, C Libioulle, E Louis, DP McGovern, M Milla, GW Montgomery, KI Morley, C Mowat, A Ng, W Newman, RA Ophoff, L Papi, O Palmieri, L Peyrin-Biroulet, J Panés, A Phillips, NJ Prescott, DD Proctor, R Roberts, R Russell, P Rutgeerts, J Sanderson, M Sans, P Schumm, F Seibold, Y Sharma, LA Simms, M Seielstad, AH Steinhart, SR Targan, LH van den Berg, M Vatn, H Verspaget, T Walters, C Wijmenga, DC Wilson, HJ Westra, RJ Xavier, ZZ Zhao, CY Ponsioen, V Andersen, L Torkvist, M Gazouli, NP Anagnou, TH Karlsen, L Kupcinskas, J Sventoraityte, JC Mansfield, S Kugathasan, MS Silverberg, J Halfvarson, JI Rotter, CG Mathew, AM Griffiths, R Gearry, T Ahmad, SR Brant, M Chamaillard, J Satsangi, JH Cho, S Schreiber, MJ Daly, JC Barrett, M Parkes, V Annese, H Hakonarson, G Radford-Smith, RH Duerr, S Vermeire, RK Weersma, JD Rioux Authors CIBERehd: Panés J, Sans M

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4. Enterotypes of the human gut microbiome Nature Authors: Arumugam M, Raes J, Pelletier E, Le Paslier D, Yamada T, Mende DR, Fernandes GR, Tap J, Bruls T, Batto JM, Bertalan M, Borruel N, Casellas F, Fernandez L, Gautier L, Hansen T, Hattori M, Hayashi T, Kleerebezem M, Kurokawa K, Leclerc M, Levenez F, Manichanh C, Nielsen HB, Nielsen T, Pons N, Poulain J, Qin J, Sicheritz-Ponten T, Tims S, Torrents D, Ugarte E, Zoetendal EG, Wang J, Guarner F, Pedersen O, de Vos WM, Brunak S, Doré J; MetaHIT Consortium, Antolín M, Artiguenave F, Blottiere HM, Almeida M, Brechot C, Cara C, Chervaux C, Cultrone A, Delorme C, Denariaz G, Dervyn R, Foerstner KU, Friss C, van de Guchte M, Guedon E, Haimet F, Huber W, van Hylckama-Vlieg J, Jamet A, Juste C, Kaci G, Knol J, Lakhdari O, Layec S, Le Roux K, Maguin E, Mérieux A, Melo Minardi R, M'rini C, Muller J, Oozeer R, Parkhill J, Renault P, Rescigno M, Sanchez N, Sunagawa S, Torrejon A, Turner K, Vandemeulebrouck G, Varela E, Winogradsky Y, Zeller G, Weissenbach J, Ehrlich SD, Bork P. Authors CIBERehd: Borruel N, Casellas F, Manichanh C, Guarner F, Antolín M, Torrejón A, Varela E 5. Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial. Lancet Authors: Malfertheiner P, Bazzoli F, Delchier JC, Celiñski K, Giguère M, Rivière M, Mégraud F; Pylera Study Group. Authors CIBERehd: Gisbert JP, Calvet X (dentro del Pylera Study Group) 6. Validation microsatellite path score in a population-based cohort of patients with colorectal canceR J Clin Oncol Authors: Bessa X, Alenda C, Paya A, Álvarez C, Iglesias M, Seoane A, Dedeu JM, Abulí A, Ilzarbe L, Navarro G, Pellise M, Balaguer F, Castellvi-Bel S, Llor X, Castells A, Jover R, Andreu M Authors CIBERehd: Pellisé M, Balaguer F, Castellvi-Bel S, Llor X, Castells A, Jover R 7. Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: a Spanish Group for Research on Sarcomas study. J Clin Oncol Authors: García-Del-Muro X, López-Pousa A, Maurel J, Martín J, Martínez-Trufero J, Casado A, Gómez-España A, Fra J, Cruz J, Poveda A, Meana A, Pericay C, Cubedo R, Rubió J, De Juan A, Laínez N, Carrasco JA, de Andrés R, Buesa JM; Spanish Group for Research on Sarcomas. Authors CIBERehd: Maurel J 8. Smoking, hepatitis B virus infection, and development of hepatocellular carcinoma

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Journal of the National Cancer Institute Authors: Sherman M, Llovet JM. Authors CIBERehd: Llovet JM 9. Hepatocellular carcinoma enters the sequencing era Gastroenterology Authors: Villanueva A, Hoshida J, Llovet JM Authors CIBERehd: Villanueva A, Llovet JM 10. Alcoholic Liver Disease: Pathogenesis and New Therapeutic Targets Gastroenterology Authors: Gao B (1), Bataller (2). Authors CIBERehd: Bataller R 11. Complementary function of the flippase ATP8B1 and the floppase ABCB4 in maintenance of canalicular membrane integrity Gastroenterology Authors: Groen AK, Romero MR, Kunne C, Hoosdally SJ, Dixon PH, Wooding C, Williamson C, Seppen J, van den Oever K, Mok KS, Paulusma CC, Linton KJ, Oude Elferink RP Authors CIBERehd: Romero MR 12. Susceptibility to amoxicillin-clavulanate-induced liver injury is influenced by multiple HLA class I and II alleles Gastroenterology Authors: Lucena MI, Molokhia M, Shen Y, Urban TJ, Aithal GP, Andrade RJ, Day CP, Ruiz-Cabello F, Donaldson PT, Stephens C, Pirmohamed M, Romero-Gomez M, Navarro JM, Fontana RJ, Miller M, Groome M, Bondon-Guitton E, Conforti A, Stricker BH, Carvajal A, Ibanez L, Yue QY, Eichelbaum M, Floratos A, Pe'er I, Daly MJ, Goldstein DB, Dillon JF, Nelson MR, Watkins PB, Daly AK; Spanish DILI Registry; EUDRAGENE; DILIN; DILIGEN; International SAEC Authors CIBERehd: Lucena MI, Andrade RJ, Stephens C, Romero-Gomez M 13. Radiofrequency ablation for nondysplastic Barrett's esophagus: to treat or not to treat? Gastroenterology Authors: Fernández-Esparrach G, Panés J. Authors CIBERehd: Fernández- Esparrach G 14. The search for an effective partner for sorafenib: the failure of Doxorubicin. Gastroenterology Authors: Reig M, Bruix J. Authors CIBERehd: Reig M, Bruix J

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15. Maintenance therapy with Peginterferon Alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C. Gastroenterology Authors: Bruix J, Poynard T, Colombo M, Schiff E, Burak K, Heathcote EJ, Berg T, Poo JL, Mello CB, Guenther R, Niederau C, Terg R, Bedossa P, Boparai N, Griffel LH, Burroughs M, Brass CA, Albrecht JK; EPIC3 Study Group Authors CIBERehd: Bruix J 16. Targeted therapies for hepatocellular carcinoma. Gastroenterology Authors: Villanueva A, Llovet JM Authors CIBERehd: Villanueva A, Llovet JM 17. MicroRNA-Based Classification of Hepatocellular Carcinoma and Oncogenic Role of miR-517a Gastroenterology Authors: Toffanin S, Hoshida Y, Lachenmayer A, Villanueva A, Cabellos L, Minguez B, Savic R, Ward SC, Thung S, Chiang DY, Alsinet C, Tovar V, Roayaie S, Schwartz M, Bruix J, Waxman S, Friedman SL, Golub T, Mazzaferro V, Llovet JM Authors CIBERehd: Villanueva A, , Minguez B, Tovar V, Bruix J, Llovet JM 18. Combining clinical, pathology, and gene expression data to predict recurrence of hepatocellular carcinoma Gastroenterology Authors: Villanueva A, Hoshida Y, Battiston C, Tovar V, Sia D, Alsinet C, Cornella H, Liberzon A, Kobayashi M, Kumada H, Thung SN, Bruix J, Newell P, April C, Fan JB, Roayaie S, Mazzaferro V, Schwartz ME, Llovet JM. Authors CIBERehd: Villanueva A, Bruix J, Llovet JM 19. Eosinophils express muscarinic receptors and corticotropin-releasing factor to disrupt the mucosal barrier in ulcerative colitis Gatroenterology Authors: Wallon C, Persborn M, Jonsson M, Wang A, Phan V, Lampinen M, Vicario M, Santos J, Sherman PM, Carlson M, Ericson AC, McKay DM, Soderholm JD Authors CIBERehd: Vicario M, Santos J 20. Confocal endomicroscopy in celiac disease. Gastroenterology Authors: Pellisé M, Panés J. Authors CIBERehd: Pellisé M, Panés J. 21. The clonal origins of dysplasia from intestinal metaplasia in the human stomach.

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Gastroenterology Authors: Gutierrez-Gonzalez L, Graham TA, Rodriguez-Justo M, Leedham SJ, Novelli MR, Gay LJ, Ventayol-Garcia T, Green A, Mitchell I, Stoker DL, Preston SL, Bamba S, Yamada E, Kishi Y, Harrison R, Jankowski JA, Wright NA, McDonald SA. Authors CIBERehd: Gutierrez-Gonzalez L 22. 5-Fluorouracil adjuvant chemotherapy does not increase survival in patients with CpG island methylator phenotype colorectal cancer. Gastroenterology Authors: Jover R, Nguyen TP, Pérez-Carbonell L, Zapater P, Payá A, Alenda C, Rojas E, Cubiella J, Balaguer F, Morillas JD, Clofent J, Bujanda L, Reñé JM, Bessa X, Xicola RM, Nicolás-Pérez D, Castells A, Andreu M, Llor X, Boland CR, Goel A. Authors CIBERehd: Castells A 23. Immunologic basis of graft rejection and tolerance following transplantation of liver or other solid organs Gastroenterology Authors: Sánchez-Fueyo A, Strom TB Authors CIBERehd: Sánchez-Fueyo A 24. Telaprevir is effective given every 8 or 12 hours with ribavirin and peginterferon alfa-2a or -2b to patients with chronic hepatitis C. Gastroenterology Authors: Marcellin P, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Serfaty L, De Backer K, Van Heeswijk R, Luo D, Picchio G, Beumont M. Authors CIBERehd: Forns X 25. Three-Year Efficacy and Safety of Tenofovir Disoproxil Fumarate Treatment for Chronic Hepatitis B Gastroenterology Authors: Heathcote EJ, Marcellin P, Buti M, Gane E, De Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Gurel S, Snow-Lampart A, Borroto-Esoda K, Mondou E, Anderson J, Sorbel J, Rousseau F. Authors CIBERehd: Buti M 26. Prognostic Importance of the Cause of Renal Failure in Patients With Cirrhosis Gastroenterology Authors: Martin-Llahi M (1,2,3), Guevara M (1,2,3), Torre A (1,2,3), Fagundes C (1,2,3), Restuccia T (1,2,3), Gilabert R (1,2,3), Sola E (1,2,3), Pereira G (1,2,3), Marinelli M (1,2,3), Pavesi M (1,2,3), Fernandez J (1,2,3), Rodes J (1,2,3), Arroyo V (1,2,3), Gines P (1,2,3). Authors CIBERehd: Guevara M, Gilabert R, Pavesi M , Fernandez J , Arroyo V , Gines P

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27. Mitochondrial interference by anti-HIV drugs: mechanisms beyond Pol-γ inhibition. Trends Pharmacol Sci. Authors: Apostolova N, Blas-García A, Esplugues JV. Authors CIBERehd: Apostolova N, Blas-García A, Esplugues JV. 28. Cognitive dysfunction in cirrhosis is associated with falls. A prospective study. Hepatology Authors: Soriano G, Román E, Córdoba J, Torrens M, Poca M, Torras X, Villanueva C, Gich IJ, Vargas V, Guarner C. Authors CIBERehd: Soriano G, Córdoba J, Vargas V, Guarner C. 29. Clinical decision making and research in hepatocellular carcinoma: pivotal role of imaging techniques. Hepatology Authors: Bruix J, Reig M, Rimola J, Forner A, Burrel M, Vilana R, Ayuso C. Authors CIBERehd: Bruix J, Reig M, Forner A 30. Where are we in the search of noninvasive NASH biomarkers? Hepatology Authors: Mato JM, Lu SC. Authors CIBERehd: Mato JM 31. Methionine adenosyltransferase 1A gene deletion disrupts hepatic VLDL assembly in mice Hepatology Authors: Cano A, Buqué X, Martínez-Uña M, Aurrekoetxea I, Menor A, García-Rodriguez JL, Lu SC, Martínez-Chantar ML, Mato JM, Ochoa B, Aspichueta P. Authors CIBERehd: Martínez-Chantar ML, Mato JM 32. Effects of bilirubin and sera from jaundiced patients on osteoblasts: contribution to the development of osteoporosis in liver diseases. Hepatology Authors: Ruiz-Gaspà S, Martinez-Ferrer A, Guañabens N, Dubreuil M, Peris P, Enjuanes A, Martinez de Osaba MJ, Alvarez L, Monegal A, Combalia A, Parés A. Authors CIBERehd: Ruiz-Gaspà S, Guañabens N, Dubreuil M, Peris P, Martinez de Osaba MJ, Alvarez L, Parés A. 33. Connective Tissue Growth Factor Autocriny in Human Hepatocellular Carcinoma: Oncogenic Role and Regulation by Epidermal Growth Factor Receptor/Yes-Associated Protein-Mediated Activation Hepatology

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Authors: Urtasun, R; Latasa, MU; Demartis, MI; Balzani, S; Goni, S; Garcia-Irigoyen, O; Elizalde, M; Azcona, M; Pascale, RM; Feo, F; Bioulac-Sage, P; Balabaud, C; Muntane, J; Prieto, J; Berasain, C; Avila, MA Authors CIBERehd: Muntane J, Prieto J 34. The use of liver biopsy evaluation in discrimination of idiopathic autoimmune hepatitis vs. Drug-Induced Liver Injury. Hepatology 2011 Authors: SUZUKI A, BRUNT EM, KLEINER DE, MIQUEL R, SMYRK TC, ANDRADE RJ, LUCENA MI, CASTIELLA A, LINDOR K, BJÖRNSSON E. Authors CIBERehd: ANDRADE RJ, LUCENA MI 35. Response-guided peg-interferon plus ribavirin treatment duration in chronic hepatitis C: meta-analyses of randomized, controlled trials and implications for the future. Hepatology Authors: Di Martino V, Richou C, Cervoni JP, Sanchez-Tapias JM, Jensen DM, Mangia A, Buti M, Sheppard F, Ferenci P, Thévenot T. Authors CIBERehd: Di Martino V, Richou C, Cervoni JP, Sanchez-Tapias JM, Jensen DM, Mangia A, Buti M, Sheppard F, Ferenci P, Thévenot T. 36. Compromising mitochondrial function with the antiretroviral drug efavirenz induces cell survival-promoting autophagy. Hepatology Authors: Apostolova N, Gomez-Sucerquia LJ, Gortat A, Blas-Garcia A, Esplugues JV. Authors CIBERehd: Apostolova N, Blas-Garcia A, Esplugues JV. 37. Survival After Yttrium-90 Resin Microsphere Radioembolization of Hepatocellular Carcinoma Across Barcelona Clinic Liver Cancer Stages: A European Evaluation Hepatology Authors: Sangro, B; Carpanese, L; Cianni, R; Golfieri, R; Gasparini, D; Ezziddin, S; Paprottka, PM; Fiore, F; Van Buskirk, M; Bilbao, JI; Ettorre, GM; Salvatori, R; Giampalma, E; Geatti, O; Wilhelm, K; Hoffmann, RT; Izzo, F; Inarrairaegui, M; Maini, CL; Urigo, C; Cappelli, A; Vit, A; Ahmadzadehfar, H; Jakobs, TF; Lastoria, S Authors CIBERehd: Sangro B 38. Idiopathic noncirrhotic portal hypertension. Hepatology Authors: Schouten JN, Garcia-Pagan JC, Valla DC, Janssen HL Authors CIBERehd: Garcia-Pagan JC

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39. Toll-Like Receptor 4 and Myeloid Differentiation Factor 88 Provide Mechanistic Insights Into the Cause and Effects of Interleukin-6 Activation in Mouse Liver Regeneration Hepatology Authors: Vaquero J; Campbell JS; Haque J; McMahan RS; Riehle KJ; Bauer RL; Fausto N Authors CIBERehd: Vaquero J 40. Obesity is an independent risk factor for clinical decompensation in patients with cirrhosis Hepatology Authors: Berzigotti A, Garcia-Tsao G, Bosch J, Grace N, Burroughs A, Morillas R, Escorsell A, Garcia-Pagan JC, Patch D, Matloff DS, Groszmann RJ; the Portal Hypertension Collaborative Group. Authors CIBERehd: Berzigotti A, Bosch J, Morillas R, Escorsell A, Garcia-Pagan JC, 41. Critical role of tumor necrosis factor receptor 1, but not 2, in hepatic stellate cell proliferation, extracellular matrix remodeling, and liver fibrogenesis. Hepatology Authors: Tarrats N, Moles A, Morales A, García-Ruiz C, Fernández-Checa JC, Marí M. Authors CIBERehd: Morales A, García-Ruiz C, Fernández-Checa JC, Marí M. 42. Inhibition of Placental Growth Factor Activity Reduces the Severity of Fibrosis, Inflammation, and Portal Hypertension in Cirrhotic Mice Hepatology Authors: Van Steenkiste C (1), R()ibera J (3), Geerts A (1), Pauta M (3), Tugues S (3,5), Casteleyn C (6), Libbrecht L (2), Olievier K (1), Schroyen B (7), Reynaert H (7), van Grunsven LA (7), Blomme EB (1), Coulon S (1), Heindryckx F (1), De Vos m (1), Stassen JM (8), Vinckier S (9), Altamirano J (4), Bataller R (4), Carmeliet P (10,9), Van Vlierberghe H (1), Colle I (1), Morales-Ruiz M (3). Authors CIBERehd: Altamirano J, Bataller R, Morales-Ruiz M. 43. Enhanced T cell responses against hepatitis C virus by ex vivo targeting of adenoviral particles to dendritic cells. Hepatology Authors: Echeverria I, Pereboev A, Silva L, Zabaleta A, Riezu-Boj JI, Bes M, Cubero M, Borras-Cuesta F, Lasarte JJ, Esteban JI, Prieto J, Sarobe P. Authors CIBERehd: Cubero M, Esteban JI, Prieto J, 44. Genetic Variation in IL28B with respect to Vertical Transmission of Hepatitis C Virus and Spontaneous Clearance in HCV Infected Children Hepatology Authors: Ruiz-Extremera, Angela; Muñoz-Gámez, Jose Antonio; Salmeron-Ruiz, Maria Angustias Muñoz de Rueda, Paloma; Quiles-Perez, Rosa; Gila-Medina, Ana; Casado, Jorge;

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Martín, Ana; Sanjuan-Nuñez, Laura; Carazo, Angel; Pavon, Esther Jose; Ocete-Hita, Esther; León, Josefa; Salmeron, Javier. Authors CIBERehd: Ruiz-Extremera, Angela; Muñoz de Rueda, Paloma; Quiles-Perez, Rosa; Gila-Medina, Ana; ; León, Josefa; Salmeron, Javier. 45. Management of hepatocellular carcinoma: an update. Hepatology Authors: Bruix J, Sherman M. Authors CIBERehd: Bruix J 46. Interleukin 10-mediated Heme Oxygenase 1-induced underlying mechanism in inflammatory downregulation by norfloxacin in cirrhosis Hepatology Authors: Isabel Gómez-Hurtado, Pedro Zapater, Pablo Bellot Sonia Pascual, Miguel Pérez-Mateo, José Such, Rubén Francés Authors CIBERehd: Pedro Zapater, Pablo Bellot, Sonia Pascual, José Such, Rubén Francés 47. Hepatitis C virus receptors claudin-1 and occludin after liver transplantation and influence on early viral kinetics. Hepatology Authors: Mensa L, Crespo G, Gastinger MJ, Kabat J, Pérez-del-Pulgar S, Miquel R, Emerson SU, Purcell RH, Forns X. Authors CIBERehd: Pérez-del-Pulgar S, Forns X. 48. Noninvasive assessment of liver fibrosis. Hepatology Authors: Martínez SM, Crespo G, Navasa M, Forns X. Authors CIBERehd: Navasa M, Forns X 49. Improved Dendritic Cell-Based Immunization Against Hepatitis C Virus Using Peptide Inhibitors of Interleukin 10 Hepatology Authors: Diaz-Valdes, N; Manterolal, L; Belsue, V; Riezu-Boj, JI; Larrea, E; Echeverria, I; Llopiz, D; Lopez-Sagaseta, J; Lerat, H; Pawlotsky, JM; Prieto, J; Lasarte, JJ; Borras-Cuesta, F; Sarobe, P Authors CIBERehd: Prieto J 50. Critical role of the liver in the induction of systemic inflammation in rats with preascitic cirrhosis Hepatology Authors: M Úbeda, M Muñoz, MJ Borrero, D Díaz, R Francés, J Montserrat, M Lario, L Lledó, J Such, M Álvarez-Mon, A Albillos

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Authors CIBERehd: R Francés,J Such, M Álvarez-Mon, A Albillos 51. Early use of immunosuppressives or TNF antagonists for the treatment of Crohn's disease: time for a change. Gut Authors: Ordás I, Feagan BG, Sandborn WJ. Authors CIBERehd: Ordás I 52. Hypoxia and proinflammatory factors upregulate apelin receptor expression in human stellate cells and hepatocytes Gut Authors: Melgar-Lesmes P (), Pauta M (), Reichenbach V (), Casals G (), Ros J (), Bataller R (), Morales-Ruiz M (), Jimenez W (). Authors CIBERehd: Bataller R, Morales-Ruiz M , Jimenez W 53. Mesenchymal stem cell therapy of Crohn's disease: are the far-away hills getting closer? Gut Authors: J Panés, D Benitez-Ribas, A Salas. Authors CIBERehd: Panés J 54. Von Willebrand factor levels predict clinical outcome in patients with cirrhosis and portal hypertension. Gut Authors: La Mura V, Reverter JC, Flores-Arroyo A, Raffa S, Reverter E, Seijo S, Abraldes JG, Bosch J, García-Pagán JC. Authors CIBERehd: Abraldes JG, Bosch J, García-Pagán JC. 55. Short- and long-term effects of the transjugular intrahepatic portosystemic shunt on portal vein thrombosis in patients with cirrhosis. Gut Authors: Luca A, Miraglia R, Caruso S, Milazzo M, Sapere C, Maruzzelli L, Vizzini G, Tuzzolino F, Gridelli B, Bosch J Authors CIBERehd: Bosch J 56. The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study. Gut Authors: S Vermeire, S Ghosh, J Panes, JF Dahlerup, A Luegering, J Sirotiakova, U Strauch, G Burgess, J Spanton, SW Martin, W Niezychowski Authors CIBERehd: Panés J 57. Evaluation of esophageal mucosa integrity by intraluminal impedance technique

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Gut Authors: Farré R, Blondeau K, Clement D, Vicario M, Cardozo L, Vieth M, Mertens V, Pauwels A, Jimenez M, Tack J, Sifrim D Authors CIBERehd: Farré R, Jimenez M, Viacario M 58. H1N1 vaccines in a large observational cohort of patients with inflammatory bowel disease treated with immunomodulators and biological therapy Gut Authors: JF Rahier, P Papay, J Salleron, S Sebastian, M Marzo, L Peyrin-Biroulet, V Garcia-Sanchez, W Fries, DP van Asseldonk, K Farkas, NK de Boer, T Sipponen, P Ellul, E Louis, STC Peake, U Kopylov, J Maul, B Makhoul, G Fiorino, Y Yazdanpanah, M Chaparro, for the European Crohn’s and Colitis Organisation (ECCO). Authors CIBERehd: M Chaparro 59. Hepatic fatty acid translocase CD36 upregulation is associated with insulin resistance, hyperinsulinaemia and increased steatosis in non-alcoholic steatohepatitis and chronic hepatitis C Gut Authors: Miquilena-Colina ME, Lima-Cabello E, Sánchez-Campos S, García-Mediavilla MV, Fernández-Bermejo M, Lozano-Rodríguez T, Vargas-Castrillón J, Buqué X, Ochoa B, Aspichueta P, González-Gallego J, García-Monzón C Authors CIBERehd: Sánchez-Campos S, García-Mediavilla MV, Vargas-Castrillón J, González-Gallego J, García-Monzón C 60. Management of patients with cirrhosis awaiting liver transplantation Gut Authors: Cardenas A (1,2), Gines P (2,3). Authors CIBERehd: Gines P 61. Nor-ursodeoxycholic acid reverses hepatocyte-specific nemo-dependent steatohepatitis. Gut Authors: Beraza, Naiara; Ofner-Ziegenfuss, Lisa; Ehedego, Haksier; Boekschoten, Mark; Bischoff, Stephan C.; Mueller, Michael; Trauner, Michael; Trautwein, Christian. Authors CIBERehd: Beraza, Naiara 62. Endothelial expression of transcription factor Kruppel-like factor 2 and its vasoprotective target genes in the normal and cirrhotic rat liver. Gut Authors: Gracia-Sancho J, Russo L, García-Calderó H, García-Pagán JC, García-Cardeña G, Bosch J. Authors CIBERehd: Gracia-Sancho J, Russo L, García-Calderó H, García-Pagán JC, Bosch J.

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