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596 results on '"Pietro, Lampertico"'

201. Prevalence and impact on post-transplant outcome of sarcopenia among patients with cirrhosis on waiting-list for liver transplantation: Preliminary data from an Italian single center experience

Author

M. Rusalen, Federica Invernizzi, Gemma Rossi, G. Fornoni, S. Crespi, B. Antonelli, Massimo Iavarone, Gianpaolo Carrafiello, Pietro Lampertico, and Maria Francesca Donato

Subjects
Pediatrics, medicine.medical_specialty, Cirrhosis, Hepatology, business.industry, medicine.medical_treatment, Gastroenterology, Liver transplantation, medicine.disease, Single Center, Outcome (game theory), Post transplant, Waiting list, Sarcopenia, medicine, business
Published
2021
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203. Excellent long-term virological and clinical response in HDV compensated cirrhotics treated with high dose Bulevirtide beyond 2.5 years: A case series

Author

Elena Trombetta, Alessandro Rimondi, Silvia Giovanelli, Sc. Uceda Renteria, Peter Ferenci, Marta Borghi, Riccardo Perbellini, Alessandro Loglio, Pietro Lampertico, Heidemarie Holzmann, Daniele Prati, Laura Porretti, and Ferruccio Ceriotti

Subjects
Series (stratigraphy), Pediatrics, medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, medicine, business, Term (time)
Published
2021
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204. Incidence of liver-related events in 647 HCV cirrhotics treated with DAA: A 5-year single center study

Author

M.P. Anolli, Marta Borghi, Roberta Soffredini, Riccardo Perbellini, I. Fanetti, Pietro Lampertico, Roberta D'Ambrosio, Elisabetta Degasperi, Massimo Iavarone, Angelo Sangiovanni, and Giulia Tosetti

Subjects
medicine.medical_specialty, Hepatology, business.industry, Incidence (epidemiology), Internal medicine, Gastroenterology, Medicine, business, Single Center
Published
2021
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205. Tenofovir Alafenamide improves proximal tubular markers in CHB patients long-term treated with Tenofovir Disoproxil Fumarate: A real-life study based on the EASL switching criteria

Author

M.G. Rumi, C. Gentile, Riccardo Perbellini, Sc. Uceda Renteria, D. Sambarino, Fabio Facchetti, Marta Borghi, Alessandro Loglio, Roberta Soffredini, Mauro Viganò, and Pietro Lampertico

Subjects
medicine.medical_specialty, Hepatology, Tenofovir, business.industry, Gastroenterology, Urology, medicine, Life study, business, Tenofovir alafenamide, medicine.drug
Published
2021
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206. Regorafenib improves survival after sorafenib in patients with recurrent HCC after liver transplantation

Author

M. Romero Cristóbal, Marcus-Alexander Wörns, R. Prince, L. Scuddeler, G. Sapisochin, M.L. González-Diéguez, Claudio Zavaglia, Helene Regnault, Maria Margarita Anders, Federica Invernizzi, Jordi Bruix, Giuliana Amaddeo, Lucia Cesarini, M. Reig, Álvaro Díaz-González, Matteo Angelo Manini, Matthias Pinter, Marco Sanduzzi-Zamparelli, M. Fraile-López, R. Tortora, Tommy Ivanics, Stefano Mazza, P. Daechul Yoon, Maria Francesca Donato, M.J. Blanco Rodríguez, Vincenzo Mazzaferro, Federico Piñero, M. Varela, Carolin Czauderna, Gonzalo Crespo, A. Fernandez Yunquera, Gerda Elisabeth Villadsen, Massimo Iavarone, G. Aballay Soteras, M. De Giorgio, Pietro Lampertico, G.G. Di Costanzo, Sherrie Bhoori, and Arndt Weinmann

Subjects
Sorafenib, Oncology, medicine.medical_specialty, Hepatology, business.industry, medicine.medical_treatment, Gastroenterology, Liver transplantation, chemistry.chemical_compound, chemistry, Regorafenib, Internal medicine, medicine, In patient, business, medicine.drug
Published
2021
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207. Real life experiences in HCV management in 2018

Author

Nicola Caporaso, Giovanni Battista Gaeta, Stefano Bonora, Giovanni Di Perri, Francesca Ceccherini-Silberstein, Sergio Babudieri, Raffaele Bruno, Giuliano Rizzardini, Pietro Lampertico, Pietro Andreone, Gloria Taliani, Alessio Aghemo, Tullio Prestileo, Nicola Coppola, Anna Linda Zignego, Antonio Gasbarrini, Vito Di Marco, Massimo Andreoni, F. Cartabellotta, Adriano M. Pellicelli, Alfredo Alberti, Giovanni Raimondo, Maurizia Rossana Brunetto, Valeria Cento, Alessia Ciancio, Mauro Viganò, Savino Bruno, Massimo Puoti, Carlo Federico Perno, Vincenza Calvaruso, Antonio Craxì, Piero Colombatto, Stefano Fagiuoli, Mauro Viganò, Massimo Andreoni, Carlo Federico Perno, Antonio Craxì, Alessio Aghemo, Alfredo Alberti, Pietro Andreone, Sergio Babudieri, Stefano Bonora, Maurizia Rossana Brunetto ORCID Icon, Raffaele Bruno, Savino Bruno, Vincenza Calvaruso, Nicola Caporaso, Fabio Cartabellotta, Francesca Ceccherini-Silberstein, Valeria Cento, Alessia Ciancio, Piero Colombatto ORCID Icon, Nicola Coppola, Vito Di Marco, Giovanni Di Perri, Stefano Fagiuoli, Giovanni Battista Gaeta, Antonio Gasbarrini ORCID Icon, Pietro Lampertico, Adriano Pellicelli, Tullio Prestileo, Massimo Puoti, Giovanni Raimondo, Giuliano Rizzardini, Gloria Taliani & Anna Linda Zignego (for the AdHoc (Advancing Hepatitis C for the Optimization of Cure) Working Party.) ORCID Icon, Vigano M., Andreoni M., Perno C.F., Craxi A., Aghemo A., Alberti A., Andreone P., Babudieri S., Bonora S., Brunetto M.R., Bruno R., Bruno S., Calvaruso V., Caporaso N., Cartabellotta F., Ceccherini-Silberstein F., Cento V., Ciancio A., Colombatto P., Coppola N., Di Marco V., Di Perri G., Fagiuoli S., Gaeta G.B., Gasbarrini A., Lampertico P., Pellicelli A., Prestileo T., Puoti M., Raimondo G., Rizzardini G., Taliani G., Zignego A.L., Viganò, Mauro, Andreoni, Massimo, Perno, Carlo Federico, Craxì, Antonio, Aghemo, Alessio, Alberti, Alfredo, Andreone, Pietro, Babudieri, Sergio, Bonora, Stefano, Brunetto, Maurizia Rossana, Bruno, Raffaele, Bruno, Savino, Calvaruso, Vincenza, Caporaso, Nicola, Cartabellotta, Fabio, Ceccherini-Silberstein, Francesca, Cento, Valeria, Ciancio, Alessia, Colombatto, Piero, Coppola, Nicola, Di Marco, Vito, Di Perri, Giovanni, Fagiuoli, Stefano, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Lampertico, Pietro, Pellicelli, Adriano, Prestileo, Tullio, Puoti, Massimo, Raimondo, Giovanni, Rizzardini, Giuliano, Taliani, Gloria, Zignego, Anna Linda, Vigano, M., Andreoni, M., Perno, C. F., Craxi, A., Aghemo, A., Alberti, A., Andreone, P., Babudieri, S., Bonora, S., Brunetto, M. R., Bruno, R., Bruno, S., Calvaruso, V., Caporaso, N., Cartabellotta, F., Ceccherini-Silberstein, F., Cento, V., Ciancio, A., Colombatto, P., Coppola, N., Di Marco, V., Di Perri, G., Fagiuoli, S., Gaeta, G. B., Gasbarrini, A., Lampertico, P., Pellicelli, A., Prestileo, T., Puoti, M., Raimondo, G., Rizzardini, G., Taliani, G., Zignego, A. L., Vigano, M, Andreoni, M, Perno, C, Craxi, A, Aghemo, A, Alberti, A, Andreone, P, Babudieri, S, Bonora, S, Brunetto, M, Bruno, R, Bruno, S, Calvaruso, V, Caporaso, N, Cartabellotta, F, Ceccherini-Silberstein, F, Cento, V, Ciancio, A, Colombatto, P, Coppola, N, Di Marco, V, Di Perri, G, Fagiuoli, S, Gaeta, G, Gasbarrini, A, Lampertico, P, Pellicelli, A, Prestileo, T, Puoti, M, Raimondo, G, Rizzardini, G, Taliani, G, and Zignego, A

Subjects
0301 basic medicine, hepatitis C virus, Sofosbuvir, Sustained Virologic Response, Antiviral therapy, chronic liver disease, DAAs, HCV, Microbiology, Microbiology (medical), Infectious Diseases, Virology, medicine.disease_cause, Chronic liver disease, Health Services Accessibility, 0302 clinical medicine, direct acting antivirals, hepatitis C viru, Mass Screening, 030212 general & internal medicine, Chronic, ComputingMilieux_MISCELLANEOUS, Hepatitis C, Hepatitis B, Pibrentasvir, Antiviral Agents, Disease Progression, Hepatitis C, Chronic, Humans, Italy, medicine.drug, Human, Settore MED/17 - Malattie Infettive, Hepatitis C virus, 030106 microbiology, Infectious Disease, 03 medical and health sciences, medicine, Mass screening, DAA, Hepatitis B virus, Antiviral Agent, business.industry, medicine.disease, business
Abstract

Introduction: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Treatment of chronic hepatitis C has considerably improved in the last few years thanks to the introduction of direct-acting antivirals able to achieve sustained virological response in more than 95% of patients. Successful anti-HCV treatment can halt liver disease progression and solve the HCV-related extra-hepatic manifestations, eventually reducing liver-related and overall mortality. Areas covered: With the aim to respond to unmet needs in patient’s identification, universal access to antiviral therapy and treatment optimization in specific setting of HCV-infected patients, a group of Italian experts met in Stresa in May 2018. The summary of the considerations arising from this meeting and the final statements are reported in this paper. Expert commentary: All the advances on HCV cure may have a real clinical impact not only in individual patients but also at the social health level if they are applied to all infected patients, independently from the stage of liver disease. Further improvements are needed in order to attain HCV elimination, such as the development of an enhanced screening program working in parallel to the present treatment options.

Published
2018

208. Hepatitis B virus long-term impact of antiviral therapy nucleot(s)ide analogues (NUCs)

Author

Alessandro Loglio, G. Grossi, Pietro Lampertico, and Mauro Viganò

Subjects
Liver Cirrhosis, 0301 basic medicine, Hepatitis B virus, HBsAg, medicine.medical_specialty, Carcinoma, Hepatocellular, Guanine, Cirrhosis, Sustained Virologic Response, medicine.disease_cause, Antiviral Agents, Gastroenterology, 03 medical and health sciences, Liver disease, Hepatitis B, Chronic, 0302 clinical medicine, Internal medicine, medicine, Humans, Decompensation, Hepatitis B e Antigens, Tenofovir, Randomized Controlled Trials as Topic, Hepatitis B Surface Antigens, Hepatology, business.industry, Liver Neoplasms, Entecavir, Hepatitis B, medicine.disease, Surgery, 030104 developmental biology, Hepatocellular carcinoma, Quality of Life, 030211 gastroenterology & hepatology, Safety, business, medicine.drug
Abstract

The goal of antiviral therapy is to improve the quality of life and survival of patients with chronic hepatitis B (CHB) by halting the progression to cirrhosis, end-stage liver disease or hepatocellular carcinoma (HCC), thus preventing anticipated liver-related death. Oral administration of potent and less resistance-prone nucleot(s)ide analogues (NUCs), such as entecavir (ETV) and tenofovir disoproxil fumarate (TDF) has become the most popular treatment strategy worldwide because of their excellent efficacy and safety profile as well as easy management confirmed in both registration trials and in clinical practice studies. Long-term administration of ETV or TDF suppresses HBV replication in >95% of patients, resulting in biochemical remission, histological improvement including the regression of cirrhosis and prevention or reversal of clinical decompensation but not the development of HCC, particularly in patients with cirrhosis. Moreover, NUCs can be administered to all patients including those with severe liver disease, the elderly and in those who do not respond, are unwilling to take or have contraindications to interferon. The need for long-term, perhaps indefinite, treatment is the main limitation of NUCs therapy with the associated costs, unknown long-term safety and the low rates of hepatitis B surface antigen (HBsAg) seroclearance, which is still the best stopping rule for NUCs-treated patients with cirrhosis.

Published
2017
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209. Review article: long-term safety of nucleoside and nucleotide analogues in HBV-monoinfected patients

Author

Hung Chan, Harry L.A. Janssen, Simone I. Strasser, Thomas Berg, Pietro Lampertico, and R. Schindler

Subjects
Hepatitis B virus, medicine.medical_specialty, Guanine, Renal function, medicine.disease_cause, Antiviral Agents, Gastroenterology, 03 medical and health sciences, Hepatitis B, Chronic, 0302 clinical medicine, Internal medicine, Humans, Medicine, Pharmacology (medical), 030212 general & internal medicine, Tenofovir, Intensive care medicine, Adverse effect, Hepatitis, Hepatology, Nucleotides, business.industry, Nucleosides, Entecavir, Hepatitis B, medicine.disease, Treatment Outcome, Lactic acidosis, 030211 gastroenterology & hepatology, business, Viral hepatitis, medicine.drug
Abstract

Summary Background Nucleos(t)ide analogues (NUCs) for chronic hepatitis B treatment achieve high rates of viral suppression and are generally well tolerated. Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are the currently preferred first-line agents. The safety of these agents in clinical practice is particularly relevant since long-term treatment is usually required. Aim To summarise and critically discuss recent real-world evidence on the safety of treatment with ETV or TDF in hepatitis B virus (HBV)-monoinfected patients. Methods PubMed and conference proceedings up to 15th June 2015 were searched using the terms ((((Hepatitis_B) OR HBV) AND ((tenofovir) OR entecavir)) AND (((lactic_acidosis) OR bone) OR renal)). Results In selected populations included in registration studies, both ETV and TDF were well tolerated with no clinically significant renal toxicity or lactic acidosis. Growing ‘real-world’ clinical experience with these agents includes some reports of ETV-associated lactic acidosis and TDF-associated renal impairment; however, evidence from cohort studies appears to be conflicting. In the case of ETV-related lactic acidosis, a small number of cases have been reported, all in patients with decompensated cirrhosis. The degree of association between TDF treatment and changes in markers of renal function varies between studies: discrepancies may result from the use of different definitions and cut-offs for reporting renal toxicities, and differences in patient populations. Conclusions Pre-treatment and on-treatment monitoring of eGFR and phosphorus, with prompt appropriate dose adjustment or treatment switch can minimise the impact of NUC renal toxicity. Standardisation of measures of renal impairment and identification of early molecular markers remain an unmet need.

Published
2016
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210. Reactivation of hepatitis B virus during targeted therapies for cancer and immune-mediated disorders

Author

Giuseppe Serra, Mauro Viganò, G. Grossi, Pietro Lampertico, and Giovanni Casella

Subjects
Hepatitis B virus, HBsAg, medicine.medical_treatment, Clinical Biochemistry, medicine.disease_cause, Antiviral Agents, Targeted therapy, 03 medical and health sciences, Drug Delivery Systems, 0302 clinical medicine, Neoplasms, Drug Discovery, medicine, Animals, Humans, Immunosuppression Therapy, Pharmacology, Hepatitis B Surface Antigens, business.industry, Antibodies, Monoclonal, virus diseases, Cancer, Immunosuppression, Hepatitis B, medicine.disease, digestive system diseases, Immune System Diseases, 030220 oncology & carcinogenesis, Immunology, Virus Activation, 030211 gastroenterology & hepatology, Rituximab, Viral hepatitis, business, Immunosuppressive Agents, medicine.drug
Abstract

Targeted therapies have gained popularity in the treatment of several oncologic and immune-mediated diseases. Immunosuppression caused by these drugs has been associated to reactivation of hepatitis B virus (HBV) in both hepatitis B surface antigen (HBsAg) positive patients (overt infection) and HBsAg negative/anti-hepatitis B core antigen (anti-HBc) positive carriers (resolved infection), leading to premature discontinuation of therapy and potentially fatal hepatitis.This review summarizes the evidence of HBV reactivation in patients with overt or resolved HBV infection undergoing targeted therapies for cancer or immune-mediated disorders, providing recommendations for the management of these patients.The risk of HBV reactivation relies on the immunosuppressive potency and duration of these therapies, the underlying disease and the virological patient's profile. However, HBV reactivation is preventable by screening for HBV markers in all patients scheduled to receive targeted therapies, assessing the virological profile and patient's clinical state, followed by appropriate antiviral treatment or prophylaxis in those patients at high risk of HBV reactivation. Close monitoring of HBV carriers at low risk of reactivation is warranted with the aim to start antiviral therapy as soon as HBV reactivates.

Published
2016
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211. PAGE-B predicts the risk of developing hepatocellular carcinoma in Caucasians with chronic hepatitis B on 5-year antiviral therapy

Author

Bettina E. Hansen, Onur Keskin, Heng Chi, G. Mangia, Cihan Yurdaydin, Maria Buti, Juan de la Revilla, Nikolaos K. Gatselis, Jose Luis Calleja, Ramazan Idilman, Rafael Esteban, Kostantinos Galanis, George V. Papatheodoridis, Pietro Lampertico, John Goulis, Spilios Manolakopoulos, Savvoula Savvidou, Harry L.A. Janssen, Massimo Colombo, Vana Sypsa, Ioannis Vlachogiannakos, George N. Dalekos, and Gastroenterology & Hepatology

Subjects
Adult, Male, Risk, Oncology, medicine.medical_specialty, Pathology, Carcinoma, Hepatocellular, Guanine, Antiviral Agents, Cohort Studies, 03 medical and health sciences, Hepatitis B, Chronic, 0302 clinical medicine, SDG 3 - Good Health and Well-being, Interquartile range, Internal medicine, medicine, Humans, Tenofovir, Aged, Proportional Hazards Models, Framingham Risk Score, Hepatology, business.industry, Proportional hazards model, Liver Neoplasms, Hazard ratio, Entecavir, Middle Aged, Hepatitis B, medicine.disease, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Female, 030211 gastroenterology & hepatology, business, medicine.drug, Cohort study
Abstract

Background & Aims: Risk scores for hepatocellular carcinoma (HCC) developed in Asians offer poor-moderate predictability in Caucasian patients with chronic hepatitis B (CHB). This nine center cohort study aimed to develop and validate an accurate HCC risk score in Caucasian CHB patients treated with the current oral antivirals, entecavir/tenofovir. Methods: We included 1815 adult Caucasians with CHB and no HCC at baseline who received entecavir/tenofovir for >= 12 months. Using data from eight centers (derivation dataset, n = 1325), a HCC risk score was developed based on multivariable Cox models and points system for simplification. Harrell's c-index was used as discrimination, bootstrap for internal validation and the data from the 9th and largest center (validation dataset, n = 490) for external validation. Results: The 5-year cumulative HCC incidence rates were 5.7% and 8.4% in the derivation and validation dataset, respectively. In the derivation dataset, age, gender, platelets and cirrhosis were independently associated with HCC. The PAGE-B score was developed based on age, gender and platelets (c-index = 0.82, 0.81 after bootstrap validation). The addition of cirrhosis did not substantially improve the discrimination (c-index = 0.84). The predictability of PAGE-B score was similar (c-index = 0.82) in the validation dataset. Patients with PAGE-B 10-17, >= 18 had 5-year cumulative HCC incidence rates of 0%, 3%, 17% in the derivation and 0%, 4%, 16% in the validation dataset. Conclusion: PAGE-B, which is based only on baseline patients' age, gender and platelets, represents a simple and reliable score for prediction of the 5-year HCC risk in Caucasian CHB patients under entecavir/tenofovir. (C) 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Published
2016
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212. Decompensated Cirrhosis and Sickle Cell Disease: Case Reports and Review of the Literature

Author

Roberta D'Ambrosio, Pietro Lampertico, Giovanna Graziadei, Maria Francesca Donato, Marco Maggioni, and Maria Domenica Cappellini

Subjects
Adult, Liver Cirrhosis, Male, medicine.medical_specialty, Cirrhosis, Clinical Biochemistry, Cell, Anemia, Sickle Cell, Disease, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Cholestasis, Internal medicine, medicine, Humans, Liver decompensation, Genetics (clinical), medicine.diagnostic_test, business.industry, Biochemistry (medical), Clinical course, Hematology, Middle Aged, medicine.disease, Decompensated cirrhosis, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Liver biopsy, Female, 030211 gastroenterology & hepatology, Erythrocyte Transfusion, business
Abstract

Although its prevalence is unknown, liver involvement by sickle cell disease is not uncommon and encompasses different clinical spectra including non cholestatic and cholestatic disorders. Few data have been provided on chronic sickle cell intrahepatic cholestasis (SCIC) clinical course, although cirrhosis has been reported in sickle cell disease. However, no effective therapeutic approaches have been recognized either to prevent or treat this condition. Here we present two cases of adult sickle cell disease patients with decompensated cirrhosis. Their liver biopsies showed sickle cell thrombi within the hepatic sinusoids. Despite erythroexchange (EEX) transfusions, both patients suffered from major sickle cell disease-related events, suggesting that EEX transfusions may not be enough to impact on advanced liver involvement by sickle cell disease.

Published
2017
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213. S1070 A Phase 3 Study Comparing Switching: Tenofovir Disoproxil Fumarate (TDF) to Tenofovir Alafenamide (TAF) With Continued TDF Treatment in Virologically Suppressed Patients With Chronic Hepatitis B: Final Week 96 Results

Author

George Y. Wu, Young-Suk Lim, Scott Fung, Mandana Khalili, Leland J. Yee, Anuj Gaggar, John F. Flaherty, Edward Tam, Sang Hoon Ahn, Ho S. Bae, Yang Liu, Patricia Halton, Pietro Lampertico, Jia-Horng Kao, Xiaoli Ma, Maria Buti, Alnoor Ramji, Kosh Agarwal, Henry Chan, and Hie-Won Hann

Subjects
medicine.medical_specialty, Hepatology, Chronic hepatitis, Tenofovir, business.industry, Internal medicine, Gastroenterology, medicine, Phases of clinical research, business, Tenofovir alafenamide, medicine.drug
Published
2020
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215. Correlation between HBV core-related antigen and the new quantitative IGG anti-core in treated caucasian HBeAg-negative patients and inactive carriers with and without a functional cure

Author

Alessandro Loglio, Floriana Facchetti, Elisa Farina, Nicoletta Nandi, Alberto Perego, Riccardo Perbellini, Sara Colonia Uceda Renteria, Marta Borghi, Roberta Soffredini, Corinna Orsini, Giovanna Lunghi, Ferruccio Ceriotti, and Pietro Lampertico

Subjects
Hepatology
Published
2020
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216. Early recurrence of hepatocellular carcinoma after liver transplantation can be predicted by FDG-PET and microvascular invasion at explant pathology

Author

T. De Feo, Federica Invernizzi, Massimo Iavarone, Gemma Rossi, Stefano Mazza, Maria Francesca Donato, Daniele Dondossola, Umberto Maggi, B. Antonelli, A. De Monti, L. Florimonte, and Pietro Lampertico

Subjects
Pathology, medicine.medical_specialty, Hepatology, Early Recurrence, business.industry, medicine.medical_treatment, Hepatocellular carcinoma, Gastroenterology, medicine, Liver transplantation, business, medicine.disease, Explant culture
Published
2020
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217. Health Status of Patients Who Underwent Liver Transplantation During the Coronavirus Outbreak at a Large Center in Milan, Italy

Author

Maria Francesca Donato, Giorgio Rossi, Federica Invernizzi, and Pietro Lampertico

Subjects
Graft Rejection, Male, Pediatrics, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Health Status, medicine.medical_treatment, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pneumonia, Viral, Liver transplantation, medicine.disease_cause, Severity of Illness Index, Article, Disease Outbreaks, Betacoronavirus, Pandemic, medicine, liver transplant recipients, Humans, Pandemics, Aged, Coronavirus, Noninvasive Ventilation, immunosuppression, Hepatology, SARS-CoV-2, business.industry, Liver Diseases, Gastroenterology, COVID-19, Outbreak, Middle Aged, Respiration, Artificial, Telemedicine, Transplant Recipients, Liver Transplantation, Hospitalization, Italy, Female, Noninvasive ventilation, Coronavirus Infections, business, Immunosuppressive Agents
Published
2020
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218. Sa1522 EFFICACY AND SAFETY OF SWITCHING TO TENOFOVIR ALAFENAMIDE IN VIRALLY SUPPRESSED CHRONIC HEPATITIS B PATIENTS WITH RENAL IMPAIRMENT: WEEK 24 RESULTS FROM A PHASE 2 OPEN-LABEL STUDY

Author

Susanna K. Tan, Shuyuan Mo, John F. Flaherty, Chi-Yi Chen, Pietro Lampertico, Wan-Long Chuang, Sarjita Naik, Anuj Gaggar, Ho Bae, Leland J. Yee, Syed-Mohammed Jafri, Carla S. Coffin, Harry L.A. Janssen, Young-Suk Lim, Claire Fournier, Jeong Heo, and Huy N. Trinh

Subjects
medicine.medical_specialty, Hepatology, Chronic hepatitis, Open label study, business.industry, Internal medicine, Gastroenterology, Medicine, business, Tenofovir alafenamide
Published
2020
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219. Effectiveness and safety of switching to entecavir hepatitis B patients developing kidney dysfunction during tenofovir

Author

Erica Villa, Pietro Lampertico, Gloria Taliani, Aldo Marrone, Fabrizio Bronte, Maurizio Russello, G. Grossi, Pietro Andreone, Massimo Fasano, Sara Labanca, Mauro Viganò, Giuseppina Brancaccio, Vincenzo Occhipinti, Alessandra Tucci, Floriana Facchetti, Vincenzo Messina, Roberto Ganga, Alessandro Loglio, Stefano Fagiuoli, Teresa Santantonio, Nicola Coppola, Alfredo Marzano, Maria Grazia Rumi, Serena Zaltron, Francesco Castelli, Vigano, M, Loglio, A, Labanca, S, Zaltron, S, Castelli, F, Andreone, P, Messina, V, Ganga, R, Coppola, N, Marrone, A, Russello, M, Marzano, A, Tucci, A, Taliani, G, Fasano, M, Fagiuoli, S, Villa, E, Bronte, F, Santantonio, T, Brancaccio, G, Occhipinti, V, Facchetti, F, Grossi, G, Rumi, M, Lampertico, P, Vigano M., Loglio A., Labanca S., Zaltron S., Castelli F., Andreone P., Messina V., Ganga R., Coppola N., Marrone A., Russello M., Marzano A., Tucci A., Taliani G., Fasano M., Fagiuoli S., Villa E., Bronte F., Santantonio T., Brancaccio G., Occhipinti V., Facchetti F., Grossi G., Rumi M., Lampertico P., and Viganò, M

Subjects
Male, Time Factors, Sustained Virologic Response, hepatitis B viru, Kidney, Gastroenterology, hepatitis B virus, liver, liver function tests, renal dysfunction, viral hepatitis, chemistry.chemical_compound, 0302 clinical medicine, 80 and over, Adefovir, Chronic, Aged, 80 and over, medicine.diagnostic_test, Drug Substitution, Hepatology, Entecavir, Middle Aged, Hepatitis B, Treatment Outcome, medicine.anatomical_structure, Italy, 030220 oncology & carcinogenesis, Female, Kidney Diseases, 030211 gastroenterology & hepatology, Viral hepatitis, medicine.drug, Adult, medicine.medical_specialty, Guanine, Aged, Antiviral Agents, Hepatitis B, Chronic, Humans, Recovery of Function, Retrospective Studies, Tenofovir, Renal function, 03 medical and health sciences, Internal medicine, medicine, liver function test, Creatinine, business.industry, viral hepatiti, medicine.disease, chemistry, business, Liver function tests
Abstract

Background and Aims: Tenofovir disoproxil fumarate (TDF) is recommended for chronic hepatitis B (CHB) treatment, but it may induce kidney dysfunction whose management is not yet known. This Italian, multicentre, retrospective study aimed to assess the efficacy and safety of switching to entecavir (ETV) patients who developed TDF-associated glomerular and/or tubular dysfunction. Methods: A total of 103 TDF-treated patients were included as follows: age 64years, 83% male, 49% cirrhotics, 98% with undetectable HBV DNA, 47% with previous lamivudine resistance (LMV-R) and 71% previously treated with adefovir. Twenty-nine (28%) were switched to ETV because estimated glomerular filtration rate (eGFR MDRD ) was

Published
2019

220. A variant in the MICA gene is associated with liver fibrosis progression in chronic hepatitis C through TGF-b1 dependent mechanisms

Author

Mayada Metwally, Olivier Latchoumanin, Jacob Nattermann, Elizabeth E. Powell, Khaled Thabet, Mark W. Douglas, Ulrich Spengler, Rasha El Sharkawy, Duncan McLeod, Alessandra Mangia, Thomas Berg, Lindsay Mollison, Maria Lorena Abate, Wendy Cheng, Gregory J. Dore, Rocío Gallego-Durán, Liang Qiao, Janett Fischer, Jacob George, Mustafa A. M. Najim, Roberta D'Ambrosio, Christopher Liddle, Manuel Romero-Gómez, Pietro Lampertico, Mohammed Eslam, Martin Weltman, Stephen M. Riordan, David Sheridan, Rosanna Santoro, William L. Irving, Elisabetta Bugianesi, Ali Bayoumi, Sydney Medical Foundation, University of Sydney, National Health and Medical Research Council (Australia), German Research Foundation, The Hector Foundation, Egypt Government, and Australian Government

Subjects
0301 basic medicine, Liver Cirrhosis, Male, health care facilities, manpower, and services, education, lcsh:Medicine, Genome-wide association study, Polymorphism, Single Nucleotide, Article, Transforming Growth Factor beta1, 03 medical and health sciences, 0302 clinical medicine, Fibrosis, medicine, Humans, Allele, lcsh:Science, health care economics and organizations, Multidisciplinary, business.industry, lcsh:R, GTPase-Activating Proteins, Histocompatibility Antigens Class I, Hepatitis C, Hepatitis C, Chronic, medicine.disease, Phenotype, digestive system diseases, 3. Good health, stomatognathic diseases, 030104 developmental biology, Liver, Hepatocellular carcinoma, Hepatic stellate cell, Cancer research, lcsh:Q, Female, business, 030217 neurology & neurosurgery, Transforming growth factor, Signal Transduction
Abstract

International Liver Disease Genetics Consortium (ILDGC)., Hepatocarcinogenesis is tightly linked to liver fibrosis. Recently, two GWAS variants, MICA rs2596542 and DEPDC5 rs1012068 were identified as being associated with the development of HCV-induced hepatocellular carcinoma (HCC) in Japanese patients. The role of these variants on hepatic inflammation and fibrosis that are closely associated with HCC development is not known, nor are the biological mechanisms underlying their impact on the liver. Here, we demonstrate in 1689 patients with chronic hepatitis C (CHC) (1,501 with CHC and 188 with HCV-related HCC), that the MICA (T) allele, despite not being associated with HCC susceptibility, is associated with increased fibrosis stage (OR: 1.47, 95% CI: 1.05–2.06, p = 0.02) and fibrosis progression rate (hazards ratio: 1.41, 95% CI: 1.04–1.90, p = 0.02). The DEPDC5 variant was not associated with any of these phenotypes. MICA expression was down-regulated in advanced fibrosis stages. Further, (T) allele carriage was associated with lower MICA expression in liver and serum. Transforming growth factor-β1 (TGF-β1) expression suppresses MICA expression in hepatic stellate cells. Our findings suggest a novel mechanism linking susceptibility to advanced fibrosis and subsequently indirectly to HCC, to the level of MICA expression through TGF-β1-dependent mechanisms., M.E., C.L., M.D. and J.G. are supported by the Robert W. Storr Bequest to the Sydney Medical Foundation, University of Sydney; a National Health and Medical Research Council of Australia (NHMRC) Program Grant (APP1053206, APP1149976) and Project grants (APP1107178 and APP1108422). G.D. is supported by an NHMRC Fellowship (1028432). U.S. and J.N. are supported by DFG SFB-TR57 and the Hector-Foundation (M63). R.E. and K.T. are supported by a scholarship from the Egyptian government. A.B. is supported by an Australian Government Research Training Program (RTP) scholarship.

Published
2019

221. Predictors of hepatocellular carcinoma in HCV cirrhotic patients treated with direct acting antivirals

Author

Maurizia Rossana Brunetto, Pietro Andreone, Massimo Colombo, Vincenza Calvaruso, Savino Bruno, L. Marzi, Patrick Maisonneuve, Alfredo Di Leo, Massimo Zuin, Ana Lleo, Giulia Troshina, Alessia Giorgini, Fabio Conti, Simona Bollani, Vito Di Marco, Andrea Aglitti, Maria Rendina, V. Boccaccio, Pietro Lampertico, Alessio Aghemo, Alessia Ciancio, Barbara Coco, Erica Villa, Marcello Persico, Elisabetta Degasperi, Lleo A1, Aglitti A2, Aghemo A1, Maisonneuve P3, Bruno S1, Persico M4, Rendina M5, Ciancio A6, Lampertico P7, Brunetto MR8, Di Marco Vito, Zuin M10, Andreone P11, Villa E12, Troshina G6, Degasperi E7, Coco B13, Calvaruso Vincenza, Giorgini AM10, Conti F11, Di Leo A5, Marzi L12, Boccaccio V14, Bollani S15, Colombo M16., Lleo, Ana, Aglitti, Andrea, Aghemo, Alessio, Maisonneuve, Patrick, Bruno, Savino, Persico, Marcello, Rendina, Maria, Ciancio, Alessia, Lampertico, Pietro, Brunetto, Maurizia R., Di Marco, Vito, Zuin, Massimo, Andreone, Pietro, Villa, Erica, Troshina, Giulia, Degasperi, Elisabetta, Coco, Barbara, Calvaruso, Vincenza, Giorgini, Alessia M., Conti, Fabio, Di Leo, Alfredo, Marzi, Luca, Boccaccio, Vincenzo, Bollani, Simona, and Colombo, Massimo

Subjects
Liver Cirrhosis, Male, Cirrhosis, Sustained Virologic Response, Hepatocellular carcinoma, Direct antiviral agents, DIRECT ACTING ANTIVIRALS, Gastroenterology, Cohort Studies, 0302 clinical medicine, Risk Factors, Chronic, Incidence (epidemiology), Liver Neoplasms, Middle Aged, Hepatitis C, Tumor recurrence, HCV, Aged, Antiviral Agents, Carcinoma, Hepatocellular, Disease Progression, Female, Hepatitis C, Chronic, Humans, Italy, Neoplasm Recurrence, Local, alpha-Fetoproteins, Local, 030220 oncology & carcinogenesis, Portal hypertension, 030211 gastroenterology & hepatology, Cohort study, medicine.medical_specialty, Early Recurrence, 03 medical and health sciences, Internal medicine, medicine, neoplasms, Cirrhosi, Hepatology, business.industry, Carcinoma, Hepatocellular, medicine.disease, digestive system diseases, Neoplasm Recurrence, Direct antiviral agent, business
Abstract

Background: Despite the dramatic improvement in viral eradication rates that has been reached with direct antiviral agents (DAAs),the real benefit of viral eradication after DAAs on hepatocellular carcinoma (HCC) development is still controversial. Aim: To prospectively assess the risk of HCC occurrence and early recurrence in a large cohort of DAAtreated HCV-cirrhotic patients and to identify potential predictors of HCC development. Methods: We analyzed data prospectively collected from 1927 consecutive HCV-infected cirrhotic patients treated with DAA from January to December 2015 in 10 tertiary liver centers in Italy and followed-up for one year after therapy. 161 patients had a previous HCC. Results: 38/161 subjects developed tumor recurrence during the follow-up (recurrence rate = 24.8 per 100-year), patients with SVR had a significantly lower rate of recurrence. Lack of SVR and alphafetoprotein (AFP) were independent predictors of HCC recurrence. 50/1766 patients without a previous HCC history developed HCC during follow-up (incidence rate = 2.4 per 100-year). Lack of SVR was the strongest predictor of HCC development. Furthermore, patients with SVR and no stigmata of portal hypertension have a lower incidence rate of HCC (1.0 per 100-year). Conclusions: SVR is associated with a significant decrease of recurrent or de novo HCC. Baseline AFP and signs of portal hypertension can help to stratify the risk of HCC. © 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved

Published
2019

222. THU-117-Evaluation of risk factors associated with failure to a first-line NS5A-containing regimen in HCV-infected patients naive to direct acting antivirals: Particular focus on natural resistance

Author

Pietro Lampertico, Giulia Morsica, Silvia Galli, Giustino Parruti, Pietro Andreone, Adriano M. Pellicelli, Velia Chiara Di Maio, Rossana Scutari, Carlo Federico Perno, Antonio Craxì, Ada Bertoli, Filomena Morisco, Caterina Pasquazzi, Stefano Bonora, Vincenza Calvaruso, Roberta D'Ambrosio, Laura Ambra Nicolini, Riccardo Campoli, Francesca Ceccherini Silberstein, Valeria Ghisetti, Elisabetta Teti, V. Boccaccio, Gloria Taliani, Miriam Lichtner, Silvia Barbaliscia, Valeria Micheli, Luca Foroghi, Carlo Magni, Massimo Siciliano, Massimo Andreoni, Giovanni Battista Gaeta, P Paba, Ennio Polilli, Giuliano Rizzardini, Martina Milana, Bianca Bruzzone, Valeria Pace Palitti, Stefania Paolucci, Massimo Puoti, Angelico Mario, Vanni Borghi, C. Masetti, Renato Maserati, Coppola Nicola, Sergio Babudieri, Valeria Cento, N. Iapadre, Loredana Sarmati, Marianna Aragri, and Gianluca Fiorentino

Subjects
Oncology, medicine.medical_specialty, Focus (computing), Hepatology, business.industry, First line, HCV, NS5A, risk factors, DIRECT ACTING ANTIVIRALS, NS5A, Natural resistance, Regimen, Internal medicine, HCV, medicine, risk factors, business
Published
2019

223. Endo-therapies for biliary duct-to-duct anastomotic stricture after liver transplantation: Outcomes of a nationwide survey

Author

Paolo Ravelli, A. Cerofolini, Helga Bertani, Milutin Bulajic, Vincenzo Mazzaferro, Mario Traina, Paolo Cantù, Alberto Fantin, Ilaria Tarantino, Massimiliano Mutignani, Davide Ghinolfi, Luca Barresi, Rita Conigliaro, T. Staiano, Pietro Lampertico, R. Rosa, Luca Rodella, Antonio Pisani, Roberto Penagini, Giovanni Lombardi, Giorgia Catalano, M. Monteleone, Alberto Merighi, Luca Maroni, Umberto Maggi, Luciano De Carlis, Guido Costamagna, Enzo Masci, Dario Ligresti, A. Baldan, Lucio Caccamo, E. Zucchi, E. Nadal, Maurizio Zilli, Edoardo Forti, I. Parzanese, Maurizio Vecchi, Franco Filipponi, Andrea Tringali, Mauro Salizzoni, Maria Francesca Donato, V. Boarino, Giulio Santi, Giorgio Rossi, Federico Barbaro, Antonio Di Sario, Cantu, P, Tarantino, I, Baldan, A, Mutignani, M, Tringali, A, Lombardi, G, Cerofolini, A, Di Sario, A, Catalano, G, Bertani, H, Ghinolfi, D, Boarino, V, Masci, E, Bulajic, M, Pisani, A, Fantin, A, Ligresti, D, Barresi, L, Traina, M, Ravelli, P, Forti, E, Barbaro, F, Costamagna, G, Rodella, L, Maroni, L, Salizzoni, M, Conigliaro, R, Filipponi, F, Merighi, A, Staiano, T, Monteleone, M, Mazzaferro, V, Zucchi, E, Zilli, M, Nadal, E, Rosa, R, Santi, G, Parzanese, I, De Carlis, L, Donato, M, Lampertico, P, Maggi, U, Caccamo, L, Rossi, G, Vecchi, M, and Penagini, R

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Biliary Tract Diseases, Self Expandable Metallic Stents, Constriction, Pathologic, Anastomosis, Liver transplantation, Nationwide survey, Clinical success, Young Adult, ERCP, Surveys and Questionnaires, Medicine, Humans, biliary anastomotic stricture, Aged, Retrospective Studies, Cholangiopancreatography, Endoscopic Retrograde, Cholestasis, Hepatology, medicine.diagnostic_test, liver transplantation, business.industry, Middle Aged, equipment and supplies, Survival Analysis, Surgery, Endoscopy, fully covered metal stenting, medicine.anatomical_structure, Treatment Outcome, Italy, Radiological weapon, Female, Stents, business, Duct (anatomy), Plastics, plastic multistenting
Abstract

Background: The most appropriate endo-therapeutic approach to biliary anastomotic strictures is yet to be defined. Aim: To retrospectively report on the endo-therapy of duct-to-duct anastomotic strictures during 2013 in Italy. Methods: Data were collected from 16 Endoscopy Units at the Italian Liver Transplantation Centers (BASALT study group). Results: Complete endo-therapy and follow-up data are available for 181 patients: 101 treated with plastic multistenting, 26 with fully covered self-expandable metal stenting and 54 with single stenting. Radiological success was achieved for 145 patients (80%), that is, 88% of plastic multistenting, 88% of self-expandable metal stenting and 61% of single stenting (P

Published
2019

224. Serum hepatitis B core-related antigen (HBcrAg) correlates with covalently closed circular DNA transcriptional activity in chronic hepatitis B patients

Author

Pietro Lampertico, Miroslava Subic, Caroline Scholtes, Massimo Levrero, Clothilde Miaglia, Fanny Lebossé, Alessandro Loglio, Françoise Berby, Floriana Facchetti, Fabien Zoulim, Barbara Testoni, Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
0301 basic medicine, Adult, Male, Transcriptional Activation, Hepatitis B virus, Adolescent, Genotype, [SDV]Life Sciences [q-bio], medicine.disease_cause, Antiviral Agents, Cohort Studies, 03 medical and health sciences, Liver disease, Young Adult, 0302 clinical medicine, Hepatitis B, Chronic, Antigen, medicine, Humans, Hepatitis B e Antigens, biomarker, chronic hepatitis b (chb), covalently closed circular dna (cccdna), hepatitis b virus (hbv), patient management, pregenomic rna (pgrna), adolescent, adult, aged, antiviral agents, biomarkers, cohort studies, dna, circular, dna, viral, disease progression, female, genotype, hepatitis b core antigens, hepatitis b e antigens, hepatitis b virus, hepatitis b, chronic, humans, liver, male, middle aged, young adult, transcriptional activation, Aged, Hepatology, medicine.diagnostic_test, business.industry, cccDNA, Hepatitis B, Middle Aged, medicine.disease, Hepatitis B Core Antigens, 3. Good health, 030104 developmental biology, HBeAg, Liver, Immunoassay, Immunology, DNA, Viral, Disease Progression, 030211 gastroenterology & hepatology, Female, DNA, Circular, Liver cancer, business, Biomarkers
Abstract

It has been proposed that serum hepatitis B core-related antigen (HBcrAg) reflects intrahepatic covalently closed circular (ccc)DNA levels. However, the correlation of HBcrAg with serum and intrahepatic viral markers and liver histology has not been comprehensively investigated in a large sample. We aimed to determine if HBcrAg could be a useful therapeutic marker in patients with chronic hepatitis B.HBcrAg was measured by chemiluminescent enzyme immunoassay in 130 (36 hepatitis B e antigen [HBeAg]+ and 94 HBeAg-) biopsy proven, untreated, patients with chronic hepatitis B. HBcrAg levels were correlated with: a) serum hepatitis B virus (HBV)-DNA, quantitative hepatitis B surface antigen and alanine aminotransferase levels; b) intrahepatic total (t)HBV-DNA, cccDNA, pregenomic (pg)RNA and cccDNA transcriptional activity (defined as pgRNA/cccDNA ratio); c) fibrosis and necroinflammatory activity scores.HBcrAg levels were significantly higher in HBeAg+ vs. HBeAg- patients and correlated with serum HBV-DNA, intrahepatic tHBV-DNA, pgRNA and cccDNA levels, and transcriptional activity. Patients who were negative for HBcrAg (3 LogU/ml) had less liver cccDNA and lower cccDNA activity than the HBcrAg+ group. Principal component analysis coupled with unsupervised clustering identified that in a subgroup of HBeAg- patients, higher HBcrAg levels were associated with higher serum HBV-DNA, intrahepatic tHBV-DNA, pgRNA, cccDNA transcriptional activity and with higher fibrosis and necroinflammatory activity scores.Our results indicate that HBcrAg is a surrogate marker of both intrahepatic cccDNA and its transcriptional activity. HBcrAg could be useful in the evaluation of new antiviral therapies aiming at a functional cure of HBV infection either by directly or indirectly targeting the intrahepatic cccDNA pool.Hepatitis B virus causes a chronic infection which develops into severe liver disease and liver cancer. The viral covalently closed circular DNA (cccDNA) is responsible for the persistence of the infection in hepatocytes. To better manage patient treatment and follow-up, and to develop new antiviral treatments directly targeting the intrahepatic pool of cccDNA, serum surrogate markers reflecting the viral activity in the liver are urgently needed. In this work, we demonstrate that quantification of hepatitis B core-related antigen in serum correlates with cccDNA amount and activity and could be used to monitor disease progression.

Published
2019
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225. Preliminary experience on safety of regorafenib after sorafenib failure in recurrent hepatocellular carcinoma after liver transplantation

Author

Federica Invernizzi, Gabriel Aballay Soteras, Pietro Lampertico, Maria Reig, Federico Piñero, Marcus-Alexander Wörns, Massimo Iavarone, Maria Francesca Donato, Marco Sanduzzi-Zamparelli, Maria Jose Blanco Rodríguez, Margarita Anders, Vincenzo Mazzaferro, Gerda Elisabeth Villadsen, Miguel Fraile López, Matteo Angelo Manini, Helene Regnault, Jordi Bruix, María Luisa González-Diéguez, Massimo De Giorgio, Mario Romero Cristóbal, Matthias Pinter, Maria Varela, Carolin Czauderna, Gonzalo Crespo, Giuliana Amaddeo, Sherrie Bhoori, and Arndt Weinmann

Subjects
Male, Pyridines, medicine.medical_treatment, 030230 surgery, Liver transplantation, chemotherapy, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Immunology and Allergy, Pharmacology (medical), Liver Neoplasms, Middle Aged, Sorafenib, Prognosis, Recurrent Hepatocellular Carcinoma, side effects, Hepatocellular carcinoma, Female, medicine.drug, Adult, medicine.medical_specialty, Carcinoma, Hepatocellular, cancer/malignancy/neoplasia, clinical research/practice, 03 medical and health sciences, Young Adult, Internal medicine, Regorafenib, medicine, Humans, Adverse effect, Aged, Retrospective Studies, Transplantation, drug interaction, Performance status, business.industry, Phenylurea Compounds, medicine.disease, Discontinuation, Liver Transplantation, chemistry, Drug Resistance, Neoplasm, Neoplasm Recurrence, Local, pharmacology, business, liver transplantation/hepatology, Follow-Up Studies
Abstract

Regorafenib is one option for second-line treatment of hepatocellular carcinoma (HCC), improving overall survival (OS) of sorafenib-tolerant patients who develop progression. We aim to evaluate the safety and outcomes of regorafenib as second-line treatment for HCC recurrence after liver transplantation (LT). This is a retrospective, multicenter, international study including regorafenib-treated LT patients (2015-2018), with analysis of baseline characteristics and evolutionary events during sorafenib/regorafenib treatment. Twenty-eight LT patients (57 years, 7% cirrhotics, 54% performance status 1) were included. Median time from LT to regorafenib initiation was 3.9 (1.1-18.5) years; median time on sorafenib was 11.3 (0.7-76.4) months and 14 (1-591) days from sorafenib discontinuation to regorafenib. During regorafenib (6.3 months), all patients had at least one adverse event (AE), the most common grade 3/4 AEs were fatigue (n = 7) and dermatological reaction (n = 5). While no liver rejection was observed, plasma levels of immunosuppressive drugs increased in five. Twenty-four patients developed progression (38% extrahepatic growth, 33% new extrahepatic lesions/vascular invasion). Median OS from regorafenib initiation was 12.9 (95% CI, 6.7-19.1) and 38.4 months (95% CI, 18.5-58.4) for the sorafenib initiation. This is the first study showing safety of regorafenib after LT, thus providing the rational of considering regorafenib in the clinical decision-making in sorafenib-tolerant patients with HCC recurrence after LT.

Published
2019
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226. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial

Author

Zobair M Younossi, Vlad Ratziu, Rohit Loomba, Mary Rinella, Quentin M Anstee, Zachary Goodman, Pierre Bedossa, Andreas Geier, Susanne Beckebaum, Philip N Newsome, David Sheridan, Muhammad Y Sheikh, James Trotter, Whitfield Knapple, Eric Lawitz, Manal F Abdelmalek, Kris V Kowdley, Aldo J Montano-Loza, Jerome Boursier, Philippe Mathurin, Elisabetta Bugianesi, Giuseppe Mazzella, Antonio Olveira, Helena Cortez-Pinto, Isabel Graupera, David Orr, Lise Lotte Gluud, Jean-Francois Dufour, David Shapiro, Jason Campagna, Luna Zaru, Leigh MacConell, Reshma Shringarpure, Stephen Harrison, Arun J Sanyal, Manal Abdelmalek, Gary Abrams, Humberto Aguilar, Aijaz Ahmed, Elmar Aigner, Guruprasad Aithal, Aftab Ala, William Alazawi, Agustin Albillos, Michael Allison, Sfa Al-Shamma, Raul Andrade, Pietro Andreone, Mario Angelico, Victor Ankoma-Sey, Quentin Anstee, Rodolphe Anty, Victor Araya, Juan Ignacio Arenas Ruiz, Perttu Arkkila, Marty Arora, Tarik Asselah, Jennifer Au, Oyekoya Ayonrinde, Robert James Bailey, Maya Balakrishnan, Kiran Bambha, Meena Bansal, Sidney Barritt, John Bate, Jorge Beato, Jaideep Behari, Pablo Bellot, Ziv Ben Ari, Michael Bennett, Marina Berenguer, Benedetta Terziroli Beretta-Piccoli, Thomas Berg, Maurizio Bonacini, Lucia Bonet, Brian Borg, Marc Bourliere, William Bowman, David Bradley, Marija Brankovic, Marius Braun, Jean-Pierre Bronowicki, Savino Bruno, Cindy Cai, Amy Calderon, José Luis Calleja Panero, Elizabeth Carey, Michal Carmiel, Jose Antonio Carrión, Matthew Cave, Cristina Chagas, Tawfik Chami, Alan Chang, Allan Coates, Jeremy Cobbold, Charlote Costentin, Kathleen Corey, Lynsey Corless, Javier Crespo, Oscar Cruz Pereira, Victor de Ledinghen, Andrew deLemos, Moises Diago, Mamie Dong, Jean-François Dufour, Predrag Dugalic, Winston Dunn, Magby Elkhashab, Michael Epstein, Maria Desamparados Escudero-Garcia, Ohad Etzion, Larry Evans, Robert Falcone, Conrado Fernandez, Jose Ferreira, Scott Fink, Kevin Finnegan, Roberto Firpi-Morell, Annarosa Floreani, Thierry Fontanges, Ryan Ford, Ewan Forrest, Andrew Fowell, Anna Ludovica Fracanzani, Sven Francque, Bradley Freilich, Juan Frias, Michael Fuchs, Javier Fuentes, Michael Galambos, Juan Gallegos, Anja Geerts, Jacob George, Maged Ghali, Reem Ghalib, Pierre Gholam, Pere Gines, Norman Gitlin, Tobias Goeser, John Goff, Stuart Gordon, Frederic Gordon, Odile Goria, Shaun Greer, Alla Grigorian, Henning Gronbaek, Maeva Guillaume, Naresh Gunaratnam, Dina Halegoua-De Marzio, Bilal Hameed, Stephanie Hametner, James Hamilton, Marek Hartleb, Tarek Hassanein, Dieter Häussinger, Paul Hellstern, Robert Herring, Eva Heurich, Christophe Hezode, Holger Hinrichsen, Peter Holland Fischer, Yves Horsmans, Jonathan Huang, Hyder Hussaini, Antoine Jakiche, Lennox Jeffers, Blake Jones, Rosa Jorge, Francisco Jorquera, Shoba Joshi, Alisan Kahraman, Kelly Kaita, Nicholas Karyotakis, Zeid Kayali, Stergios Kechagias, Thomas Kepczyk, Mandana Khalili, Hicham Khallafi, Johannes Kluwe, Anita Kohli, Kevin Korenblat, Kris Kowdley, Aleksander Krag, Richard Krause, Andreas Kremer, Karen Krok, Miodrag Krstic, Marcelo Kugelmas, Sonal Kumar, Scott Kuwada, Damien Labarriere, Michelle Lai, Wim Laleman, Pietro Lampertico, Alice Lee, Vincent Leroy, Steven Lidofsky, Tina Huey Lim, Joseph Lim, Donald Lipkis, Ester Little, Amadeo Lonardo, Michelle Long, Velimir Anthony Christopher Luketic, Yoav Lurie, Guilherme Macedo, Joana Magalhaes, Mihály Makara, Benedict Maliakkal, Michael Manns, Pinelopi Manousou, Parvez Mantry, Giulio Marchesini, Carla Marinho, Paul Marotta, Hanns-Ulrich Marschall, Linda Martinez, Marlyn Mayo, Mark McCullen, William McLaughlin, Uta Merle, Raphael Merriman, Apurva Modi, Esther Molina, Aldo Montano-Loza, Carlos Monteverde, Amilcar Morales Cardona, Sulleman Moreea, Christophe Moreno, Filomena Morisco, Abdullah Mubarak, Beat Muellhaupt, Sandeep Mukherjee, Tobias Müller, Aleksandar Nagorni, Jahnavi Naik, Guy Neff, Moises Nevah, Philip Newsome, Eric Nguyen-Khac, Mazen Noureddin, Jude Oben, Hans Orlent, James Orr, Grisell Ortiz-Lasanta, Violaine Ozenne, Prashant Pandya, Angelo Paredes, James Park, Joykumar Patel, Keyur Patel, Sonali Paul, Heather Patton, Markus Peck-Radosavljevic, Salvatore Petta, Stephen Pianko, Anna Piekarska, Neville Pimstone, Joseph Pisegna, Paul Pockros, Stanislas Pol, Michael Porayko, John Poulos, David Pound, Joe Pouzar, Jose Presa Ramos, Nikolaos Pyrsopoulos, Nila Rafiq, Kate Muller, Alnoor Ramji, Ravi Ravinuthala, Chakradhar Reddy, Gautham Reddy K G, K. Rajender Reddy K R, Frederic Regenstein, Robert Reindollar, Justin Reynolds, Andres Riera, Jose Rivera Acosta, Geert Robaeys, Stuart Roberts, Federico Rodriguez-Perez, Sandor Romero, Manuel Romero-Gomez, Raymond Rubin, Mariagrazia Rumi, Simon Rushbrook, Christian Rust, Michael Ryan, Rifaat Safadi, Adnan Said, Kimmo Salminen, Didier Samuel, John Santoro, Arun Sanyal, Souvik Sarkar, Cynthia Schaeffer, Jörn Schattenberg, Ingolf Schiefke, Eugene Schiff, Wolfgang Schmidt, Jeffrey Schneider, Jeoffrey Schouten, Michael Schultz, Giada Sebastiani, David Semela, Thomas Sepe, Aasim Sheikh, Muhammad Sheikh, Kenneth Sherman, Oren Shibolet, Mitchell Shiffman, Asma Siddique, Cyril Sieberhagen, Samuel Sigal, Katarzyna Sikorska, Krzysztof Simon, Marie Sinclair, Richard Skoien, Joel Solis, Siddharth Sood, Bob Souder, James Spivey, Per Stal, Laura Stinton, Simone Strasser, Petar Svorcan, Gyongzi Szabo, Andrew Talal, Edward Tam, Brent Tetri, Paul Thuluvath, Hillel Tobias, Krzysztof Tomasiewicz, Dawn Torres, Albert Tran, Michael Trauner, Christian Trautwein, Emanuel Tsochatzis, Esther Unitt, Victor Vargas, Istvan Varkonyi, Ella Veitsman, Umberto Vespasiani Gentilucci, David Victor, John Vierling, Catherine Vincent, Aron Vincze, Manfred von der Ohe, Natasha Von Roenn, Raj Vuppalanchi, Michael Waters, Kymberly Watt, Julia Wattacheril, Martin Weltman, Amanda Wieland, Gregory Wiener, Alonzo Williams A, Jeffrey Williams J, Jason Wilson, Maria Yataco, Eric Yoshida, Ziad Younes, Liyun Yuan, Adam Zivony, Donald Zogg, Heinz Zoller, Fabien Zoulim, Eli Zuckerman, Massimo Zuin, Younossi Z.M., Ratziu V., Loomba R., Rinella M., Anstee Q.M., Goodman Z., Bedossa P., Geier A., Beckebaum S., Newsome P.N., Sheridan D., Sheikh M.Y., Trotter J., Knapple W., Lawitz E., Abdelmalek M.F., Kowdley K.V., Montano-Loza A.J., Boursier J., Mathurin P., Bugianesi E., Mazzella G., Olveira A., Cortez-Pinto H., Graupera I., Orr D., Gluud L.L., Dufour J.-F., Shapiro D., Campagna J., Zaru L., MacConell L., Shringarpure R., Harrison S., Sanyal A.J., Abdelmalek M., Abrams G., Aguilar H., Ahmed A., Aigner E., Aithal G., Ala A., Alazawi W., Albillos A., Allison M., Al-Shamma S., Andrade R., Andreone P., Angelico M., Ankoma-Sey V., Anstee Q., Anty R., Araya V., Arenas Ruiz J.I., Arkkila P., Arora M., Asselah T., Au J., Ayonrinde O., Bailey R.J., Balakrishnan M., Bambha K., Bansal M., Barritt S., Bate J., Beato J., Behari J., Bellot P., Ben Ari Z., Bennett M., Berenguer M., Beretta-Piccoli B.T., Berg T., Bonacini M., Bonet L., Borg B., Bourliere M., Bowman W., Bradley D., Brankovic M., Braun M., Bronowicki J.-P., Bruno S., Cai C., Calleja Panero J.L., Carey E., Carmiel M., Carrion J.A., Cave M., Chagas C., Chami T., Chang A., Coates A., Cobbold J., Corey K., Corless L., Crespo J., Cruz Pereira O., de Ledinghen V., deLemos A., Diago M., Dugalic P., Dunn W., Elkhashab M., Epstein M., Escudero-Garcia M.D., Etzion O., Evans L., Falcone R., Fernandez C., Ferreira J., Fink S., Finnegan K., Firpi-Morell R., Floreani A., Fontanges T., Ford R., Forrest E., Fowell A., Fracanzani A.L., Francque S., Freilich B., Frias J., Fuchs M., Fuentes J., Galambos M., Gallegos J., Geerts A., George J., Ghali M., Ghalib R., Gholam P., Gines P., Gitlin N., Goeser T., Goff J., Gordon S., Gordon F., Goria O., Greer S., Grigorian A., Gronbaek H., Guillaume M., Gunaratnam N., Halegoua-De Marzio D., Hameed B., Hametner S., Hamilton J., Hartleb M., Hassanein T., Haussinger D., Hellstern P., Herring R., Heurich E., Hezode C., Hinrichsen H., Holland Fischer P., Horsmans Y., Huang J., Jakiche A., Jeffers L., Jones B., Jorge R., Jorquera F., Kahraman A., Kaita K., Karyotakis N., Kayali Z., Kechagias S., Kepczyk T., Khalili M., Khallafi H., Kluwe J., Kohli A., Korenblat K., Kowdley K., Krag A., Krause R., Kremer A., Krok K., Krstic M., Kugelmas M., Kumar S., Labarriere D., Lai M., Lampertico P., Lee A., Leroy V., Lidofsky S., Lim T.H., Lim J., Lipkis D., Little E., Lonardo A., Long M., Lurie Y., Macedo G., Makara M., Maliakkal B., Manns M., Manousou P., Mantry P., Marchesini G., Marinho C., Marotta P., Marschall H.-U., Mayo M., McCullen M., McLaughlin W., Merriman R., Modi A., Molina E., Montano-Loza A., Monteverde C., Moreea S., Moreno C., Morisco F., Mubarak A., Muellhaupt B., Mukherjee S., Muller T., Nagorni A., Naik J., Neff G., Nevah M., Newsome P., Nguyen-Khac E., Noureddin M., Oben J., Orlent H., Orr J., Ortiz-Lasanta G., Ozenne V., Pandya P., Paredes A., Park J., Patel J., Patel K., Uta M., Patton H., Peck-Radosavljevic M., Petta S., Pianko S., Piekarska A., Pimstone N., Pockros P., Pol S., Porayko M., Poulos J., Pound D., Pouzar J., Presa Ramos J., Pyrsopoulos N., Rafiq N., Muller K., Ramji A., Ravinuthala R., Reddy C., Reddy K G G., Reddy K R K.R., Regenstein F., Reindollar R., Riera A., Rivera Acosta J., Robaeys G., Roberts S., Rodriguez-Perez F., Romero-Gomez M., Rubin R., Rumi M., Rushbrook S., Rust C., Ryan M., Safadi R., Said A., Salminen K., Samuel D., Santoro 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M., Ratziu, V., Loomba, R., Rinella, M., Anstee, Q. M., Goodman, Z., Bedossa, P., Geier, A., Beckebaum, S., Newsome, P. N., Sheridan, D., Sheikh, M. Y., Trotter, J., Knapple, W., Lawitz, E., Abdelmalek, M. F., Kowdley, K. V., Montano-Loza, A. J., Boursier, J., Mathurin, P., Bugianesi, E., Mazzella, G., Olveira, A., Cortez-Pinto, H., Graupera, I., Orr, D., Gluud, L. L., Dufour, J. -F., Shapiro, D., Campagna, J., Zaru, L., Macconell, L., Shringarpure, R., Harrison, S., Sanyal, A. J., Abdelmalek, M., Abrams, G., Aguilar, H., Ahmed, A., Aigner, E., Aithal, G., Ala, A., Alazawi, W., Albillos, A., Allison, M., Al-Shamma, S., Andrade, R., Andreone, P., Angelico, M., Ankoma-Sey, V., Anstee, Q., Anty, R., Araya, V., Arenas Ruiz, J. I., Arkkila, P., Arora, M., Asselah, T., Au, J., Ayonrinde, O., Bailey, R. J., Balakrishnan, M., Bambha, K., Bansal, M., Barritt, S., Bate, J., Beato, J., Behari, J., Bellot, P., Ben Ari, Z., Bennett, M., Berenguer, M., Beretta-Piccoli, B. 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L., Francque, S., Freilich, B., Frias, J., Fuchs, M., Fuentes, J., Galambos, M., Gallegos, J., Geerts, A., George, J., Ghali, M., Ghalib, R., Gholam, P., Gines, P., Gitlin, N., Goeser, T., Goff, J., Gordon, S., Gordon, F., Goria, O., Greer, S., Grigorian, A., Gronbaek, H., Guillaume, M., Gunaratnam, N., Halegoua-De Marzio, D., Hameed, B., Hametner, S., Hamilton, J., Hartleb, M., Hassanein, T., Haussinger, D., Hellstern, P., Herring, R., Heurich, E., Hezode, C., Hinrichsen, H., Holland Fischer, P., Horsmans, Y., Huang, J., Jakiche, A., Jeffers, L., Jones, B., Jorge, R., Jorquera, F., Kahraman, A., Kaita, K., Karyotakis, N., Kayali, Z., Kechagias, S., Kepczyk, T., Khalili, M., Khallafi, H., Kluwe, J., Kohli, A., Korenblat, K., Kowdley, K., Krag, A., Krause, R., Kremer, A., Krok, K., Krstic, M., Kugelmas, M., Kumar, S., Labarriere, D., Lai, M., Lampertico, P., Lee, A., Leroy, V., Lidofsky, S., Lim, T. H., Lim, J., Lipkis, D., Little, E., Lonardo, A., Long, M., Lurie, Y., Macedo, G., Makara, M., Maliakkal, B., Manns, M., Manousou, P., Mantry, P., Marchesini, G., Marinho, C., Marotta, P., Marschall, H. -U., Mayo, M., Mccullen, M., Mclaughlin, W., Merriman, R., Modi, A., Molina, E., Montano-Loza, A., Monteverde, C., Moreea, S., Moreno, C., Morisco, F., Mubarak, A., Muellhaupt, B., Mukherjee, S., Muller, T., Nagorni, A., Naik, J., Neff, G., Nevah, M., Newsome, P., Nguyen-Khac, E., Noureddin, M., Oben, J., Orlent, H., Orr, J., Ortiz-Lasanta, G., Ozenne, V., Pandya, P., Paredes, A., Park, J., Patel, J., Patel, K., Uta, M., Patton, H., Peck-Radosavljevic, M., Petta, S., Pianko, S., Piekarska, A., Pimstone, N., Pockros, P., Pol, S., Porayko, M., Poulos, J., Pound, D., Pouzar, J., Presa Ramos, J., Pyrsopoulos, N., Rafiq, N., Muller, K., Ramji, A., Ravinuthala, R., Reddy, C., Reddy K G, G., Reddy K R, K. R., Regenstein, F., Reindollar, R., Riera, A., Rivera Acosta, J., Robaeys, G., Roberts, S., Rodriguez-Perez, F., Romero-Gomez, M., Rubin, R., Rumi, M., Rushbrook, S., Rust, C., Ryan, M., Safadi, R., Said, A., Salminen, K., Samuel, D., Santoro, J., Sanyal, A., Sarkar, S., Schaeffer, C., Schattenberg, J., Schiefke, I., Schiff, E., Schmidt, W., Schneider, J., Schouten, J., Schultz, M., Sebastiani, G., Semela, D., Sepe, T., Sheikh, A., Sheikh, M., Sherman, K., Shibolet, O., Shiffman, M., Siddique, A., Sieberhagen, C., Sigal, S., Sikorska, K., Simon, K., Sinclair, M., Skoien, R., Solis, J., Sood, S., Souder, B., Spivey, J., Stal, P., Stinton, L., Strasser, S., Svorcan, P., Szabo, G., Talal, A., Tam, E., Tetri, B., Thuluvath, P., Tobias, H., Tomasiewicz, K., Torres, D., Trauner, M., Trautwein, C., Tsochatzis, E., Unitt, E., Vargas, V., Varkonyi, I., Veitsman, E., Vespasiani Gentilucci, U., Victor, D., Vierling, J., Vincent, C., Vincze, A., von der Ohe, M., Von Roenn, N., Vuppalanchi, R., Waters, M., Watt, K., Weltman, M., Wieland, A., Wiener, G., Williams A, A., Williams J, J., Wilson, J., Yataco, M., Yoshida, E., Younes, Z., Yuan, L., Zivony, A., Zogg, D., Zoller, H., Zoulim, F., Zuckerman, E., Zuin, M., Younossi, Zobair M, Ratziu, Vlad, Loomba, Rohit, Rinella, Mary, Anstee, Quentin M, Goodman, Zachary, Bedossa, Pierre, Geier, Andrea, Beckebaum, Susanne, Newsome, Philip N, Sheridan, David, Sheikh, Muhammad Y, Trotter, Jame, Knapple, Whitfield, Lawitz, Eric, Abdelmalek, Manal F, Kowdley, Kris V, Montano-Loza, Aldo J, Boursier, Jerome, Mathurin, Philippe, Bugianesi, Elisabetta, Mazzella, Giuseppe, Olveira, Antonio, Cortez-Pinto, Helena, Graupera, Isabel, Orr, David, Gluud, Lise Lotte, Dufour, Jean-Francoi, Shapiro, David, Campagna, Jason, Zaru, Luna, MacConell, Leigh, Shringarpure, Reshma, Harrison, Stephen, Sanyal, Arun J, Abdelmalek, Manal, Abrams, Gary, Aguilar, Humberto, Ahmed, Aijaz, Aigner, Elmar, Aithal, Guruprasad, Ala, Aftab, Alazawi, William, Albillos, Agustin, Allison, Michael, Al-Shamma, Sfa, Andrade, Raul, Andreone, Pietro, Angelico, Mario, Ankoma-Sey, Victor, Anstee, Quentin, Anty, Rodolphe, Araya, Victor, Arenas Ruiz, Juan Ignacio, Arkkila, Perttu, Arora, Marty, Asselah, Tarik, Au, Jennifer, Ayonrinde, Oyekoya, Bailey, Robert Jame, Balakrishnan, Maya, Bambha, Kiran, Bansal, Meena, Barritt, Sidney, Bate, John, Beato, Jorge, Behari, Jaideep, Bellot, Pablo, Ben Ari, Ziv, Bennett, Michael, Berenguer, Marina, Beretta-Piccoli, Benedetta Terziroli, Berg, Thoma, Bonacini, Maurizio, Bonet, Lucia, Borg, Brian, Bourliere, Marc, Bowman, William, Bradley, David, Brankovic, Marija, Braun, Mariu, Bronowicki, Jean-Pierre, Bruno, Savino, Cai, Cindy, Calleja Panero, José Lui, Carey, Elizabeth, Carmiel, Michal, Carrión, Jose Antonio, Cave, Matthew, Chagas, Cristina, Chami, Tawfik, Chang, Alan, Coates, Allan, Cobbold, Jeremy, Corey, Kathleen, Corless, Lynsey, Crespo, Javier, Cruz Pereira, Oscar, de Ledinghen, Victor, deLemos, Andrew, Diago, Moise, Dufour, Jean-Françoi, Dugalic, Predrag, Dunn, Winston, Elkhashab, Magby, Epstein, Michael, Escudero-Garcia, Maria Desamparado, Etzion, Ohad, Evans, Larry, Falcone, Robert, Fernandez, Conrado, Ferreira, Jose, Fink, Scott, Finnegan, Kevin, Firpi-Morell, Roberto, Floreani, Annarosa, Fontanges, Thierry, Ford, Ryan, Forrest, Ewan, Fowell, Andrew, Fracanzani, Anna Ludovica, Francque, Sven, Freilich, Bradley, Frias, Juan, Fuchs, Michael, Fuentes, Javier, Galambos, Michael, Gallegos, Juan, Geerts, Anja, George, Jacob, Ghali, Maged, Ghalib, Reem, Gholam, Pierre, Gines, Pere, Gitlin, Norman, Goeser, Tobia, Goff, John, Gordon, Stuart, Gordon, Frederic, Goria, Odile, Greer, Shaun, Grigorian, Alla, Gronbaek, Henning, Guillaume, Maeva, Gunaratnam, Naresh, Halegoua-De Marzio, Dina, Hameed, Bilal, Hametner, Stephanie, Hamilton, Jame, Hartleb, Marek, Hassanein, Tarek, Häussinger, Dieter, Hellstern, Paul, Herring, Robert, Heurich, Eva, Hezode, Christophe, Hinrichsen, Holger, Holland Fischer, Peter, Horsmans, Yve, Huang, Jonathan, Jakiche, Antoine, Jeffers, Lennox, Jones, Blake, Jorge, Rosa, Jorquera, Francisco, Kahraman, Alisan, Kaita, Kelly, Karyotakis, Nichola, Kayali, Zeid, Kechagias, Stergio, Kepczyk, Thoma, Khalili, Mandana, Khallafi, Hicham, Kluwe, Johanne, Kohli, Anita, Korenblat, Kevin, Kowdley, Kri, Krag, Aleksander, Krause, Richard, Kremer, Andrea, Krok, Karen, Krstic, Miodrag, Kugelmas, Marcelo, Kumar, Sonal, Labarriere, Damien, Lai, Michelle, Lampertico, Pietro, Lee, Alice, Leroy, Vincent, Lidofsky, Steven, Lim, Tina Huey, Lim, Joseph, Lipkis, Donald, Little, Ester, Lonardo, Amadeo, Long, Michelle, Lurie, Yoav, Macedo, Guilherme, Makara, Mihály, Maliakkal, Benedict, Manns, Michael, Manousou, Pinelopi, Mantry, Parvez, Marchesini, Giulio, Marinho, Carla, Marotta, Paul, Marschall, Hanns-Ulrich, Mayo, Marlyn, McCullen, Mark, McLaughlin, William, Merriman, Raphael, Modi, Apurva, Molina, Esther, Montano-Loza, Aldo, Monteverde, Carlo, Moreea, Sulleman, Moreno, Christophe, Morisco, Filomena, Mubarak, Abdullah, Muellhaupt, Beat, Mukherjee, Sandeep, Müller, Tobia, Nagorni, Aleksandar, Naik, Jahnavi, Neff, Guy, Nevah, Moise, Newsome, Philip, Nguyen-Khac, Eric, Noureddin, Mazen, Oben, Jude, Orlent, Han, Orr, Jame, Ortiz-Lasanta, Grisell, Ozenne, Violaine, Pandya, Prashant, Paredes, Angelo, Park, Jame, Patel, Joykumar, Patel, Keyur, Uta, Merle, Patton, Heather, Peck-Radosavljevic, Marku, Petta, Salvatore, Pianko, Stephen, Piekarska, Anna, Pimstone, Neville, Pockros, Paul, Pol, Stanisla, Porayko, Michael, Poulos, John, Pound, David, Pouzar, Joe, Presa Ramos, Jose, Pyrsopoulos, Nikolao, Rafiq, Nila, Muller, Kate, Ramji, Alnoor, Ravinuthala, Ravi, Reddy, Chakradhar, Reddy K G, Gautham, Reddy K R, K. Rajender, Regenstein, Frederic, Reindollar, Robert, Riera, Andre, Rivera Acosta, Jose, Robaeys, Geert, Roberts, Stuart, Rodriguez-Perez, Federico, Romero-Gomez, Manuel, Rubin, Raymond, Rumi, Mariagrazia, Rushbrook, Simon, Rust, Christian, Ryan, Michael, Safadi, Rifaat, Said, Adnan, Salminen, Kimmo, Samuel, Didier, Santoro, John, Sanyal, Arun, Sarkar, Souvik, Schaeffer, Cynthia, Schattenberg, Jörn, Schiefke, Ingolf, Schiff, Eugene, Schmidt, Wolfgang, Schneider, Jeffrey, Schouten, Jeoffrey, Schultz, Michael, Sebastiani, Giada, Semela, David, Sepe, Thoma, Sheikh, Aasim, Sheikh, Muhammad, Sherman, Kenneth, Shibolet, Oren, Shiffman, Mitchell, Siddique, Asma, Sieberhagen, Cyril, Sigal, Samuel, Sikorska, Katarzyna, Simon, Krzysztof, Sinclair, Marie, Skoien, Richard, Solis, Joel, Sood, Siddharth, Souder, Bob, Spivey, Jame, Stal, Per, Stinton, Laura, Strasser, Simone, Svorcan, Petar, Szabo, Gyongzi, Talal, Andrew, Tam, Edward, Tetri, Brent, Thuluvath, Paul, Tobias, Hillel, Tomasiewicz, Krzysztof, Torres, Dawn, Trauner, Michael, Trautwein, Christian, Tsochatzis, Emanuel, Unitt, Esther, Vargas, Victor, Varkonyi, Istvan, Veitsman, Ella, Vespasiani Gentilucci, Umberto, Victor, David, Vierling, John, Vincent, Catherine, Vincze, Aron, von der Ohe, Manfred, Von Roenn, Natasha, Vuppalanchi, Raj, Waters, Michael, Watt, Kymberly, Weltman, Martin, Wieland, Amanda, Wiener, Gregory, Williams A, Alonzo, Williams J, Jeffrey, Wilson, Jason, Yataco, Maria, Yoshida, Eric, Younes, Ziad, Yuan, Liyun, Zivony, Adam, Zogg, Donald, Zoller, Heinz, Zoulim, Fabien, Zuckerman, Eli, Zuin, Massimo, and REGENERATE Study Investigators

Subjects
Male, Biopsy, Clinical Trial, Phase III, Administration, Oral, 030204 cardiovascular system & hematology, Chronic liver disease, Settore MED/04, Biomarkers/analysis, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Liver Function Tests, Non-alcoholic Fatty Liver Disease, Clinical endpoint, Medicine, 030212 general & internal medicine, 610 Medicine & health, Chenodeoxycholic Acid/administration & dosage, education.field_of_study, Liver Function Test, Research Support, Non-U.S. Gov't, Fatty liver, Obeticholic acid, NASH, OBETICHOLIC ACID, General Medicine, Middle Aged, Multicenter Study, Randomized Controlled Trial, Administration, Female, Biomarkers, Chenodeoxycholic Acid, Double-Blind Method, Humans, Human, Oral, medicine.medical_specialty, Population, Placebo, 03 medical and health sciences, Research Support, N.I.H., Extramural, Internal medicine, Journal Article, education, Intention-to-treat analysis, business.industry, Biomarker, Interim analysis, medicine.disease, Non-alcoholic Fatty Liver Disease/drug therapy, chemistry, Human medicine, business
Abstract

© 2019 Elsevier Ltd. All rights reserved., Background: Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. Methods: In this multicentre, randomised, double-blind, placebo-controlled study, adult patients with definite NASH, non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2-F3, or F1 with at least one accompanying comorbidity, were randomly assigned using an interactive web response system in a 1:1:1 ratio to receive oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily. Patients were excluded if cirrhosis, other chronic liver disease, elevated alcohol consumption, or confounding conditions were present. The primary endpoints for the month-18 interim analysis were fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of fibrosis, with the study considered successful if either primary endpoint was met. Primary analyses were done by intention to treat, in patients with fibrosis stage F2-F3 who received at least one dose of treatment and reached, or would have reached, the month 18 visit by the prespecified interim analysis cutoff date. The study also evaluated other histological and biochemical markers of NASH and fibrosis, and safety. This study is ongoing, and registered with ClinicalTrials.gov, NCT02548351, and EudraCT, 20150-025601-6. Findings: Between Dec 9, 2015, and Oct 26, 2018, 1968 patients with stage F1-F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2-F3 fibrosis were included in the primary analysis (311 in the placebo group, 312 in the obeticholic acid 10 mg group, and 308 in the obeticholic acid 25 mg group). The fibrosis improvement endpoint was achieved by 37 (12%) patients in the placebo group, 55 (18%) in the obeticholic acid 10 mg group (p=0·045), and 71 (23%) in the obeticholic acid 25 mg group (p=0·0002). The NASH resolution endpoint was not met (25 [8%] patients in the placebo group, 35 [11%] in the obeticholic acid 10 mg group [p=0·18], and 36 [12%] in the obeticholic acid 25 mg group [p=0·13]). In the safety population (1968 patients with fibrosis stages F1-F3), the most common adverse event was pruritus (123 [19%] in the placebo group, 183 [28%] in the obeticholic acid 10 mg group, and 336 [51%] in the obeticholic acid 25 mg group); incidence was generally mild to moderate in severity. The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group). Interpretation: Obeticholic acid 25 mg significantly improved fibrosis and key components of NASH disease activity among patients with NASH. The results from this planned interim analysis show clinically significant histological improvement that is reasonably likely to predict clinical benefit. This study is ongoing to assess clinical outcomes.

Published
2019
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227. Epidemiology, features and outcomes of patients transplanted for hepatocellular carcinoma in the last decade: a single center experience

Author

Gemma Rossi, Pietro Lampertico, Massimo Iavarone, Federica Invernizzi, Maria Francesca Donato, Marco Maggioni, A. Zefilippo, Angelo Sangiovanni, Daniele Dondossola, T. De Feo, and B. Antonelli

Subjects
medicine.medical_specialty, Hepatology, business.industry, Hepatocellular carcinoma, General surgery, Epidemiology, Gastroenterology, medicine, Single Center, business, medicine.disease
Published
2020
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228. Changes in bone mineral density during monotherapy with tenofovir disoproxil fumarate: a 6-year real life longitudinal cohort study in chronic hepatitis B caucasian patients

Author

M.G. Rumi, Pietro Lampertico, F. Cerini, E. Farina, Alessandro Loglio, Mauro Viganò, Riccardo Perbellini, and Fabio Facchetti

Subjects
Bone mineral, medicine.medical_specialty, Hepatology, Tenofovir, Chronic hepatitis, business.industry, Internal medicine, Gastroenterology, medicine, Longitudinal cohort, business, medicine.drug
Published
2020
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229. Genetic variants do not predict the development of hepatocellular carcinoma in cross-sectional and longitudinal studies including caucasian compensated hbv cirrhotics treated with nuc for 10 years

Author

Marta Borghi, Fabio Facchetti, Angelo Sangiovanni, Enrico Galmozzi, M.G. Rumi, Massimo Iavarone, Mauro Viganò, Riccardo Perbellini, Alessandro Loglio, and Pietro Lampertico

Subjects
Oncology, medicine.medical_specialty, Hepatology, business.industry, Hepatocellular carcinoma, Internal medicine, Gastroenterology, medicine, Genetic variants, medicine.disease, business
Published
2020
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230. A genetic risk score predicts de novo hepatocellular carcinoma in hepatits c cirrhotic patients treated with direct-acting antivirals

Author

Angelo Sangiovanni, Roberta Soffredini, Massimo Iavarone, Luca Valenti, Serena Pelusi, Riccardo Perbellini, Roberta D'Ambrosio, Pietro Lampertico, Enrico Galmozzi, Elisabetta Degasperi, Marta Borghi, and Fabio Facchetti

Subjects
Oncology, medicine.medical_specialty, Hepatology, business.industry, Hepatocellular carcinoma, Internal medicine, Gastroenterology, medicine, Genetic risk, medicine.disease, DIRECT ACTING ANTIVIRALS, business
Published
2020
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231. TLL1 variants do not predict hepatocellular carcinoma development in HCV cirrhotic patients treated with direct-acting antivirals

Author

Roberta D'Ambrosio, Massimo Iavarone, Elisabetta Degasperi, Roberta Soffredini, Enrico Galmozzi, Pietro Lampertico, Floriana Facchetti, and Elisa Farina

Subjects
Adult, Liver Cirrhosis, Male, medicine.medical_specialty, Cirrhosis, Carcinoma, Hepatocellular, Genotyping Techniques, Sustained Virologic Response, Tolloid-Like Metalloproteinases, Hepatitis C virus, medicine.disease_cause, Gastroenterology, Antiviral Agents, Polymorphism, Single Nucleotide, White People, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Virology, Diabetes mellitus, Internal medicine, Genotype, medicine, Humans, Cumulative incidence, Genetic Predisposition to Disease, 030212 general & internal medicine, Aged, Aged, 80 and over, Hepatology, business.industry, Incidence (epidemiology), Incidence, Liver Neoplasms, TLL1, Hepatitis C, Chronic, Middle Aged, medicine.disease, Infectious Diseases, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Female, business
Abstract

Tolloid-like 1 gene (TLL1) variant rs17047200 has been associated with hepatocellular carcinoma (HCC) in Japanese hepatitis C virus (HCV) patients with sustained virological response (SVR) to interferon or direct-acting antiviral (DAA)-based regimens. We investigated whether this holds true also in Caucasian cirrhotic patients cured by DAAs. Consecutive Caucasian HCV cirrhotics receiving DAA between December 2014 and December 2016 in a single centre were enrolled. Cirrhosis was defined histologically (METAVIR F4) or by liver stiffness measurement (LSM > 11.9 kPa). TLL1 rs17047200 was analysed by TaqMan SNP genotyping assay. 452 patients were enrolled: median age 63 (28-87) years, 58% males, 47% HCV-1b, LSM 19.1 (12.0-75.0) kPa and Fibrosis-4 (FIB-4) score 4.9 (0.3-46.0). 96% patients achieved an SVR. TLL1 genotype was AA in 329 (73%) and AT/TT in 123 (27%) (MAF = 0.14, HWE P > 0.05). Patients' clinical features were similar across TLL1 genotypes. After 33 (3-47) months from DAA start, 31 patients developed HCC, with a 3-year estimated cumulative probability being 7.5% (95% CI: 5%-10%). The cumulative incidence of HCC was 9% in TLL1 AA vs 7% in AT/TT patients (P = 0.55). Male sex (HR: 3.78, 95% CI: 1.4-10.1, P = 0.008), diabetes (HR: 3.5, 95% CI: 1.68-7.27, P = 0.001) and FIB-4 (HR: 1.09, 95% CI: 1.03-1.14, P = 0.001) were baseline-independent predictors of HCC. The incidence of HCC was not influenced by TLL1 genotypes even when considering an additional group of 348 noncirrhotic patients, being 2% in AA vs 1% AT/TT patients (P = 0.58). In a large cohort of Caucasian HCV cirrhotics treated with DAA, TLL1 variants do not predict HCC development.

Published
2018

232. Genetic variation in FCER1A predicts peginterferon alfa-2a-induced hepatitis B surface antigen clearance in East Asian patients with chronic hepatitis B

Author

Robert Plesniak, Teerha Piratvisuth, Vedran Pavlovic, Hua He, Yun Fan Liaw, Lai Wei, Pietro Lampertico, Adriana Motoc, Xiaoping Chen, Jia-Horng Kao, Graham R. Foster, Aruna T. Bansal, Cynthia Wat, and George V. Papatheodoridis

Subjects
Adult, Male, HBsAg, Single-nucleotide polymorphism, Antiviral Agents, Polymorphism, Single Nucleotide, Serology, Polyethylene Glycols, 03 medical and health sciences, 0302 clinical medicine, Hepatitis B, Chronic, Asian People, Virology, Genetic variation, Genotype, Medicine, Humans, 030212 general & internal medicine, Allele, Alleles, Hepatitis B Surface Antigens, Hepatology, business.industry, Receptors, IgE, Genetic Variation, Interferon-alpha, RNA Polymerase III, Middle Aged, Microarray Analysis, FCER1A, Recombinant Proteins, Infectious Diseases, Immunology, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, business, Peginterferon alfa-2a, medicine.drug, Genome-Wide Association Study
Abstract

In a multicentre, genome-wide association study to identify host genetic factors associated with treatment response in adult chronic hepatitis B patients, genotype data were obtained by microarray analysis from 1669 patients who received peginterferon alfa-2a for ≥ 24 weeks with/without a nucleos(t)ide analog. Treatment response was assessed at least 24 weeks post-treatment, using serological and/or virological endpoints. Thirty-six single-marker analyses and a gene-by-gene analysis were conducted. No single nucleotide polymorphisms (SNPs) achieved genome-wide significance (P

Published
2018

233. AISF position paper on HCV in immunocompromised patients

Author

Gabriele Missale, Mauro Viganò, Marco Astegiano, Mauro Salizzoni, C. Chialà, Angelo Pera, Patrizia Racca, Massimo Di Maio, Mario Salomone, M. Puoti, Simone Parisi, Paolo Bironzo, M. Rendina, Carla Pasquina, Clodoveo Ferri, Luisa Pasulo, Rita Tozzi, A. Tucci, Pietro Lampertico, Emanuele Angelucci, Bruno Daniele, Patrizia Burra, Franco Riccardini, Marco Lagget, Fabio Salvatore Macaluso, Davide Giuseppe Ribaldone, Luca Miele, Clara Lisa Peroni, Raffaele Bruno, Anna Linda Zignego, Ambrogio Orlando, Giovanni Battista Gaeta, Giuseppe Montrucchio, Daniela Libertucci, Massimo Marignani, Agostino Colli, Enrico Fusaro, Antonio Craxì, Giorgio Maria Saracco, Barbara Imperatrice, Paolo Caraceni, Luisa Giaccone, Chiara Baratelli, Giuliano Torre, Luigi Biancone, Elisabetta De Gasperi, Mario Rizzetto, Maria Grazia Clemente, Francesco Paolo Russo, Aldo Giacardi, Riccardo Volpes, Edoardo G. Giannini, Daniele Curci, Rossella Della Valle, Salvatore Petta, Pierluigi Toniutto, Alessandro Busca, Pietro Vajro, Giorgio Verme, Chiara Mazzarelli, Paolo Grossi, Maria Chiara Ditto, Lorella Orsucci, Umberto Vitolo, Alberto Mella, Salvatore Madonia, Federica Cavallo, Maria Giuseppina Cabras, Stefano Bonora, Massimiliano Conforti, Vito Di Marco, Mario Pirisi, Giuseppe Cariti, Marta Coscia, Giuseppina Brancaccio, L. Scaglione, Stefano Fagiuoli, Alfredo Marzano, Stefano Cusinato, Roberto Minutolo, Giuseppe Rossi, Enrico Brignardello, Maurizia Rossana Brunetto, Marzano A., Angelucci E., Astegiano M., Baratelli C., Biancone L., Bironzo P., Brancaccio G., Brunetto M.R., Bruno R., Burra P., Cabras M.G., Caraceni P., Chiala C., Clemente M.G., Colli A., Daniele B., De Gasperi E., Di Marco V., Ditto M.C., Fagiuoli S., Ferri C., Gaeta G.B., Grossi P.A., Imperatrice B., Lampertico P., Macaluso F.S., Madonia S., Marignani M., Mazzarelli C., Mella A., Missale G., Parisi S., Pasulo L., Puoti M., Rendina M., Ribaldone D., Rossi G., Toniutto P., Tucci A., Vajro P., Vigano M., Volpes R., Zignego A.L., Giannini E.G., Miele L., Russo F.P., Petta S., Bonora S., Brignardello E., Busca A., Cariti G., Cavallo F., Conforti M., Coscia M., Craxi A., Curci D., Cusinato S., Di Maio M., Valle R.D., Fusaro E., Giacardi A., Giaccone L., Lagget M., Libertucci D., Minutolo R., Montrucchio G., Orlando A., Orsucci L., Pasquina C., Pera A., Peroni C.L., Pirisi M., Racca P., Riccardini F., Rizzetto M., Salizzoni M., Salomone M., Saracco G.M., Scaglione L., Torre G., Tozzi R., Vitolo U., Verme G., Angelucci, E, Astegiano, M, Baratelli, C, Biancone, L, Bironzo, P, Brancaccio, G, Brunetto, M, Bruno, R, Burra, P, Cabras, M, l Caraceni, P, Chialà, C, Clemente, M, Colli, A, Daniele, B, De Gasperi, E, Di Marco, V, Ditto, M, Fagiuoli, S, Ferri, C, Gaeta, G, Grossi, P, Imperatrice, B, Lampertico, P, Macaluso, F, Madonia, S, Marignani, M, Mazzarelli, C, Mella, A, Missale, G, Parisi, S, Pasulo, L, Puoti, M, Rendina, M, Ribaldone, D, Rossi, G, Toniutto, P, Tucci, A, Vajro, P, Viganò, M, Volpes, R, Zignego, A, Giannini, E, Miele, L, Russo, F, Petta, S, Bonora, S, Brignardello, E, Busca, A, Cariti, G, Cavallo, F, Conforti, M, Coscia, M, Craxì, A, Curci, D, Cusinato, S, Di Maio, M, Valle, R, Fusaro, E, Giacardi, A, Giaccone, L, Lagget, M, Libertucci, D, Minutolo, R, Montrucchio, G, Orlando, A, Orsucci, L, Pasquina, C, Pera, A, Peroni, C, Pirisi, M, Racca, P, Riccardini, F, Rizzetto, M, Salizzoni, M, Salomone, M, Saracco, G, Scaglione, L, Torre, G, Tozzi, R, Vitolo, U, Verme, G, Marzano, Alfredo, Angelucci, Emanuele, Astegiano, Marco, Baratelli, Chiara, Biancone, Luigi, Bironzo, Paolo, Brancaccio, Giuseppina, Brunetto, Maurizia Rossana, Bruno, Raffaele, Burra, Patrizia, Cabras, Maria Giuseppina, Caraceni, Paolo, Chialà, Claudia, Clemente, Maria Grazia, Colli, Agostino, Daniele, Bruno, De Gasperi, Elisabetta, Di Marco, Vito, Ditto, Maria Chiara, Fagiuoli, Stefano, Ferri, Clodoveo, Gaeta, Giovanni Battista, Grossi, Paolo Antonio, Imperatrice, Barbara, Lampertico, Pietro, Macaluso, Fabio Salvatore, Madonia, Salvatore, Marignani, Massimo, Mazzarelli, Chiara, Mella, Alberto, Missale, Gabriele, Parisi, Simone, Pasulo, Luisa, Puoti, Massimo, Rendina, Maria, Ribaldone, Davide, Rossi, Giuseppe, Toniutto, Pierluigi, Tucci, Alessandra, Vajro, Pietro, Viganò, Mauro, Volpes, Riccardo, Zignego, Anna Linda, Giannini, Edoardo G., Miele, Luca, Russo, Francesco Paolo, Petta, Salvatore, Bonora, Stefano, Brignardello, Enrico, Busca, Alessandro, Cariti, Giuseppe, Cavallo, Federica, Conforti, Massimiliano, Coscia, Marta, Craxì, Antonio, Curci, Daniele, Cusinato, Stefano, Di Maio, Massimo, Valle, Rossella Della, Fusaro, Enrico, Giacardi, Aldo, Giaccone, Luisa, Lagget, Marco, Libertucci, Daniela, Minutolo, Roberto, Montrucchio, Giuseppe, Orlando, Ambrogio, Orsucci, Lorella, Pasquina, Carla, Pera, Angelo, Peroni, Clara Lisa, Pirisi, Mario, Racca, Patrizia, Riccardini, Franco, Rizzetto, Mario, Salizzoni, Mauro, Salomone, Mario, Saracco, Giorgio Maria, Scaglione, Luca, Torre, Giuliano, Tozzi, Rita, Vitolo, Umberto, Verme, Giorgio, and Ditto, MARIA CHIARA

Subjects
medicine.medical_specialty, Transplant Recipient, Comorbidity, Antiviral Agents, Organ transplantation, 03 medical and health sciences, Immunocompromised Host, 0302 clinical medicine, Internal medicine, Neoplasms, medicine, Immunocompromised patient, Humans, Chronic, Intensive care medicine, Antiviral Agent, Hepatology, business.industry, Gastroenterology, Hepatitis C, Chronic, medicine.disease, Hepatitis C, Organ transplant, HCV, Immunocompromised patients, Transplant Recipients, Immunocompetence, Italy, 030220 oncology & carcinogenesis, HCV, Immunocompromised patients, Organ transplant, Position paper, Neoplasm, 030211 gastroenterology & hepatology, business, Direct acting, Human
Abstract

This report summarizes the clinical features and the indications for treating HCV infection in immunocompromised and transplanted patients in the Direct Acting Antiviral drugs era.

Published
2018

234. Effectiveness and safety of sofosbuvir-based direct-acting antiviral combinations in HCV-2 and HCV-3 kidney transplant recipients

Author

Serena Zaltron, Roberta D'Ambrosio, Maria Cristina Vinci, Piergiorgio Messa, Lucia Parlati, Pietro Lampertico, Luisa Pasulo, Mariarosaria Campise, Marianna Franchina, and Stanislas Pol

Subjects
Oncology, Adult, Male, medicine.medical_specialty, Sofosbuvir, Sustained Virologic Response, Hepacivirus, Kidney transplant, Antiviral Agents, Internal medicine, Medicine, Humans, Aged, business.industry, Middle Aged, Hepatitis C, Kidney Transplantation, Transplant Recipients, Treatment Outcome, Nephrology, Drug Therapy, Combination, Female, business, Direct acting, medicine.drug, Follow-Up Studies
Published
2018

235. Immunosuppressive and antiviral treatment of hepatitis C virus-associated glomerular disease: A long-term follow-up

Author

Fabrizio Fabrizi, Piergiorgio Messa, Mirella Fraquelli, Donata Cresseri, Francesca Donato, Patrizia Passerini, Pietro Lampertico, Alessio Aghemo, and Gabriella Moroni

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Hepacivirus, Hepatitis C virus, 030232 urology & nephrology, Biomedical Engineering, Medicine (miscellaneous), Alpha interferon, Bioengineering, medicine.disease_cause, Gastroenterology, Antiviral Agents, Biomaterials, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Recurrence, Internal medicine, Ribavirin, medicine, Humans, Aged, Hepatitis, biology, business.industry, Interferon-alpha, Immunosuppression, General Medicine, Hepatitis C, Hepatitis C, Chronic, Middle Aged, medicine.disease, biology.organism_classification, Cryoglobulinemia, Treatment Outcome, chemistry, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, Kidney Diseases, business, Immunosuppressive Agents, Follow-Up Studies
Abstract

Background: The evidence in the medical literature on the treatment of hepatitis C virus–associated glomerular disease is extremely limited. The advent of nonconventional immunosuppressive agents and direct-acting antivirals promises high efficacy and safety. Aims: We conducted an open-label, single-arm clinical study to examine the efficacy and safety of a combined approach for hepatitis C virus–associated glomerular disease. Methods: In the first phase of the study, patients with hepatitis C virus–associated glomerular disease received interferon-based antiviral therapy and immunosuppressive agents; since 2013, interferon-free antiviral therapy was adopted and novel immunosuppressants (including B-cell depleting agents and mycophenolate mofetil) or immunomodulators (ribavirin) were choiced. Virological and clinical responses were evaluated over a long observation period (median follow-up of 60 weeks and 46.5 months after the end of treatment with interferon and direct-acting antiviral agents, respectively). Results: We enrolled 25 consecutive patients with hepatitis C virus–associated glomerular disease, 8 being liver transplant recipients for hepatitis C. A total of 13 patients received therapy with direct-acting antivirals and experienced sustained viral response (serum hepatitis C virus RNA Conclusion: Treatment with direct-acting antivirals provides excellent rates of viral response and safety in patients with hepatitis C virus–related glomerular disease; viral response was frequently accompanied by clinical improvement. The absence of hepatitis C virus RNA from serum allowed immunosuppressive and immunomodulatory therapies with benefits for glomerular abnormalities and no concern on hepatitis C virus replication.

Published
2018

236. Factors Associated With Increased Risk of De Novo or Recurrent Hepatocellular Carcinoma in Patients With Cirrhosis Treated With Direct-Acting Antivirals for HCV Infection

Author

Massimo Colombo, Pietro Lampertico, Alessio Aghemo, Angelo Sangiovanni, Marta Borghi, Roberta Soffredini, Massimo Iavarone, Roberta D'Ambrosio, Giovanna Lunghi, and Elisabetta Degasperi

Subjects
Adult, Male, medicine.medical_specialty, Cirrhosis, Carcinoma, Hepatocellular, Hepacivirus, Single Center, Gastroenterology, Antiviral Agents, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, medicine, Humans, Aged, Neoplasm Staging, Retrospective Studies, Aged, 80 and over, Hepatology, business.industry, Incidence, Hazard ratio, Liver Neoplasms, Retrospective cohort study, Hepatitis C, Chronic, Middle Aged, medicine.disease, Prognosis, digestive system diseases, Recurrent Hepatocellular Carcinoma, Survival Rate, Italy, Liver, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Cohort, 030211 gastroenterology & hepatology, Female, Neoplasm Recurrence, Local, Liver cancer, business, Follow-Up Studies
Abstract

Background & Aims Patients with cirrhosis and hepatitis C virus (HCV) infection treated with direct-acting antivirals (DAAs) are still at risk for developing hepatocellular carcinoma (HCC). We aimed to identify features of de novo or recurrent HCCs in these patients, and factors associated with HCC development, in a large cohort of patients with cirrhosis who received treatment with DAAs. Methods In a retrospective study, we collected data from 565 patients with cirrhosis (median age, 64 years; range, 28–87 years; 60% male, 49% infected with HCV genotype 1; median liver stiffness measurement [LSM], 19.1 kPa; 87% Child-Pugh-Turcotte score A) treated with DAAs at a single center in Italy, from December 2014 through 2016. Cirrhosis was defined based on clinical features, histologic factors (METAVIR F4), or LSM >11.9 kPa. Patients were assessed (complete blood analysis and HCV-RNA quantification) every 4 weeks during treatment; at weeks 4, 12, and 24 afterward; and at 6-month intervals thereafter. HCC surveillance was performed by ultrasound or CT scans every 3–6 months, based on history of HCC. Non-invasive markers of fibrosis, such as ratio of aspartate aminotransferase to platelets, fibrosis-4 (FIB-4) score, and LSMs were assessed. Results During a median 25 months of follow up (range, 3–39 months), HCC developed in 28/505 patients without a history of HCC (de novo HCC); the 3-year estimated cumulative probability for HCC was 6% (95% CI, 4%–9%). Of patients with de novo HCC, 75% had a single tumor and 82% of these were Barcelona liver cancer stage 0–A; the median level of alpha-fetoprotein was 6 ng/mL (range, 1.0–9240 ng/mL). Male sex (hazard ratio [HR], 6.17; 95% CI, 1.44–26.47; P = .01), diabetes (HR, 2.52; 95% CI, 1.08–5.87; P = .03), LSM (HR, 1.03; 95% CI, 1.01–1.06; P = .01), and FIB-4 score (HR, 1.08; 95% CI, 1.01–1.14; P = .01) were independently associated with de novo HCC. HCC developed in 20/60 patients with a history of HCC (HCC recurrence); the 3-year cumulative probability for recurrence was 43% (95% CI, 20%–61%). In the 20 patients with HCC recurrence, 11 had a single tumor and 90% were Child-Pugh-Turcotte score A. Diabetes was independently associated with HCC recurrence (HR, 4.12; 95% CI, 1.55–10.93; P = .004). Conclusions In a large, single-center cohort of consecutive patients with cirrhosis and who received DAA treatment for HCV infection, most liver tumors were identified at early stages. Male sex, diabetes, and non-invasive markers of liver fibrosis can be used to identify patients at increased risk for HCC following DAAs therapy.

Published
2018

237. Cancer of the Breast

Author

Franca Stagni and Pietro Lampertico

Subjects
Oncology, medicine.medical_specialty, business.industry, Internal medicine, medicine, Cancer, medicine.disease, business
Published
2018
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238. 1058 Real World Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Infection: A Meta-Analysis

Author

Ashley Brown, Markus Cornberg, Lois Larsen, Nicole Wick, Michael P. Curry, Yao Yu, Heiner Wedemeyer, José A. Carrión, Andreas Pangerl, Juan Turnes, Francesco Negro, Pietro Lampertico, and Marcello Persico

Subjects
medicine.medical_specialty, Hepatology, Chronic hepatitis, business.industry, Internal medicine, Meta-analysis, Gastroenterology, Medicine, Glecaprevir / pibrentasvir, business, Virus
Published
2019
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239. FRI-197-Prediction of elastographic reversion of cirrhosis after 5 years of entecavir or tenofovir disoproxil fumarate therapy in caucasian chronic hepatitis B patients

Author

Spilios Manolakopoulos, Harry L.A. Janssen, Vana Sypsa, George N. Dalekos, George V. Papatheodoridis, Anastasia Kourikou, Heng Chi, Thomas Berg, Kostas Galanis, Pietro Lampertico, Ioannis Vlachogiannakos, Rafael Esteban, Savvoula Savvidou, Marta López-Gómez, Rhea Veelken, Theodoros Voulgaris, Florian van Bömmel, Bettina E. Hansen, Onur Keskin, Ioannis Goulis, Nikolaos K. Gatselis, José Luis Calleja Panero, Cihan Yurdaydin, Maria Buti, Ramazan Idilman, and Alessandro Loglio

Subjects
medicine.medical_specialty, Cirrhosis, Hepatology, Tenofovir, business.industry, Reversion, Entecavir, medicine.disease, Gastroenterology, Chronic hepatitis, Internal medicine, medicine, business, medicine.drug
Published
2019
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240. FRI-473-Safety and effectiveness of regorafenib in recurrent HCC after liver transplantation and progression on sorafenib: A real-life multicentre study

Author

Mario Cristobal Romero, Matthias Pinter, Maria Margarita Anders, Wörns Marcus, Vincenzo Mazzaferro, Pietro Lampertico, Aballay Soteras Gabriel Alejandro, Maria Varela, Federico Piñero, Maria Reig, Sherrie Bhoori, Federica Invernizzi, Massimo De Giorgio, Carolin Czauderna, Maria Jose Blanco Rodríguez, Gonzalo Crespo, Gerda Elisabeth Villadsen, Massimo Lavarone, Arndt Weinmann, Matteo Angelo Manini, Maria Luisa Gonzalez Dieguez, Marco Sanduzzi Zamparelli, Miguel Fraile, Jordi Bruix, Maria Francesca Donato, Hélène Regnault, and Giuliana Amaddeo

Subjects
Sorafenib, Oncology, medicine.medical_specialty, Hepatology, business.industry, medicine.medical_treatment, Liver transplantation, chemistry.chemical_compound, chemistry, Regorafenib, Internal medicine, Medicine, business, medicine.drug
Published
2019
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241. GS-03-Global real world evidence of sofosbuvir/velpatasvir as a simple, effective regimen for the treatment of chronic hepatitis C patients: Integrated analysis of 12 clinical practice cohorts

Author

Francisco Andrés Pérez Hernández, Juan Turnes, Denis Ouzan, Stefano Fagiuoli, Sergio Borgia, Pietro Lampertico, Stephen D. Shafran, Michael Mertens, Nicole Wick, Scott Milligan, Valeria Piazzolla, Heiner Wedemeyer, Dawn Fishbein, Fabrice Carrat, George V. Papatheodoridis, Mandana Khalili, Alessandra Mangia, Kim Vanstraelen, Alnoor Ramji, and Karen Doucette

Subjects
Clinical Practice, medicine.medical_specialty, Regimen, Hepatology, Chronic hepatitis, business.industry, Medizin, medicine, Intensive care medicine, business, Real world evidence, Sofosbuvir/velpatasvir, Simple (philosophy)
Published
2019
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242. THU-141-Efficacy and safety of elbasvir/grazoprevir in a large real-life cohort of HCV-infected patients

Author

Alberto Colombo, Sandro Panese, Mauro Viganò, Simona Landonio, Agostino Colli, Barbara Menzaghi, Caterina Uberti-Foppa, Veronica Paon, Paolo Sacchi, Maria Cristina Rossi, Francesca Cattelan, Andrea Capretti, Maria Cristina Vinci, Luisa Pasulo, Valter Vincenzi, S. Lobello, Giada Carolo, Liliana Chemello, Ombretta Spinelli, Roberta D'Ambrosio, Monia Mendeni, Franco Capra, Alessandro Soria, Roberta Soffredini, Maurizio Carrara, M. Colpani, Massimo Puoti, Giancarlo Spinzi, Alfredo Alberti, Pietro Lampertico, Luisa Cavalletto, Angiola Spinetti, Elisabetta Degasperi, Massimo Zuin, Alessio Aghemo, Laura Comi, Giovanna Cardaci, Valentina Zuccaro, Massimo Memoli, Paolo Poggio, Angelo Pan, Vinicio Manfrin, Alessia Giorgini, Marie Graciella Pigozzi, Serena Zaltron, Francesco Castelli, Franco Noventa, Paolo Grossi, Monica Schiavini, Clara Dibenedetto, Antonella d'Arminio Monforte, Roberto Gulminetti, Elisabetta Buscarini, Piergiorgio Scotton, Stefano Fagiuoli, Martina Gambato, Francesco Russo, Andrea Gori, Paolo Fabris, Caterina Pozzan, and Maria Grazia Rumi

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Cohort, medicine, Elbasvir, Grazoprevir, business
Published
2019
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243. THU-133-Resistance-guided retreatment of HCV infected patients with a previous failure to an NS5A inhibitor-containing regimen: Italian real life experience

Author

Ada Bertoli, Gloria Taliani, Ilaria Lenci, Stefano Novati, Teresa Santantonio, Raffaele Cozzolongo, C. Masetti, Nunzia Cuomo, Laura Donnarumma, Giovanni Cenderrello, Silvia Barbaliscia, Adriano De Santis, Bianca Bruzzone, Giovanni Raimondo, Massimo Puoti, Carlo Federico Perno, Simona Landonio, Roberto Gulminetti, Elisabetta Degasperi, Giustino Parruti, Vincenza Calvaruso, Marianna Aragri, Teresa Pollicino, Pietro Lampertico, Laura Ambra Nicolini, Velia Chiara Di Maio, Valeria Ghisetti, Adriano M. Pellicelli, Ivana Maida, Caterina Pasquazzi, Valeria Cento, Roberto Ganga, Coppola Nicola, C. Paternoster, Maurizia Rossana Brunetto, Alessia Ciancio, Sergio Babudieri, Massimo Andreoni, Silberstein Francesca Ceccherini, Maurizio Zazzi, Maria Rendina, Miriam Lichtner, Angelico Mario, Ennio Polilli, Giuliano Rizzardini, Vanni Borghi, Maria Paola Callegaro, Valeria Pace Palitti, Stefania Paolucci, Carmine Minichini, Simona Marenco, Antonio Craxì, Filomena Morisco, Vincenzo Sangiovanni, Giulia Morsica, Valeria Micheli, Elisabetta Teti, and Pietro Andreone

Subjects
medicine.medical_specialty, Regimen, Hepatology, business.industry, Internal medicine, medicine, NS5A, business
Published
2019
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244. FRI-376-Early treatment with sorafenib and mTOR inhibitor in recurrent hepatocellular carcinoma after liver transplantation: Safety and survival

Author

Lucia Cesarini, Claudio Zavaglia, Pietro Lampertico, Aldo Airoldi, Massimo Iavarone, Luca S. Belli, Angelo Sangiovanni, Umberto Maggi, Federica Invernizzi, B. Antonelli, Maria Francesca Donato, Giorgio Rossi, Stefano Mazza, and Matteo Angelo Manini

Subjects
Sorafenib, Hepatology, business.industry, medicine.medical_treatment, medicine, Cancer research, Liver transplantation, Discovery and development of mTOR inhibitors, business, Recurrent Hepatocellular Carcinoma, medicine.drug
Published
2019
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245. THU-134-Clinical and virological characteristics of patients with chronic hepatitis C and failure to voxilaprevir/velpatasvir/sofosbuvir treatment

Author

Johannes Vermehren, Julian Schulze zur Wiesch, Francesca Ceccherini Silberstein, Elisabetta Degasperi, Christoph Sarrazin, Adolfo de Salazar, Julia Dietz, Velia Chiara Di Maio, Heinz Zoller, Magdalena Lara, Maria Buti, Federico García, Juan Ignacio, Pietro Lampertico, Stefan Zeuzem, Stefania Paolucci, Rudolf E. Stauber, Arenas Ruiz-Tapiador, Maria Josefa Rodriguez Pardo, Blanca Figueruela, and Dolores Merino

Subjects
medicine.medical_specialty, Hepatology, Sofosbuvir, Chronic hepatitis, business.industry, Internal medicine, Voxilaprevir, medicine, business, Gastroenterology, Velpatasvir, medicine.drug
Published
2019
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246. THU-166-Treatment of 320 genotype 3 cirrhotic patients with 12 weeks of sofosbuvir/velpatasvir with or without ribavirin: Real life experience from Italy

Author

Giancarlo Spinzi, Vito Di Marco, Giada Carolo, Caterina Pozzan, Barbara Menzaghi, Giuliana Cologni, Roberta Soffredini, Mauro Viganò, Colombatto Piero, Carlo Magni, Serena Zaltron, Francesco Castelli, Roberta D'Ambrosio, Monia Mendeni, Alfredo Alberti, Paolo Grossi, Massimo Zuin, Maria Grazia Rumi, Veronica Paon, Luisa Pasulo, Alberto Colombo, Pietro Lampertico, Paolo Sacchi, Monica Schiavini, Alessio Aghemo, Andrea Capretti, Maria Cristina Vinci, Valter Vincenzi, Andrea Lombardi, Alessia Giorgini, Lorenzo Difrancesco, Maria Antonietta Di Rosolini, Piergiorgio Scotton, Francesco Russo, Antonio Albanese, Sandro Panese, Andrea Gori, Franco Noventa, Stefano Fagiuoli, F. Cartabellotta, Agostino Colli, Martina Gambato, Caterina Uberti-Foppa, Angelo Pan, Luisa Cavalletto, Clara Dibenedetto, Antonio Di Giacomo, Franco Capra, Angiola Spinetti, S. Lobello, M. Colpani, Ombretta Spinelli, Vinicio Manfrin, Liliana Chemello, Roberto Gulminetti, Alessandro Soria, Irene Cacciola, Maurizia Rossana Brunetto, Vincenza Calvaruso, Antonella d'Arminio Monforte, Massimo Memoli, Elisabetta Buscarini, Alessia Ciancio, and Massimo Puoti

Subjects
medicine.medical_specialty, chemistry.chemical_compound, Hepatology, chemistry, business.industry, Internal medicine, Ribavirin, Genotype, medicine, business, Gastroenterology, Sofosbuvir/velpatasvir
Published
2019
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247. FRI-183-A phase 3 study comparing switching from tenofovir disoproxil fumarate to tenofovir alafenamide with continued TDF treatment in virologically-suppressed patients with chronic hepatitis B (CHB): week 48 efficacy and safety results

Author

Seung Kew Yoon, Wan-Long Chuang, Maria Buti, Alnoor Ramji, John F. Flaherty, George Y. Wu, Vithika Suri, Scott Fung, Chi-Yi Chen, Edward Tam, Pietro Lampertico, Xiaoli Ma, Becket Feierbach, Ho Bae, Anuj Gaggar, Young-Suk Lim, Audrey H. Lau, Sang Hoon Ahn, Mani Subramanian, Huy N. Trinh, Won Young Tak, Kosh Agarwal, and Henry Chan

Subjects
medicine.medical_specialty, Hepatology, Chronic hepatitis, Tenofovir, business.industry, Internal medicine, Phases of clinical research, Medicine, business, Tenofovir alafenamide, Gastroenterology, medicine.drug
Published
2019
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248. SAT-130-Incidence and outcome of portal vein thrombosis in 817 HBV and HCV compensated cirrhotic patients under antiviral treatment: a single center longitudinal study

Author

Roberta Soffredini, Giulia Tosetti, Massimo Iavarone, Floriana Facchetti, Massimo Primignani, Pietro Lampertico, Alessandro Loglio, Elisabetta Degasperi, Roberta D'Ambrosio, Mauro Viganò, Maria Grazia Rumi, and Marta Borghi

Subjects
medicine.medical_specialty, Longitudinal study, Hepatology, business.industry, Internal medicine, Incidence (epidemiology), medicine, Antiviral treatment, business, Single Center, medicine.disease, Gastroenterology, Portal vein thrombosis
Published
2019
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249. PS-184-Real-world effectiveness and safety of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus infection: A meta-analysis

Author

Lois Larsen, Andreas Pangerl, Francesco Negro, Heiner Wedemeyer, José A. Carrión, Markus Cornberg, Juan Turnes, Nicole Wick, Marcello Persico, Michael P. Curry, Yao Yu, Ashley Brown, and Pietro Lampertico

Subjects
Hepatology, Chronic hepatitis, business.industry, Meta-analysis, Medicine, Glecaprevir / pibrentasvir, business, Virology, Virus
Published
2019
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250. The impact of sustained virological response (SVR) on the criteria used to rule out high risk esophageal varices (HRV) in HCV-related compensated advanced chronic liver disease (cACLD)

Author

Roberta Soffredini, Elisabetta Degasperi, Massimo Primignani, V. La Mura, Pietro Lampertico, Giulia Tosetti, Elena Arsiè, Roberta D'Ambrosio, Pietro Soru, and Marta Borghi

Subjects
Virological response, medicine.medical_specialty, Esophageal varices, Hepatology, business.industry, Internal medicine, Gastroenterology, medicine, medicine.disease, Chronic liver disease, business
Published
2019
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