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1. Pretreatment gamma‐glutamyl transferase predicts mortality in patients with chronic hepatitis B treated with nucleotide/nucleoside analogs

Author

Tyng‐Yuan Jang, Po‐Cheng Liang, Dae Won Jun, Jang Han Jung, Hidenori Toyoda, Chih‐Wen Wang, Man‐Fung Yuen, Ka Shing Cheung, Satoshi Yasuda, Sung Eun Kim, Eileen L. Yoon, Jihyun An, Masaru Enomoto, Ritsuzo Kozuka, Makoto Chuma, Akito Nozaki, Toru Ishikawa, Tsunamasa Watanabe, Masanori Atsukawa, Taeang Arai, Korenobu Hayama, Masatoshi Ishigami, Yong Kyun Cho, Eiichi Ogawa, Hyoung Su Kim, Jae‐Jun Shim, Haruki Uojima, Soung Won Jeong, Sang Bong Ahn, Koichi Takaguchi, Tomonori Senoh, Maria Buti, Elena Vargas‐Accarino, Hiroshi Abe, Hirokazu Takahashi, Kaori Inoue, Jee‐Fu Huang, Wan‐Long Chuang, Ming‐Lun Yeh, Chia‐Yen Dai, Chung‐Feng Huang, Mindie H. Nguyen, and Ming‐Lung Yu

Subjects
GGT, HBV, mortality, NA, treatment, Medicine (General), R5-920
Abstract

Abstract Elevated serum gamma‐glutamyl transferase (GGT) levels are associated with chronic hepatitis B (CHB)‐related hepatocellular carcinoma. However, their role in predicting mortality in patients with CHB treated with nucleotide/nucleoside analogs (NAs) remains elusive. Altogether, 2843 patients with CHB treated with NAs were recruited from a multinational cohort. Serum GGT levels before and 6 months (Month‐6) after initiating NAs were measured to explore their association with all‐cause, liver‐related, and non‐liver‐related mortality. The annual incidence of all‐cause mortality was 0.9/100 person‐years over a follow‐up period of 17,436.3 person‐years. Compared with patients who survived, those who died had a significantly higher pretreatment (89.3 vs. 67.4 U/L, p = 0.002) and Month‐6‐GGT levels (62.1 vs. 38.4 U/L, p 75 percentile of pretreatment GGT levels was observed with respect to the all‐cause mortality (trend p

Published
2024
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2. LINK-B: study protocol of a retrospective and prospective project for identification and linkage to care of people living with hepatitis B in a large health area of Barcelona

Author

Ariadna Rando, Maria Buti, FRANCISCO RODRIGUEZ-FRIAS, Rafael Esteban, Ana Barreira Díaz, Anna Feliu-Prius, Adriana Palom, Elena Vargas-Accarino, Judit Vico-Romero, Nieves Palomo, and Mar Riveiro-Barciela

Subjects
Medicine
Abstract

Introduction An estimated 290 million people are living with hepatitis B virus (HBV) worldwide; in Spain, the prevalence of hepatitis B virus surface antigen (HBsAg) is 0.4%. In our setting, many HBsAg-positive individuals are not linked to care, which implies a barrier to receiving treatment and controlling the infection. The main objective of this project is to evaluate the performance of a programme designed to achieve appropriate linkage to specialist care of HBsAg-positive individuals, newly tested or previously tested and lost to follow-up.Methods and analysis This is a retrospective and prospective study in which all HBsAg-positive cases recorded in the microbiology database will be identified. The retrospective phase will include cases detected between 2018 and 2020, and the prospective phase will run from January 2021 to June 2022. The project will be carried out in a tertiary university hospital covering the northern health area of Barcelona with a catchment population of 450 000 inhabitants and 16 affiliated primary care centres. The central laboratory detects approximately 1200 HBsAg-positive individuals every year; therefore, we expect to identify around 4000 patients over the duration of the project. The medical records of HBsAg-positive individuals will be consulted to identify and retrieve those who have not been appropriately linked to care. Candidates will be contacted to offer specialist disease assessment and follow-up. A website will be created to provide HBV-related information to primary care physicians, and a mobile phone application will be available to patients to improve the linkage circuits and ensure follow-up continuity.Ethics and dissemination The Vall d’Hebrón Hospital Ethics Committee (PR(AG)201/2021) and the Spanish Agency of Medicines and Medical Devices approved this study. The findings will be disseminated through peer-reviewed publications and conference presentations. This programme could increase the number of HBsAg-positive individuals properly linked to care and achieve better HBV monitoring, which will have a positive impact on WHO’s viral hepatitis elimination goals.

Published
2022
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3. Partial restoration of immune response in Hepatitis C patients after viral clearance by direct-acting antiviral therapy.

Author

Meritxell Llorens-Revull, Maria Isabel Costafreda, Angie Rico, Mercedes Guerrero-Murillo, Maria Eugenia Soria, Sofía Píriz-Ruzo, Elena Vargas-Accarino, Pablo Gabriel-Medina, Francisco Rodríguez-Frías, Mar Riveiro-Barciela, Celia Perales, Josep Quer, Silvia Sauleda, Juan Ignacio Esteban, and Marta Bes

Subjects
Medicine, Science
Abstract

Background & aimsHCV CD4+ and CD8+ specific T cells responses are functionally impaired during chronic hepatitis C infection. DAAs therapies eradicate HCV infection in more than 95% of treated patients. However, the impact of HCV elimination on immune responses remain controversial. Here, we aimed to investigate whether HCV cure by DAAs could reverse the impaired immune response to HCV.MethodsWe analyzed 27 chronic HCV infected patients undergoing DAA treatment in tertiary care hospital, and we determined the phenotypical and functional changes in both HCV CD8+ and CD4+ specific T-cells before and after viral clearance. PD-1, TIM-3 and LAG-3 cell-surface expression was assessed by flow cytometry to determine CD4+ T cell exhaustion. Functional responses to HCV were analyzed by IFN-Ɣ ELISPOT, intracellular cytokine staining (IL-2 and IFN-Ɣ) and CFSE-based proliferation assays.ResultsWe observed a significant decrease in the expression of PD-1 in CD4+ T-cells after 12 weeks of viral clearance in non-cirrhotic patients (p = 0.033) and in treatment-naive patients (p = 0.010), indicating a partial CD4 phenotype restoration. IFN-Ɣ and IL-2 cytokines production by HCV-specific CD4+ and CD8+ T cells remained impaired upon HCV eradication. Finally, a significant increase of the proliferation capacity of both HCV CD4+ and CD8+ specific T-cells was observed after HCV elimination by DAAs therapies.ConclusionsOur results show that in chronically infected patients HCV elimination by DAA treatment lead to partial reversion of CD4+ T cell exhaustion. Moreover, proliferative capacity of HCV-specific CD4+ and CD8+ T cells is recovered after DAA's therapies.

Published
2021
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4. LINK-B: study protocol of a retrospective and prospective project for identification and linkage to care of people living with hepatitis B in a large health area of Barcelona

Author

Ana Barreira Díaz, Ariadna Rando, Anna Feliu-Prius, Adriana Palom, Francisco Rodríguez-Frías, Elena Vargas-Accarino, Judit Vico-Romero, Nieves Palomo, Mar Riveiro-Barciela, Rafael Esteban, Maria Buti, Institut Català de la Salut, [Barreira Díaz A, Riveiro-Barciela M, Buti M] Unitat Hepàtica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. [Rando A] Servei de Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Feliu-Prius A, Vargas-Accarino E] Unitat Hepàtica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Palom A, Vico-Romero J, Palomo N] Unitat Hepàtica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Rodríguez-Frías F] Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Servei de Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Esteban R] Unitat Hepàtica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Hepatitis B virus, Hepatitis B Surface Antigens, Health Services Administration::Patient Care Management::Delivery of Health Care::Telemedicine [HEALTH CARE], Otros calificadores::/diagnóstico [Otros calificadores], General Medicine, Telemedicina, Antígens, Hepatitis B, Biological Factors::Antigens::Antigens, Viral::Hepatitis Antigens::Hepatitis B Antigens::Hepatitis B Surface Antigens [CHEMICALS AND DRUGS], Virus Diseases::DNA Virus Infections::Hepadnaviridae Infections::Hepatitis B [DISEASES], administración de los servicios de salud::gestión de la atención al paciente::prestación sanitaria::telemedicina [ATENCIÓN DE SALUD], virosis::infecciones por virus ADN::infecciones por Hepadnaviridae::hepatitis B [ENFERMEDADES], Other subheadings::/diagnosis [Other subheadings], Humans, Prospective Studies, Hepatitis B - Diagnòstic, factores biológicos::antígenos::antígenos víricos::antígenos de las hepatitis::antígenos de la hepatitis B::antígenos de superficie de la hepatitis B [COMPUESTOS QUÍMICOS Y DROGAS], Retrospective Studies
Abstract

Hepatology; Telemedicine; Virologia Hepatologia; Telemedicina; Virologia Hepatología; Telemedicina; Virología Introduction An estimated 290 million people are living with hepatitis B virus (HBV) worldwide; in Spain, the prevalence of hepatitis B virus surface antigen (HBsAg) is 0.4%. In our setting, many HBsAg-positive individuals are not linked to care, which implies a barrier to receiving treatment and controlling the infection. The main objective of this project is to evaluate the performance of a programme designed to achieve appropriate linkage to specialist care of HBsAg-positive individuals, newly tested or previously tested and lost to follow-up. Methods and analysis This is a retrospective and prospective study in which all HBsAg-positive cases recorded in the microbiology database will be identified. The retrospective phase will include cases detected between 2018 and 2020, and the prospective phase will run from January 2021 to June 2022. The project will be carried out in a tertiary university hospital covering the northern health area of Barcelona with a catchment population of 450 000 inhabitants and 16 affiliated primary care centres. The central laboratory detects approximately 1200 HBsAg-positive individuals every year; therefore, we expect to identify around 4000 patients over the duration of the project. The medical records of HBsAg-positive individuals will be consulted to identify and retrieve those who have not been appropriately linked to care. Candidates will be contacted to offer specialist disease assessment and follow-up. A website will be created to provide HBV-related information to primary care physicians, and a mobile phone application will be available to patients to improve the linkage circuits and ensure follow-up continuity. Ethics and dissemination The Vall d’Hebrón Hospital Ethics Committee (PR(AG)201/2021) and the Spanish Agency of Medicines and Medical Devices approved this study. The findings will be disseminated through peer-reviewed publications and conference presentations. This programme could increase the number of HBsAg-positive individuals properly linked to care and achieve better HBV monitoring, which will have a positive impact on WHO’s viral hepatitis elimination goals. This project is supported by Gilead Sciences through the competitive research 'HBV Treat' (protocol number IN-ES-320-6107).

Published
2022

5. Differential characteristics and outcomes of Asian and non‐Asian patients with HBV‐related hepatocellular carcinoma

Author

Lindsey Trinh, Maria Buti, Mar Riveiro-Barciela, Jennifer Leong, Daniel Q. Huang, Ramsey Cheung, Lewis R. Roberts, Ju Dong Yang, Mindie H. Nguyen, Myron Schwartz, Mayumi Maeda, Joseph Hoang, Khin Naing Thin, and Elena Vargas Accarino

Subjects
medicine.medical_specialty, Cirrhosis, Hepatology, business.industry, Hepatitis C, Hepatitis B, medicine.disease, Gastroenterology, digestive system diseases, BCLC Stage, Transplantation, 03 medical and health sciences, Liver disease, 0302 clinical medicine, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Internal medicine, medicine, 030211 gastroenterology & hepatology, business, Survival analysis
Abstract

BACKGROUND & AIMS The epidemiology of hepatitis B virus (HBV) infection differs between Asians and non-Asians, but little is known regarding the effect of ethnicity on outcomes of HBV-related hepatocellular carcinoma (HCC). We aim to characterize the presentation and survival outcomes in Asian and non-Asian patients with HBV-related HCC. METHODS We analyzed the baseline characteristics and long-term survival of 613 Asian and 410 non-Asian patients with HBV-related HCC from three US and one Spanish centre. RESULTS Overall, non-Asian patients were more likely to have HIV or hepatitis C co-infection, cirrhosis, decompensated liver disease and advanced BCLC stage (all P ≤ .04). Compared with Asians, non-Asians were more likely to be listed for transplantation (P

Published
2021
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6. Effectiveness of entecavir vs tenofovir disoproxil fumarate for functional cure of chronic hepatitis B in an international cohort

Author

Yao-Chun Hsu, Dae Won Jun, Cheng-Yuan Peng, Ming-Lun Yeh, Huy Trinh, Grace Lai-Hung Wong, Sung Eun Kim, Chien-Hung Chen, Hyunwoo Oh, Chia-Hsin Lin, Lindsey Trinh, Vincent Wai-Sun Wong, Eilleen Yoon, Sang Bong Ahn, Daniel Huang, Yong Kyun Cho, Jae Yoon Jeong, Soung Won Jeong, Hyoung Su Kim, Qing Xie, Li Liu, Mar Riveiro-Barciela, Pei-Chien Tsai, Elena Vargas Accarino, Hidenori Toyoda, Masaru Enomoto, Carmen Preda, Sebastián Marciano, Joseph Hoang, Chung-Feng Huang, Ritsuzo Kozuka, Satoshi Yasuda, Doina Istratescu, Dong-Hyun Lee, Jia-Ying Su, Yen-Tsung Huang, Jee Fu Huang, Chia-Yen Dai, Wan-Long Chuang, Man-Fung Yuen, Adrian Gadano, Ramsey Cheung, Seng Gee Lim, Maria Buti, Ming-Lung Yu, and Mindie H. Nguyen

Subjects
Male, Cohort Studies, Hepatitis B virus, Hepatitis B, Chronic, Hepatitis B Surface Antigens, Treatment Outcome, Hepatology, Humans, Middle Aged, Tenofovir, Antiviral Agents, Retrospective Studies
Abstract

Both entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are first-line therapies for chronic hepatitis B (CHB), but their comparative effectiveness with regards to hepatitis B surface antigen (HBsAg) seroclearance remains unclear.This international multicenter cohort study enrolled 7697 treatment-naïve CHB patients (median age 50 years; male 66.75%) initiated on either ETV (n = 5430) or TDF (n = 2267) without baseline malignancy or immunosuppression from 23 centers across 10 countries or regions. Patients were observed for HBsAg seroclearance until death, loss to follow-up, or treatment discontinuation or switching. The incidences of HBsAg seroclearance were adjusted for competing mortality and compared between ETV and TDF cohorts with inverse probability of treatment weighting (IPTW) and also by multivariable regression analysis.The study population was followed up for a median duration of 56.1 months with 36,929 11 person-years of observation. HBsAg seroclearance occurred in 70 ETV-treated and 21 TDF-treated patients, yielding 8-year cumulative incidence of 1.69% (95% confidence interval [CI] 1.32-2.17) for ETV and 1.34% (95% CI 0.85-2.10%), for TDF (p = 0.58). In the IPTW analysis with the two study cohorts more balanced in background covariates, the age-adjusted hazard ratio (HR) of TDF versus ETV for HBsAg seroclearance was 0.91 (95% CI 0.50-1.64; p = 0.75). Furthermore, there was no significant difference between the two medications in the multivariable competing risk regression model (adjusted sub-distributional HR 0.92 for TDF vs. ETV; 95% CI 0.56-1.53; p = 0.76).ETV and TDF did not differ significantly in the incidence of HBsAg seroclearance, which rarely occurred with either regimen.

Published
2022

7. Cost-effectiveness analysis of an active search to retrieve HCV patients lost to follow-up (RELINK-C strategy) and the impact of COVID-19

Author

Elena Vargas‐Accarino, Joan Martínez‐Campreciós, Raquel Domínguez‐Hernández, Ariadna Rando‐Segura, Mar Riveiro‐Barciela, Francisco Rodríguez‐Frías, Ana Barreira, Adriana Palom, Miguel Ángel Casado, Rafael Esteban, and María Buti

Subjects
Hepatology, Cost-Benefit Analysis, Cost-effectiveness analysis, COVID-19, COVID-19 pandemic, Hepacivirus, Hepatitis C elimination, Antiviral Agents, Hepatitis C, Infectious Diseases, Linkage to care, Virology, Humans, Lost to follow-up patients, Lost to Follow-Up, Quality-Adjusted Life Years
Abstract

Gilead Sciences Altres ajuts: acords transformatius de la UAB

Published
2022

10. Ultra Deep Sequencing of Circulating Cell-Free DNA as a Potential Tool for Hepatocellular Carcinoma Management

Author

Mónica Higuera, Elena Vargas-Accarino, María Torrens, Josep Gregori, María Teresa Salcedo, Joan Martínez-Campreciós, Gloria Torres, María Bermúdez-Ramos, Itxarone Bilbao, Mercedes Guerrero-Murillo, Xavier Serres-Créixams, Xavier Merino, Francisco Rodríguez-Frías, Josep Quer, Beatriz Mínguez, Institut Català de la Salut, [Higuera M, Torrens M, Torres G] Grup de Recerca en Malalties Hepàtiques, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. [Vargas-Accarino E, Martínez-Campreciós J] Grup de Recerca en Malalties Hepàtiques, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Gregori J] Grup de Recerca en Hepatitis Viral, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. [Salcedo MT] Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Servei d’Anatomia Patològica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Spanish Biomedical Research Network Centre in Oncology (CIBERONC), Instituto de Salud Carlos III, Madrid, Spain. [Bermúdez-Ramos M] Grup de Recerca en Malalties Hepàtiques, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. [Bilbao I] Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Servei de Cirurgia Hepatobiliopancreàtica i Trasplantaments, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Guerrero-Murillo M] Grup de Recerca en Hepatitis Viral, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. [Serres-Créixams X, Merino X] Servei de Radiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Rodríguez-Frías F] Servei de Bioquímica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Servei de Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Departament de Bioquímica i Biologia Molecular, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Quer J] Grup de Recerca en Hepatitis Viral, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Departament de Bioquímica i Biologia Molecular, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Mínguez B] Grup de Recerca en Malalties Hepàtiques, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Unitat Hepàtica, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Cancer Research, técnicas de investigación::técnicas genéticas::análisis de secuencias::análisis de secuencias de ADN [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], liquid biopsy, cfDNA, HCC, biomarkers, neoplasias::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias hepáticas::carcinoma hepatocelular [ENFERMEDADES], Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::Cell-Free Nucleic Acids [CHEMICALS AND DRUGS], Other subheadings::/therapy [Other subheadings], Fetge - Càncer - Aspectes genètics, Investigative Techniques::Genetic Techniques::Sequence Analysis::Sequence Analysis, DNA [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Fetge - Càncer - Tractament, Àcids nucleics - Anàlisi, Neoplasms::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Liver Neoplasms::Carcinoma, Hepatocellular [DISEASES], nucleótidos y nucleósidos de ácidos nucleicos::ácidos nucleicos::ácidos nucleicos libres de células [COMPUESTOS QUÍMICOS Y DROGAS], Oncology, Otros calificadores::/terapia [Otros calificadores]
Abstract

Biomarkers; cfDNA; Liquid biopsy Biomarcadores; cfDNA; Biopsia líquida Biomarcadors; cfDNA; Biòpsia líquida Background: Cell-free DNA (cfDNA) concentrations have been described to be inversely correlated with prognosis in cancer. Mutations in HCC-associated driver genes in cfDNA have been reported, but their relation with patient’s outcome has not been described. Our aim was to elucidate whether mutations found in cfDNA could be representative from those present in HCC tissue, providing the rationale to use the cfDNA to monitor HCC. Methods: Tumoral tissue, paired nontumor adjacent tissue and blood samples were collected from 30 HCC patients undergoing curative therapies. Deep sequencing targeting HCC driver genes was performed. Results: Patients with more than 2 ng/µL of cfDNA at diagnosis had higher mortality (mean OS 24.6 vs. 31.87 months, p = 0.01) (AUC = 0.782). Subjects who died during follow-up, had a significantly higher number of mutated genes (p = 0.015) and number of mutations (p = 0.015) on cfDNA. Number of mutated genes (p = 0.001), detected mutations (p = 0.001) in cfDNA and ratio (number of mutations/cfDNA) (p = 0.003) were significantly associated with recurrence. However, patients with a ratio (number of mutations/cfDNA) above 6 (long-rank p = 0.0003) presented a higher risk of recurrence than those with a ratio under 6. Detection of more than four mutations in cfDNA correlated with higher risk of death (long-rank p = 0.042). Conclusions: In summary, cfDNA and detection of prevalent HCC mutations could have prognostic implications in early-stage HCC patients This research was funded by Instituto de Salud Carlos III (ISCIII) (PI18/00961) and (PI21/00714) to B.M. PI19/00301 by Instituto de Salud Carlos III (ISCIII) and Centro para el Desarrollo Tecnológico Industrial (CDTI) from the Spanish Ministry of Economy and Business, grant number IDI-20200297 to J.Q., E.V.-A. is a recipient of a predoctoral fellowship from Instituto de Salud Carlos III (ISCIII) (FI18/00027).

Published
2022
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11. Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

Author

Ramsey Cheung, Vincent Wai-Sun Wong, Man-Fung Yuen, Mindie H. Nguyen, Mar Riveiro-Barciela, Qing Xie, Li Liu, Chia-Yen Dai, Yao-Chun Hsu, Ming-Lung Yu, Cheng Yuan Peng, Joseph Hoang, Ming-Lun Yeh, Masaru Enomoto, Ka Shing Cheung, Huy N. Trinh, Maria Buti, Elena Vargas Accarino, Carmen Monica Preda, Jia-Ling Wu, Yee Hui Yeo, Wan-Long Chuang, Jee-Fu Huang, Dong Hyun Lee, Chung-Feng Huang, Ritsuzo Kozuka, Chien-Hung Chen, Grace Lai-Hung Wong, Doina Istratescu, and Pei-Chien Tsai

Subjects
0301 basic medicine, Male, medicine.medical_specialty, HBsAg, China, Hepatitis B virus, Guanine, Viremia, Malignancy, medicine.disease_cause, Gastroenterology, Antiviral Agents, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Hepatitis B, Chronic, Internal medicine, medicine, Immunology and Allergy, Humans, Cumulative incidence, Tenofovir, Hepatitis B Surface Antigens, business.industry, Incidence, Fatty liver, Alanine Transaminase, Bilirubin, Entecavir, Middle Aged, medicine.disease, Fatty Liver, 030104 developmental biology, Infectious Diseases, Treatment Outcome, DNA, Viral, 030211 gastroenterology & hepatology, Female, business, medicine.drug, Cohort study
Abstract

Background Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood. Methods This is an international multicenter cohort study of treatment-naive patients with chronic hepatitis B who started ETV or TDF treatment without baseline cancer. Patients were observed for HBsAg seroclearance until death or loss to follow-up. We calculated the incidences and explored the baseline determinants of HBsAg seroclearance using competing risk regression. Results The analysis included 4769 patients (median age, 50 years; 69.05% male), with a median follow-up of 5.16 years (26 614.47 person-years). HBsAg clearance occurred in 58 patients, yielding a 10-year cumulative incidence of 2.11% (95% confidence interval, 1.54%–2.88%) and an annual rate of 0.22% (.17%–.28%). Baseline predictors included low-level viremia with hepatitis B virus DNA 200 U/L (3.68 [2.07–6.53]), serum bilirubin (1.11 per mg/dL; [1.06–1.17 mg/dL]), and fatty liver (1.84 [1.03–3.29]). Conclusion HBsAg seroclearance rarely occurs in patients with chronic hepatitis B treated with ETV or TDF and is associated with low-level viremia, alanine aminotransferase flare, bilirubin level, and fatty liver. Functional cure of hepatitis B virus infection rarely occurred at an average annual rate of 0.22% during first-line oral antiviral treatment, with higher chances observed in patients with low-level viremia, high-level aminotransferase flare, elevation of serum bilirubin, and fatty liver.

Published
2021

12. Partial restoration of immune response in Hepatitis C patients after viral clearance by direct-acting antiviral therapy

Author

Maria Isabel Costafreda, Mar Riveiro-Barciela, Silvia Sauleda, Sofía Píriz-Ruzo, Celia Perales, Meritxell Llorens-Revull, Juan Ignacio Esteban, Francisco Rodriguez-Frias, María Eugenia Soria, Pablo Gabriel-Medina, Mercedes Guerrero-Murillo, Josep Quer, Marta Bes, Angie Rico, Elena Vargas-Accarino, Instituto de Salud Carlos III, Institut Català de la Salut, [Llorens-Revull M, Quer J] Laboratori d'Hepatitis Viral-Malalties Hepàtiques, Unitat del Fetge, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Costafreda MI] Laboratori d'Hepatitis Viral-Malalties Hepàtiques, Unitat del Fetge, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Transfusion Safety Laboratory, Banc de Sang i Teixits (BST), Barcelona, Spain. [Rico A] Laboratori d'Hepatitis Viral-Malalties Hepàtiques, Unitat del Fetge, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Transfusion Safety Laboratory, Banc de Sang i Teixits (BST), Barcelona, Spain. [Guerrero-Murillo M, Píriz-Ruzo S, Vargas-Accarino E] Laboratori d'Hepatitis Viral-Malalties Hepàtiques, Unitat del Fetge, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Soria ME] Centro de Biología Molecular 'Severo Ochoa' (CSIC-UAM), Campus de Cantoblanco, Madrid, Spain. Department of Clinical Microbiology, IIS-Fundación Jiménez Díaz, UAM, Madrid, Spain. [Gabriel-Medina P] Unitat de Patologia Hepàtica, Bioquímica i Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Rodríguez-Frías F] Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. Unitat de Patologia Hepàtica, Bioquímica i Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Unitat de Bioquímica Clínica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. [Riveiro-Barciela M] Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Unitat del Fetge, Servei de Medicina Interna, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Esteban JI] Laboratori d'Hepatitis Viral-Malalties Hepàtiques, Unitat del Fetge, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. Unitat del Fetge, Servei de Medicina Interna, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
0301 basic medicine, RNA viruses, CD4-Positive T-Lymphocytes, Physiology, Cancer Treatment, enfermedades del sistema digestivo::enfermedades hepáticas::hepatitis::hepatitis crónica::enfermedades del sistema digestivo::enfermedades hepáticas::hepatitis::hepatitis C crónica [ENFERMEDADES], Hepacivirus, CD8-Positive T-Lymphocytes, White Blood Cells, 0302 clinical medicine, Resposta immunitària, Animal Cells, Immune Physiology, Medicine and Health Sciences, Other subheadings::/therapeutic use [Other subheadings], Immune Response, Medicaments antivírics - Ús terapèutic - Eficàcia, Pathology and laboratory medicine, Otros calificadores::/terapia [Otros calificadores], Innate Immune System, Multidisciplinary, Digestive System Diseases::Liver Diseases::Hepatitis::Hepatitis, Chronic::Digestive System Diseases::Liver Diseases::Hepatitis::Hepatitis C, Chronic [DISEASES], medicine.diagnostic_test, T Cells, Hepatitis C virus, ELISPOT, Liver Diseases, virus diseases, Hepatitis C, Hepatitis crònica activa, Medical microbiology, Middle Aged, Phenotype, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents [CHEMICALS AND DRUGS], medicine.anatomical_structure, Oncology, Viruses, Liver Fibrosis, Cytokines, Medicine, 030211 gastroenterology & hepatology, Cellular Types, Pathogens, Research Article, Adult, T cell, Immune Cells, Science, Immunology, Reversion, Cytotoxic T cells, Cytokine Therapy, Gastroenterology and Hepatology, Microbiology, Antiviral Agents, Flow cytometry, 03 medical and health sciences, Immune system, medicine, Humans, Immune response, Blood Cells, Flaviviruses, business.industry, Otros calificadores::/uso terapéutico [Otros calificadores], Organisms, Viral pathogens, Biology and Life Sciences, Cell Biology, Other subheadings::/therapy [Other subheadings], Molecular Development, Hepatitis C, Chronic, medicine.disease, Fibrosis, Hepatitis viruses, digestive system diseases, Microbial pathogens, 030104 developmental biology, Immune System, acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos [COMPUESTOS QUÍMICOS Y DROGAS], business, Hepatitis C - Tractament, CD8, Developmental Biology
Abstract

Background & aims HCV CD4+ and CD8+ specific T cells responses are functionally impaired during chronic hepatitis C infection. DAAs therapies eradicate HCV infection in more than 95% of treated patients. However, the impact of HCV elimination on immune responses remain controversial. Here, we aimed to investigate whether HCV cure by DAAs could reverse the impaired immune response to HCV. Methods We analyzed 27 chronic HCV infected patients undergoing DAA treatment in tertiary care hospital, and we determined the phenotypical and functional changes in both HCV CD8+ and CD4+ specific T-cells before and after viral clearance. PD-1, TIM-3 and LAG-3 cell-surface expression was assessed by flow cytometry to determine CD4+ T cell exhaustion. Functional responses to HCV were analyzed by IFN-γ ELISPOT, intracellular cytokine staining (IL-2 and IFN-γ) and CFSE-based proliferation assays. Results We observed a significant decrease in the expression of PD-1 in CD4+ T-cells after 12 weeks of viral clearance in non-cirrhotic patients (p = 0.033) and in treatment-naive patients (p = 0.010), indicating a partial CD4 phenotype restoration. IFN-γ and IL-2 cytokines production by HCV-specific CD4+ and CD8+ T cells remained impaired upon HCV eradication. Finally, a significant increase of the proliferation capacity of both HCV CD4+ and CD8+ specific T-cells was observed after HCV elimination by DAAs therapies. Conclusions Our results show that in chronically infected patients HCV elimination by DAA treatment lead to partial reversion of CD4+ T cell exhaustion. Moreover, proliferative capacity of HCV-specific CD4+ and CD8+ T cells is recovered after DAA’s therapies., Instituto de Salud Carlos III, cofinanced by the European Regional Development Fund (ERDF): grant numbers PI16/00337, PI18/00210 and PI19/00301. C.P. is supported by the Miguel Servet program of the Instituto de Salud Carlos III (CP14/00121 and CPII19/00001) cofinanced by the European Regional Development Fund (ERDF)

Published
2021

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

Author

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

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

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

Published
2020

14. SAT-472-Massive sequencing of circulating DNA as a potential tool for diagnosis and follow-up in patients with hepatocellular carcinoma

Author

Francisco Rodriguez-Frias, Josep Gregori, Itxarone Bilbao, Elena Vargas-Accarino, Josep Quer, María Teresa Salcedo, Monica Higuera, María Eugenia Soria, Beatriz Minguez, and Maria Torrens

Subjects
Hepatology, business.industry, Hepatocellular carcinoma, Cancer research, Medicine, Circulating DNA, In patient, business, medicine.disease
Published
2019
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