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1. Secondary Sclerosing Cholangitis After SARS-CoV2: ICU Ketamine Use or Virus-Specific Biliary Tropism and Injury in the Context of Biliary Ischemia in Critically Ill Patients?

Author: Bartoli,Alessandra, Cursaro,Carmela, Seferi,Hajrie, Andreone,Pietro, Bartoli,Alessandra, Cursaro,Carmela, Seferi,Hajrie, and Andreone,Pietro
Abstract: Alessandra Bartoli,1,2 Carmela Cursaro,1 Hajrie Seferi,1 Pietro Andreone3,4 1Division of Internal Medicine and Metabolism, Department ofÂ Internal Medicine, Ospedale Civile di Baggiovara, University of Modena and Reggio Emilia, Modena, Italy; 2Post Graduate School of Allergy and Clinical Immunology, Department of Internal Medicine, University of Modena and Reggio Emilia, Modena, Italy; 3Chief of Division ofÂ Internal Medicine andÂ metabolism, Department ofÂ Internal Medicine, University Hospital ofÂ Modena, Modena, Italy; 4Chief of Post Graduate School of Allergy and Clinical Immunology, Department of Internal Medicine, University of Modena and Reggio Emilia, Modena, ItalyCorrespondence: Alessandra Bartoli, University of Modena and Reggio Emilia, Ospedale Civile di Baggiovara, Via Pietro Giardini 1355, Baggiovara, MO, 41126, Italy, Email alessandra.bartoli25@yahoo.comPurpose: From the beginning of the Severe Acute Respiratory Syndrome CoronaVirus-2 (SARS-CoV2) pandemic, different cases of a cholangiopathy with features of secondary sclerosing cholangitis in critically ill patients (SSC-CIP) have been reported. Patients developing it are generally recovering from severe Coronavirus disease 19 (COVID-19) and required intensive care unit (ICU) admission and mechanical ventilation. Many of them have been administered with ketamine during their ICU stay. The pathogenesis of this novel disease is still debated, and, since prognosis is poor, efforts are needed in order to better understand it.Patients and Methods: In this review, we focused our attention on COVID-19 SSC clinical, imaging, and histology findings in order to clarify the different pathogenetic options, particularly in regard of the ischemic-direct viral damage and ketamine-related theories, beginning with a recapitulation of SSC-CIP and ketamine-induced cholangiopathy in abusers. The research has been conducted using PubMed and Google Scholar databases. Key-words were âSecondary Sclerosing Cholangiopathyâ
Published: 2023

2. Elastography Point Quantification in the evaluation of liver fibrosis in NAFLD patients

Author: Andreone, Pietro, Cevenini, Monica <1986>, Andreone, Pietro, and Cevenini, Monica <1986>
Abstract: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. Several non-invasive approaches to stage liver fibrosis in NAFLD patients are being developed. Elastography Point Quantification (ElastPQ) is a non-invasive method to assess liver fibrosis measuring liver stiffness. We evaluated the diagnostic performance of ElastPQ for identifying different degrees of fibrosis in NAFLD patients. We compared ElastPQ with other non-invasive tests and identify the best liver stiffness cut offs for every fibrosis stage. ElastPQ was performed in a training cohort of patients with biopsy-proved NAFLD, liver serum tests and Transient Elastography (TE). The diagnostic performance of ElastPQ was evaluated using AUROC and compared with TE, Fibrosis-4 score, NAFLD fibrosis score and AST/ALT. ElastPQ was performed in a validation cohort in order to validate the data. 106 patients with NAFLD were enrolled. The median stiffness values using ElastPQ was 4.69 kPa (2.82-29.86). The mean liver stiffness divided for category of fibrosis stage were: 4.18 kPa (mild fibrosis F0-1), 4.49 kPa (significant fibrosis F2), 6.89 kPa >(advanced fibrosis F3) and 12.14 kPa (cirrhosis F4). In multivariate analysis, liver stiffness was associated with the fibrosis stage (ß=2.987; p<0.001). The AUCs for the association with significant, advanced fibrosis and cirrhosis were 0.783 (95%IC 0.693-0.857), 0.855 (95%IC 0.773- 0.916) and 0.897 (95%IC 0.822-0.947), respectively. Diagnostic performance of ElastPQ compared to TE, resulted non-inferior in evaluating significant fibrosis (p=0.956), advanced fibrosis (p=0.171) and cirrhosis (p=0.773). ElastPQ had a higher diagnostic performance compared to FIB-4, NFS and AAR. The best fibrosis cuts off identified in the training cohort (80 patients enrolled) were 5.22 kPa, 6.3 kPa and 9.61 kPa respectively for fibrosis >F2, >F3 and F4. ElastPQ is a promising technique for liver fibrosis evaluation
Published: 2022

3. Corrigendum to 'An international genome-wide meta-analysis of primary biliary cholangitis: Novel risk loci and candidate drugs' [J Hepatol 2021;75(3):572-581]

Author: Heather J, Cordell, James J, Fryett, Kazuko, Ueno, Rebecca, Darlay, Yoshihiro, Aiba, Yuki, Hitomi, Minae, Kawashima, Nao, Nishida, Seik-Soon, Khor, Olivier, Gervai, Yosuke, Kawai, Masao, Nagasaki, Katsushi, Tokunaga, Ruqi, Tang, Yongyong, Shi, Zhiqiang, Li, Brian D, Juran, Elizabeth J, Atkinson, Alessio, Gerussi, Marco, Carbone, Rosanna, Asselta, Angela, Cheung, Mariza, de Andrade, Aris, Bara, Julie, Horowitz, Manuel A R, Ferreira, Dylan, Sun, David E, Jone, Steven, Flack, Ann, Spicer, Victoria L, Mulcahy, Jinyoung, Byun, Younghun, Han, Richard N, Sandford, Konstantinos N, Lazaridi, Christopher I, Amo, Gideon M, Hirschfield, Michael F, Seldin, Pietro, Invernizzi, Katherine A, Siminovitch, Xiong, Ma, Minoru, Nakamura, George F, Mell, Siminovitch, Katherine A., Hirschfield, Gideon M., Mason, Andrew, Vincent, Catherine, Xie, Gang, Zhang, Jinyi, Tang, Ruqi, Ma, Xiong, Li, Zhiqiang, Shi, Yongyong, Affronti, Andrea, Almasio, Piero L., Alvaro, Domenico, Andreone, Pietro, Andriulli, Angelo, Azzaroli, Francesco, Battezzati, Pier Maria, Benedetti, Antonio, Bragazzi, Maria Consiglia, Brunetto, Maurizia, Bruno, Savino, Calvaruso, Vincenza, Cardinale, Vincenzo, Casella, Giovanni, Cazzagon, Nora, Ciaccio, Antonio, Coco, Barbara, Colli, Agostino, Colloredo, Guido, Colombo, Massimo, Colombo, Silvia, Cristoferi, Laura, Cursaro, Carmela, Saveria Crocè, Lory, Crosignani, Andrea, D’Amato, Daphne, Donato, Francesca, Elia, Gianfranco, Fabris, Luca, Fagiuoli, Stefano, Ferrari, Carlo, Floreani, Annarosa, Galli, Andrea, Giannini, Edoardo, Grattagliano, Ignazio, Lampertico, Pietro, Lleo, Ana, Malinverno, Federica, Mancuso, Clara, Marra, Fabio, Marzioni, Marco, Massironi, Sara, Mattalia, Alberto, Miele, Luca, Milani, Chiara, Morini, Lorenzo, Morisco, Filomena, Muratori, Luigi, Muratori, Paolo, Niro, Grazia A., O’Donnell, Sarah, Picciotto, Antonio, Portincasa, Piero, Rigamonti, Cristina, Ronca, Vincenzo, Rosina, Floriano, Spinzi, Giancarlo, Strazzabosco, Mario, Tarocchi, Mirko, Tiribelli, Claudio, Toniutto, Pierluigi, Valenti, Luca, Vinci, Maria, Zuin, Massimo, Consortium, Japan-PBC-GWAS, PBC Consortium, U, Consortium, UK-PBC, Luca, Miele (ORCID:0000-0003-3464-0068), Heather J, Cordell, James J, Fryett, Kazuko, Ueno, Rebecca, Darlay, Yoshihiro, Aiba, Yuki, Hitomi, Minae, Kawashima, Nao, Nishida, Seik-Soon, Khor, Olivier, Gervai, Yosuke, Kawai, Masao, Nagasaki, Katsushi, Tokunaga, Ruqi, Tang, Yongyong, Shi, Zhiqiang, Li, Brian D, Juran, Elizabeth J, Atkinson, Alessio, Gerussi, Marco, Carbone, Rosanna, Asselta, Angela, Cheung, Mariza, de Andrade, Aris, Bara, Julie, Horowitz, Manuel A R, Ferreira, Dylan, Sun, David E, Jone, Steven, Flack, Ann, Spicer, Victoria L, Mulcahy, Jinyoung, Byun, Younghun, Han, Richard N, Sandford, Konstantinos N, Lazaridi, Christopher I, Amo, Gideon M, Hirschfield, Michael F, Seldin, Pietro, Invernizzi, Katherine A, Siminovitch, Xiong, Ma, Minoru, Nakamura, George F, Mell, Siminovitch, Katherine A., Hirschfield, Gideon M., Mason, Andrew, Vincent, Catherine, Xie, Gang, Zhang, Jinyi, Tang, Ruqi, Ma, Xiong, Li, Zhiqiang, Shi, Yongyong, Affronti, Andrea, Almasio, Piero L., Alvaro, Domenico, Andreone, Pietro, Andriulli, Angelo, Azzaroli, Francesco, Battezzati, Pier Maria, Benedetti, Antonio, Bragazzi, Maria Consiglia, Brunetto, Maurizia, Bruno, Savino, Calvaruso, Vincenza, Cardinale, Vincenzo, Casella, Giovanni, Cazzagon, Nora, Ciaccio, Antonio, Coco, Barbara, Colli, Agostino, Colloredo, Guido, Colombo, Massimo, Colombo, Silvia, Cristoferi, Laura, Cursaro, Carmela, Saveria Crocè, Lory, Crosignani, Andrea, D’Amato, Daphne, Donato, Francesca, Elia, Gianfranco, Fabris, Luca, Fagiuoli, Stefano, Ferrari, Carlo, Floreani, Annarosa, Galli, Andrea, Giannini, Edoardo, Grattagliano, Ignazio, Lampertico, Pietro, Lleo, Ana, Malinverno, Federica, Mancuso, Clara, Marra, Fabio, Marzioni, Marco, Massironi, Sara, Mattalia, Alberto, Miele, Luca, Milani, Chiara, Morini, Lorenzo, Morisco, Filomena, Muratori, Luigi, Muratori, Paolo, Niro, Grazia A., O’Donnell, Sarah, Picciotto, Antonio, Portincasa, Piero, Rigamonti, Cristina, Ronca, Vincenzo, Rosina, Floriano, Spinzi, Giancarlo, Strazzabosco, Mario, Tarocchi, Mirko, Tiribelli, Claudio, Toniutto, Pierluigi, Valenti, Luca, Vinci, Maria, Zuin, Massimo, Consortium, Japan-PBC-GWAS, PBC Consortium, U, Consortium, UK-PBC, and Luca, Miele (ORCID:0000-0003-3464-0068)
Abstract: N/A
Published: 2022

4. Elastography Point Quantification in the evaluation of liver fibrosis in NAFLD patients

Author: Andreone, Pietro, Cevenini, Monica <1986>, Andreone, Pietro, and Cevenini, Monica <1986>
Abstract: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. Several non-invasive approaches to stage liver fibrosis in NAFLD patients are being developed. Elastography Point Quantification (ElastPQ) is a non-invasive method to assess liver fibrosis measuring liver stiffness. We evaluated the diagnostic performance of ElastPQ for identifying different degrees of fibrosis in NAFLD patients. We compared ElastPQ with other non-invasive tests and identify the best liver stiffness cut offs for every fibrosis stage. ElastPQ was performed in a training cohort of patients with biopsy-proved NAFLD, liver serum tests and Transient Elastography (TE). The diagnostic performance of ElastPQ was evaluated using AUROC and compared with TE, Fibrosis-4 score, NAFLD fibrosis score and AST/ALT. ElastPQ was performed in a validation cohort in order to validate the data. 106 patients with NAFLD were enrolled. The median stiffness values using ElastPQ was 4.69 kPa (2.82-29.86). The mean liver stiffness divided for category of fibrosis stage were: 4.18 kPa (mild fibrosis F0-1), 4.49 kPa (significant fibrosis F2), 6.89 kPa >(advanced fibrosis F3) and 12.14 kPa (cirrhosis F4). In multivariate analysis, liver stiffness was associated with the fibrosis stage (ß=2.987; p<0.001). The AUCs for the association with significant, advanced fibrosis and cirrhosis were 0.783 (95%IC 0.693-0.857), 0.855 (95%IC 0.773- 0.916) and 0.897 (95%IC 0.822-0.947), respectively. Diagnostic performance of ElastPQ compared to TE, resulted non-inferior in evaluating significant fibrosis (p=0.956), advanced fibrosis (p=0.171) and cirrhosis (p=0.773). ElastPQ had a higher diagnostic performance compared to FIB-4, NFS and AAR. The best fibrosis cuts off identified in the training cohort (80 patients enrolled) were 5.22 kPa, 6.3 kPa and 9.61 kPa respectively for fibrosis >F2, >F3 and F4. ElastPQ is a promising technique for liver fibrosis evaluation
Published: 2022

5. A randomized, placebo-controlled, phase II study of obeticholic acid for primary sclerosing cholangitis.

Author: Kowdley, Kris V, Kowdley, Kris V, Vuppalanchi, Raj, Levy, Cynthia, Floreani, Annarosa, Andreone, Pietro, LaRusso, Nicholas F, Shrestha, Roshan, Trotter, James, Goldberg, David, Rushbrook, Simon, Hirschfield, Gideon M, Schiano, Thomas, Jin, Yuying, Pencek, Richard, MacConell, Leigh, Shapiro, David, Bowlus, Christopher L, AESOP Study Investigators, Kowdley, Kris V, Kowdley, Kris V, Vuppalanchi, Raj, Levy, Cynthia, Floreani, Annarosa, Andreone, Pietro, LaRusso, Nicholas F, Shrestha, Roshan, Trotter, James, Goldberg, David, Rushbrook, Simon, Hirschfield, Gideon M, Schiano, Thomas, Jin, Yuying, Pencek, Richard, MacConell, Leigh, Shapiro, David, Bowlus, Christopher L, and AESOP Study Investigators
Abstract: Background & aimsPrimary sclerosing cholangitis (PSC) is a rare, cholestatic liver disease with no currently approved therapies. Obeticholic acid (OCA) is a potent farnesoid X receptor (FXR) agonist approved for the treatment of primary biliary cholangitis. We investigated the efficacy and safety of OCA in patients with PSC.MethodsAESOP was a phase II, randomized, double-blind, placebo-controlled, dose-finding study. Eligible patients were 18 to 75 years of age with a diagnosis of PSC and serum alkaline phosphatase (ALP) ≥2× the upper limit of normal (ULN) and total bilirubin <2.5× ULN. Patients were randomized 1:1:1 to receive placebo, OCA 1.5-3.0 mg, or OCA 5-10 mg once daily for a 24-week, double-blind phase followed by a 2-year, long-term safety extension (LTSE). Primary endpoints were change in ALP from baseline to week 24, and safety.ResultsThe intent-to-treat population comprised 76 patients randomized to placebo (n = 25), OCA 1.5-3.0 mg (n = 25), and OCA 5-10 mg (n = 26). At week 24, serum ALP was significantly reduced with OCA 5-10 mg vs. placebo (least-square [LS] mean difference = -83.4 [SE = 40.3] U/L; 95% CI -164.28 to -2.57; p = 0.043). Serum ALP was not significantly reduced with OCA 1.5-3.0 mg vs. placebo at week 24 (LS mean [SE] difference = -78.29 [41.81] U/L; 95% CI -162.08 to 5.50; p = 0.067). Total bilirubin remained comparable to baseline in all groups. The most common treatment-emergent adverse event was dose-related pruritus (placebo 46%; OCA 1.5-3.0 mg 60%; OCA 5-10 mg 67%). Reductions in ALP were maintained during the LTSE, and no new safety signals emerged.ConclusionsTreatment with OCA 5-10 mg reduced serum ALP in patients with PSC. Mild to moderate dose-related pruritus was the most common adverse event.RegistrationClinicalTrials.gov: NCT02177136; EudraCT: 2014-002205-38.Lay summaryPrimary sclerosing cholangitis (PSC) is a long-term disease that damages the bile
Published: 2020

6. Impact of Protein Induced by Vitamin K Absence (PIVKA-II) in diagnosis and monitoring of patients with hepatocellular carcinoma

Author: Andreone, Pietro, Guarneri, Valeria <1988>, Andreone, Pietro, and Guarneri, Valeria <1988>
Abstract: Background and Aims: Hepatocellular carcinoma (HCC) represents the second leading cause of cancer deaths worldwide. Protein induced by vitamin K absence (PIVKA-II) has been proposed as potential screening biomarker for HCC.This study has been designed to evaluate the role of PIVKA-II as diagnostic HCC marker, through the comparison between PIVKA-II and alpha-fetoprotein (AFP) serum levels on HCC patients and the two control groupsof patients with liver disease and without HCC. Methods: In an Italian prospective cohort, PIVKA-II levels were assessed on serum samplesby an automated chemiluminescent immunoassay (Abbott ARCHITECT). The study population included 65 patients with HCC (both “de novo” and recurrent), 111 with liver cirrhosis (LC) and 111 with chronic hepatitis C (CHC). Results: PIVKA-II levels were increased in patients with HCC (median 63.75, range: 12-2675 mAU/mL) compared to LC (median value: 30.95, range: 11.70–1251mAU / mL, Mann Whitney test p < 0.0001) and CHC (median value: 24.89, range: 12.98-67.68mAU / mL, p < 0.0001).The area under curve (AUC) for PIVKA-II was 0.817 (95% Confidence Interval(CI), 0.752-0.881). At the optimal threshold of 37 mAU / mL, identified by the Youden Index, the sensitivity and specificity were 79% and 76%, respectively. PIVKA-II was a better biomarker than AFP for the diagnosis of HCC, since the AUC for AFP was 0.670 (95% CI 0.585-0.754, p<0.0001) and at the best cutoff of 16.4 ng / mL AFP yielded 98% specificity but only 34% sensitivity. Conclusions:These initial data suggest the potential utility of this tool in the diagnosis of HCC.PIVKA-II alone or in combination may help to an early diagnosis of HCC and a significant optimization of patient management.
Published: 2020

7. Molecular characterization of gene defects associated with Progressive Familial Intrahepatic Cholestasis by Next Generation Sequencing

Author: Andreone, Pietro, Mattiaccio, Alessandro <1985>, Andreone, Pietro, and Mattiaccio, Alessandro <1985>
Abstract: Progressive Familial Intrahepatic Cholestasis (PFIC) is a group of autosomal recessive diseases that affects especially newborns and children, with progression to liver failure in the first decades of life. PFIC is classified into five types based on the genetic defect involved in bile transport. It is caused by homozygous or compound heterozygous mutations in ATP8B1, ABCB11, ABCB4, TJP2 and NR1H4 genes. Other benign late-onset phenotypes and non-progressive forms (BRIC, LPAC, DIC and ICP) are caused by heterozygous mutations in the same gene pattern. Other genes have been recently involved in both progressive and non-progressive forms. The aim of the project is to develop and validate a broad, reliable, rapid and cost-saving NGS genetic test for PFIC patients. 96 patients were tested for the first described genes and 80 patients were sequenced with the latest discovered candidate genes for PFIC and other related benign phenotypes. Bioinformatic and statistic pipelines were applied. A total of 184 different variants has been identified in our cohort: 18 pathogenic, 46 VUS, 44 likely benign and 76 benign. P/LP mutations were found in 12% of patients: 2 in ATP8B1, 3 in ABCB11, ABCB4 and TJP2 each, one in ABCC2, JAG1, NOTCH2. Many patients had multiple variants in several genes. Patients had from 7 to 35 variants each and some SNPs were significantly associated with biochemical parameters and phenotypic features (e.g. liver fibrosis) that could better explain clinics and accelerate the progression to liver failure. Our detection rate is according to other studies proposing multi-gene panels. Our analysis may be useful for the molecular diagnostics of PFIC and a better characterization and understanding of the linking between molecular defects and different subtypes of the disease. The high SNPs prevalence let us to hypothesize a synergistic haplotype effect in determining different multifactorial cholestasis phenotypes and overlapping features.
Published: 2020

8. A randomized, placebo-controlled, phase II study of obeticholic acid for primary sclerosing cholangitis.

Author: Kowdley, Kris V, Kowdley, Kris V, Vuppalanchi, Raj, Levy, Cynthia, Floreani, Annarosa, Andreone, Pietro, LaRusso, Nicholas F, Shrestha, Roshan, Trotter, James, Goldberg, David, Rushbrook, Simon, Hirschfield, Gideon M, Schiano, Thomas, Jin, Yuying, Pencek, Richard, MacConell, Leigh, Shapiro, David, Bowlus, Christopher L, AESOP Study Investigators, Kowdley, Kris V, Kowdley, Kris V, Vuppalanchi, Raj, Levy, Cynthia, Floreani, Annarosa, Andreone, Pietro, LaRusso, Nicholas F, Shrestha, Roshan, Trotter, James, Goldberg, David, Rushbrook, Simon, Hirschfield, Gideon M, Schiano, Thomas, Jin, Yuying, Pencek, Richard, MacConell, Leigh, Shapiro, David, Bowlus, Christopher L, and AESOP Study Investigators
Abstract: Background & aimsPrimary sclerosing cholangitis (PSC) is a rare, cholestatic liver disease with no currently approved therapies. Obeticholic acid (OCA) is a potent farnesoid X receptor (FXR) agonist approved for the treatment of primary biliary cholangitis. We investigated the efficacy and safety of OCA in patients with PSC.MethodsAESOP was a phase II, randomized, double-blind, placebo-controlled, dose-finding study. Eligible patients were 18 to 75 years of age with a diagnosis of PSC and serum alkaline phosphatase (ALP) ≥2× the upper limit of normal (ULN) and total bilirubin <2.5× ULN. Patients were randomized 1:1:1 to receive placebo, OCA 1.5-3.0 mg, or OCA 5-10 mg once daily for a 24-week, double-blind phase followed by a 2-year, long-term safety extension (LTSE). Primary endpoints were change in ALP from baseline to week 24, and safety.ResultsThe intent-to-treat population comprised 76 patients randomized to placebo (n = 25), OCA 1.5-3.0 mg (n = 25), and OCA 5-10 mg (n = 26). At week 24, serum ALP was significantly reduced with OCA 5-10 mg vs. placebo (least-square [LS] mean difference = -83.4 [SE = 40.3] U/L; 95% CI -164.28 to -2.57; p = 0.043). Serum ALP was not significantly reduced with OCA 1.5-3.0 mg vs. placebo at week 24 (LS mean [SE] difference = -78.29 [41.81] U/L; 95% CI -162.08 to 5.50; p = 0.067). Total bilirubin remained comparable to baseline in all groups. The most common treatment-emergent adverse event was dose-related pruritus (placebo 46%; OCA 1.5-3.0 mg 60%; OCA 5-10 mg 67%). Reductions in ALP were maintained during the LTSE, and no new safety signals emerged.ConclusionsTreatment with OCA 5-10 mg reduced serum ALP in patients with PSC. Mild to moderate dose-related pruritus was the most common adverse event.RegistrationClinicalTrials.gov: NCT02177136; EudraCT: 2014-002205-38.Lay summaryPrimary sclerosing cholangitis (PSC) is a long-term disease that damages the bile
Published: 2020

9. Molecular characterization of gene defects associated with Progressive Familial Intrahepatic Cholestasis by Next Generation Sequencing

Author: Andreone, Pietro, Mattiaccio, Alessandro <1985>, Andreone, Pietro, and Mattiaccio, Alessandro <1985>
Abstract: Progressive Familial Intrahepatic Cholestasis (PFIC) is a group of autosomal recessive diseases that affects especially newborns and children, with progression to liver failure in the first decades of life. PFIC is classified into five types based on the genetic defect involved in bile transport. It is caused by homozygous or compound heterozygous mutations in ATP8B1, ABCB11, ABCB4, TJP2 and NR1H4 genes. Other benign late-onset phenotypes and non-progressive forms (BRIC, LPAC, DIC and ICP) are caused by heterozygous mutations in the same gene pattern. Other genes have been recently involved in both progressive and non-progressive forms. The aim of the project is to develop and validate a broad, reliable, rapid and cost-saving NGS genetic test for PFIC patients. 96 patients were tested for the first described genes and 80 patients were sequenced with the latest discovered candidate genes for PFIC and other related benign phenotypes. Bioinformatic and statistic pipelines were applied. A total of 184 different variants has been identified in our cohort: 18 pathogenic, 46 VUS, 44 likely benign and 76 benign. P/LP mutations were found in 12% of patients: 2 in ATP8B1, 3 in ABCB11, ABCB4 and TJP2 each, one in ABCC2, JAG1, NOTCH2. Many patients had multiple variants in several genes. Patients had from 7 to 35 variants each and some SNPs were significantly associated with biochemical parameters and phenotypic features (e.g. liver fibrosis) that could better explain clinics and accelerate the progression to liver failure. Our detection rate is according to other studies proposing multi-gene panels. Our analysis may be useful for the molecular diagnostics of PFIC and a better characterization and understanding of the linking between molecular defects and different subtypes of the disease. The high SNPs prevalence let us to hypothesize a synergistic haplotype effect in determining different multifactorial cholestasis phenotypes and overlapping features.
Published: 2020

10. Impact of Protein Induced by Vitamin K Absence (PIVKA-II) in diagnosis and monitoring of patients with hepatocellular carcinoma

Author: Andreone, Pietro, Guarneri, Valeria <1988>, Andreone, Pietro, and Guarneri, Valeria <1988>
Abstract: Background and Aims: Hepatocellular carcinoma (HCC) represents the second leading cause of cancer deaths worldwide. Protein induced by vitamin K absence (PIVKA-II) has been proposed as potential screening biomarker for HCC.This study has been designed to evaluate the role of PIVKA-II as diagnostic HCC marker, through the comparison between PIVKA-II and alpha-fetoprotein (AFP) serum levels on HCC patients and the two control groupsof patients with liver disease and without HCC. Methods: In an Italian prospective cohort, PIVKA-II levels were assessed on serum samplesby an automated chemiluminescent immunoassay (Abbott ARCHITECT). The study population included 65 patients with HCC (both “de novo” and recurrent), 111 with liver cirrhosis (LC) and 111 with chronic hepatitis C (CHC). Results: PIVKA-II levels were increased in patients with HCC (median 63.75, range: 12-2675 mAU/mL) compared to LC (median value: 30.95, range: 11.70–1251mAU / mL, Mann Whitney test p < 0.0001) and CHC (median value: 24.89, range: 12.98-67.68mAU / mL, p < 0.0001).The area under curve (AUC) for PIVKA-II was 0.817 (95% Confidence Interval(CI), 0.752-0.881). At the optimal threshold of 37 mAU / mL, identified by the Youden Index, the sensitivity and specificity were 79% and 76%, respectively. PIVKA-II was a better biomarker than AFP for the diagnosis of HCC, since the AUC for AFP was 0.670 (95% CI 0.585-0.754, p<0.0001) and at the best cutoff of 16.4 ng / mL AFP yielded 98% specificity but only 34% sensitivity. Conclusions:These initial data suggest the potential utility of this tool in the diagnosis of HCC.PIVKA-II alone or in combination may help to an early diagnosis of HCC and a significant optimization of patient management.
Published: 2020

11. 5-metil-tetraidrofolato nel trattamento dell'ipertensione portale in pazienti con cirrosi e in profilassi farmacologica con beta-bloccanti per il rischio di sanguinamento da varici esofagee: trial randomizzato in doppio cieco controllato con placebo

Author: Andreone, Pietro, Di Donato, Roberto <1984>, Andreone, Pietro, and Di Donato, Roberto <1984>
Abstract: Introduzione: La cirrosi viene frequentemente complicata dall’incremento della pressione portale e dal conseguente sviluppo di varici esofago-gastriche, ascite e sanguinamento da varici. L'azione dei β-bloccanti nel ridurre il valore dell’HVPG, dipende da un diminuito afflusso portale, secondario alla riduzione dell'indice e alla vasocostrizione splancnica Purtroppo, le resistenze vascolari intraepatiche sono scarsamente influenzate dall’azione dei beta-bloccanti. Il 5-metiltetraidrofolato (5-MTHF) può migliorare la funzione vascolare attraverso la sua azione sulla eNOS e sullo stress ossidativo vascolare Attualmente non è noto se il 5-MTHF possa avere lo stesso effetto sulla microcircolazione epatica. Obiettivi: Valutare l’efficacia del trattamento per 3 mesi con 5-MTHF in associazione con propranololo rispetto a propranololo + placebo, in termini di riduzione dell’HVPG nei pazienti cirrotici con ipertensione portale (PI). Obiettivi secondari sono: a) Valutare la tollerabilità del 5-MTHF nei pazienti cirrotici con PI; b) Valutare se vi sia un miglioramento del tono vascolare intraepatico mediato dalla diminuzione dello stress ossidativo e dalla maggiore biodisponibilità di NO nei pazienti con cirrosi e PI. Risultati: In entrambi i gruppi si evidenzia una riduzione del valore dell’HVPG rispetto al valore basale, ma la modificazione risultava significativamente maggiore nel gruppo trattato con 5-MTHF rispetto al gruppo placebo (20.8%, SD 15.4 nel gruppo 5-MTHF vs 9.2%, SD 21.3 nel gruppo placebo; p=0.033). Analoga riduzione si evidenzia per il valore dell’elastometria misurata con FibroScan® (21.8%, SD 34.7 nel gruppo 5-MTHF vs 4.4%, SD 32.5 nel gruppo placebo, p=0.064). Discussione: l'analisi di confronto tra il gruppo di trattamento e il gruppo placebo mostra una differenza statisticamente significativa in termini di entità di riduzione del gradiente pressorio porto-epatico. Ulteriori studi multicentrici, su coorti più ampie sono auspicabili per validare l’utilizzo, Introduction: Cirrhosis is frequently complicated by the increase of portal pressure and development of esophageal varices, ascites and upper gastrointestinal bleeding. The mechanism of action of β-blockers in reducing the value of HVPG depends on a decreased portal inflow, secondary to the reduction of the index and to splanchnic vasoconstriction. Unfortunately, intrahepatic vascular resistance is poorly influenced by the action of beta-blockers. 5-methyltetrahydrofolate (5-MTHF) can improve vascular function through its action on eNOS and vascular oxidative stress Currently it is not known whether 5-MTHF may have the same effect on liver microcirculation. Objectives: to evaluate the efficacy of 3 months treatment with 5-MTHF in combination with propranolol compared to propranolol + placebo in terms of reduction of HVPG in cirrhotic patients with portal hypertension (PI). Secondary objectives are: a) to evaluate the tolerability of 5-MTHF in cirrhotic patients with PI; b) to evaluate if there is an improvement in the intrahepatic vascular tone mediated by the decrease of oxidative stress because of greater bioavailability of NO in patients with cirrhosis and PI. Results: in both groups there was a reduction in the HVPG value compared to baseline, but the change was significantly higher in the 5-MTHF group compared to the placebo group (20.8%, SD 15.4 in the 5-MTHF vs 9.2%, SD 21.3 in the placebo group, p=0.033). A similar reduction was noted for the value of elastometry measured with FibroScan® (21.8%, SD 34.7 in the 5-MTHF group vs. 4.4%, SD 32.5 in the placebo group, p = 0.064). Discussion: the comparison analysis between the treatment group and the placebo group shows a statistically significant difference in terms of reduction of porto-systemic pressure gradient. Further multi-center studies on larger cohorts are desirable to validate the use of 5-MTHF + placebo in reducing the portal pressure value measured with HVPG
Published: 2019

12. Range of normal liver stiffness and factors associated with increased stiffness measurements in apparently healthy individuals

Author: Bazerbachi, Fateh, Haffar, Samir, Wang, Zhen, Cabezas, Joaquín, Arias-Loste, Maria Teresa, Crespo, Javier, Darwish-Murad, Sarwa, Ikram, M. Arfan, Olynyk, John K., Gan, Eng, Petta, Salvatore, Berzuini, Alessandra, Prati, Daniele, de Lédinghen, Victor, Wong, Vincent W., Del Poggio, Paolo, Chávez-Tapia, Norberto C., Chen, Yong-Peng, Cheng, Pin-Nan, Yuen, Man-Fung, Das, Kausik, Chowdhury, Abhijit, Caballeria, Llorenç, Fabrellas, Núria, Ginès, Pere, Kumar, Manoj, Sarin, Shiv Kumar, Conti, Fabio, Andreone, Pietro, Sirli, Roxana, Cortez-Pinto, Helena, Carvalhana, Sofia, Sugihara, Takaaki, Kim, Seung Up, Parikh, Pathik, Chayama, Kazuaki, Corpechot, Christophe, Kim, Kang Mo, Papatheodoridis, George, Alsebaey, Ayman, Kamath, Patrick S., Murad, M. Hassan, Watt, Kymberly D., Bazerbachi, Fateh, Haffar, Samir, Wang, Zhen, Cabezas, Joaquín, Arias-Loste, Maria Teresa, Crespo, Javier, Darwish-Murad, Sarwa, Ikram, M. Arfan, Olynyk, John K., Gan, Eng, Petta, Salvatore, Berzuini, Alessandra, Prati, Daniele, de Lédinghen, Victor, Wong, Vincent W., Del Poggio, Paolo, Chávez-Tapia, Norberto C., Chen, Yong-Peng, Cheng, Pin-Nan, Yuen, Man-Fung, Das, Kausik, Chowdhury, Abhijit, Caballeria, Llorenç, Fabrellas, Núria, Ginès, Pere, Kumar, Manoj, Sarin, Shiv Kumar, Conti, Fabio, Andreone, Pietro, Sirli, Roxana, Cortez-Pinto, Helena, Carvalhana, Sofia, Sugihara, Takaaki, Kim, Seung Up, Parikh, Pathik, Chayama, Kazuaki, Corpechot, Christophe, Kim, Kang Mo, Papatheodoridis, George, Alsebaey, Ayman, Kamath, Patrick S., Murad, M. Hassan, and Watt, Kymberly D.
Abstract: BACKGROUND & AIMS: Transient elastography (TE) is a noninvasive technique used to measure liver stiffness to estimate the severity of fibrosis. The range of liver stiffness measurements (LSMs) in healthy individuals is unclear. We performed a systematic review to determine the range of LSMs, examined by TE, in healthy individuals and individuals who are susceptible to fibrosis. METHODS: We collected data from 16,082 individuals, in 26 cohorts, identified from systematic searches of Embase, Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews for studies of liver stiffness measurements. Studies analyzed included apparently healthy adults (normal levels of liver enzymes, low-risk alcohol use patterns, and negative for markers of viral hepatitis). The presence of diabetes, hypertension, dyslipidemia, or steatosis, based on ultrasound examination, was known for most participants. We performed a meta-analysis of data from individual participants. The cohort was divided into 4 groups; participants with a body mass index /m2 were examined with the medium probe and those with a body mass index ≥30 kg/m2 were examined with the extra-large probe. Linear regression models were conducted after adjusting for potential confounding factors of LSMs. We performed several sensitivity analyses. RESULTS: We established LSM ranges for healthy individuals measured with both probes-these did not change significantly in sensitivity analyses of individuals with platelets ≥150,000/mm3 and levels of alanine aminotransferase ≤33 IU/L in men or ≤25 IU/L in women. In multivariate analysis, factors that modified LSMs with statistical significance included diabetes, dyslipidemia, waist circumference, level of aspartate aminotransferase, and systolic blood pressure at examination time. Significant increases in LSMs were associated with the metabolic syndrome in individuals examined by either probe. Diabetes in obese individuals increased the risk
Published: 2019

13. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients

Author: Nelson, David R., Zeuzem, Stefan, Andreone, Pietro, Ferenci, Peter, Herring, Robert, Jensen, Donald M., Marcellin, Patrick, Pockros, Paul J., Rodríguez-Torres, Maribel, Rossaro, Lorenzo, Rustgi, Vinod K., Sepe, Thomas, Sulkowski, Mark, Thomason, Isaac R., Yoshida, Eric M., Chan, Anna, Hill, George, Nelson, David R., Zeuzem, Stefan, Andreone, Pietro, Ferenci, Peter, Herring, Robert, Jensen, Donald M., Marcellin, Patrick, Pockros, Paul J., Rodríguez-Torres, Maribel, Rossaro, Lorenzo, Rustgi, Vinod K., Sepe, Thomas, Sulkowski, Mark, Thomason, Isaac R., Yoshida, Eric M., Chan, Anna, and Hill, George
Abstract: Introduction. Balapiravir (R1626, RG1626) is the prodrug of a nucleoside analogue inhibitor of the hepatitis C virus (HCV) RNA-dependent RNA polymerase (R1479, RG1479). This phase 2, double-blind international trial evaluated the optimal treatment regimen of balapiravir plus peginterferon alfa-2a (40KD)/ribavirin. Material and methods. Treatment-naive genotype 1 patients (N = 516) were randomized to one of seven treatment groups in which they received balapiravir 500, 1,000, or 1,500 mg twice daily, peginterferon alfa2a (40KD) 180 or 90 Mg/week and ribavirin 1,000/1,200 mg/day or peginterferon alfa-2a (40KD)/ribavirin. The planned treatment duration with balapiravir was reduced from 24 to 12 weeks due to safety concerns. Results. The percentage of patients with undetectable HCV RNA was consistently higher in all balapiravir groups from week 2 to 12. However, high rates of dose modifications and discontinuations of one/all study drugs compromised the efficacy assessment and resulted in similar sustained virological response rates in the balapiravir groups (range 32-50%) and the peginterferon alfa-2a (40KD)/ribavirin group (43%). Balapiravir was discontinued for safety reasons in 28-36% of patients (most often for lymphopenia) and the percentage of patients with serious adverse events (especially hematological, infection, ocular events) was dose related. Serious hematological adverse events (particularly neutropenia, lymphopenia) were more common in balapiravir recipients. Two deaths in the balapiravir/peginterferon alfa-2a/ribavirin combination groups were considered possibly related to study medication. Conclusion. Further development of balapiravir for the treatment of chronic hepatitis C has been halted because of the unacceptable benefit to risk ratio revealed in this study (www.ClinicalTrials.gov NCT 00517439).
Published: 2019

14. Range of normal liver stiffness and factors associated with increased stiffness measurements in apparently healthy individuals

Author: Bazerbachi, Fateh, Haffar, Samir, Wang, Zhen, Cabezas, Joaquín, Arias-Loste, Maria Teresa, Crespo, Javier, Darwish-Murad, Sarwa, Ikram, M. Arfan, Olynyk, John K., Gan, Eng, Petta, Salvatore, Berzuini, Alessandra, Prati, Daniele, de Lédinghen, Victor, Wong, Vincent W., Del Poggio, Paolo, Chávez-Tapia, Norberto C., Chen, Yong-Peng, Cheng, Pin-Nan, Yuen, Man-Fung, Das, Kausik, Chowdhury, Abhijit, Caballeria, Llorenç, Fabrellas, Núria, Ginès, Pere, Kumar, Manoj, Sarin, Shiv Kumar, Conti, Fabio, Andreone, Pietro, Sirli, Roxana, Cortez-Pinto, Helena, Carvalhana, Sofia, Sugihara, Takaaki, Kim, Seung Up, Parikh, Pathik, Chayama, Kazuaki, Corpechot, Christophe, Kim, Kang Mo, Papatheodoridis, George, Alsebaey, Ayman, Kamath, Patrick S., Murad, M. Hassan, Watt, Kymberly D., Bazerbachi, Fateh, Haffar, Samir, Wang, Zhen, Cabezas, Joaquín, Arias-Loste, Maria Teresa, Crespo, Javier, Darwish-Murad, Sarwa, Ikram, M. Arfan, Olynyk, John K., Gan, Eng, Petta, Salvatore, Berzuini, Alessandra, Prati, Daniele, de Lédinghen, Victor, Wong, Vincent W., Del Poggio, Paolo, Chávez-Tapia, Norberto C., Chen, Yong-Peng, Cheng, Pin-Nan, Yuen, Man-Fung, Das, Kausik, Chowdhury, Abhijit, Caballeria, Llorenç, Fabrellas, Núria, Ginès, Pere, Kumar, Manoj, Sarin, Shiv Kumar, Conti, Fabio, Andreone, Pietro, Sirli, Roxana, Cortez-Pinto, Helena, Carvalhana, Sofia, Sugihara, Takaaki, Kim, Seung Up, Parikh, Pathik, Chayama, Kazuaki, Corpechot, Christophe, Kim, Kang Mo, Papatheodoridis, George, Alsebaey, Ayman, Kamath, Patrick S., Murad, M. Hassan, and Watt, Kymberly D.
Abstract: BACKGROUND & AIMS: Transient elastography (TE) is a noninvasive technique used to measure liver stiffness to estimate the severity of fibrosis. The range of liver stiffness measurements (LSMs) in healthy individuals is unclear. We performed a systematic review to determine the range of LSMs, examined by TE, in healthy individuals and individuals who are susceptible to fibrosis. METHODS: We collected data from 16,082 individuals, in 26 cohorts, identified from systematic searches of Embase, Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews for studies of liver stiffness measurements. Studies analyzed included apparently healthy adults (normal levels of liver enzymes, low-risk alcohol use patterns, and negative for markers of viral hepatitis). The presence of diabetes, hypertension, dyslipidemia, or steatosis, based on ultrasound examination, was known for most participants. We performed a meta-analysis of data from individual participants. The cohort was divided into 4 groups; participants with a body mass index /m2 were examined with the medium probe and those with a body mass index ≥30 kg/m2 were examined with the extra-large probe. Linear regression models were conducted after adjusting for potential confounding factors of LSMs. We performed several sensitivity analyses. RESULTS: We established LSM ranges for healthy individuals measured with both probes-these did not change significantly in sensitivity analyses of individuals with platelets ≥150,000/mm3 and levels of alanine aminotransferase ≤33 IU/L in men or ≤25 IU/L in women. In multivariate analysis, factors that modified LSMs with statistical significance included diabetes, dyslipidemia, waist circumference, level of aspartate aminotransferase, and systolic blood pressure at examination time. Significant increases in LSMs were associated with the metabolic syndrome in individuals examined by either probe. Diabetes in obese individuals increased the risk
Published: 2019

15. Pretreatment prediction of response to ursodeoxycholic acid in primary biliary cholangitis: development and validation of the UDCA Response Score

Author: Carbone, M, Nardi, A, Flack, S, Carpino, G, Varvaropoulou, N, Gavrila, C, Spicer, A, Badrock, J, Bernuzzi, F, Cardinale, V, Ainsworth, H, Heneghan, M, Thorburn, D, Bathgate, A, Jones, R, Neuberger, J, Battezzati, P, Zuin, M, Taylor-Robinson, S, Donato, M, Kirby, J, Mitchell-Thain, R, Floreani, A, Sampaziotis, F, Muratori, L, Alvaro, D, Marzioni, M, Miele, L, Marra, F, Giannini, E, Gaudio, E, Ronca, V, Bonato, G, Cristoferi, L, Malinverno, F, Gerussi, A, Stocken, D, Cordell, H, Hirschfield, G, Alexander, G, Sandford, R, Jones, D, Invernizzi, P, Mells, G, Thomas, C, Rahman, M, Yapp, T, Lye Ch'ng, C, Harrison, M, Sturgess, R, Galaska, R, Healey, C, Whiteman, J, Czaijkowski, M, Gray, C, Gunasekera, A, Gyawli, P, Premchand, P, Mann, S, Elliott, K, Kapur, K, Watson, A, Foster, G, Trembling, P, Subhani, J, Harvey, R, Mccorry, R, Adgey, C, Hobson, L, Mulvaney-Jones, C, Evans, R, Mathialahan, T, Ramanaden, D, Gasem, J, Van Duyvenvoorde, G, Shorrock, C, Seward, K, Southern, P, Tibble, J, Penn, R, Gorard, D, Maiden, J, Damant, R, Palegwala, A, Jones, S, Dolwani, S, Prince, M, Silvestre, V, Foxton, M, Dungca, E, Mitchison, H, Wheatley, N, Gooding, I, Doyle, H, Karmo, M, Kent, M, Saksena, S, Braim, D, Patel, M, Lord, S, Ede, R, Paton, A, Austin, A, Lancaster, N, Sayer, J, Gibbins, A, Hogben, K, Hovell, C, Fisher, N, Carter, M, Koss, K, Musselwhite, J, Muscariu, F, Piotreowicz, A, Mckay, A, Grimley, C, Neal, D, Ting Tan, L, Lim, G, Brighton, J, Foale, C, Ala, A, Saeed, A, Flahive, K, Wood, G, Townshend, P, Ford, C, Brown, J, Kordula, J, Bowles, J, Wilkinson, M, Palmer, C, Ramage, J, Gordon, H, Featherstone, J, Ridpath, J, Ngatchu, T, Levi, S, Shaukat, S, Sadeghian, J, Shidrawi, R, Williams, B, Abouda, G, Duggan, C, Hynes, A, Narain, M, Rees, I, Salam, I, Crossey, M, Brown, A, Macnicol, C, Williams, S, Wilhelmsen, E, Banim, P, Raymode, P, Chilton, A, Das, D, Lee, H, Curtis, H, Gess, M, Durant, E, Drake, I, Bishop, R, Davies, M, Aldersley, M, Ncube, N, Mcnair, A, Srirajaskanthan, R, Sen, S, Casey, R, Bird, G, Mendall, M, Cowley, C, Barnardo, A, Kitchen, P, Yoong, K, Amore, K, Sirdefield, D, Orpe, J, Mathew, R, Macfaul, G, Wrigth, A, Shah, A, Evans, C, Keggans, J, Bird, B, Baxter, G, Saha, S, Pollock, K, Hughes, M, Bramley, P, Grieve, E, Young, K, Fraser, A, Mukhopadhya, A, Ocker, K, Mills, P, Hines, F, Shallcross, C, Wilkins, J, Grellier, L, Campbell, S, Martin, K, Innes, C, Shepherd, A, Rushbrook, S, Valliani, T, Przemioslo, R, Fairlamb, H, Macdonald, C, Eastick, A, Metcalf, J, Tanqueray, E, Shmueli, U, Holbrook, B, Davis, A, Browning, J, Naqvi, A, Walker, K, Lee, T, Verheyden, J, Slininger, S, Ryder, S, Chapman, R, Collier, J, O'Donnell, D, Stafford, L, Williamson, K, Kent, L, Klass, H, Ninkovic, M, March, L, Cramp, M, Simpson, D, Dickson, C, Sharer, N, Hayes, M, Goggin, P, Quinne, M, Pearson, S, Hoeroldt, B, Jones, L, Wright, A, Booth, J, Loftus, A, Lipscomb, G, Dewhurst, H, Gunter, E, Williams, E, Fouracres, A, Farrington, L, Graves, L, Hussaini, H, Stableforth, B, Marriott, S, Ayres, R, Leoni, M, Burroughs, A, Marshall, E, Tyrer, D, Lombard, M, Patanwala, I, Dali-Kemmery, L, Lambourne, V, Maltby, J, Vyas, S, Colley, J, Shinder, B, Singhal, S, Jones, J, Mills, M, Gleeson, D, Carnahan, M, Butterworth, J, Boulton, K, Taylor, N, George, K, Harding, T, Tregonning, J, Douglass, A, Brown, C, Clifford, G, Panter, S, Gocher, D, Shearman, J, Bray, G, Hamilton, M, Butcher, G, Forton, D, Mclindon, J, Curtis, J, Shewan, T, Cowan, M, Whatley, G, Nasseri, M, Grover, B, Sivaramakrishnan, N, Ducker, S, Houghton, K, Griffiths, L, Tripoli, S, Pitcher, M, Shpuza, E, White, N, Ghosh, D, Douds, A, Green, M, Brookes, M, Cumlat, L, Wong, V, Warner, K, Netherton, K, Mandal, A, Jain, S, Gupta, H, Sanghi, P, Pereira, S, Gunson, B, Lim, R, Gallagher, S, Clement, D, Brind, A, Watts, G, Mupudzi, M, Wright, M, Gitahi, J, Gordon, F, Unitt, E, Pateman, H, Batham, S, Delahooke, T, Grant, A, Conder, J, Higham, A, Cox, M, O'Donohoe, L, Currie, L, King, A, Oblak, M, Collins, C, Whalley, S, Quinn, M, Baird, Y, Amey, I, Fraser, J, Li, A, Cotterill, D, Bell, A, Singhal, A, Gee, I, Greer, S, Ang, Y, Ransford, R, Allison, J, Gotto, J, Dyer, S, Sweeting, H, Millson, C, Labbadia, G, Bragazzi, M, Andreone, P, Azzaroli, F, Galli, A, Tarocchi, M, Gasbarrini, A, Grieco, A, Marrone, G, Valenti, L, Maroni, L, Rigamonti, C, Picciotto, A, Carbone, Marco, Nardi, Alessandra, Flack, Steve, Carpino, Guido, Varvaropoulou, Nikoletta, Gavrila, Caius, Spicer, Ann, Badrock, Jonathan, Bernuzzi, Francesca, Cardinale, Vincenzo, Ainsworth, Holly F, Heneghan, Michael A, Thorburn, Douglas, Bathgate, Andrew, Jones, Rebecca, Neuberger, James M, Battezzati, Pier Maria, Zuin, Massimo, Taylor-Robinson, Simon, Donato, Maria F, Kirby, John, Mitchell-Thain, Robert, Floreani, Annarosa, Sampaziotis, Fotios, Muratori, Luigi, Alvaro, Domenico, Marzioni, Marco, Miele, Luca, Marra, Fabio, Giannini, Edoardo, Gaudio, Eugenio, Ronca, Vincenzo, Bonato, Giulia, Cristoferi, Laura, Malinverno, Federica, Gerussi, Alessio, Stocken, Deborah D, Cordell, Heather J, Hirschfield, Gideon M, Alexander, Graeme J, Sandford, Richard N, Jones, David E, Invernizzi, Pietro, Mells, George F, Thomas, Caradog, Rahman, Meshbah, Yapp, Tom, Lye Ch'ng, Chin, Harrison, Melanie, Sturgess, Richard, Galaska, Roman, Healey, Chris, Whiteman, Jessica, Czaijkowski, Marek, Gray, Catherine, Gunasekera, Anton, Gyawli, Pranab, Premchand, Purushothaman, Mann, Steven, Elliott, Keith, Kapur, Kapil, Watson, Alan, Foster, Graham, Trembling, Paul, Subhani, Javaid, Harvey, Rory, McCorry, Roger, Adgey, Carolyn, Hobson, Lucie, Mulvaney-Jones, Caroline, Evans, Richard, Mathialahan, Thiriloganathan, Ramanaden, David, Gasem, Jaber, Van Duyvenvoorde, Greta, Shorrock, Christopher, Seward, Katie, Southern, Paul, Tibble, Jeremy, Penn, Ruth, Gorard, David, Maiden, Jane, Damant, Rose, Palegwala, Altaf, Jones, Susan, Alexander, Graeme, Mells, George, Sandford, Richard, Dolwani, Sunil, Prince, Martin, Silvestre, Valeria, Foxton, Matthew, Dungca, Eleanor, Mitchison, Harriet, Wheatley, Natalie, Gooding, Ian, Doyle, Helen, Karmo, Mazn, Kent, Melanie, Saksena, Sushma, Braim, Delyth, Patel, Minesh, Lord, Susan, Ede, Roland, Paton, Alison, Austin, Andrew, Lancaster, Nicola, Sayer, Joanna, Gibbins, Andrew, Hogben, Karen, Hovell, Chris, Fisher, Neil, Carter, Martyn, Koss, Konrad, Musselwhite, Janine, Muscariu, Florin, Piotreowicz, Andrzej, McKay, Alexandra, Grimley, Charles, Neal, David, Ting Tan, Lai, Lim, Guan, Brighton, Jacqueline, Foale, Carole, Ala, Aftab, Saeed, Athar, Flahive, Kerry, Wood, Gordon, Townshend, Paula, Ford, Chris, Brown, Jonathan, Kordula, Jean, Bowles, Jane, Wilkinson, Mark, Palmer, Caroline, Ramage, John, Gordon, Harriet, Featherstone, James, Ridpath, Jo, Ngatchu, Theodore, Levi, Sass, Shaukat, Syed, Sadeghian, Joy, Shidrawi, Ray, Williams, Bronwen, Abouda, George, Jones, Sarah, Duggan, Claire, Hynes, Abigail, Narain, Mark, Rees, Ian, Salam, Imroz, Crossey, Mary, Brown, Ashley, MacNicol, Carolyn, Williams, Simon, Wilhelmsen, Elva, Banim, Paul, Raymode, Parizade, Chilton, Andrew, Das, Debasish, Lee, Hye-Jeong, Curtis, Howard, Heneghan, Michael, Gess, Markus, Durant, Emma, Drake, I. M., Bishop, Rebecca, Davies, Mervyn, Aldersley, Mark, Ncube, Noma, McNair, Alistair, Srirajaskanthan, Raj, Sen, Sambit, Casey, Rebecca, Bird, George, Mendall, Mike, Cowley, Caroline, Barnardo, Adrian, Kitchen, Paul, Yoong, Kevin, Amore, Kelly, Sirdefield, Dawn, Orpe, Jacky, Mathew, Ray, MacFaul, George, Wrigth, Aruna, Shah, Amir, Evans, Chris, Keggans, Janie, Bird, Bridget, Baxter, Gwen, Saha, Subrata, Pollock, Katharine, Hughes, Maggie, Bramley, Peter, Grieve, Emma, Young, Karin, Fraser, Andrew, Mukhopadhya, Ashis, Ocker, Kate, Mills, Peter, Hines, Francis, Shallcross, Chris, Wilkins, Joy, Grellier, Leonie, Campbell, Stewart, Martin, Kirsty, Innes, Caron, Shepherd, Alan, Rushbrook, Simon, Valliani, Talal, Przemioslo, Robert, Fairlamb, Helen, Macdonald, Chris, Eastick, Anne, Metcalf, Jane, Tanqueray, Elizabeth, Shmueli, Udi, Holbrook, Becky, Davis, Andrew, Browning, Julie, Naqvi, Asifabbas, Walker, Kirsten, Lee, Tom, Verheyden, Juliette, Slininger, Susan, Ryder, Stephen D, Chapman, Roger, Collier, Jane, O'Donnell, Denise, Stafford, Lizzie, Williamson, Kate, Kent, Linda, Klass, Howard, Ninkovic, Mary, March, Linda, Cramp, Matthew, Simpson, Diane, Dickson, Christine, Sharer, Nicholas, Hayes, Maria, Goggin, Patrick, Quinne, Mary, Pearson, Sallyanne, Hoeroldt, Barbara, Jones, Linda, Wright, Alice, Booth, Jonathan, Loftus, Alison, Lipscomb, George, Dewhurst, Hannah, Gunter, Emma, Williams, Earl, Fouracres, Anna, Farrington, Liz, Graves, Lyn, Hussaini, Hyder, Stableforth, Bill, Marriott, Suzie, Ayres, Reuben, Leoni, Marina, Burroughs, Andrew, Marshall, Eileen, Tyrer, David, Martin, Kate, Lombard, Martin, Patanwala, Imran, Dali-Kemmery, Lola, Lambourne, Victoria, Maltby, Julia, Vyas, Samir, Colley, Julie, Shinder, Bal, Singhal, Saket, Jones, Jayne, Mills, Marisa, Gleeson, Dermot, Carnahan, Mandy, Butterworth, Jeff, Boulton, Kerenza, Taylor, Natalie, George, Keith, Harding, Tim, Tregonning, Julie, Douglass, Andrew, Brown, Carly, Clifford, Gayle, Panter, Simon, Gocher, Denise, Shearman, Jeremy, Bray, Gary, Hamilton, Maria, Butcher, Graham, Forton, Daniel, Mclindon, John, Curtis, Janette, Das, Debashis, Shewan, Tracey, Cowan, Matthew, Whatley, Gregory, Nasseri, Mariam, Grover, Bob, Sivaramakrishnan, Nurani, Ducker, Samantha, Houghton, Kathryn, Jones, David, Griffiths, Laura, Tripoli, Sherill, Pitcher, Maxton, Shpuza, Ervin, White, Nikki, Ghosh, Deb, Douds, Andrew, Green, Marie, Brookes, Matthew, Cumlat, Lourdes, Wong, Voi Shim, Warner, Karen, Netherton, Kimberley, Mandal, Adtya, Jain, Snjiv, Gupta, Hemant, Sanghi, Pradeep, Pereira, Steve, Neuberger, James, Gunson, Bridget, Hirschfield, Gideon, Lim, Reina Teegan, Gallagher, Susan, Clement, Darren, Brind, Alison, Watts, Gill, Mupudzi, Mcdonald, Wright, Mark, Gitahi, Jane, Gordon, Fiona, Gocher, Denis, Unitt, Esther, Pateman, Hilary, Batham, Sally, Delahooke, Toby, Grant, Allister, Conder, Jill, Higham, Andrew, Cox, Mark, O'Donohoe, Lynn, Currie, Lynn, King, Alistair, Oblak, Metod, Collins, Carole, Whalley, Simon, Quinn, Marie, Baird, Yolanda, Amey, Isobel, Fraser, Jocelyn, Li, Andy, Cotterill, Donna, Bell, Andrew, Singhal, Amit, Gee, Ian, Greer, Sandra, Ang, Yeng, Ransford, Rupert, Allison, Joanna, Gotto, James, Dyer, Simon, Sweeting, Helen, Millson, Charles, Labbadia, Giancarlo, Bragazzi, Maria Consiglia, Andreone, Pietro, Azzaroli, Francesco, Galli, Andrea, Tarocchi, Mirko, Gasbarrini, Antonio, GRIECO, ANTONIO, Marrone, Giuseppe, Donato, Maria Francesca, Valenti, Luca, Maroni, Luca, Rigamonti, Cristina, Picciotto, Antonino, Carbone, M, Nardi, A, Flack, S, Carpino, G, Varvaropoulou, N, Gavrila, C, Spicer, A, Badrock, J, Bernuzzi, F, Cardinale, V, Ainsworth, H, Heneghan, M, Thorburn, D, Bathgate, A, Jones, R, Neuberger, J, Battezzati, P, Zuin, M, Taylor-Robinson, S, Donato, M, Kirby, J, Mitchell-Thain, R, Floreani, A, Sampaziotis, F, Muratori, L, Alvaro, D, Marzioni, M, Miele, L, Marra, F, Giannini, E, Gaudio, E, Ronca, V, Bonato, G, Cristoferi, L, Malinverno, F, Gerussi, A, Stocken, D, Cordell, H, Hirschfield, G, Alexander, G, Sandford, R, Jones, D, Invernizzi, P, Mells, G, Thomas, C, Rahman, M, Yapp, T, Lye Ch'ng, C, Harrison, M, Sturgess, R, Galaska, R, Healey, C, Whiteman, J, Czaijkowski, M, Gray, C, Gunasekera, A, Gyawli, P, Premchand, P, Mann, S, Elliott, K, Kapur, K, Watson, A, Foster, G, Trembling, P, Subhani, J, Harvey, R, Mccorry, R, Adgey, C, Hobson, L, Mulvaney-Jones, C, Evans, R, Mathialahan, T, Ramanaden, D, Gasem, J, Van Duyvenvoorde, G, Shorrock, C, Seward, K, Southern, P, Tibble, J, Penn, R, Gorard, D, Maiden, J, Damant, R, Palegwala, A, Jones, S, Dolwani, S, Prince, M, Silvestre, V, Foxton, M, Dungca, E, Mitchison, H, Wheatley, N, Gooding, I, Doyle, H, Karmo, M, Kent, M, Saksena, S, Braim, D, Patel, M, Lord, S, Ede, R, Paton, A, Austin, A, Lancaster, N, Sayer, J, Gibbins, A, Hogben, K, Hovell, C, Fisher, N, Carter, M, Koss, K, Musselwhite, J, Muscariu, F, Piotreowicz, A, Mckay, A, Grimley, C, Neal, D, Ting Tan, L, Lim, G, Brighton, J, Foale, C, Ala, A, Saeed, A, Flahive, K, Wood, G, Townshend, P, Ford, C, Brown, J, Kordula, J, Bowles, J, Wilkinson, M, Palmer, C, Ramage, J, Gordon, H, Featherstone, J, Ridpath, J, Ngatchu, T, Levi, S, Shaukat, S, Sadeghian, J, Shidrawi, R, Williams, B, Abouda, G, Duggan, C, Hynes, A, Narain, M, Rees, I, Salam, I, Crossey, M, Brown, A, Macnicol, C, Williams, S, Wilhelmsen, E, Banim, P, Raymode, P, Chilton, A, Das, D, Lee, H, Curtis, H, Gess, M, Durant, E, Drake, I, Bishop, R, Davies, M, Aldersley, M, Ncube, N, Mcnair, A, Srirajaskanthan, R, Sen, S, Casey, R, Bird, G, Mendall, M, Cowley, C, Barnardo, A, Kitchen, P, Yoong, K, Amore, K, Sirdefield, D, Orpe, J, Mathew, R, Macfaul, G, Wrigth, A, Shah, A, Evans, C, Keggans, J, Bird, B, Baxter, G, Saha, S, Pollock, K, Hughes, M, Bramley, P, Grieve, E, Young, K, Fraser, A, Mukhopadhya, A, Ocker, K, Mills, P, Hines, F, Shallcross, C, Wilkins, J, Grellier, L, Campbell, S, Martin, K, Innes, C, Shepherd, A, Rushbrook, S, Valliani, T, Przemioslo, R, Fairlamb, H, Macdonald, C, Eastick, A, Metcalf, J, Tanqueray, E, Shmueli, U, Holbrook, B, Davis, A, Browning, J, Naqvi, A, Walker, K, Lee, T, Verheyden, J, Slininger, S, Ryder, S, Chapman, R, Collier, J, O'Donnell, D, Stafford, L, Williamson, K, Kent, L, Klass, H, Ninkovic, M, March, L, Cramp, M, Simpson, D, Dickson, C, Sharer, N, Hayes, M, Goggin, P, Quinne, M, Pearson, S, Hoeroldt, B, Jones, L, Wright, A, Booth, J, Loftus, A, Lipscomb, G, Dewhurst, H, Gunter, E, Williams, E, Fouracres, A, Farrington, L, Graves, L, Hussaini, H, Stableforth, B, Marriott, S, Ayres, R, Leoni, M, Burroughs, A, Marshall, E, Tyrer, D, Lombard, M, Patanwala, I, Dali-Kemmery, L, Lambourne, V, Maltby, J, Vyas, S, Colley, J, Shinder, B, Singhal, S, Jones, J, Mills, M, Gleeson, D, Carnahan, M, Butterworth, J, Boulton, K, Taylor, N, George, K, Harding, T, Tregonning, J, Douglass, A, Brown, C, Clifford, G, Panter, S, Gocher, D, Shearman, J, Bray, G, Hamilton, M, Butcher, G, Forton, D, Mclindon, J, Curtis, J, Shewan, T, Cowan, M, Whatley, G, Nasseri, M, Grover, B, Sivaramakrishnan, N, Ducker, S, Houghton, K, Griffiths, L, Tripoli, S, Pitcher, M, Shpuza, E, White, N, Ghosh, D, Douds, A, Green, M, Brookes, M, Cumlat, L, Wong, V, Warner, K, Netherton, K, Mandal, A, Jain, S, Gupta, H, Sanghi, P, Pereira, S, Gunson, B, Lim, R, Gallagher, S, Clement, D, Brind, A, Watts, G, Mupudzi, M, Wright, M, Gitahi, J, Gordon, F, Unitt, E, Pateman, H, Batham, S, Delahooke, T, Grant, A, Conder, J, Higham, A, Cox, M, O'Donohoe, L, Currie, L, King, A, Oblak, M, Collins, C, Whalley, S, Quinn, M, Baird, Y, Amey, I, Fraser, J, Li, A, Cotterill, D, Bell, A, Singhal, A, Gee, I, Greer, S, Ang, Y, Ransford, R, Allison, J, Gotto, J, Dyer, S, Sweeting, H, Millson, C, Labbadia, G, Bragazzi, M, Andreone, P, Azzaroli, F, Galli, A, Tarocchi, M, Gasbarrini, A, Grieco, A, Marrone, G, Valenti, L, Maroni, L, Rigamonti, C, Picciotto, A, Carbone, Marco, Nardi, Alessandra, Flack, Steve, Carpino, Guido, Varvaropoulou, Nikoletta, Gavrila, Caius, Spicer, Ann, Badrock, Jonathan, Bernuzzi, Francesca, Cardinale, Vincenzo, Ainsworth, Holly F, Heneghan, Michael A, Thorburn, Douglas, Bathgate, Andrew, Jones, Rebecca, Neuberger, James M, Battezzati, Pier Maria, Zuin, Massimo, Taylor-Robinson, Simon, Donato, Maria F, Kirby, John, Mitchell-Thain, Robert, Floreani, Annarosa, Sampaziotis, Fotios, Muratori, Luigi, Alvaro, Domenico, Marzioni, Marco, Miele, Luca, Marra, Fabio, Giannini, Edoardo, Gaudio, Eugenio, Ronca, Vincenzo, Bonato, Giulia, Cristoferi, Laura, Malinverno, Federica, Gerussi, Alessio, Stocken, Deborah D, Cordell, Heather J, Hirschfield, Gideon M, Alexander, Graeme J, Sandford, Richard N, Jones, David E, Invernizzi, Pietro, Mells, George F, Thomas, Caradog, Rahman, Meshbah, Yapp, Tom, Lye Ch'ng, Chin, Harrison, Melanie, Sturgess, Richard, Galaska, Roman, Healey, Chris, Whiteman, Jessica, Czaijkowski, Marek, Gray, Catherine, Gunasekera, Anton, Gyawli, Pranab, Premchand, Purushothaman, Mann, Steven, Elliott, Keith, Kapur, Kapil, Watson, Alan, Foster, Graham, Trembling, Paul, Subhani, Javaid, Harvey, Rory, McCorry, Roger, Adgey, Carolyn, Hobson, Lucie, Mulvaney-Jones, Caroline, Evans, Richard, Mathialahan, Thiriloganathan, Ramanaden, David, Gasem, Jaber, Van Duyvenvoorde, Greta, Shorrock, Christopher, Seward, Katie, Southern, Paul, Tibble, Jeremy, Penn, Ruth, Gorard, David, Maiden, Jane, Damant, Rose, Palegwala, Altaf, Jones, Susan, Alexander, Graeme, Mells, George, Sandford, Richard, Dolwani, Sunil, Prince, Martin, Silvestre, Valeria, Foxton, Matthew, Dungca, Eleanor, Mitchison, Harriet, Wheatley, Natalie, Gooding, Ian, Doyle, Helen, Karmo, Mazn, Kent, Melanie, Saksena, Sushma, Braim, Delyth, Patel, Minesh, Lord, Susan, Ede, Roland, Paton, Alison, Austin, Andrew, Lancaster, Nicola, Sayer, Joanna, Gibbins, Andrew, Hogben, Karen, Hovell, Chris, Fisher, Neil, Carter, Martyn, Koss, Konrad, Musselwhite, Janine, Muscariu, Florin, Piotreowicz, Andrzej, McKay, Alexandra, Grimley, Charles, Neal, David, Ting Tan, Lai, Lim, Guan, Brighton, Jacqueline, Foale, Carole, Ala, Aftab, Saeed, Athar, Flahive, Kerry, Wood, Gordon, Townshend, Paula, Ford, Chris, Brown, Jonathan, Kordula, Jean, Bowles, Jane, Wilkinson, Mark, Palmer, Caroline, Ramage, John, Gordon, Harriet, Featherstone, James, Ridpath, Jo, Ngatchu, Theodore, Levi, Sass, Shaukat, Syed, Sadeghian, Joy, Shidrawi, Ray, Williams, Bronwen, Abouda, George, Jones, Sarah, Duggan, Claire, Hynes, Abigail, Narain, Mark, Rees, Ian, Salam, Imroz, Crossey, Mary, Brown, Ashley, MacNicol, Carolyn, Williams, Simon, Wilhelmsen, Elva, Banim, Paul, Raymode, Parizade, Chilton, Andrew, Das, Debasish, Lee, Hye-Jeong, Curtis, Howard, Heneghan, Michael, Gess, Markus, Durant, Emma, Drake, I. M., Bishop, Rebecca, Davies, Mervyn, Aldersley, Mark, Ncube, Noma, McNair, Alistair, Srirajaskanthan, Raj, Sen, Sambit, Casey, Rebecca, Bird, George, Mendall, Mike, Cowley, Caroline, Barnardo, Adrian, Kitchen, Paul, Yoong, Kevin, Amore, Kelly, Sirdefield, Dawn, Orpe, Jacky, Mathew, Ray, MacFaul, George, Wrigth, Aruna, Shah, Amir, Evans, Chris, Keggans, Janie, Bird, Bridget, Baxter, Gwen, Saha, Subrata, Pollock, Katharine, Hughes, Maggie, Bramley, Peter, Grieve, Emma, Young, Karin, Fraser, Andrew, Mukhopadhya, Ashis, Ocker, Kate, Mills, Peter, Hines, Francis, Shallcross, Chris, Wilkins, Joy, Grellier, Leonie, Campbell, Stewart, Martin, Kirsty, Innes, Caron, Shepherd, Alan, Rushbrook, Simon, Valliani, Talal, Przemioslo, Robert, Fairlamb, Helen, Macdonald, Chris, Eastick, Anne, Metcalf, Jane, Tanqueray, Elizabeth, Shmueli, Udi, Holbrook, Becky, Davis, Andrew, Browning, Julie, Naqvi, Asifabbas, Walker, Kirsten, Lee, Tom, Verheyden, Juliette, Slininger, Susan, Ryder, Stephen D, Chapman, Roger, Collier, Jane, O'Donnell, Denise, Stafford, Lizzie, Williamson, Kate, Kent, Linda, Klass, Howard, Ninkovic, Mary, March, Linda, Cramp, Matthew, Simpson, Diane, Dickson, Christine, Sharer, Nicholas, Hayes, Maria, Goggin, Patrick, Quinne, Mary, Pearson, Sallyanne, Hoeroldt, Barbara, Jones, Linda, Wright, Alice, Booth, Jonathan, Loftus, Alison, Lipscomb, George, Dewhurst, Hannah, Gunter, Emma, Williams, Earl, Fouracres, Anna, Farrington, Liz, Graves, Lyn, Hussaini, Hyder, Stableforth, Bill, Marriott, Suzie, Ayres, Reuben, Leoni, Marina, Burroughs, Andrew, Marshall, Eileen, Tyrer, David, Martin, Kate, Lombard, Martin, Patanwala, Imran, Dali-Kemmery, Lola, Lambourne, Victoria, Maltby, Julia, Vyas, Samir, Colley, Julie, Shinder, Bal, Singhal, Saket, Jones, Jayne, Mills, Marisa, Gleeson, Dermot, Carnahan, Mandy, Butterworth, Jeff, Boulton, Kerenza, Taylor, Natalie, George, Keith, Harding, Tim, Tregonning, Julie, Douglass, Andrew, Brown, Carly, Clifford, Gayle, Panter, Simon, Gocher, Denise, Shearman, Jeremy, Bray, Gary, Hamilton, Maria, Butcher, Graham, Forton, Daniel, Mclindon, John, Curtis, Janette, Das, Debashis, Shewan, Tracey, Cowan, Matthew, Whatley, Gregory, Nasseri, Mariam, Grover, Bob, Sivaramakrishnan, Nurani, Ducker, Samantha, Houghton, Kathryn, Jones, David, Griffiths, Laura, Tripoli, Sherill, Pitcher, Maxton, Shpuza, Ervin, White, Nikki, Ghosh, Deb, Douds, Andrew, Green, Marie, Brookes, Matthew, Cumlat, Lourdes, Wong, Voi Shim, Warner, Karen, Netherton, Kimberley, Mandal, Adtya, Jain, Snjiv, Gupta, Hemant, Sanghi, Pradeep, Pereira, Steve, Neuberger, James, Gunson, Bridget, Hirschfield, Gideon, Lim, Reina Teegan, Gallagher, Susan, Clement, Darren, Brind, Alison, Watts, Gill, Mupudzi, Mcdonald, Wright, Mark, Gitahi, Jane, Gordon, Fiona, Gocher, Denis, Unitt, Esther, Pateman, Hilary, Batham, Sally, Delahooke, Toby, Grant, Allister, Conder, Jill, Higham, Andrew, Cox, Mark, O'Donohoe, Lynn, Currie, Lynn, King, Alistair, Oblak, Metod, Collins, Carole, Whalley, Simon, Quinn, Marie, Baird, Yolanda, Amey, Isobel, Fraser, Jocelyn, Li, Andy, Cotterill, Donna, Bell, Andrew, Singhal, Amit, Gee, Ian, Greer, Sandra, Ang, Yeng, Ransford, Rupert, Allison, Joanna, Gotto, James, Dyer, Simon, Sweeting, Helen, Millson, Charles, Labbadia, Giancarlo, Bragazzi, Maria Consiglia, Andreone, Pietro, Azzaroli, Francesco, Galli, Andrea, Tarocchi, Mirko, Gasbarrini, Antonio, GRIECO, ANTONIO, Marrone, Giuseppe, Donato, Maria Francesca, Valenti, Luca, Maroni, Luca, Rigamonti, Cristina, and Picciotto, Antonino
Abstract: Background: Treatment guidelines recommend a stepwise approach to primary biliary cholangitis: all patients begin treatment with ursodeoxycholic acid (UDCA) monotherapy and those with an inadequate biochemical response after 12 months are subsequently considered for second-line therapies. However, as a result, patients at the highest risk can wait the longest for effective treatment. We determined whether UDCA response can be accurately predicted using pretreatment clinical parameters. Methods: We did logistic regression analysis of pretreatment variables in a discovery cohort of patients in the UK with primary biliary cholangitis to derive the best-fitting model of UDCA response, defined as alkaline phosphatase less than 1·67 times the upper limit of normal (ULN), measured after 12 months of treatment with UDCA. We validated the model in an external cohort of patients with primary biliary cholangitis and treated with UDCA in Italy. Additionally, we assessed correlations between model predictions and key histological features, such as biliary injury and fibrosis, on liver biopsy samples. Findings: 2703 participants diagnosed with primary biliary cholangitis between Jan 1, 1998, and May 31, 2015, were included in the UK-PBC cohort for derivation of the model. The following pretreatment parameters were associated with lower probability of UDCA response: higher alkaline phosphatase concentration (p<0·0001), higher total bilirubin concentration (p=0·0003), lower aminotransferase concentration (p=0·0012), younger age (p<0·0001), longer interval from diagnosis to the start of UDCA treatment (treatment time lag, p<0·0001), and worsening of alkaline phosphatase concentration from diagnosis (p<0·0001). Based on these variables, we derived a predictive score of UDCA response. In the external validation cohort, 460 patients diagnosed with primary biliary cholangitis were treated with UDCA, with follow-up data until May 31, 2016. In this validation cohort, the area under the re
Published: 2018

16. Pretreatment prediction of response to ursodeoxycholic acid in primary biliary cholangitis: development and validation of the UDCA Response Score

Author: Carbone, M, Nardi, A, Flack, S, Carpino, G, Varvaropoulou, N, Gavrila, C, Spicer, A, Badrock, J, Bernuzzi, F, Cardinale, V, Ainsworth, H, Heneghan, M, Thorburn, D, Bathgate, A, Jones, R, Neuberger, J, Battezzati, P, Zuin, M, Taylor-Robinson, S, Donato, M, Kirby, J, Mitchell-Thain, R, Floreani, A, Sampaziotis, F, Muratori, L, Alvaro, D, Marzioni, M, Miele, L, Marra, F, Giannini, E, Gaudio, E, Ronca, V, Bonato, G, Cristoferi, L, Malinverno, F, Gerussi, A, Stocken, D, Cordell, H, Hirschfield, G, Alexander, G, Sandford, R, Jones, D, Invernizzi, P, Mells, G, Thomas, C, Rahman, M, Yapp, T, Lye Ch'ng, C, Harrison, M, Sturgess, R, Galaska, R, Healey, C, Whiteman, J, Czaijkowski, M, Gray, C, Gunasekera, A, Gyawli, P, Premchand, P, Mann, S, Elliott, K, Kapur, K, Watson, A, Foster, G, Trembling, P, Subhani, J, Harvey, R, Mccorry, R, Adgey, C, Hobson, L, Mulvaney-Jones, C, Evans, R, Mathialahan, T, Ramanaden, D, Gasem, J, Van Duyvenvoorde, G, Shorrock, C, Seward, K, Southern, P, Tibble, J, Penn, R, Gorard, D, Maiden, J, Damant, R, Palegwala, A, Jones, S, Dolwani, S, Prince, M, Silvestre, V, Foxton, M, Dungca, E, Mitchison, H, Wheatley, N, Gooding, I, Doyle, H, Karmo, M, Kent, M, Saksena, S, Braim, D, Patel, M, Lord, S, Ede, R, Paton, A, Austin, A, Lancaster, N, Sayer, J, Gibbins, A, Hogben, K, Hovell, C, Fisher, N, Carter, M, Koss, K, Musselwhite, J, Muscariu, F, Piotreowicz, A, Mckay, A, Grimley, C, Neal, D, Ting Tan, L, Lim, G, Brighton, J, Foale, C, Ala, A, Saeed, A, Flahive, K, Wood, G, Townshend, P, Ford, C, Brown, J, Kordula, J, Bowles, J, Wilkinson, M, Palmer, C, Ramage, J, Gordon, H, Featherstone, J, Ridpath, J, Ngatchu, T, Levi, S, Shaukat, S, Sadeghian, J, Shidrawi, R, Williams, B, Abouda, G, Duggan, C, Hynes, A, Narain, M, Rees, I, Salam, I, Crossey, M, Brown, A, Macnicol, C, Williams, S, Wilhelmsen, E, Banim, P, Raymode, P, Chilton, A, Das, D, Lee, H, Curtis, H, Gess, M, Durant, E, Drake, I, Bishop, R, Davies, M, Aldersley, M, Ncube, N, Mcnair, A, Srirajaskanthan, R, Sen, S, Casey, R, Bird, G, Mendall, M, Cowley, C, Barnardo, A, Kitchen, P, Yoong, K, Amore, K, Sirdefield, D, Orpe, J, Mathew, R, Macfaul, G, Wrigth, A, Shah, A, Evans, C, Keggans, J, Bird, B, Baxter, G, Saha, S, Pollock, K, Hughes, M, Bramley, P, Grieve, E, Young, K, Fraser, A, Mukhopadhya, A, Ocker, K, Mills, P, Hines, F, Shallcross, C, Wilkins, J, Grellier, L, Campbell, S, Martin, K, Innes, C, Shepherd, A, Rushbrook, S, Valliani, T, Przemioslo, R, Fairlamb, H, Macdonald, C, Eastick, A, Metcalf, J, Tanqueray, E, Shmueli, U, Holbrook, B, Davis, A, Browning, J, Naqvi, A, Walker, K, Lee, T, Verheyden, J, Slininger, S, Ryder, S, Chapman, R, Collier, J, O'Donnell, D, Stafford, L, Williamson, K, Kent, L, Klass, H, Ninkovic, M, March, L, Cramp, M, Simpson, D, Dickson, C, Sharer, N, Hayes, M, Goggin, P, Quinne, M, Pearson, S, Hoeroldt, B, Jones, L, Wright, A, Booth, J, Loftus, A, Lipscomb, G, Dewhurst, H, Gunter, E, Williams, E, Fouracres, A, Farrington, L, Graves, L, Hussaini, H, Stableforth, B, Marriott, S, Ayres, R, Leoni, M, Burroughs, A, Marshall, E, Tyrer, D, Lombard, M, Patanwala, I, Dali-Kemmery, L, Lambourne, V, Maltby, J, Vyas, S, Colley, J, Shinder, B, Singhal, S, Jones, J, Mills, M, Gleeson, D, Carnahan, M, Butterworth, J, Boulton, K, Taylor, N, George, K, Harding, T, Tregonning, J, Douglass, A, Brown, C, Clifford, G, Panter, S, Gocher, D, Shearman, J, Bray, G, Hamilton, M, Butcher, G, Forton, D, Mclindon, J, Curtis, J, Shewan, T, Cowan, M, Whatley, G, Nasseri, M, Grover, B, Sivaramakrishnan, N, Ducker, S, Houghton, K, Griffiths, L, Tripoli, S, Pitcher, M, Shpuza, E, White, N, Ghosh, D, Douds, A, Green, M, Brookes, M, Cumlat, L, Wong, V, Warner, K, Netherton, K, Mandal, A, Jain, S, Gupta, H, Sanghi, P, Pereira, S, Gunson, B, Lim, R, Gallagher, S, Clement, D, Brind, A, Watts, G, Mupudzi, M, Wright, M, Gitahi, J, Gordon, F, Unitt, E, Pateman, H, Batham, S, Delahooke, T, Grant, A, Conder, J, Higham, A, Cox, M, O'Donohoe, L, Currie, L, King, A, Oblak, M, Collins, C, Whalley, S, Quinn, M, Baird, Y, Amey, I, Fraser, J, Li, A, Cotterill, D, Bell, A, Singhal, A, Gee, I, Greer, S, Ang, Y, Ransford, R, Allison, J, Gotto, J, Dyer, S, Sweeting, H, Millson, C, Labbadia, G, Bragazzi, M, Andreone, P, Azzaroli, F, Galli, A, Tarocchi, M, Gasbarrini, A, Grieco, A, Marrone, G, Valenti, L, Maroni, L, Rigamonti, C, Picciotto, A, Carbone, Marco, Nardi, Alessandra, Flack, Steve, Carpino, Guido, Varvaropoulou, Nikoletta, Gavrila, Caius, Spicer, Ann, Badrock, Jonathan, Bernuzzi, Francesca, Cardinale, Vincenzo, Ainsworth, Holly F, Heneghan, Michael A, Thorburn, Douglas, Bathgate, Andrew, Jones, Rebecca, Neuberger, James M, Battezzati, Pier Maria, Zuin, Massimo, Taylor-Robinson, Simon, Donato, Maria F, Kirby, John, Mitchell-Thain, Robert, Floreani, Annarosa, Sampaziotis, Fotios, Muratori, Luigi, Alvaro, Domenico, Marzioni, Marco, Miele, Luca, Marra, Fabio, Giannini, Edoardo, Gaudio, Eugenio, Ronca, Vincenzo, Bonato, Giulia, Cristoferi, Laura, Malinverno, Federica, Gerussi, Alessio, Stocken, Deborah D, Cordell, Heather J, Hirschfield, Gideon M, Alexander, Graeme J, Sandford, Richard N, Jones, David E, Invernizzi, Pietro, Mells, George F, Thomas, Caradog, Rahman, Meshbah, Yapp, Tom, Lye Ch'ng, Chin, Harrison, Melanie, Sturgess, Richard, Galaska, Roman, Healey, Chris, Whiteman, Jessica, Czaijkowski, Marek, Gray, Catherine, Gunasekera, Anton, Gyawli, Pranab, Premchand, Purushothaman, Mann, Steven, Elliott, Keith, Kapur, Kapil, Watson, Alan, Foster, Graham, Trembling, Paul, Subhani, Javaid, Harvey, Rory, McCorry, Roger, Adgey, Carolyn, Hobson, Lucie, Mulvaney-Jones, Caroline, Evans, Richard, Mathialahan, Thiriloganathan, Ramanaden, David, Gasem, Jaber, Van Duyvenvoorde, Greta, Shorrock, Christopher, Seward, Katie, Southern, Paul, Tibble, Jeremy, Penn, Ruth, Gorard, David, Maiden, Jane, Damant, Rose, Palegwala, Altaf, Jones, Susan, Alexander, Graeme, Mells, George, Sandford, Richard, Dolwani, Sunil, Prince, Martin, Silvestre, Valeria, Foxton, Matthew, Dungca, Eleanor, Mitchison, Harriet, Wheatley, Natalie, Gooding, Ian, Doyle, Helen, Karmo, Mazn, Kent, Melanie, Saksena, Sushma, Braim, Delyth, Patel, Minesh, Lord, Susan, Ede, Roland, Paton, Alison, Austin, Andrew, Lancaster, Nicola, Sayer, Joanna, Gibbins, Andrew, Hogben, Karen, Hovell, Chris, Fisher, Neil, Carter, Martyn, Koss, Konrad, Musselwhite, Janine, Muscariu, Florin, Piotreowicz, Andrzej, McKay, Alexandra, Grimley, Charles, Neal, David, Ting Tan, Lai, Lim, Guan, Brighton, Jacqueline, Foale, Carole, Ala, Aftab, Saeed, Athar, Flahive, Kerry, Wood, Gordon, Townshend, Paula, Ford, Chris, Brown, Jonathan, Kordula, Jean, Bowles, Jane, Wilkinson, Mark, Palmer, Caroline, Ramage, John, Gordon, Harriet, Featherstone, James, Ridpath, Jo, Ngatchu, Theodore, Levi, Sass, Shaukat, Syed, Sadeghian, Joy, Shidrawi, Ray, Williams, Bronwen, Abouda, George, Jones, Sarah, Duggan, Claire, Hynes, Abigail, Narain, Mark, Rees, Ian, Salam, Imroz, Crossey, Mary, Brown, Ashley, MacNicol, Carolyn, Williams, Simon, Wilhelmsen, Elva, Banim, Paul, Raymode, Parizade, Chilton, Andrew, Das, Debasish, Lee, Hye-Jeong, Curtis, Howard, Heneghan, Michael, Gess, Markus, Durant, Emma, Drake, I. M., Bishop, Rebecca, Davies, Mervyn, Aldersley, Mark, Ncube, Noma, McNair, Alistair, Srirajaskanthan, Raj, Sen, Sambit, Casey, Rebecca, Bird, George, Mendall, Mike, Cowley, Caroline, Barnardo, Adrian, Kitchen, Paul, Yoong, Kevin, Amore, Kelly, Sirdefield, Dawn, Orpe, Jacky, Mathew, Ray, MacFaul, George, Wrigth, Aruna, Shah, Amir, Evans, Chris, Keggans, Janie, Bird, Bridget, Baxter, Gwen, Saha, Subrata, Pollock, Katharine, Hughes, Maggie, Bramley, Peter, Grieve, Emma, Young, Karin, Fraser, Andrew, Mukhopadhya, Ashis, Ocker, Kate, Mills, Peter, Hines, Francis, Shallcross, Chris, Wilkins, Joy, Grellier, Leonie, Campbell, Stewart, Martin, Kirsty, Innes, Caron, Shepherd, Alan, Rushbrook, Simon, Valliani, Talal, Przemioslo, Robert, Fairlamb, Helen, Macdonald, Chris, Eastick, Anne, Metcalf, Jane, Tanqueray, Elizabeth, Shmueli, Udi, Holbrook, Becky, Davis, Andrew, Browning, Julie, Naqvi, Asifabbas, Walker, Kirsten, Lee, Tom, Verheyden, Juliette, Slininger, Susan, Ryder, Stephen D, Chapman, Roger, Collier, Jane, O'Donnell, Denise, Stafford, Lizzie, Williamson, Kate, Kent, Linda, Klass, Howard, Ninkovic, Mary, March, Linda, Cramp, Matthew, Simpson, Diane, Dickson, Christine, Sharer, Nicholas, Hayes, Maria, Goggin, Patrick, Quinne, Mary, Pearson, Sallyanne, Hoeroldt, Barbara, Jones, Linda, Wright, Alice, Booth, Jonathan, Loftus, Alison, Lipscomb, George, Dewhurst, Hannah, Gunter, Emma, Williams, Earl, Fouracres, Anna, Farrington, Liz, Graves, Lyn, Hussaini, Hyder, Stableforth, Bill, Marriott, Suzie, Ayres, Reuben, Leoni, Marina, Burroughs, Andrew, Marshall, Eileen, Tyrer, David, Martin, Kate, Lombard, Martin, Patanwala, Imran, Dali-Kemmery, Lola, Lambourne, Victoria, Maltby, Julia, Vyas, Samir, Colley, Julie, Shinder, Bal, Singhal, Saket, Jones, Jayne, Mills, Marisa, Gleeson, Dermot, Carnahan, Mandy, Butterworth, Jeff, Boulton, Kerenza, Taylor, Natalie, George, Keith, Harding, Tim, Tregonning, Julie, Douglass, Andrew, Brown, Carly, Clifford, Gayle, Panter, Simon, Gocher, Denise, Shearman, Jeremy, Bray, Gary, Hamilton, Maria, Butcher, Graham, Forton, Daniel, Mclindon, John, Curtis, Janette, Das, Debashis, Shewan, Tracey, Cowan, Matthew, Whatley, Gregory, Nasseri, Mariam, Grover, Bob, Sivaramakrishnan, Nurani, Ducker, Samantha, Houghton, Kathryn, Jones, David, Griffiths, Laura, Tripoli, Sherill, Pitcher, Maxton, Shpuza, Ervin, White, Nikki, Ghosh, Deb, Douds, Andrew, Green, Marie, Brookes, Matthew, Cumlat, Lourdes, Wong, Voi Shim, Warner, Karen, Netherton, Kimberley, Mandal, Adtya, Jain, Snjiv, Gupta, Hemant, Sanghi, Pradeep, Pereira, Steve, Neuberger, James, Gunson, Bridget, Hirschfield, Gideon, Lim, Reina Teegan, Gallagher, Susan, Clement, Darren, Brind, Alison, Watts, Gill, Mupudzi, Mcdonald, Wright, Mark, Gitahi, Jane, Gordon, Fiona, Gocher, Denis, Unitt, Esther, Pateman, Hilary, Batham, Sally, Delahooke, Toby, Grant, Allister, Conder, Jill, Higham, Andrew, Cox, Mark, O'Donohoe, Lynn, Currie, Lynn, King, Alistair, Oblak, Metod, Collins, Carole, Whalley, Simon, Quinn, Marie, Baird, Yolanda, Amey, Isobel, Fraser, Jocelyn, Li, Andy, Cotterill, Donna, Bell, Andrew, Singhal, Amit, Gee, Ian, Greer, Sandra, Ang, Yeng, Ransford, Rupert, Allison, Joanna, Gotto, James, Dyer, Simon, Sweeting, Helen, Millson, Charles, Labbadia, Giancarlo, Bragazzi, Maria Consiglia, Andreone, Pietro, Azzaroli, Francesco, Galli, Andrea, Tarocchi, Mirko, Gasbarrini, Antonio, GRIECO, ANTONIO, Marrone, Giuseppe, Donato, Maria Francesca, Valenti, Luca, Maroni, Luca, Rigamonti, Cristina, Picciotto, Antonino, Carbone, M, Nardi, A, Flack, S, Carpino, G, Varvaropoulou, N, Gavrila, C, Spicer, A, Badrock, J, Bernuzzi, F, Cardinale, V, Ainsworth, H, Heneghan, M, Thorburn, D, Bathgate, A, Jones, R, Neuberger, J, Battezzati, P, Zuin, M, Taylor-Robinson, S, Donato, M, Kirby, J, Mitchell-Thain, R, Floreani, A, Sampaziotis, F, Muratori, L, Alvaro, D, Marzioni, M, Miele, L, Marra, F, Giannini, E, Gaudio, E, Ronca, V, Bonato, G, Cristoferi, L, Malinverno, F, Gerussi, A, Stocken, D, Cordell, H, Hirschfield, G, Alexander, G, Sandford, R, Jones, D, Invernizzi, P, Mells, G, Thomas, C, Rahman, M, Yapp, T, Lye Ch'ng, C, Harrison, M, Sturgess, R, Galaska, R, Healey, C, Whiteman, J, Czaijkowski, M, Gray, C, Gunasekera, A, Gyawli, P, Premchand, P, Mann, S, Elliott, K, Kapur, K, Watson, A, Foster, G, Trembling, P, Subhani, J, Harvey, R, Mccorry, R, Adgey, C, Hobson, L, Mulvaney-Jones, C, Evans, R, Mathialahan, T, Ramanaden, D, Gasem, J, Van Duyvenvoorde, G, Shorrock, C, Seward, K, Southern, P, Tibble, J, Penn, R, Gorard, D, Maiden, J, Damant, R, Palegwala, A, Jones, S, Dolwani, S, Prince, M, Silvestre, V, Foxton, M, Dungca, E, Mitchison, H, Wheatley, N, Gooding, I, Doyle, H, Karmo, M, Kent, M, Saksena, S, Braim, D, Patel, M, Lord, S, Ede, R, Paton, A, Austin, A, Lancaster, N, Sayer, J, Gibbins, A, Hogben, K, Hovell, C, Fisher, N, Carter, M, Koss, K, Musselwhite, J, Muscariu, F, Piotreowicz, A, Mckay, A, Grimley, C, Neal, D, Ting Tan, L, Lim, G, Brighton, J, Foale, C, Ala, A, Saeed, A, Flahive, K, Wood, G, Townshend, P, Ford, C, Brown, J, Kordula, J, Bowles, J, Wilkinson, M, Palmer, C, Ramage, J, Gordon, H, Featherstone, J, Ridpath, J, Ngatchu, T, Levi, S, Shaukat, S, Sadeghian, J, Shidrawi, R, Williams, B, Abouda, G, Duggan, C, Hynes, A, Narain, M, Rees, I, Salam, I, Crossey, M, Brown, A, Macnicol, C, Williams, S, Wilhelmsen, E, Banim, P, Raymode, P, Chilton, A, Das, D, Lee, H, Curtis, H, Gess, M, Durant, E, Drake, I, Bishop, R, Davies, M, Aldersley, M, Ncube, N, Mcnair, A, Srirajaskanthan, R, Sen, S, Casey, R, Bird, G, Mendall, M, Cowley, C, Barnardo, A, Kitchen, P, Yoong, K, Amore, K, Sirdefield, D, Orpe, J, Mathew, R, Macfaul, G, Wrigth, A, Shah, A, Evans, C, Keggans, J, Bird, B, Baxter, G, Saha, S, Pollock, K, Hughes, M, Bramley, P, Grieve, E, Young, K, Fraser, A, Mukhopadhya, A, Ocker, K, Mills, P, Hines, F, Shallcross, C, Wilkins, J, Grellier, L, Campbell, S, Martin, K, Innes, C, Shepherd, A, Rushbrook, S, Valliani, T, Przemioslo, R, Fairlamb, H, Macdonald, C, Eastick, A, Metcalf, J, Tanqueray, E, Shmueli, U, Holbrook, B, Davis, A, Browning, J, Naqvi, A, Walker, K, Lee, T, Verheyden, J, Slininger, S, Ryder, S, Chapman, R, Collier, J, O'Donnell, D, Stafford, L, Williamson, K, Kent, L, Klass, H, Ninkovic, M, March, L, Cramp, M, Simpson, D, Dickson, C, Sharer, N, Hayes, M, Goggin, P, Quinne, M, Pearson, S, Hoeroldt, B, Jones, L, Wright, A, Booth, J, Loftus, A, Lipscomb, G, Dewhurst, H, Gunter, E, Williams, E, Fouracres, A, Farrington, L, Graves, L, Hussaini, H, Stableforth, B, Marriott, S, Ayres, R, Leoni, M, Burroughs, A, Marshall, E, Tyrer, D, Lombard, M, Patanwala, I, Dali-Kemmery, L, Lambourne, V, Maltby, J, Vyas, S, Colley, J, Shinder, B, Singhal, S, Jones, J, Mills, M, Gleeson, D, Carnahan, M, Butterworth, J, Boulton, K, Taylor, N, George, K, Harding, T, Tregonning, J, Douglass, A, Brown, C, Clifford, G, Panter, S, Gocher, D, Shearman, J, Bray, G, Hamilton, M, Butcher, G, Forton, D, Mclindon, J, Curtis, J, Shewan, T, Cowan, M, Whatley, G, Nasseri, M, Grover, B, Sivaramakrishnan, N, Ducker, S, Houghton, K, Griffiths, L, Tripoli, S, Pitcher, M, Shpuza, E, White, N, Ghosh, D, Douds, A, Green, M, Brookes, M, Cumlat, L, Wong, V, Warner, K, Netherton, K, Mandal, A, Jain, S, Gupta, H, Sanghi, P, Pereira, S, Gunson, B, Lim, R, Gallagher, S, Clement, D, Brind, A, Watts, G, Mupudzi, M, Wright, M, Gitahi, J, Gordon, F, Unitt, E, Pateman, H, Batham, S, Delahooke, T, Grant, A, Conder, J, Higham, A, Cox, M, O'Donohoe, L, Currie, L, King, A, Oblak, M, Collins, C, Whalley, S, Quinn, M, Baird, Y, Amey, I, Fraser, J, Li, A, Cotterill, D, Bell, A, Singhal, A, Gee, I, Greer, S, Ang, Y, Ransford, R, Allison, J, Gotto, J, Dyer, S, Sweeting, H, Millson, C, Labbadia, G, Bragazzi, M, Andreone, P, Azzaroli, F, Galli, A, Tarocchi, M, Gasbarrini, A, Grieco, A, Marrone, G, Valenti, L, Maroni, L, Rigamonti, C, Picciotto, A, Carbone, Marco, Nardi, Alessandra, Flack, Steve, Carpino, Guido, Varvaropoulou, Nikoletta, Gavrila, Caius, Spicer, Ann, Badrock, Jonathan, Bernuzzi, Francesca, Cardinale, Vincenzo, Ainsworth, Holly F, Heneghan, Michael A, Thorburn, Douglas, Bathgate, Andrew, Jones, Rebecca, Neuberger, James M, Battezzati, Pier Maria, Zuin, Massimo, Taylor-Robinson, Simon, Donato, Maria F, Kirby, John, Mitchell-Thain, Robert, Floreani, Annarosa, Sampaziotis, Fotios, Muratori, Luigi, Alvaro, Domenico, Marzioni, Marco, Miele, Luca, Marra, Fabio, Giannini, Edoardo, Gaudio, Eugenio, Ronca, Vincenzo, Bonato, Giulia, Cristoferi, Laura, Malinverno, Federica, Gerussi, Alessio, Stocken, Deborah D, Cordell, Heather J, Hirschfield, Gideon M, Alexander, Graeme J, Sandford, Richard N, Jones, David E, Invernizzi, Pietro, Mells, George F, Thomas, Caradog, Rahman, Meshbah, Yapp, Tom, Lye Ch'ng, Chin, Harrison, Melanie, Sturgess, Richard, Galaska, Roman, Healey, Chris, Whiteman, Jessica, Czaijkowski, Marek, Gray, Catherine, Gunasekera, Anton, Gyawli, Pranab, Premchand, Purushothaman, Mann, Steven, Elliott, Keith, Kapur, Kapil, Watson, Alan, Foster, Graham, Trembling, Paul, Subhani, Javaid, Harvey, Rory, McCorry, Roger, Adgey, Carolyn, Hobson, Lucie, Mulvaney-Jones, Caroline, Evans, Richard, Mathialahan, Thiriloganathan, Ramanaden, David, Gasem, Jaber, Van Duyvenvoorde, Greta, Shorrock, Christopher, Seward, Katie, Southern, Paul, Tibble, Jeremy, Penn, Ruth, Gorard, David, Maiden, Jane, Damant, Rose, Palegwala, Altaf, Jones, Susan, Alexander, Graeme, Mells, George, Sandford, Richard, Dolwani, Sunil, Prince, Martin, Silvestre, Valeria, Foxton, Matthew, Dungca, Eleanor, Mitchison, Harriet, Wheatley, Natalie, Gooding, Ian, Doyle, Helen, Karmo, Mazn, Kent, Melanie, Saksena, Sushma, Braim, Delyth, Patel, Minesh, Lord, Susan, Ede, Roland, Paton, Alison, Austin, Andrew, Lancaster, Nicola, Sayer, Joanna, Gibbins, Andrew, Hogben, Karen, Hovell, Chris, Fisher, Neil, Carter, Martyn, Koss, Konrad, Musselwhite, Janine, Muscariu, Florin, Piotreowicz, Andrzej, McKay, Alexandra, Grimley, Charles, Neal, David, Ting Tan, Lai, Lim, Guan, Brighton, Jacqueline, Foale, Carole, Ala, Aftab, Saeed, Athar, Flahive, Kerry, Wood, Gordon, Townshend, Paula, Ford, Chris, Brown, Jonathan, Kordula, Jean, Bowles, Jane, Wilkinson, Mark, Palmer, Caroline, Ramage, John, Gordon, Harriet, Featherstone, James, Ridpath, Jo, Ngatchu, Theodore, Levi, Sass, Shaukat, Syed, Sadeghian, Joy, Shidrawi, Ray, Williams, Bronwen, Abouda, George, Jones, Sarah, Duggan, Claire, Hynes, Abigail, Narain, Mark, Rees, Ian, Salam, Imroz, Crossey, Mary, Brown, Ashley, MacNicol, Carolyn, Williams, Simon, Wilhelmsen, Elva, Banim, Paul, Raymode, Parizade, Chilton, Andrew, Das, Debasish, Lee, Hye-Jeong, Curtis, Howard, Heneghan, Michael, Gess, Markus, Durant, Emma, Drake, I. M., Bishop, Rebecca, Davies, Mervyn, Aldersley, Mark, Ncube, Noma, McNair, Alistair, Srirajaskanthan, Raj, Sen, Sambit, Casey, Rebecca, Bird, George, Mendall, Mike, Cowley, Caroline, Barnardo, Adrian, Kitchen, Paul, Yoong, Kevin, Amore, Kelly, Sirdefield, Dawn, Orpe, Jacky, Mathew, Ray, MacFaul, George, Wrigth, Aruna, Shah, Amir, Evans, Chris, Keggans, Janie, Bird, Bridget, Baxter, Gwen, Saha, Subrata, Pollock, Katharine, Hughes, Maggie, Bramley, Peter, Grieve, Emma, Young, Karin, Fraser, Andrew, Mukhopadhya, Ashis, Ocker, Kate, Mills, Peter, Hines, Francis, Shallcross, Chris, Wilkins, Joy, Grellier, Leonie, Campbell, Stewart, Martin, Kirsty, Innes, Caron, Shepherd, Alan, Rushbrook, Simon, Valliani, Talal, Przemioslo, Robert, Fairlamb, Helen, Macdonald, Chris, Eastick, Anne, Metcalf, Jane, Tanqueray, Elizabeth, Shmueli, Udi, Holbrook, Becky, Davis, Andrew, Browning, Julie, Naqvi, Asifabbas, Walker, Kirsten, Lee, Tom, Verheyden, Juliette, Slininger, Susan, Ryder, Stephen D, Chapman, Roger, Collier, Jane, O'Donnell, Denise, Stafford, Lizzie, Williamson, Kate, Kent, Linda, Klass, Howard, Ninkovic, Mary, March, Linda, Cramp, Matthew, Simpson, Diane, Dickson, Christine, Sharer, Nicholas, Hayes, Maria, Goggin, Patrick, Quinne, Mary, Pearson, Sallyanne, Hoeroldt, Barbara, Jones, Linda, Wright, Alice, Booth, Jonathan, Loftus, Alison, Lipscomb, George, Dewhurst, Hannah, Gunter, Emma, Williams, Earl, Fouracres, Anna, Farrington, Liz, Graves, Lyn, Hussaini, Hyder, Stableforth, Bill, Marriott, Suzie, Ayres, Reuben, Leoni, Marina, Burroughs, Andrew, Marshall, Eileen, Tyrer, David, Martin, Kate, Lombard, Martin, Patanwala, Imran, Dali-Kemmery, Lola, Lambourne, Victoria, Maltby, Julia, Vyas, Samir, Colley, Julie, Shinder, Bal, Singhal, Saket, Jones, Jayne, Mills, Marisa, Gleeson, Dermot, Carnahan, Mandy, Butterworth, Jeff, Boulton, Kerenza, Taylor, Natalie, George, Keith, Harding, Tim, Tregonning, Julie, Douglass, Andrew, Brown, Carly, Clifford, Gayle, Panter, Simon, Gocher, Denise, Shearman, Jeremy, Bray, Gary, Hamilton, Maria, Butcher, Graham, Forton, Daniel, Mclindon, John, Curtis, Janette, Das, Debashis, Shewan, Tracey, Cowan, Matthew, Whatley, Gregory, Nasseri, Mariam, Grover, Bob, Sivaramakrishnan, Nurani, Ducker, Samantha, Houghton, Kathryn, Jones, David, Griffiths, Laura, Tripoli, Sherill, Pitcher, Maxton, Shpuza, Ervin, White, Nikki, Ghosh, Deb, Douds, Andrew, Green, Marie, Brookes, Matthew, Cumlat, Lourdes, Wong, Voi Shim, Warner, Karen, Netherton, Kimberley, Mandal, Adtya, Jain, Snjiv, Gupta, Hemant, Sanghi, Pradeep, Pereira, Steve, Neuberger, James, Gunson, Bridget, Hirschfield, Gideon, Lim, Reina Teegan, Gallagher, Susan, Clement, Darren, Brind, Alison, Watts, Gill, Mupudzi, Mcdonald, Wright, Mark, Gitahi, Jane, Gordon, Fiona, Gocher, Denis, Unitt, Esther, Pateman, Hilary, Batham, Sally, Delahooke, Toby, Grant, Allister, Conder, Jill, Higham, Andrew, Cox, Mark, O'Donohoe, Lynn, Currie, Lynn, King, Alistair, Oblak, Metod, Collins, Carole, Whalley, Simon, Quinn, Marie, Baird, Yolanda, Amey, Isobel, Fraser, Jocelyn, Li, Andy, Cotterill, Donna, Bell, Andrew, Singhal, Amit, Gee, Ian, Greer, Sandra, Ang, Yeng, Ransford, Rupert, Allison, Joanna, Gotto, James, Dyer, Simon, Sweeting, Helen, Millson, Charles, Labbadia, Giancarlo, Bragazzi, Maria Consiglia, Andreone, Pietro, Azzaroli, Francesco, Galli, Andrea, Tarocchi, Mirko, Gasbarrini, Antonio, GRIECO, ANTONIO, Marrone, Giuseppe, Donato, Maria Francesca, Valenti, Luca, Maroni, Luca, Rigamonti, Cristina, and Picciotto, Antonino
Abstract: Background: Treatment guidelines recommend a stepwise approach to primary biliary cholangitis: all patients begin treatment with ursodeoxycholic acid (UDCA) monotherapy and those with an inadequate biochemical response after 12 months are subsequently considered for second-line therapies. However, as a result, patients at the highest risk can wait the longest for effective treatment. We determined whether UDCA response can be accurately predicted using pretreatment clinical parameters. Methods: We did logistic regression analysis of pretreatment variables in a discovery cohort of patients in the UK with primary biliary cholangitis to derive the best-fitting model of UDCA response, defined as alkaline phosphatase less than 1·67 times the upper limit of normal (ULN), measured after 12 months of treatment with UDCA. We validated the model in an external cohort of patients with primary biliary cholangitis and treated with UDCA in Italy. Additionally, we assessed correlations between model predictions and key histological features, such as biliary injury and fibrosis, on liver biopsy samples. Findings: 2703 participants diagnosed with primary biliary cholangitis between Jan 1, 1998, and May 31, 2015, were included in the UK-PBC cohort for derivation of the model. The following pretreatment parameters were associated with lower probability of UDCA response: higher alkaline phosphatase concentration (p<0·0001), higher total bilirubin concentration (p=0·0003), lower aminotransferase concentration (p=0·0012), younger age (p<0·0001), longer interval from diagnosis to the start of UDCA treatment (treatment time lag, p<0·0001), and worsening of alkaline phosphatase concentration from diagnosis (p<0·0001). Based on these variables, we derived a predictive score of UDCA response. In the external validation cohort, 460 patients diagnosed with primary biliary cholangitis were treated with UDCA, with follow-up data until May 31, 2016. In this validation cohort, the area under the re
Published: 2018

17. Prevalent use of Combined Prophylaxis of Hepatitis B after liver transplantation in Italy: Results of a national survey in a large cohort

Author: Marzano, A, Andreone, P, Boccagni, P, Burra, P, Caneschi, F, Conoscitore, P, Coppola, C, De Carlis, L, Fagiuoli, S, Forte, P, Gaeta, G, Iemmolo, R, Suffredini, A, Mazzola, M, Merli, M, Parrilli, G, Piai, G, Piras, M, Salizzoni, M, Tamè, M, Tisone, G, Toniutto, P, Vennarecci, G, Volpes, R, Zamboni, F, Caccamo, L, Bertuzzo, V, Bongiovanni, A, Brin-Dicci, G, Cocchis, D, Ettorre, G, Gianni, E, Giusto, M, Lenisa, I, Lucà, M, Mameli, L, Mangoni, I, Manini, M, Paoli, S, Russo, F, Staiano, L, Stornaiuolo, G, Toti, L, Valente, G, Vukotic, R, Marzano, Alfredo, Andreone, Pietro, Boccagni, Patrizia, Burra, Patrizia, Caneschi, Francesco, Conoscitore, Pasquale F., Coppola, Carmine, De Carlis, Luciano, Fagiuoli, Stefano, Forte, Paolo, Gaeta, Giovanni B., Iemmolo, Rosa M., Suffredini, Anna Lotti, Mazzola, Michele, Merli, Manuela, Parrilli, Gianpaolo, Piai, Guido, Piras, Maria R., Salizzoni, Mauro, Tamè, Mariarosa, Tisone, Giuseppe, Toniutto, Pierluigi, Vennarecci, Giovanni, Volpes, Riccardo, Zamboni, Fausto, Caccamo, Lucio, Bertuzzo, Valentina R., Bongiovanni, Assunta S., Brin-Dicci, Gaetano, Cocchis, Donatella, Ettorre, Giuseppe M., Gianni, Elena, Giusto, Michela, Lenisa, Ilaria, Lucà, Maria G., Mameli, Laura, Mangoni, Iacopo, Manini, Matteo A., Paoli, Serena, Russo, Francesco P., Staiano, Laura, Stornaiuolo, Gianfranca, Toti, Luca, Valente, Giovanna, Vukotic, Ranka, Marzano, A, Andreone, P, Boccagni, P, Burra, P, Caneschi, F, Conoscitore, P, Coppola, C, De Carlis, L, Fagiuoli, S, Forte, P, Gaeta, G, Iemmolo, R, Suffredini, A, Mazzola, M, Merli, M, Parrilli, G, Piai, G, Piras, M, Salizzoni, M, Tamè, M, Tisone, G, Toniutto, P, Vennarecci, G, Volpes, R, Zamboni, F, Caccamo, L, Bertuzzo, V, Bongiovanni, A, Brin-Dicci, G, Cocchis, D, Ettorre, G, Gianni, E, Giusto, M, Lenisa, I, Lucà, M, Mameli, L, Mangoni, I, Manini, M, Paoli, S, Russo, F, Staiano, L, Stornaiuolo, G, Toti, L, Valente, G, Vukotic, R, Marzano, Alfredo, Andreone, Pietro, Boccagni, Patrizia, Burra, Patrizia, Caneschi, Francesco, Conoscitore, Pasquale F., Coppola, Carmine, De Carlis, Luciano, Fagiuoli, Stefano, Forte, Paolo, Gaeta, Giovanni B., Iemmolo, Rosa M., Suffredini, Anna Lotti, Mazzola, Michele, Merli, Manuela, Parrilli, Gianpaolo, Piai, Guido, Piras, Maria R., Salizzoni, Mauro, Tamè, Mariarosa, Tisone, Giuseppe, Toniutto, Pierluigi, Vennarecci, Giovanni, Volpes, Riccardo, Zamboni, Fausto, Caccamo, Lucio, Bertuzzo, Valentina R., Bongiovanni, Assunta S., Brin-Dicci, Gaetano, Cocchis, Donatella, Ettorre, Giuseppe M., Gianni, Elena, Giusto, Michela, Lenisa, Ilaria, Lucà, Maria G., Mameli, Laura, Mangoni, Iacopo, Manini, Matteo A., Paoli, Serena, Russo, Francesco P., Staiano, Laura, Stornaiuolo, Gianfranca, Toti, Luca, Valente, Giovanna, and Vukotic, Ranka
Abstract: BACKGROUND: Prophylaxis of hepatitis B after liver transplantation with antiviral(s) and immunoglobulins effciently protect the majority of recipients; however recent experiences suggest a decline of HBsag-positive candidates and the use of hepatitis B immunoglobulin-free schedules. MetHoDs: this national survey evaluated the epidemiology and clinical results of hepatitis B prophylaxis among 10,365 liver transplants performed in 25 years in 13 italian centers. RESULTS: With a percentage of 22, 2260 procedures were performed in HBsAg-positive recipients and 714 out of 1080 anti-HBc-positive grafts were used in HBsag-negative recipients; a total of 2974 patients (29%) were considered at risk of hepatitis B after liver transplantation. similar rates (18% of HBsag-positive candidates and 15% of anti-HBc-positive grafts) were registered in the last collected year. combined prophylaxis with Hepatitis B immunoglobulins remained prevalent among centers and was effective in 96% of HBsag-positive recipients and in 94% of HBsag-negative recipients of anti-HBc-positive grafts. CONCLUSIONS: Data from this survey confrm: the excellent results of combined prophylaxis; the past and persistent use of Hepatitis B immunoglobulin-on and only rare-off prophylactic regimens, in contrast with the newest reports; the increasing use of anti-HBc-positive grafts; the past and present high prevalence of HBsag-positive recipients, due to an increase in candidates with either hepatocellular carcinoma and Hepatitis Delta Virus coinfection in the last years
Published: 2018

18. Pretreatment prediction of response to ursodeoxycholic acid in primary biliary cholangitis: development and validation of the UDCA Response Score

Author: Carbone, Marco, Nardi, Alessandra, Flack, Steve, Carpino, Guido, Varvaropoulou, Nikoletta, Gavrila, Caiu, Spicer, Ann, Badrock, Jonathan, Bernuzzi, Francesca, Cardinale, Vincenzo, Ainsworth, Holly F, Heneghan, Michael A, Thorburn, Dougla, Bathgate, Andrew, Jones, Rebecca, Neuberger, James M, Battezzati, Pier Maria, Zuin, Massimo, Taylor-Robinson, Simon, Donato, Maria F, Kirby, John, Mitchell-Thain, Robert, Floreani, Annarosa, Sampaziotis, Fotio, Muratori, Luigi, Alvaro, Domenico, Marzioni, Marco, Miele, Luca, Marra, Fabio, Giannini, Edoardo, Gaudio, Eugenio, Ronca, Vincenzo, Bonato, Giulia, Cristoferi, Laura, Malinverno, Federica, Gerussi, Alessio, Stocken, Deborah D, Cordell, Heather J, Hirschfield, Gideon M, Alexander, Graeme J, Sandford, Richard N, Jones, David E, Invernizzi, Pietro, Mells, George F, Thomas, Caradog, Rahman, Meshbah, Yapp, Tom, Lye Ch'ng, Chin, Harrison, Melanie, Sturgess, Richard, Galaska, Roman, Healey, Chri, Whiteman, Jessica, Czaijkowski, Marek, Gray, Catherine, Gunasekera, Anton, Gyawli, Pranab, Premchand, Purushothaman, Mann, Steven, Elliott, Keith, Kapur, Kapil, Watson, Alan, Foster, Graham, Trembling, Paul, Subhani, Javaid, Harvey, Rory, Mccorry, Roger, Adgey, Carolyn, Hobson, Lucie, Mulvaney-Jones, Caroline, Evans, Richard, Mathialahan, Thiriloganathan, Ramanaden, David, Gasem, Jaber, Van Duyvenvoorde, Greta, Shorrock, Christopher, Seward, Katie, Southern, Paul, Tibble, Jeremy, Penn, Ruth, Gorard, David, Maiden, Jane, Damant, Rose, Palegwala, Altaf, Jones, Susan, Alexander, Graeme, Mells, George, Sandford, Richard, Dolwani, Sunil, Prince, Martin, Silvestre, Valeria, Foxton, Matthew, Dungca, Eleanor, Mitchison, Harriet, Wheatley, Natalie, Gooding, Ian, Doyle, Helen, Karmo, Mazn, Kent, Melanie, Saksena, Sushma, Braim, Delyth, Patel, Minesh, Lord, Susan, Ede, Roland, Paton, Alison, Austin, Andrew, Lancaster, Nicola, Sayer, Joanna, Gibbins, Andrew, Hogben, Karen, Hovell, Chri, Fisher, Neil, Carter, Martyn, Koss, Konrad, Musselwhite, Janine, Muscariu, Florin, Piotreowicz, Andrzej, Mckay, Alexandra, Grimley, Charle, Neal, David, Ting Tan, Lai, Lim, Guan, Brighton, Jacqueline, Foale, Carole, Ala, Aftab, Saeed, Athar, Flahive, Kerry, Wood, Gordon, Townshend, Paula, Ford, Chri, Brown, Jonathan, Kordula, Jean, Bowles, Jane, Wilkinson, Mark, Palmer, Caroline, Ramage, John, Gordon, Harriet, Featherstone, Jame, Ridpath, Jo, Ngatchu, Theodore, Levi, Sa, Shaukat, Syed, Sadeghian, Joy, Shidrawi, Ray, Williams, Bronwen, Abouda, George, Jones, Sarah, Duggan, Claire, Hynes, Abigail, Narain, Mark, Rees, Ian, Salam, Imroz, Crossey, Mary, Brown, Ashley, Macnicol, Carolyn, Williams, Simon, Wilhelmsen, Elva, Banim, Paul, Raymode, Parizade, Chilton, Andrew, Das, Debasish, Lee, Hye-Jeong, Curtis, Howard, Heneghan, Michael, Gess, Marku, Durant, Emma, Drake, I. M., Bishop, Rebecca, Davies, Mervyn, Aldersley, Mark, Ncube, Noma, Mcnair, Alistair, Srirajaskanthan, Raj, Sen, Sambit, Casey, Rebecca, Bird, George, Mendall, Mike, Cowley, Caroline, Barnardo, Adrian, Kitchen, Paul, Yoong, Kevin, Amore, Kelly, Sirdefield, Dawn, Orpe, Jacky, Mathew, Ray, Macfaul, George, Wrigth, Aruna, Shah, Amir, Evans, Chri, Keggans, Janie, Bird, Bridget, Baxter, Gwen, Saha, Subrata, Pollock, Katharine, Hughes, Maggie, Bramley, Peter, Grieve, Emma, Young, Karin, Fraser, Andrew, Mukhopadhya, Ashi, Ocker, Kate, Mills, Peter, Hines, Franci, Shallcross, Chri, Wilkins, Joy, Grellier, Leonie, Campbell, Stewart, Martin, Kirsty, Innes, Caron, Shepherd, Alan, Rushbrook, Simon, Valliani, Talal, Przemioslo, Robert, Fairlamb, Helen, Macdonald, Chri, Eastick, Anne, Metcalf, Jane, Tanqueray, Elizabeth, Shmueli, Udi, Holbrook, Becky, Davis, Andrew, Browning, Julie, Naqvi, Asifabba, Walker, Kirsten, Lee, Tom, Verheyden, Juliette, Slininger, Susan, Ryder, Stephen D, Chapman, Roger, Collier, Jane, O'Donnell, Denise, Stafford, Lizzie, Williamson, Kate, Kent, Linda, Klass, Howard, Ninkovic, Mary, March, Linda, Cramp, Matthew, Simpson, Diane, Dickson, Christine, Sharer, Nichola, Hayes, Maria, Goggin, Patrick, Quinne, Mary, Pearson, Sallyanne, Hoeroldt, Barbara, Jones, Linda, Wright, Alice, Booth, Jonathan, Loftus, Alison, Lipscomb, George, Dewhurst, Hannah, Gunter, Emma, Williams, Earl, Fouracres, Anna, Farrington, Liz, Graves, Lyn, Hussaini, Hyder, Stableforth, Bill, Marriott, Suzie, Ayres, Reuben, Leoni, Marina, Burroughs, Andrew, Marshall, Eileen, Tyrer, David, Martin, Kate, Lombard, Martin, Patanwala, Imran, Dali-Kemmery, Lola, Lambourne, Victoria, Maltby, Julia, Vyas, Samir, Colley, Julie, Shinder, Bal, Singhal, Saket, Jones, Jayne, Mills, Marisa, Gleeson, Dermot, Carnahan, Mandy, Butterworth, Jeff, Boulton, Kerenza, Taylor, Natalie, George, Keith, Harding, Tim, Tregonning, Julie, Douglass, Andrew, Brown, Carly, Clifford, Gayle, Panter, Simon, Gocher, Denise, Shearman, Jeremy, Bray, Gary, Hamilton, Maria, Butcher, Graham, Forton, Daniel, Mclindon, John, Curtis, Janette, Das, Debashi, Shewan, Tracey, Cowan, Matthew, Whatley, Gregory, Nasseri, Mariam, Grover, Bob, Sivaramakrishnan, Nurani, Ducker, Samantha, Houghton, Kathryn, Jones, David, Griffiths, Laura, Tripoli, Sherill, Pitcher, Maxton, Shpuza, Ervin, White, Nikki, Ghosh, Deb, Douds, Andrew, Green, Marie, Brookes, Matthew, Cumlat, Lourde, Wong, Voi Shim, Warner, Karen, Netherton, Kimberley, Mandal, Adtya, Jain, Snjiv, Gupta, Hemant, Sanghi, Pradeep, Pereira, Steve, Neuberger, Jame, Gunson, Bridget, Hirschfield, Gideon, Lim, Reina Teegan, Gallagher, Susan, Clement, Darren, Brind, Alison, Watts, Gill, Mupudzi, Mcdonald, Wright, Mark, Gitahi, Jane, Gordon, Fiona, Gocher, Deni, Unitt, Esther, Pateman, Hilary, Batham, Sally, Delahooke, Toby, Grant, Allister, Conder, Jill, Higham, Andrew, Cox, Mark, O'Donohoe, Lynn, Currie, Lynn, King, Alistair, Oblak, Metod, Collins, Carole, Whalley, Simon, Quinn, Marie, Baird, Yolanda, Amey, Isobel, Fraser, Jocelyn, Li, Andy, Cotterill, Donna, Bell, Andrew, Singhal, Amit, Gee, Ian, Greer, Sandra, Ang, Yeng, Ransford, Rupert, Allison, Joanna, Gotto, Jame, Dyer, Simon, Sweeting, Helen, Millson, Charle, Labbadia, Giancarlo, Bragazzi, Maria Consiglia, Andreone, Pietro, Azzaroli, Francesco, Galli, Andrea, Tarocchi, Mirko, Gasbarrini, Antonio, Grieco, Antonio, Marrone, Giuseppe, Donato, Maria Francesca, Valenti, Luca, Maroni, Luca, Rigamonti, Cristina, Picciotto, Antonino, Miele, Luca (ORCID:0000-0003-3464-0068), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Grieco, Antonio (ORCID:0000-0002-0544-8993), Carbone, Marco, Nardi, Alessandra, Flack, Steve, Carpino, Guido, Varvaropoulou, Nikoletta, Gavrila, Caiu, Spicer, Ann, Badrock, Jonathan, Bernuzzi, Francesca, Cardinale, Vincenzo, Ainsworth, Holly F, Heneghan, Michael A, Thorburn, Dougla, Bathgate, Andrew, Jones, Rebecca, Neuberger, James M, Battezzati, Pier Maria, Zuin, Massimo, Taylor-Robinson, Simon, Donato, Maria F, Kirby, John, Mitchell-Thain, Robert, Floreani, Annarosa, Sampaziotis, Fotio, Muratori, Luigi, Alvaro, Domenico, Marzioni, Marco, Miele, Luca, Marra, Fabio, Giannini, Edoardo, Gaudio, Eugenio, Ronca, Vincenzo, Bonato, Giulia, Cristoferi, Laura, Malinverno, Federica, Gerussi, Alessio, Stocken, Deborah D, Cordell, Heather J, Hirschfield, Gideon M, Alexander, Graeme J, Sandford, Richard N, Jones, David E, Invernizzi, Pietro, Mells, George F, Thomas, Caradog, Rahman, Meshbah, Yapp, Tom, Lye Ch'ng, Chin, Harrison, Melanie, Sturgess, Richard, Galaska, Roman, Healey, Chri, Whiteman, Jessica, Czaijkowski, Marek, Gray, Catherine, Gunasekera, Anton, Gyawli, Pranab, Premchand, Purushothaman, Mann, Steven, Elliott, Keith, Kapur, Kapil, Watson, Alan, Foster, Graham, Trembling, Paul, Subhani, Javaid, Harvey, Rory, Mccorry, Roger, Adgey, Carolyn, Hobson, Lucie, Mulvaney-Jones, Caroline, Evans, Richard, Mathialahan, Thiriloganathan, Ramanaden, David, Gasem, Jaber, Van Duyvenvoorde, Greta, Shorrock, Christopher, Seward, Katie, Southern, Paul, Tibble, Jeremy, Penn, Ruth, Gorard, David, Maiden, Jane, Damant, Rose, Palegwala, Altaf, Jones, Susan, Alexander, Graeme, Mells, George, Sandford, Richard, Dolwani, Sunil, Prince, Martin, Silvestre, Valeria, Foxton, Matthew, Dungca, Eleanor, Mitchison, Harriet, Wheatley, Natalie, Gooding, Ian, Doyle, Helen, Karmo, Mazn, Kent, Melanie, Saksena, Sushma, Braim, Delyth, Patel, Minesh, Lord, Susan, Ede, Roland, Paton, Alison, Austin, Andrew, Lancaster, Nicola, Sayer, Joanna, Gibbins, Andrew, Hogben, Karen, Hovell, Chri, Fisher, Neil, Carter, Martyn, Koss, Konrad, Musselwhite, Janine, Muscariu, Florin, Piotreowicz, Andrzej, Mckay, Alexandra, Grimley, Charle, Neal, David, Ting Tan, Lai, Lim, Guan, Brighton, Jacqueline, Foale, Carole, Ala, Aftab, Saeed, Athar, Flahive, Kerry, Wood, Gordon, Townshend, Paula, Ford, Chri, Brown, Jonathan, Kordula, Jean, Bowles, Jane, Wilkinson, Mark, Palmer, Caroline, Ramage, John, Gordon, Harriet, Featherstone, Jame, Ridpath, Jo, Ngatchu, Theodore, Levi, Sa, Shaukat, Syed, Sadeghian, Joy, Shidrawi, Ray, Williams, Bronwen, Abouda, George, Jones, Sarah, Duggan, Claire, Hynes, Abigail, Narain, Mark, Rees, Ian, Salam, Imroz, Crossey, Mary, Brown, Ashley, Macnicol, Carolyn, Williams, Simon, Wilhelmsen, Elva, Banim, Paul, Raymode, Parizade, Chilton, Andrew, Das, Debasish, Lee, Hye-Jeong, Curtis, Howard, Heneghan, Michael, Gess, Marku, Durant, Emma, Drake, I. M., Bishop, Rebecca, Davies, Mervyn, Aldersley, Mark, Ncube, Noma, Mcnair, Alistair, Srirajaskanthan, Raj, Sen, Sambit, Casey, Rebecca, Bird, George, Mendall, Mike, Cowley, Caroline, Barnardo, Adrian, Kitchen, Paul, Yoong, Kevin, Amore, Kelly, Sirdefield, Dawn, Orpe, Jacky, Mathew, Ray, Macfaul, George, Wrigth, Aruna, Shah, Amir, Evans, Chri, Keggans, Janie, Bird, Bridget, Baxter, Gwen, Saha, Subrata, Pollock, Katharine, Hughes, Maggie, Bramley, Peter, Grieve, Emma, Young, Karin, Fraser, Andrew, Mukhopadhya, Ashi, Ocker, Kate, Mills, Peter, Hines, Franci, Shallcross, Chri, Wilkins, Joy, Grellier, Leonie, Campbell, Stewart, Martin, Kirsty, Innes, Caron, Shepherd, Alan, Rushbrook, Simon, Valliani, Talal, Przemioslo, Robert, Fairlamb, Helen, Macdonald, Chri, Eastick, Anne, Metcalf, Jane, Tanqueray, Elizabeth, Shmueli, Udi, Holbrook, Becky, Davis, Andrew, Browning, Julie, Naqvi, Asifabba, Walker, Kirsten, Lee, Tom, Verheyden, Juliette, Slininger, Susan, Ryder, Stephen D, Chapman, Roger, Collier, Jane, O'Donnell, Denise, Stafford, Lizzie, Williamson, Kate, Kent, Linda, Klass, Howard, Ninkovic, Mary, March, Linda, Cramp, Matthew, Simpson, Diane, Dickson, Christine, Sharer, Nichola, Hayes, Maria, Goggin, Patrick, Quinne, Mary, Pearson, Sallyanne, Hoeroldt, Barbara, Jones, Linda, Wright, Alice, Booth, Jonathan, Loftus, Alison, Lipscomb, George, Dewhurst, Hannah, Gunter, Emma, Williams, Earl, Fouracres, Anna, Farrington, Liz, Graves, Lyn, Hussaini, Hyder, Stableforth, Bill, Marriott, Suzie, Ayres, Reuben, Leoni, Marina, Burroughs, Andrew, Marshall, Eileen, Tyrer, David, Martin, Kate, Lombard, Martin, Patanwala, Imran, Dali-Kemmery, Lola, Lambourne, Victoria, Maltby, Julia, Vyas, Samir, Colley, Julie, Shinder, Bal, Singhal, Saket, Jones, Jayne, Mills, Marisa, Gleeson, Dermot, Carnahan, Mandy, Butterworth, Jeff, Boulton, Kerenza, Taylor, Natalie, George, Keith, Harding, Tim, Tregonning, Julie, Douglass, Andrew, Brown, Carly, Clifford, Gayle, Panter, Simon, Gocher, Denise, Shearman, Jeremy, Bray, Gary, Hamilton, Maria, Butcher, Graham, Forton, Daniel, Mclindon, John, Curtis, Janette, Das, Debashi, Shewan, Tracey, Cowan, Matthew, Whatley, Gregory, Nasseri, Mariam, Grover, Bob, Sivaramakrishnan, Nurani, Ducker, Samantha, Houghton, Kathryn, Jones, David, Griffiths, Laura, Tripoli, Sherill, Pitcher, Maxton, Shpuza, Ervin, White, Nikki, Ghosh, Deb, Douds, Andrew, Green, Marie, Brookes, Matthew, Cumlat, Lourde, Wong, Voi Shim, Warner, Karen, Netherton, Kimberley, Mandal, Adtya, Jain, Snjiv, Gupta, Hemant, Sanghi, Pradeep, Pereira, Steve, Neuberger, Jame, Gunson, Bridget, Hirschfield, Gideon, Lim, Reina Teegan, Gallagher, Susan, Clement, Darren, Brind, Alison, Watts, Gill, Mupudzi, Mcdonald, Wright, Mark, Gitahi, Jane, Gordon, Fiona, Gocher, Deni, Unitt, Esther, Pateman, Hilary, Batham, Sally, Delahooke, Toby, Grant, Allister, Conder, Jill, Higham, Andrew, Cox, Mark, O'Donohoe, Lynn, Currie, Lynn, King, Alistair, Oblak, Metod, Collins, Carole, Whalley, Simon, Quinn, Marie, Baird, Yolanda, Amey, Isobel, Fraser, Jocelyn, Li, Andy, Cotterill, Donna, Bell, Andrew, Singhal, Amit, Gee, Ian, Greer, Sandra, Ang, Yeng, Ransford, Rupert, Allison, Joanna, Gotto, Jame, Dyer, Simon, Sweeting, Helen, Millson, Charle, Labbadia, Giancarlo, Bragazzi, Maria Consiglia, Andreone, Pietro, Azzaroli, Francesco, Galli, Andrea, Tarocchi, Mirko, Gasbarrini, Antonio, Grieco, Antonio, Marrone, Giuseppe, Donato, Maria Francesca, Valenti, Luca, Maroni, Luca, Rigamonti, Cristina, Picciotto, Antonino, Miele, Luca (ORCID:0000-0003-3464-0068), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), and Grieco, Antonio (ORCID:0000-0002-0544-8993)
Abstract: Background: Treatment guidelines recommend a stepwise approach to primary biliary cholangitis: all patients begin treatment with ursodeoxycholic acid (UDCA) monotherapy and those with an inadequate biochemical response after 12 months are subsequently considered for second-line therapies. However, as a result, patients at the highest risk can wait the longest for effective treatment. We determined whether UDCA response can be accurately predicted using pretreatment clinical parameters. Methods: We did logistic regression analysis of pretreatment variables in a discovery cohort of patients in the UK with primary biliary cholangitis to derive the best-fitting model of UDCA response, defined as alkaline phosphatase less than 1·67 times the upper limit of normal (ULN), measured after 12 months of treatment with UDCA. We validated the model in an external cohort of patients with primary biliary cholangitis and treated with UDCA in Italy. Additionally, we assessed correlations between model predictions and key histological features, such as biliary injury and fibrosis, on liver biopsy samples. Findings: 2703 participants diagnosed with primary biliary cholangitis between Jan 1, 1998, and May 31, 2015, were included in the UK-PBC cohort for derivation of the model. The following pretreatment parameters were associated with lower probability of UDCA response: higher alkaline phosphatase concentration (p<0·0001), higher total bilirubin concentration (p=0·0003), lower aminotransferase concentration (p=0·0012), younger age (p<0·0001), longer interval from diagnosis to the start of UDCA treatment (treatment time lag, p<0·0001), and worsening of alkaline phosphatase concentration from diagnosis (p<0·0001). Based on these variables, we derived a predictive score of UDCA response. In the external validation cohort, 460 patients diagnosed with primary biliary cholangitis were treated with UDCA, with follow-up data until May 31, 2016. In this validation cohort, the area under the re
Published: 2018

19. Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

Author: Ascione, Antonio, De Luca, Massimo, Melazzini, Mario, Montilla, Simona, Trotta, Maria Paola, Petta, Salvatore, Puoti, Massimo, Sangiovanni, Vincenzo, Messina, Vincenzo, Bruno, Savino, Izzi, Antonio, Villa, Erica, Aghemo, Alessio, Zignego, Anna Linda, Orlandini, Alessandra, Fontanella, Luca, Gasbarrini, Antonio, Marzioni, Marco, Giannini, Edoardo G., Craxì, Antonio, Abbati, Giuseppe, Alberti, Alfredo, Andreone, Pietro, Andreoni, Massimo, Angeli, Paolo, Angelico, Mario, Angarano, Gioacchino, Angrisani, Debora, Antinori, Andrea, Antonini, Cinzia, Avancini, Ivo, Barone, Michele, Bruno, Raffaele, Benedetti, Antonio, Bernabucci, Veronica, Blanc, Pier, Boarini, Chiara, Boffa, Nicola, Boglione, Lucio, Borghi, Vanni, Borgia, Guglielmo, Brancaccio, Giuseppina, Brunetto, Maurizia, Cacciola, Irene, Calabrese, Paolo, Calvaruso, Vincenza, Campagnolo, Davide, Canovari, Benedetta, Caporaso, Nicola, Capra, Franco, Carolo, Giada, Cassola, Giovanni, Castelli, Francesco, Cauda, Roberto, Silberstein, Francesca Ceccherini, Cecere, Roberto, Chessa, Luchino, Chiodera, Alessandro, Chirianni, Antonio, Ciancio, Alessia, Cima, Serena, Coco, Barbara, Colombo, Massimo, Coppola, Nicola, Corti, Giampaolo, Cosco, Lucio, Corradori, Silvia, Cozzolongo, Raffaele, Cristaudo, Antonio, Danieli, Elena, Monforte, Antonella D’Arminio, Monache, Marco delle, Del Poggio, Paolo, de Luca, Andrea, Dentone, Chiara, Di Biagio, Antonio, Di Leo, Alfredo, Di Perri, Giovanni, Di Stefano, Marco, D’Offizi, Giampiero, Donato, Francesca, Durante, Emanuele, Erne, Elke, Fagiuoli, Stefano, Falasca, Katia, Federico, Alessandro, Felder, Martina, Ferrari, Carlo, Gaeta, Giovanni Battista, Ganga, Roberto, Gatti, Pietro, Giacomet, Vania, Giacometti, Andrea, Gianstefani, Alice, Giordani, Maria, Giorgini, Alessia, Grieco, Antonio, Guerra, Michele, Gulminetti, Roberto, Ieluzzi, Donatella, Imparato, Michele, Iodice, Valentina, La Monica, Silvia, Lazzarin, Adriano, Lenzi, Marco, Levrero, Massimo, Lichtner, Myriam, Lionetti, Raffaella, Guercio, Carmela Lo, Madonna, Salvatore, Magnani, Silvia, Maida, Ivana, Marignani, Massimo, Marrone, Aldo, Marsetti, Fabio, Martini, Silvia, Masarone, Mario, Maserati, Renato, Mastroianni, Claudio Maria, Memoli, Massimo, Menzaghi, Barbara, Merli, Manuela, Miele, Luca, Milella, Michele, Mondelli, Mario, Montalbano, Marzia, Monti, Monica, Morelli, Olivia, Morisco, Filomena, Nardone, Gaetano, Novara, Sergio, Onnelli, Giovanna, Onofrio, Mirella, Paganin, Simona, Pani, Luca, Parisi, Maria Rita, Parruti, Giustino, Pasquazzi, Caterina, Pasulo, Luisa, Perno, Carlo Federico, Persico, Marcello, Piai, Guido, Picciotto, Antonino, Pigozzi, Grazielle Marie, Piovesan, Sara, Piras, Maria Chiara, Pirisi, Massimo, Piscaglia, Anna Maria, Ponti, Laura, Potenza, Domenico, Pravadelli, Cecilia, Quartini, Mariano, Quirino, Tiziana, Raimondo, Giovanni, Rapaccini, Gian Ludovico, Rendina, Maria, Rizzardini, Giuliano, Rizzetto, Mario, Rizzo, Salvatore, Romagnoli, Dante, Romano, Antonietta, Rossi, Cristina, Rumi, Maria Grazia, Russello, Maurizio, Russo, Francesca Paolo, Russo, Maria Luisa, Sansonno, Domenico Ettore, Santantonio, Teresa Antonia, Saracco, Giorgio, Schimizzi, Anna Maria, Serviddio, Gaetano, Simeone, Filomena, Solinas, Attilio, Soria, Alessandro, Tabone, Marco, Taliani, Gloria, Tarantino, Giuseppe, Tarquini, Pierluigi, Tavio, Marcello, Termite, Antonio, Teti, Elisabetta, Toniutto, Pierluigi, Torti, Carlo, Tundi, Paolo, Vecchiet, Giacomo, Verucchi, Gabriella, Gentilucci, Umberto Vespasiani, Vinci, Maria, Vullo, Vincenzo, Zolfino, Teresa, Zuin, Massimo, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Cauda, Roberto (ORCID:0000-0002-1498-4229), de Luca, Andrea (ORCID:0000-0002-8311-6935), Grieco, Antonio (ORCID:0000-0002-0544-8993), Miele, Luca (ORCID:0000-0003-3464-0068), Rapaccini, Gian Ludovico (ORCID:0000-0002-6467-857X), Ascione, Antonio, De Luca, Massimo, Melazzini, Mario, Montilla, Simona, Trotta, Maria Paola, Petta, Salvatore, Puoti, Massimo, Sangiovanni, Vincenzo, Messina, Vincenzo, Bruno, Savino, Izzi, Antonio, Villa, Erica, Aghemo, Alessio, Zignego, Anna Linda, Orlandini, Alessandra, Fontanella, Luca, Gasbarrini, Antonio, Marzioni, Marco, Giannini, Edoardo G., Craxì, Antonio, Abbati, Giuseppe, Alberti, Alfredo, Andreone, Pietro, Andreoni, Massimo, Angeli, Paolo, Angelico, Mario, Angarano, Gioacchino, Angrisani, Debora, Antinori, Andrea, Antonini, Cinzia, Avancini, Ivo, Barone, Michele, Bruno, Raffaele, Benedetti, Antonio, Bernabucci, Veronica, Blanc, Pier, Boarini, Chiara, Boffa, Nicola, Boglione, Lucio, Borghi, Vanni, Borgia, Guglielmo, Brancaccio, Giuseppina, Brunetto, Maurizia, Cacciola, Irene, Calabrese, Paolo, Calvaruso, Vincenza, Campagnolo, Davide, Canovari, Benedetta, Caporaso, Nicola, Capra, Franco, Carolo, Giada, Cassola, Giovanni, Castelli, Francesco, Cauda, Roberto, Silberstein, Francesca Ceccherini, Cecere, Roberto, Chessa, Luchino, Chiodera, Alessandro, Chirianni, Antonio, Ciancio, Alessia, Cima, Serena, Coco, Barbara, Colombo, Massimo, Coppola, Nicola, Corti, Giampaolo, Cosco, Lucio, Corradori, Silvia, Cozzolongo, Raffaele, Cristaudo, Antonio, Danieli, Elena, Monforte, Antonella D’Arminio, Monache, Marco delle, Del Poggio, Paolo, de Luca, Andrea, Dentone, Chiara, Di Biagio, Antonio, Di Leo, Alfredo, Di Perri, Giovanni, Di Stefano, Marco, D’Offizi, Giampiero, Donato, Francesca, Durante, Emanuele, Erne, Elke, Fagiuoli, Stefano, Falasca, Katia, Federico, Alessandro, Felder, Martina, Ferrari, Carlo, Gaeta, Giovanni Battista, Ganga, Roberto, Gatti, Pietro, Giacomet, Vania, Giacometti, Andrea, Gianstefani, Alice, Giordani, Maria, Giorgini, Alessia, Grieco, Antonio, Guerra, Michele, Gulminetti, Roberto, Ieluzzi, Donatella, Imparato, Michele, Iodice, Valentina, La Monica, Silvia, Lazzarin, Adriano, Lenzi, Marco, Levrero, Massimo, Lichtner, Myriam, Lionetti, Raffaella, Guercio, Carmela Lo, Madonna, Salvatore, Magnani, Silvia, Maida, Ivana, Marignani, Massimo, Marrone, Aldo, Marsetti, Fabio, Martini, Silvia, Masarone, Mario, Maserati, Renato, Mastroianni, Claudio Maria, Memoli, Massimo, Menzaghi, Barbara, Merli, Manuela, Miele, Luca, Milella, Michele, Mondelli, Mario, Montalbano, Marzia, Monti, Monica, Morelli, Olivia, Morisco, Filomena, Nardone, Gaetano, Novara, Sergio, Onnelli, Giovanna, Onofrio, Mirella, Paganin, Simona, Pani, Luca, Parisi, Maria Rita, Parruti, Giustino, Pasquazzi, Caterina, Pasulo, Luisa, Perno, Carlo Federico, Persico, Marcello, Piai, Guido, Picciotto, Antonino, Pigozzi, Grazielle Marie, Piovesan, Sara, Piras, Maria Chiara, Pirisi, Massimo, Piscaglia, Anna Maria, Ponti, Laura, Potenza, Domenico, Pravadelli, Cecilia, Quartini, Mariano, Quirino, Tiziana, Raimondo, Giovanni, Rapaccini, Gian Ludovico, Rendina, Maria, Rizzardini, Giuliano, Rizzetto, Mario, Rizzo, Salvatore, Romagnoli, Dante, Romano, Antonietta, Rossi, Cristina, Rumi, Maria Grazia, Russello, Maurizio, Russo, Francesca Paolo, Russo, Maria Luisa, Sansonno, Domenico Ettore, Santantonio, Teresa Antonia, Saracco, Giorgio, Schimizzi, Anna Maria, Serviddio, Gaetano, Simeone, Filomena, Solinas, Attilio, Soria, Alessandro, Tabone, Marco, Taliani, Gloria, Tarantino, Giuseppe, Tarquini, Pierluigi, Tavio, Marcello, Termite, Antonio, Teti, Elisabetta, Toniutto, Pierluigi, Torti, Carlo, Tundi, Paolo, Vecchiet, Giacomo, Verucchi, Gabriella, Gentilucci, Umberto Vespasiani, Vinci, Maria, Vullo, Vincenzo, Zolfino, Teresa, Zuin, Massimo, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Cauda, Roberto (ORCID:0000-0002-1498-4229), de Luca, Andrea (ORCID:0000-0002-8311-6935), Grieco, Antonio (ORCID:0000-0002-0544-8993), Miele, Luca (ORCID:0000-0003-3464-0068), and Rapaccini, Gian Ludovico (ORCID:0000-0002-6467-857X)
Abstract: Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.
Published: 2018

20. Real life experiences in HCV management in 2018

Author: 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, M, Raimondo, G, Rizzardini, Giuliano, Taliani, Gloria, Zignego, Anna Linda, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), 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, M, Raimondo, G, Rizzardini, Giuliano, Taliani, Gloria, Zignego, Anna Linda, and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)
Abstract: n/a
Published: 2018

21. Forecasting Hepatitis C liver disease burden on real-life data. Does the hidden iceberg matter to reach the elimination goals?

Author: Kondili, Loreta A., Robbins, Sarah, Blach, Sarah, Gamkrelidze, Ivane, Zignego, Anna L., Brunetto, Maurizia R., Raimondo, Giovanni, Taliani, Gloria, Iannone, Andrea, Russo, Francesco P., Santantonio, Teresa A., Zuin, Massimo, Chessa, Luchino, Blanc, Pierluigi, Puoti, Massimo, Vinci, Maria Rosaria, Erne, Elke M., Strazzabosco, Mario, Massari, Marco, Lampertico, Pietro, Rumi, Maria G., Federico, Alessandro, Orlandini, Alessandra, Ciancio, Alessia, Borgia, Guglielmo, Andreone, Pietro, Caporaso, Nicola, Persico, Marcello, Ieluzzi, Donatella, Madonia, Salvatore, Gori, Andrea, Gasbarrini, Antonio, Coppola, Carmine, Brancaccio, Giuseppina, Andriulli, Angelo, Quaranta, Maria G., Montilla, Simona, Razavi, Homie, Melazzini, Mario, Vella, Stefano, Craxì, Antonio, Vinci, Maria, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Kondili, Loreta A., Robbins, Sarah, Blach, Sarah, Gamkrelidze, Ivane, Zignego, Anna L., Brunetto, Maurizia R., Raimondo, Giovanni, Taliani, Gloria, Iannone, Andrea, Russo, Francesco P., Santantonio, Teresa A., Zuin, Massimo, Chessa, Luchino, Blanc, Pierluigi, Puoti, Massimo, Vinci, Maria Rosaria, Erne, Elke M., Strazzabosco, Mario, Massari, Marco, Lampertico, Pietro, Rumi, Maria G., Federico, Alessandro, Orlandini, Alessandra, Ciancio, Alessia, Borgia, Guglielmo, Andreone, Pietro, Caporaso, Nicola, Persico, Marcello, Ieluzzi, Donatella, Madonia, Salvatore, Gori, Andrea, Gasbarrini, Antonio, Coppola, Carmine, Brancaccio, Giuseppina, Andriulli, Angelo, Quaranta, Maria G., Montilla, Simona, Razavi, Homie, Melazzini, Mario, Vella, Stefano, Craxì, Antonio, Vinci, Maria, and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)
Abstract: Background & Aims: Advances in direct-acting antiviral treatment of HCV have reinvigorated public health initiatives aimed at identifying affected individuals. We evaluated the possible impact of only diagnosed and linked-to-care individuals on overall HCV burden estimates and identified a possible strategy to achieve the WHO targets by 2030. Methods: Using a modelling approach grounded in Italian real-life data of diagnosed and treated patients, different linkage-to-care scenarios were built to evaluate potential strategies in achieving the HCV elimination goals. Results: Under the 40% linked-to-care scenario, viraemic burden would decline (60%); however, eligible patients to treat will be depleted by 2025. Increased case finding through a targeted screening strategy in 1948-1978 birth cohorts could supplement the pool of diagnosed patients by finding 75% of F0-F3 cases. Under the 60% linked-to-care scenario, viraemic infections would decline by 70% by 2030 but the patients eligible for treatment will run out by 2028. If treatment is to be maintained, a screening strategy focusing on 1958-1978 birth cohorts could capture 55% of F0-F3 individuals. Under the 80% linked-to-care scenario, screening limited in 1968-1978 birth cohorts could sustain treatment at levels required to achieve the HCV elimination goals. Conclusion: In Italy, which is an HCV endemic country, the eligible pool of patients to treat will run out between 2025 and 2028. To maintain the treatment rate and achieve the HCV elimination goals, increased case finding in targeted, high prevalence groups is required.
Published: 2018

22. Incidence of DAA failure and the clinical impact of retreatment in real-life patients treated in the advanced stage of liver disease: Interim evaluations from the PITER network

Author: Kondili, Loreta A., Gaeta, Giovanni Battista, Brunetto, Maurizia Rossana, Di Leo, Alfredo, Iannone, Andrea, Santantonio, Teresa Antonia, Giammario, Adele, Raimondo, Giovanni, Filomia, Roberto, Coppola, Carmine, Amoruso, Daniela Caterina, Blanc, Pierluigi, Del Pin, Barbara, Chemello, Liliana, Cavalletto, Luisa, Morisco, Filomena, Donnarumma, Laura, Rumi, Maria Grazia, Gasbarrini, Antonio, Siciliano, Massimo, Massari, Marco, Corsini, Romina, Coco, Barbara, Madonia, Salvatore, Cannizzaro, Marco, Zignego, Anna Linda, Monti, Monica, Russo, Francesco Paolo, Zanetto, Alberto, Persico, Marcello, Masarone, Mario, Villa, Erica, Bernabucci, Veronica, Taliani, Gloria, Biliotti, Elisa, Chessa, Luchino, Pasetto, Maria Cristina, Andreone, Pietro, Margotti, Marzia, Brancaccio, Giuseppina, Ieluzzi, Donatella, Borgia, Guglielmo, Zappulo, Emanuela, Calvaruso, Vincenza, Petta, Salvatore, Falzano, Loredana, Quaranta, Maria Giovanna, Weimer, Liliana Elena, Rosato, Stefano, Vella, Stefano, Giannini, Edoardo Giovanni, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Kondili, Loreta A., Gaeta, Giovanni Battista, Brunetto, Maurizia Rossana, Di Leo, Alfredo, Iannone, Andrea, Santantonio, Teresa Antonia, Giammario, Adele, Raimondo, Giovanni, Filomia, Roberto, Coppola, Carmine, Amoruso, Daniela Caterina, Blanc, Pierluigi, Del Pin, Barbara, Chemello, Liliana, Cavalletto, Luisa, Morisco, Filomena, Donnarumma, Laura, Rumi, Maria Grazia, Gasbarrini, Antonio, Siciliano, Massimo, Massari, Marco, Corsini, Romina, Coco, Barbara, Madonia, Salvatore, Cannizzaro, Marco, Zignego, Anna Linda, Monti, Monica, Russo, Francesco Paolo, Zanetto, Alberto, Persico, Marcello, Masarone, Mario, Villa, Erica, Bernabucci, Veronica, Taliani, Gloria, Biliotti, Elisa, Chessa, Luchino, Pasetto, Maria Cristina, Andreone, Pietro, Margotti, Marzia, Brancaccio, Giuseppina, Ieluzzi, Donatella, Borgia, Guglielmo, Zappulo, Emanuela, Calvaruso, Vincenza, Petta, Salvatore, Falzano, Loredana, Quaranta, Maria Giovanna, Weimer, Liliana Elena, Rosato, Stefano, Vella, Stefano, Giannini, Edoardo Giovanni, and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)
Abstract: Background: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. Aim: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. Methods: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers. Results: Among 3,830 patients with advanced fibrosis (F3) or cirrhosis, 139 (3.6%) failed to achieve SVR. Genotype 3, bilirubin levels >1.5mg/dl, platelet count <120,000/mm3 and the sofosbuvir+ribavirin regimen were independent predictors of failure by logistic regression analysis. The failure rate was 7.6% for patients treated with regimens that are no longer recommended or considered suboptimal (sofosbuvir+ribavirin or simeprevir+sofosbuvirÂ±ribavirin), whereas 1.4% for regimens containing sofosbuvir combined with daclatasvir or ledipasvir or other DAAs. Of the patients who failed to achieve SVR, 72 (51.8%) were retreated with a second DAA regimen, specifically 38 (52.7%) with sofosbuvir+daclatasvir, 27 (37.5%) with sofosbuvir+ledipasvir, and 7 (9.7%) with other DAAs Â±ribavirin. Among these, 69 (96%) patients achieved SVR12 and 3 (4%) failed. During a median time of 6 months (range: 5â14 months) between failure and the second DAA therapy, the Child-Pugh class worsened in 12 (16.7%) patients: from A to B in 10 patients (19.6%) and from B to C in 2 patients (10.5%), whereas it did not change in the remaining 60 patients. Following the retreatment SVR12 (median time of 6 months; range: 3â12 months), the Child-Pugh class improved in 17 (23.6%) patients: from B to A in 14 (19.4%) patients, from C to A in 1 patient (1.4%) and from C to B in 2 (2.9%) patients; it remained unchanged in 53 patients (73.6%)
Published: 2017

23. Ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin for patients with hepatitis C virus genotype 1 or 4 infection with cirrhosis (ABACUS): a prospective observational study

Author: Petta, Salvatore, Marzioni, Marco, Russo, Pierluigi, Aghemo, Alessio, Alberti, Alfredo, Ascione, Antonio, Antinori, Andrea, Bruno, Raffaele, Bruno, Savino, Chirianni, Antonio, Gaeta, Giovanni Battista, Giannini, Edoardo G, Merli, Manuela, Messina, Vincenzo, Montilla, Simona, Perno, Carlo Federico, Puoti, Massimo, Raimondo, Giovanni, Rendina, Maria, Silberstein, Francesca Ceccherini, Villa, Erica, Zignego, Anna Linda, Pani, Luca, Craxã¬, Antonio, Tabone, Marco, Andreoni, Massimo, Teti, Elisabetta, Angelico, Mario, Persico, Marcello, Masarone, Mario, Chiodera, Aledssandro, Solinas, Attilio, delle Monache, Marco, Cecere, Roberto, Maria Schimizzi, Anna, Piovesan, Sara, Campagnolo, Davide, Chiara Piras, Maria, Zolfino, Teresa, Paolo Russo, Francesca, Morelli, Olivia, Sangiovanni, Vincenzo, Onofrio, Mirella, Iodice, Valentina, Izzi, Antonio, Pirisi, Massimo, Danieli, Elena, Vinci, Maria Rosaria, Rizzardini, Giuliano, Fagiuoli, Stefano, Pasulo, Luisa, D'Arminio Monforte, Antonella, Zuin, Massimo, Giorgini, Alessia, Simeone, Filomena, Piali, Guido, Lo Guercio, Carmela, Federico, Alessandro, Brancaccio, Giuseppina, Marrone, Aldo, Abbati, Giuseppe, Boarini, Chiara, Borghi, Vanni, Bernabucci, Veronica, Corti, Giampaolo, Monti, Monica, Rizzetto, Mario, Martini, Silvia, Andreone, Pietro, Gianstefani, Alice, Lenzi, Marco, Verucchi, Gabriella, Toniutto, Pierluigi, Borgia, Guglielmo, Caporaso, Nicola, Morisco, Filomena, Nardone, Gaetano, Angrisani, Debora, Giacometti, Andrea, Benedetti, Antonio, Tarantino, Giuseppe, Marsetti, Fabio, Tavio, Marcello, Novara, Sergio, Antonia Santantonio, Teresa, Serviddio, Gaetano, Brunetto, Maurizia, Coco, Barbara, Angarano, Gioacchino, Milella, Michele, Barone, Michele, Di Leo, Alfredo, Ettore Sansonno, Domenico, Cacciola, Irene, Boffa, Nicola, Saracco, Giorgio, Di Biagio, Antonio, Picciotto, Antonino, De Luca, Andrea, Calvaruso, Vincenza, Corradori, Silvia, Ferrari, Carlo, Orlandini, Alessandra, Maida, Ivana, Torti, Carlo, Chessa, Luchino, Felder, Martina, Vespasiani Gentilucci, Umberto, Angeli, Paolo, Romano, Antonietta, Rapaccini, Gian Ludovico, Miele, Luca, Cima, Serena, Russo, Maria Luisa, Cozzolongo, Raffaele, Onnelli, Giovanna, D'Offizi, Giampiero, Lionetti, Raffaella, Montalbano, Marzia, Guerra, Michele, Di Perri, Giovanni, Boglione, Lucio, Capra, Franco, Carolo, Giada, Ieluzzi, Donatella, Antonini, Cinzia, Termite, Antonio, Madonia, Salvatore, Tarquini, Pierluigi, Parruti, Giustino, Vecchiet, Giacomo, Falasca, Katia, Menzaghi, Barbara, Quirino, Tiziana, Dentone, Chiara, Maria Piscaglia, Anna, Rossi, Cristina, Giordani, Maria, Fontanella, Luca, Cassola, Giovanni, Russello, Maurizio, Cristaudo, Antonio, Giacomet, Vania, Colombo, Massimo, Donato, Francesca, Durante, Emanuele, Cosco, Lucio, Marignani, Massimo, Quartini, Mariano, Memoli, Massimo, Ganga, Roberto, Ponti, Laura, Soria, Alessandro, Grazia Rumi, Maria, Gulminetti, Roberto, Maserati, Renato, Mondelli, Mario, Lazzarin, Adriano, Rita Parisi, Maria, Canovari, Benedetta, Avancini, Ivo, Pravadelli, Cecilia, Blanc, Pier, Pasquazzi, Caterina, Maria Mastroianni, Claudio, Lichtner, Myriam, Distefano, Marco, Magnani, Silvia, Paganin, Simona, Erne, Elke, Gatti, Pietro, Tundi, Paolo, Calabrese, Paolo, Gasbarrini, Antonio, Grieco, Antonio, Coppola, Nicola, Del Poggio, Paolo, Levrero, Massimo, Talliani, Gloria, Vullo, Vincenzo, Cauda, Roberto, La Monica, Silvia, Potenza, Domenico, Rizzo, Salvatore, Castelli, Francesco, Marie Pigozzi, Grazielle, Ciancio, Alessia, Romagnoli, Dante, Barchetti, Federica, Ivanovic, Jelena, Longo, Olimpia, Petraglia, Sandra, Paola Trotta, Maria, Vinci, Maria, de Luca, Andrea (ORCID:0000-0002-8311-6935), Rapaccini, Gian Ludovico (ORCID:0000-0002-6467-857X), Miele, Luca (ORCID:0000-0003-3464-0068), Luisa Russo, Maria, Gasbarrini,Antonio (ORCID:0000-0002-7278-4823), Grieco,Antonio (ORCID:0000-0002-0544-8993), Cauda,Roberto (ORCID:0000-0002-1498-4229), Petta, Salvatore, Marzioni, Marco, Russo, Pierluigi, Aghemo, Alessio, Alberti, Alfredo, Ascione, Antonio, Antinori, Andrea, Bruno, Raffaele, Bruno, Savino, Chirianni, Antonio, Gaeta, Giovanni Battista, Giannini, Edoardo G, Merli, Manuela, Messina, Vincenzo, Montilla, Simona, Perno, Carlo Federico, Puoti, Massimo, Raimondo, Giovanni, Rendina, Maria, Silberstein, Francesca Ceccherini, Villa, Erica, Zignego, Anna Linda, Pani, Luca, Craxã¬, Antonio, Tabone, Marco, Andreoni, Massimo, Teti, Elisabetta, Angelico, Mario, Persico, Marcello, Masarone, Mario, Chiodera, Aledssandro, Solinas, Attilio, delle Monache, Marco, Cecere, Roberto, Maria Schimizzi, Anna, Piovesan, Sara, Campagnolo, Davide, Chiara Piras, Maria, Zolfino, Teresa, Paolo Russo, Francesca, Morelli, Olivia, Sangiovanni, Vincenzo, Onofrio, Mirella, Iodice, Valentina, Izzi, Antonio, Pirisi, Massimo, Danieli, Elena, Vinci, Maria Rosaria, Rizzardini, Giuliano, Fagiuoli, Stefano, Pasulo, Luisa, D'Arminio Monforte, Antonella, Zuin, Massimo, Giorgini, Alessia, Simeone, Filomena, Piali, Guido, Lo Guercio, Carmela, Federico, Alessandro, Brancaccio, Giuseppina, Marrone, Aldo, Abbati, Giuseppe, Boarini, Chiara, Borghi, Vanni, Bernabucci, Veronica, Corti, Giampaolo, Monti, Monica, Rizzetto, Mario, Martini, Silvia, Andreone, Pietro, Gianstefani, Alice, Lenzi, Marco, Verucchi, Gabriella, Toniutto, Pierluigi, Borgia, Guglielmo, Caporaso, Nicola, Morisco, Filomena, Nardone, Gaetano, Angrisani, Debora, Giacometti, Andrea, Benedetti, Antonio, Tarantino, Giuseppe, Marsetti, Fabio, Tavio, Marcello, Novara, Sergio, Antonia Santantonio, Teresa, Serviddio, Gaetano, Brunetto, Maurizia, Coco, Barbara, Angarano, Gioacchino, Milella, Michele, Barone, Michele, Di Leo, Alfredo, Ettore Sansonno, Domenico, Cacciola, Irene, Boffa, Nicola, Saracco, Giorgio, Di Biagio, Antonio, Picciotto, Antonino, De Luca, Andrea, Calvaruso, Vincenza, Corradori, Silvia, Ferrari, Carlo, Orlandini, Alessandra, Maida, Ivana, Torti, Carlo, Chessa, Luchino, Felder, Martina, Vespasiani Gentilucci, Umberto, Angeli, Paolo, Romano, Antonietta, Rapaccini, Gian Ludovico, Miele, Luca, Cima, Serena, Russo, Maria Luisa, Cozzolongo, Raffaele, Onnelli, Giovanna, D'Offizi, Giampiero, Lionetti, Raffaella, Montalbano, Marzia, Guerra, Michele, Di Perri, Giovanni, Boglione, Lucio, Capra, Franco, Carolo, Giada, Ieluzzi, Donatella, Antonini, Cinzia, Termite, Antonio, Madonia, Salvatore, Tarquini, Pierluigi, Parruti, Giustino, Vecchiet, Giacomo, Falasca, Katia, Menzaghi, Barbara, Quirino, Tiziana, Dentone, Chiara, Maria Piscaglia, Anna, Rossi, Cristina, Giordani, Maria, Fontanella, Luca, Cassola, Giovanni, Russello, Maurizio, Cristaudo, Antonio, Giacomet, Vania, Colombo, Massimo, Donato, Francesca, Durante, Emanuele, Cosco, Lucio, Marignani, Massimo, Quartini, Mariano, Memoli, Massimo, Ganga, Roberto, Ponti, Laura, Soria, Alessandro, Grazia Rumi, Maria, Gulminetti, Roberto, Maserati, Renato, Mondelli, Mario, Lazzarin, Adriano, Rita Parisi, Maria, Canovari, Benedetta, Avancini, Ivo, Pravadelli, Cecilia, Blanc, Pier, Pasquazzi, Caterina, Maria Mastroianni, Claudio, Lichtner, Myriam, Distefano, Marco, Magnani, Silvia, Paganin, Simona, Erne, Elke, Gatti, Pietro, Tundi, Paolo, Calabrese, Paolo, Gasbarrini, Antonio, Grieco, Antonio, Coppola, Nicola, Del Poggio, Paolo, Levrero, Massimo, Talliani, Gloria, Vullo, Vincenzo, Cauda, Roberto, La Monica, Silvia, Potenza, Domenico, Rizzo, Salvatore, Castelli, Francesco, Marie Pigozzi, Grazielle, Ciancio, Alessia, Romagnoli, Dante, Barchetti, Federica, Ivanovic, Jelena, Longo, Olimpia, Petraglia, Sandra, Paola Trotta, Maria, Vinci, Maria, de Luca, Andrea (ORCID:0000-0002-8311-6935), Rapaccini, Gian Ludovico (ORCID:0000-0002-6467-857X), Miele, Luca (ORCID:0000-0003-3464-0068), Luisa Russo, Maria, Gasbarrini,Antonio (ORCID:0000-0002-7278-4823), Grieco,Antonio (ORCID:0000-0002-0544-8993), and Cauda,Roberto (ORCID:0000-0002-1498-4229)
Abstract: Background We ran a compassionate use nationwide programme (ABACUS) to provide access to ombitasvir, paritaprevir, and ritonavir, with dasabuvir, plus ribavirin for hepatitis C virus (HCV) genotype 1 infection and ombitasvir, paritaprevir, and ritonavir, plus ribavirin for HCV genotype 4 infection in patients with cirrhosis at high risk of decompensation while approval of these regimens was pending in Italy. Methods In this prospective observational study, we collected data from a compassionate use nationwide programme from March 17, 2014, to May 28, 2015. Patients with HCV genotype 1 infection and cirrhosis at high risk of decompensation were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once daily and dasabuvir (250 mg) twice daily for 12 weeks (patients with HCV genotype 1b infection) or 24 weeks (patients with HCV genotype 1a infection). Patients with HCV genotype 4 infection were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once per day for 24 weeks. All patients were given weight-based ribavirin. The primary efficacy endpoint was sustained virological response at week 12 after the end of treatment (SVR12), analysed by intention-to-treat. Univariate and multivariate logistic regression analyses were used to identify baseline characteristics associated with SVR12. Adverse events were recorded throughout the study. Findings 728 (96%) of 762 patients with cirrhosis who were given ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin therapy for 12 or 24 weeks achieved SVR12. Logistic regression analyses identified that bilirubin concentrations of less than 2 mg/dL were associated with SVR12 (odds ratio [OR] 4Â·76 [95% CI 1Â·83â12Â·3]; p=0Â·001). 166 (23%) of 734 patients included in safety analyses had an adverse event. 25 (3%) patients discontinued treatment because of adverse events. Asthenia was the most commonly reported adverse event, occurring i
Published: 2017

24. Modelling cost-effectiveness and health gains of a 'universal' vs. 'prioritized' HCV treatment policy in a real-life cohort

Author: Kondili, Loreta A, Romano, Federica, Rolli, Francesca Romana, Ruggeri, Matteo, Rosato, Stefano, Brunetto, Maurizia Rossana, Zignego, Anna Linda, Ciancio, Alessia, Di Leo, Alfredo, Raimondo, Giovanni, Ferrari, Carlo, Taliani, Gloria, Borgia, Guglielmo, Santantonio, Teresa Antonia, Blanc, Pierluigi, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Chessa, Luchino, Erne, Elke Maria, Villa, Erica, Ieluzzi, Donatella, Russo, Francesco Paolo, Andreone, Pietro, Vinci, Maria, Coppola, Carmine, Chemello, Liliana, Madonia, Salvatore, Verucchi, Gabriella, Persico, Marcello, Zuin, Massimo, Puoti, Massimo, Alberti, Alfredo, Nardone, Gerardo, Massari, Marco, Montalto, Giuseppe, Foti, Giuseppe, Rumi, Maria Grazia, Quaranta, Maria Giovanna, Cicchetti, Americo, Craxì, Antonio, Vella, Stefano, Ruggeri, Matteo (ORCID:0000-0002-5703-7424), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Cicchetti, Americo (ORCID:0000-0002-4633-9195), Kondili, Loreta A, Romano, Federica, Rolli, Francesca Romana, Ruggeri, Matteo, Rosato, Stefano, Brunetto, Maurizia Rossana, Zignego, Anna Linda, Ciancio, Alessia, Di Leo, Alfredo, Raimondo, Giovanni, Ferrari, Carlo, Taliani, Gloria, Borgia, Guglielmo, Santantonio, Teresa Antonia, Blanc, Pierluigi, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Chessa, Luchino, Erne, Elke Maria, Villa, Erica, Ieluzzi, Donatella, Russo, Francesco Paolo, Andreone, Pietro, Vinci, Maria, Coppola, Carmine, Chemello, Liliana, Madonia, Salvatore, Verucchi, Gabriella, Persico, Marcello, Zuin, Massimo, Puoti, Massimo, Alberti, Alfredo, Nardone, Gerardo, Massari, Marco, Montalto, Giuseppe, Foti, Giuseppe, Rumi, Maria Grazia, Quaranta, Maria Giovanna, Cicchetti, Americo, Craxì, Antonio, Vella, Stefano, Ruggeri, Matteo (ORCID:0000-0002-5703-7424), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), and Cicchetti, Americo (ORCID:0000-0002-4633-9195)
Abstract: n.a.
Published: 2017

25. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis

Author: Nevens, Frederik, Andreone, Pietro, Mazzella, Giuseppe, Strasser, Simone I, Bowlus, Christopher, Invernizzi, Pietro, Drenth, Joost P H, Pockros, Paul J, Regula, Jaroslaw, Beuers, Ulrich, Trauner, Michael, Jones, David E, Floreani, Annarosa, Hohenester, Simon, Luketic, Velimir, Shiffman, Mitchell, van Erpecum, Karel J, Vargas, Victor, Vincent, Catherine, Hirschfield, Gideon M, Shah, Hemant, Hansen, Bettina, Lindor, Keith D, Marschall, Hanns-Ulrich, Kowdley, Kris V, Hooshmand-Rad, Roya, Marmon, Tonya, Sheeron, Shawn, Pencek, Richard, MacConell, Leigh, Pruzanski, Mark, Shapiro, David, POISE Study Group, Nevens, Frederik, Andreone, Pietro, Mazzella, Giuseppe, Strasser, Simone I, Bowlus, Christopher, Invernizzi, Pietro, Drenth, Joost P H, Pockros, Paul J, Regula, Jaroslaw, Beuers, Ulrich, Trauner, Michael, Jones, David E, Floreani, Annarosa, Hohenester, Simon, Luketic, Velimir, Shiffman, Mitchell, van Erpecum, Karel J, Vargas, Victor, Vincent, Catherine, Hirschfield, Gideon M, Shah, Hemant, Hansen, Bettina, Lindor, Keith D, Marschall, Hanns-Ulrich, Kowdley, Kris V, Hooshmand-Rad, Roya, Marmon, Tonya, Sheeron, Shawn, Pencek, Richard, MacConell, Leigh, Pruzanski, Mark, Shapiro, David, and POISE Study Group
Published: 2016

26. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis

Author: Nevens, Frederik, Andreone, Pietro, Mazzella, Giuseppe, Strasser, Simone I, Bowlus, Christopher, Invernizzi, Pietro, Drenth, Joost P H, Pockros, Paul J, Regula, Jaroslaw, Beuers, Ulrich, Trauner, Michael, Jones, David E, Floreani, Annarosa, Hohenester, Simon, Luketic, Velimir, Shiffman, Mitchell, van Erpecum, Karel J, Vargas, Victor, Vincent, Catherine, Hirschfield, Gideon M, Shah, Hemant, Hansen, Bettina, Lindor, Keith D, Marschall, Hanns-Ulrich, Kowdley, Kris V, Hooshmand-Rad, Roya, Marmon, Tonya, Sheeron, Shawn, Pencek, Richard, MacConell, Leigh, Pruzanski, Mark, Shapiro, David, POISE Study Group, Nevens, Frederik, Andreone, Pietro, Mazzella, Giuseppe, Strasser, Simone I, Bowlus, Christopher, Invernizzi, Pietro, Drenth, Joost P H, Pockros, Paul J, Regula, Jaroslaw, Beuers, Ulrich, Trauner, Michael, Jones, David E, Floreani, Annarosa, Hohenester, Simon, Luketic, Velimir, Shiffman, Mitchell, van Erpecum, Karel J, Vargas, Victor, Vincent, Catherine, Hirschfield, Gideon M, Shah, Hemant, Hansen, Bettina, Lindor, Keith D, Marschall, Hanns-Ulrich, Kowdley, Kris V, Hooshmand-Rad, Roya, Marmon, Tonya, Sheeron, Shawn, Pencek, Richard, MacConell, Leigh, Pruzanski, Mark, Shapiro, David, and POISE Study Group
Published: 2016

27. La Trombosi Portale Non-neoplastica nel Paziente Cirrotico: studio della prevalenza ed eventuale correlazione con i maggiori score di funzionalità epatica (CTP e MELD)

Author: Andreone, Pietro, Mastroroberto, Marianna <1982>, Andreone, Pietro, and Mastroroberto, Marianna <1982>
Abstract: La trombosi portale non neoplastica (PVT) è una complicanza frequente della cirrosi epatica. Attualmente, gli unici fattori di rischio associati, ripetutamente confermati in letteratura, sono il precedente sanguinamento da varici esofagee e la piastrinopenia che sbilancia il precario equilibrio coagulativo tipico della cirrosi. Tra Gennaio 2013 e Ottobre 2015, sono stati arruolati prospetticamente 253 pazienti cirrotici (età media 58,8 ± 10,3 (23 – 75) anni) senza neoplasie anamnestiche e/o malattia ematologica e liberi da terapia anticoagulante/antiaggregante assunta er altre cause. Nel campione raccolto sono stati studiati: lo stadio di malattia secondo il Child-Pugh (CP) e il Model for end-stage liver disease (MELD) scores, eziologia, età ed esami laboratoristici. I pazienti con PVT sono stati il 13%, di cui il 63,3% maschi, significativamente più giovani dei controllonegativi (51,9 ± 13,2 (23 – 75) anni; P=0,004), con una maggior piastrinopenia (73,1 ± 48,1 (25 – 174); P = 0,001), INR > 1.25 in 54,5% dei casi (P=0,024) e MELD >10 in 86,2% (P=0,001). INR e MELD sono state considerate anche come valore continuo senza raggiungere la significatività come eziologia, ematocrito, Bilirubina ttale, AST, ALT, Albumina, Creatinina e CP score e classe. All'analisi multivariata solo la conta piastrinica è risultata indipendentemente associata alla presenza di PVT (OR = 0.97, 95% CI: 0.96-0.99; P <0.001) come da letteratura. Le trombocitopenie ereditarie (ITs) sono un gruppo eterogeneo di disordini genetici con diversi gradi di severità e cmplessità caratterizzate da piastrinopenia associata o meno a sanguinamento di variabile entità. Tali disordini, in un substrato così favorevole come la cirrosi epatica, potrebbe spiegare l'eterogeneità dei quadri clinici e la risposta apparentemente casuale alla terapia anticoagulante. Non abbiamo ancora dati che confermino questa ipotesi alternativa, ma se così fosse, probabilmente l'approccio clinico a questa problematica cambierebbe si, Non-neoplastic porta vein thrombosis (PVT) in cirrhotic patients is a frequent complication of liver cirrhosis. Yet, only confirmed data about its natural history are the association with variceal bleeding and low platelet count which influences this precarious coagulation balance. In our prospective study, from January 2013 to October 2015, we enrolled 253 cirrhotic patients (mean age 58,8 ± 10,3 (23 – 75) years) without a history of malignancy and/or hematological disease and who aren’t on oral anticoagulants or antiplatelet therapy taken for other reasons. Overall were subsequently studied according to the degree of liver disease using the Child-Pugh (CP) and Model for end-stage liver disease (MELD) scores, etiology, age and blood tests. Patient with PVT, of which 63,3% males, was significantly younger (51,9 ± 13,2 (23 – 75) yrs; P=0,004), with lesser platelet count (73,1 ± 48,1 (25 – 174); P = 0,001), INR > 1.25 in 54,5% of cases (P=0,024) and MELD >10 in 86,2% (P=0,001). INR and MELD considered as continuous variables were not significant as well as etiology, hematocrit, total Bilirubin, AST, ALT, Albumine, Creatinine and CP score and class. In multivariate analysis, only the platelet count was independently associated with the occurance of PVT (OR = 0.97, 95% CI: 0.96-0.99; P <0.001) confirming the literature. The inheritated thrombocytopenias (ITs) are a heterogeneous group of genetic disorders with different degrees of complexity and severity, characterized by a low platelets count associated or not with a bleeding tendency which varies from absent to very strict. This group of diseases, in the context of an extremely favorable substrate such as cirrhotic degeneration, would explain the heterogeneity of the cadres and random responses to anticoagulation. We have no data yet certain about this, but if this hypothesis be confirmed, the clinical approach to the disease might change dramatically.
Published: 2016

28. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis

Author: Nevens, Frederik, Andreone, Pietro, Mazzella, Giuseppe, Strasser, Simone I, Bowlus, Christopher, Invernizzi, Pietro, Drenth, Joost P H, Pockros, Paul J, Regula, Jaroslaw, Beuers, Ulrich, Trauner, Michael, Jones, David E, Floreani, Annarosa, Hohenester, Simon, Luketic, Velimir, Shiffman, Mitchell, van Erpecum, Karel J, Vargas, Victor, Vincent, Catherine, Hirschfield, Gideon M, Shah, Hemant, Hansen, Bettina, Lindor, Keith D, Marschall, Hanns-Ulrich, Kowdley, Kris V, Hooshmand-Rad, Roya, Marmon, Tonya, Sheeron, Shawn, Pencek, Richard, MacConell, Leigh, Pruzanski, Mark, Shapiro, David, POISE Study Group, Nevens, Frederik, Andreone, Pietro, Mazzella, Giuseppe, Strasser, Simone I, Bowlus, Christopher, Invernizzi, Pietro, Drenth, Joost P H, Pockros, Paul J, Regula, Jaroslaw, Beuers, Ulrich, Trauner, Michael, Jones, David E, Floreani, Annarosa, Hohenester, Simon, Luketic, Velimir, Shiffman, Mitchell, van Erpecum, Karel J, Vargas, Victor, Vincent, Catherine, Hirschfield, Gideon M, Shah, Hemant, Hansen, Bettina, Lindor, Keith D, Marschall, Hanns-Ulrich, Kowdley, Kris V, Hooshmand-Rad, Roya, Marmon, Tonya, Sheeron, Shawn, Pencek, Richard, MacConell, Leigh, Pruzanski, Mark, Shapiro, David, and POISE Study Group
Published: 2016

29. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis

Author: MS MDL 1, Cancer, Nevens, Frederik, Andreone, Pietro, Mazzella, Giuseppe, Strasser, Simone I, Bowlus, Christopher, Invernizzi, Pietro, Drenth, Joost P H, Pockros, Paul J, Regula, Jaroslaw, Beuers, Ulrich, Trauner, Michael, Jones, David E, Floreani, Annarosa, Hohenester, Simon, Luketic, Velimir, Shiffman, Mitchell, van Erpecum, Karel J, Vargas, Victor, Vincent, Catherine, Hirschfield, Gideon M, Shah, Hemant, Hansen, Bettina, Lindor, Keith D, Marschall, Hanns-Ulrich, Kowdley, Kris V, Hooshmand-Rad, Roya, Marmon, Tonya, Sheeron, Shawn, Pencek, Richard, MacConell, Leigh, Pruzanski, Mark, Shapiro, David, POISE Study Group, MS MDL 1, Cancer, Nevens, Frederik, Andreone, Pietro, Mazzella, Giuseppe, Strasser, Simone I, Bowlus, Christopher, Invernizzi, Pietro, Drenth, Joost P H, Pockros, Paul J, Regula, Jaroslaw, Beuers, Ulrich, Trauner, Michael, Jones, David E, Floreani, Annarosa, Hohenester, Simon, Luketic, Velimir, Shiffman, Mitchell, van Erpecum, Karel J, Vargas, Victor, Vincent, Catherine, Hirschfield, Gideon M, Shah, Hemant, Hansen, Bettina, Lindor, Keith D, Marschall, Hanns-Ulrich, Kowdley, Kris V, Hooshmand-Rad, Roya, Marmon, Tonya, Sheeron, Shawn, Pencek, Richard, MacConell, Leigh, Pruzanski, Mark, Shapiro, David, and POISE Study Group
Published: 2016

30. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection

Author: Sarrazin, Christoph, Castelli, Francesco, Andreone, Pietro, Buti, Maria, Colombo, Massimo, Pol, Stanislas, Calinas, Filipe, Puoti, Massimo, Olveira, Antonio, Shiffman, Mitchell, Stern, Jerry O., Kukolj, George, Roehrle, Michael, Aslanyan, Stella, Deng, Qiqi, Vinisko, Richard, Mensa, Federico J ., Nelson, David R., Sarrazin, Christoph, Castelli, Francesco, Andreone, Pietro, Buti, Maria, Colombo, Massimo, Pol, Stanislas, Calinas, Filipe, Puoti, Massimo, Olveira, Antonio, Shiffman, Mitchell, Stern, Jerry O., Kukolj, George, Roehrle, Michael, Aslanyan, Stella, Deng, Qiqi, Vinisko, Richard, Mensa, Federico J ., and Nelson, David R.
Abstract: Christoph Sarrazin,1 Francesco Castelli,2 Pietro Andreone,3 Maria Buti,4 Massimo Colombo,5 Stanislas Pol,6 Filipe Calinas,7 Massimo Puoti,8 Antonio Olveira,9 Mitchell Shiffman,10 Jerry O Stern,11 George Kukolj,12 Michael Roehrle,13 Stella Aslanyan,11 Qiqi Deng,11 Richard Vinisko,11 Federico J Mensa,11 David R Nelson,14 on behalf of the HCVerso1 and 2 study groups 1Department of Internal Medicine 1, JW Goethe University Hospital, Frankfurt, Germany; 2Department of Infectious and Tropical Diseases, University of Brescia, Brescia, 3Department of Medical and Surgical Sciences, Università di Bologna and Azienda Ospedaliero-Universitaria, Policlinico Sant‘Orsola-Malpighi, Bologna, Italy; 4Department of Internal Medicine, Hospital Universitari Vall d’Hebron and CIBERehd del Instituto Carlos III, Barcelona, Spain; 5Division of Gastroenterology and Hepatology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy; 6University Paris Descartes, Department of Hepatology, Hospital Cochin, APHP and INSERM UMS-20, Institut Pasteur, Paris, France; 7Department of Gastroenterology, Centro Hospitalar de Lisboa Central, Lisbon, Portugal; 8Department of Infectious Diseases, AO Ospedale Niguarda Cà Granda, Milan, Italy; 9Liver Unit, Hospital Universitario La Paz, CIBERehd, Madrid, Spain; 10Liver Institute of Virginia, Bon Secours Health System, Richmond, VA, USA; 11Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 12Boehringer Ingelheim Ltd/Ltée, Burlington, ON, Canada; 13Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; 14Clinical and Translational Science Institute, University of Florida, Gainesville, FL, USA Abstract: The interferon-free combination of once-daily faldaprevir 120 mg, twice-daily deleobuvir 600 mg, and weight-based ribavirin was evaluated in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotype-1b-infected, treatment-naïve patients, including those ineligible for peginterfer
Published: 2016

31. La Trombosi Portale Non-neoplastica nel Paziente Cirrotico: studio della prevalenza ed eventuale correlazione con i maggiori score di funzionalità epatica (CTP e MELD)

Author: Andreone, Pietro, Mastroroberto, Marianna <1982>, Andreone, Pietro, and Mastroroberto, Marianna <1982>
Abstract: La trombosi portale non neoplastica (PVT) è una complicanza frequente della cirrosi epatica. Attualmente, gli unici fattori di rischio associati, ripetutamente confermati in letteratura, sono il precedente sanguinamento da varici esofagee e la piastrinopenia che sbilancia il precario equilibrio coagulativo tipico della cirrosi. Tra Gennaio 2013 e Ottobre 2015, sono stati arruolati prospetticamente 253 pazienti cirrotici (età media 58,8 ± 10,3 (23 – 75) anni) senza neoplasie anamnestiche e/o malattia ematologica e liberi da terapia anticoagulante/antiaggregante assunta er altre cause. Nel campione raccolto sono stati studiati: lo stadio di malattia secondo il Child-Pugh (CP) e il Model for end-stage liver disease (MELD) scores, eziologia, età ed esami laboratoristici. I pazienti con PVT sono stati il 13%, di cui il 63,3% maschi, significativamente più giovani dei controllonegativi (51,9 ± 13,2 (23 – 75) anni; P=0,004), con una maggior piastrinopenia (73,1 ± 48,1 (25 – 174); P = 0,001), INR > 1.25 in 54,5% dei casi (P=0,024) e MELD >10 in 86,2% (P=0,001). INR e MELD sono state considerate anche come valore continuo senza raggiungere la significatività come eziologia, ematocrito, Bilirubina ttale, AST, ALT, Albumina, Creatinina e CP score e classe. All'analisi multivariata solo la conta piastrinica è risultata indipendentemente associata alla presenza di PVT (OR = 0.97, 95% CI: 0.96-0.99; P <0.001) come da letteratura. Le trombocitopenie ereditarie (ITs) sono un gruppo eterogeneo di disordini genetici con diversi gradi di severità e cmplessità caratterizzate da piastrinopenia associata o meno a sanguinamento di variabile entità. Tali disordini, in un substrato così favorevole come la cirrosi epatica, potrebbe spiegare l'eterogeneità dei quadri clinici e la risposta apparentemente casuale alla terapia anticoagulante. Non abbiamo ancora dati che confermino questa ipotesi alternativa, ma se così fosse, probabilmente l'approccio clinico a questa problematica cambierebbe si, Non-neoplastic porta vein thrombosis (PVT) in cirrhotic patients is a frequent complication of liver cirrhosis. Yet, only confirmed data about its natural history are the association with variceal bleeding and low platelet count which influences this precarious coagulation balance. In our prospective study, from January 2013 to October 2015, we enrolled 253 cirrhotic patients (mean age 58,8 ± 10,3 (23 – 75) years) without a history of malignancy and/or hematological disease and who aren’t on oral anticoagulants or antiplatelet therapy taken for other reasons. Overall were subsequently studied according to the degree of liver disease using the Child-Pugh (CP) and Model for end-stage liver disease (MELD) scores, etiology, age and blood tests. Patient with PVT, of which 63,3% males, was significantly younger (51,9 ± 13,2 (23 – 75) yrs; P=0,004), with lesser platelet count (73,1 ± 48,1 (25 – 174); P = 0,001), INR > 1.25 in 54,5% of cases (P=0,024) and MELD >10 in 86,2% (P=0,001). INR and MELD considered as continuous variables were not significant as well as etiology, hematocrit, total Bilirubin, AST, ALT, Albumine, Creatinine and CP score and class. In multivariate analysis, only the platelet count was independently associated with the occurance of PVT (OR = 0.97, 95% CI: 0.96-0.99; P <0.001) confirming the literature. The inheritated thrombocytopenias (ITs) are a heterogeneous group of genetic disorders with different degrees of complexity and severity, characterized by a low platelets count associated or not with a bleeding tendency which varies from absent to very strict. This group of diseases, in the context of an extremely favorable substrate such as cirrhotic degeneration, would explain the heterogeneity of the cadres and random responses to anticoagulation. We have no data yet certain about this, but if this hypothesis be confirmed, the clinical approach to the disease might change dramatically.
Published: 2016

32. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection

Author: Sarrazin,Christoph, Castelli,Francesco, Andreone,Pietro, Buti,Maria, Colombo,Massimo, Pol,Stanislas, Calinas,Filipe, Puoti,Massimo, Olveira,Antonio, Shiffman,Mitchell, Stern,Jerry, Kukolj,George, Roehrle,Michael, Aslanyan,Stella, Deng,Qiqi, Vinisko,Richard, Mensa,Federico, Nelson,David, Sarrazin,Christoph, Castelli,Francesco, Andreone,Pietro, Buti,Maria, Colombo,Massimo, Pol,Stanislas, Calinas,Filipe, Puoti,Massimo, Olveira,Antonio, Shiffman,Mitchell, Stern,Jerry, Kukolj,George, Roehrle,Michael, Aslanyan,Stella, Deng,Qiqi, Vinisko,Richard, Mensa,Federico, and Nelson,David
Abstract: Christoph Sarrazin,1 Francesco Castelli,2 Pietro Andreone,3 Maria Buti,4 Massimo Colombo,5 Stanislas Pol,6 Filipe Calinas,7 Massimo Puoti,8 Antonio Olveira,9 Mitchell Shiffman,10 Jerry O Stern,11 George Kukolj,12 Michael Roehrle,13 Stella Aslanyan,11 Qiqi Deng,11 Richard Vinisko,11 Federico J Mensa,11 David R Nelson,14 on behalf of the HCVerso1 and 2 study groups 1Department of Internal Medicine 1, JW Goethe University Hospital, Frankfurt, Germany; 2Department of Infectious and Tropical Diseases, University of Brescia, Brescia, 3Department of Medical and Surgical Sciences, Università di Bologna and Azienda Ospedaliero-Universitaria, Policlinico Sant‘Orsola-Malpighi, Bologna, Italy; 4Department of Internal Medicine, Hospital Universitari Vall d’Hebron and CIBERehd del Instituto Carlos III, Barcelona, Spain; 5Division of Gastroenterology and Hepatology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy; 6University Paris Descartes, Department of Hepatology, Hospital Cochin, APHP and INSERM UMS-20, Institut Pasteur, Paris, France; 7Department of Gastroenterology, Centro Hospitalar de Lisboa Central, Lisbon, Portugal; 8Department of Infectious Diseases, AO Ospedale Niguarda Cà Granda, Milan, Italy; 9Liver Unit, Hospital Universitario La Paz, CIBERehd, Madrid, Spain; 10Liver Institute of Virginia, Bon Secours Health System, Richmond, VA, USA; 11Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 12Boehringer Ingelheim Ltd/Ltée, Burlington, ON, Canada; 13Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; 14Clinical and Translational Science Institute, University of Florida, Gainesville, FL, USA Abstract: The interferon-free combination of once-daily faldaprevir 120 mg, twice-daily deleobuvir 600 mg, and weight-based ribavirin was evaluated in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotyp
Published: 2016

33. Serum anti-interferon alpha antibodies in chronic hepatitis C patients treated with pegylated interferon alpha containing therapy

Author: Andreone, Pietro, Vukotic, Ranka <1981>, Andreone, Pietro, and Vukotic, Ranka <1981>
Abstract: The development of anti-IFNα antibodies is an occurrence described in chronic hepatitis C patients during treatment with Interferonα/PEG-Interferonα. However, its relevance, especially in difficult-to treat patients, has not been defined. Methods: We retrospectively measured the serum levels of anti-IFNα antibodies (baseline and week 12) and IFNα levels (week 12) by ELISA in 76 previous non-responders, and in 14 naive patients treated with Pegylated-IFNα and Ribavirin. A group of 57 healthy donors (HD) was also assessed as control. Positivity to anti-IFNα antibodies was established on the values of HD. Results: Baseline anti-IFNα antibodies were detected in 15.5% of patients and in 7% of HD, with significantly higher concentrations in patients than HD (181.5±389.9 vs 95.9±143.0 ng mL−1, p=0.0023). All positive patients were IFNα-experienced. At week 12, the prevalence of positivity increased to 22.3 and 28.5% in experienced and naïve patients, respectively, and the levels of anti-IFNα antibodies did not differ between the two groups (391±792.3 vs 384.7±662.6 ng mL−1, respectively). IFNα concentrations were significantly lower in antibody-positive patients than in antibody-negatives (988.2±1402 vs 3462±830.8 pg mL−1, p≤0.0001) and the levels of antibodies and IFNα were inversely correlated (r=-0.405, p=0.0001). The antibody-positive population clustered in null responders (67%) and 19/21 patients (90%) did not achieve SVR. Conclusions: The development of anti-IFNα antibodies is a non-negligible occurrence in patients treated with PEG-IFNα, is stable over time, and has a relevant clinical impact when associated with low levels of circulating PEG-IFNα. It should be considered in patients undergoing treatments including PEG-IFNα.
Published: 2015

34. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection

Author: UCL - SSS/IREC/ECLI - Pôle d'Essais cliniques, UCL - (SLuc) Service de gastro-entérologie, Andreone, Pietro, Bernstein, Barry, Podsadecki, Thomas, Hu, Yiran B., Rodrigues Jr., Lino, Reesink, Henk W., Weiland, Ola, Horsmans, Yves, Müllhaupt, Beat, Maieron, Andreas, Ferenci, Peter, Koksal, Iftihar, Enejosa, Jeffrey V., Colombo, Massimo G., UCL - SSS/IREC/ECLI - Pôle d'Essais cliniques, UCL - (SLuc) Service de gastro-entérologie, Andreone, Pietro, Bernstein, Barry, Podsadecki, Thomas, Hu, Yiran B., Rodrigues Jr., Lino, Reesink, Henk W., Weiland, Ola, Horsmans, Yves, Müllhaupt, Beat, Maieron, Andreas, Ferenci, Peter, Koksal, Iftihar, Enejosa, Jeffrey V., and Colombo, Massimo G.
Abstract: Background & Aims: The interferon-free regimen of ABT-450 (a protease inhibitor), ritonavir, ombitasvir (an NS5A inhibitor), dasabuvir (a non-nucleoside polymerase inhibitor), and ribavirin has shown efficacy in patients with hepatitis C virus (HCV) genotype 1b infection - the most prevalent subgenotype worldwide. We evaluated whether ribavirin is necessary for ABT-450, ritonavir, ombitasvir, and dasabuvir to produce high rates of sustained virologic response (SVR) in these patients. Methods We performed a multicenter, open-label, phase 3 trial of 179 patients with HCV genotype 1b infection, without cirrhosis, previously treated with peginterferon and ribavirin. Patients were assigned randomly (1:1) to groups given ABT-450, ritonavir, ombitasvir, and dasabuvir, with ribavirin (group 1) or without (group 2) for 12 weeks. The primary end point was SVR 12 weeks after treatment (SVR12). We assessed the noninferiority of this regimen to the rate of response reported (64%) for a similar population treated with telaprevir, peginterferon, and ribavirin. Results Groups 1 and 2 each had high rates of SVR12, which were noninferior to the reported rate of response to the combination of telaprevir, peginterferon, and ribavirin (group 1: 96.6%; 95% confidence interval, 92.8%-100%; and group 2: 100%; 95% confidence interval, 95.9%-100%). The rate of response in group 2 was noninferior to that of group 1. No virologic failure occurred during the study. Two patients (1.1%) discontinued the study owing to adverse events, both in group 1. The most common adverse events in groups 1 and 2 were fatigue (31.9% vs 15.8%) and headache (24.2% vs 23.2%), respectively. Decreases in hemoglobin level to less than the lower limit of normal were more frequent in group 1 (42.0% vs 5.5% in group 2; P <.001), although only 2 patients had hemoglobin levels less than 10 g/dL. Conclusions The interferon-free regimen of ABT-450, ritonavir, ombitasvir, and dasabuvir, with or without ribavirin, produces
Published: 2014

35. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection

Author: Andreone, Pietro, Colombo, Massimo G, Enejosa, Jeffrey V, Koksal, Iftihar, Ferenci, Peter, Maieron, Andreas, Müllhaupt, Beat, Horsmans, Yves, Weiland, Ola, Reesink, Henk W, Rodrigues Jr., Lino, Hu, Yiran B, Podsadecki, Thomas, Bernstein, Barry, Andreone, Pietro, Colombo, Massimo G, Enejosa, Jeffrey V, Koksal, Iftihar, Ferenci, Peter, Maieron, Andreas, Müllhaupt, Beat, Horsmans, Yves, Weiland, Ola, Reesink, Henk W, Rodrigues Jr., Lino, Hu, Yiran B, Podsadecki, Thomas, and Bernstein, Barry
Abstract: BACKGROUND & AIMS The interferon-free regimen of ABT-450 (a protease inhibitor), ritonavir, ombitasvir (an NS5A inhibitor), dasabuvir (a non-nucleoside polymerase inhibitor), and ribavirin has shown efficacy in patients with hepatitis C virus (HCV) genotype 1b infection-the most prevalent subgenotype worldwide. We evaluated whether ribavirin is necessary for ABT-450, ritonavir, ombitasvir, and dasabuvir to produce high rates of sustained virologic response (SVR) in these patients. METHODS We performed a multicenter, open-label, phase 3 trial of 179 patients with HCV genotype 1b infection, without cirrhosis, previously treated with peginterferon and ribavirin. Patients were assigned randomly (1:1) to groups given ABT-450, ritonavir, ombitasvir, and dasabuvir, with ribavirin (group 1) or without (group 2) for 12 weeks. The primary end point was SVR 12 weeks after treatment (SVR12). We assessed the noninferiority of this regimen to the rate of response reported (64%) for a similar population treated with telaprevir, peginterferon, and ribavirin. RESULTS Groups 1 and 2 each had high rates of SVR12, which were noninferior to the reported rate of response to the combination of telaprevir, peginterferon, and ribavirin (group 1: 96.6%; 95% confidence interval, 92.8%-100%; and group 2: 100%; 95% confidence interval, 95.9%-100%). The rate of response in group 2 was noninferior to that of group 1. No virologic failure occurred during the study. Two patients (1.1%) discontinued the study owing to adverse events, both in group 1. The most common adverse events in groups 1 and 2 were fatigue (31.9% vs 15.8%) and headache (24.2% vs 23.2%), respectively. Decreases in hemoglobin level to less than the lower limit of normal were more frequent in group 1 (42.0% vs 5.5% in group 2; P < .001), although only 2 patients had hemoglobin levels less than 10 g/dL. CONCLUSIONS The interferon-free regimen of ABT-450, ritonavir, ombitasvir, and dasabuvir, with or without ribavirin, produces a hi
Published: 2014

36. Telaprevir for retreatment of HCV infection.

Author: UCL - Service de gastro-entérologie, UCL - SSS/IREC - Institut de recherche expérimentale et clinique, Zeuzem, Stefan, Andreone, Pietro, Pol, Stanislas, Lawitz, Eric, Diago, Moises, Roberts, Stuart, Focaccia, Roberto, Younossi, Zobair, Foster, Graham R, Horban, Andrzej, Horsmans, Yves, Ferenci, Peter, Nevens, Frederik, Müllhaupt, Beat, Pockros, Paul, Terg, Ruben, Shouval, Daniel, van Hoek, Bart, Weiland, Ola, Van Heeswijk, Rolf, De Meyer, Sandra, Luo, Don, Boogaerts, Griet, Polo, Ramon, Picchio, Gaston, Beumont, Maria, UCL - Service de gastro-entérologie, UCL - SSS/IREC - Institut de recherche expérimentale et clinique, Zeuzem, Stefan, Andreone, Pietro, Pol, Stanislas, Lawitz, Eric, Diago, Moises, Roberts, Stuart, Focaccia, Roberto, Younossi, Zobair, Foster, Graham R, Horban, Andrzej, Horsmans, Yves, Ferenci, Peter, Nevens, Frederik, Müllhaupt, Beat, Pockros, Paul, Terg, Ruben, Shouval, Daniel, van Hoek, Bart, Weiland, Ola, Van Heeswijk, Rolf, De Meyer, Sandra, Luo, Don, Boogaerts, Griet, Polo, Ramon, Picchio, Gaston, and Beumont, Maria
Abstract: Up to 60% of patients with hepatitis C virus (HCV) genotype 1 infection do not have a sustained virologic response to therapy with peginterferon alfa plus ribavirin.
Published: 2011

37. Innate and adaptive immune modulation by Pegylated Interferon Alpha therapy in chronic hepatitis B

Author: Andreone, Pietro, Micco, Lorenzo <1982>, Andreone, Pietro, and Micco, Lorenzo <1982>
Published: 2011

38. Telaprevir for retreatment of HCV infection.

Author: Zeuzem, Stefan, Andreone, Pietro, Pol, Stanislas, Lawitz, Eric, Diago, Moises, Roberts, Stuart, Focaccia, Roberto, Younossi, Zobair, Foster, Graham R, Horban, Andrzej, Ferenci, Peter, Nevens, Frederik, Müllhaupt, Beat, Pockros, Paul, Terg, Ruben, Shouval, Daniel, van Hoek, Bart, Weiland, Ola, Van Heeswijk, Rolf, De Meyer, Sandra, Luo, D, Boogaerts, Griet, Polo, Ramon, Picchio, Gaston, Beumont, Maria, Moreno, Christophe, Zeuzem, Stefan, Andreone, Pietro, Pol, Stanislas, Lawitz, Eric, Diago, Moises, Roberts, Stuart, Focaccia, Roberto, Younossi, Zobair, Foster, Graham R, Horban, Andrzej, Ferenci, Peter, Nevens, Frederik, Müllhaupt, Beat, Pockros, Paul, Terg, Ruben, Shouval, Daniel, van Hoek, Bart, Weiland, Ola, Van Heeswijk, Rolf, De Meyer, Sandra, Luo, D, Boogaerts, Griet, Polo, Ramon, Picchio, Gaston, Beumont, Maria, and Moreno, Christophe
Abstract: Up to 60% of patients with hepatitis C virus (HCV) genotype 1 infection do not have a sustained virologic response to therapy with peginterferon alfa plus ribavirin., Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, info:eu-repo/semantics/published
Published: 2011

39. Telaprevir for retreatment of HCV infection.

Author: Zeuzem, Stefan, Andreone, Pietro, Pol, Stanislas, Lawitz, Eric, Diago, Moises, Roberts, Stuart, Focaccia, Roberto, Younossi, Zobair, Foster, Graham R, Horban, Andrzej, Ferenci, Peter, Nevens, Frederik, Müllhaupt, Beat, Pockros, Paul, Terg, Ruben, Shouval, Daniel, van Hoek, Bart, Weiland, Ola, Van Heeswijk, Rolf, De Meyer, Sandra, Luo, D, Boogaerts, Griet, Polo, Ramon, Picchio, Gaston, Beumont, Maria, Moreno, Christophe, Zeuzem, Stefan, Andreone, Pietro, Pol, Stanislas, Lawitz, Eric, Diago, Moises, Roberts, Stuart, Focaccia, Roberto, Younossi, Zobair, Foster, Graham R, Horban, Andrzej, Ferenci, Peter, Nevens, Frederik, Müllhaupt, Beat, Pockros, Paul, Terg, Ruben, Shouval, Daniel, van Hoek, Bart, Weiland, Ola, Van Heeswijk, Rolf, De Meyer, Sandra, Luo, D, Boogaerts, Griet, Polo, Ramon, Picchio, Gaston, Beumont, Maria, and Moreno, Christophe
Abstract: Up to 60% of patients with hepatitis C virus (HCV) genotype 1 infection do not have a sustained virologic response to therapy with peginterferon alfa plus ribavirin., Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, info:eu-repo/semantics/published
Published: 2011

40. Innate and adaptive immune modulation by Pegylated Interferon Alpha therapy in chronic hepatitis B

Author: Andreone, Pietro, Micco, Lorenzo <1982>, Andreone, Pietro, and Micco, Lorenzo <1982>
Published: 2011

41. Adefovir dipivoxil for wait-listed and post-liver transplantation patients with lamivudine-resistant hepatitis B: Final long-term results

Author: UCL - SSS/IREC - Institut de recherche expérimentale et clinique, Schiff, Eugene, Lai, Cjing-Lung, Hadziyannis, Stephanos, Nuehaus, Peter, Terrault, Norah, Colombo, Massimo, Tillmann, Hans, Samuel, Didler, Zuezem, Stefan, Villenueve, Jean-Pierre, Arteburn, Sarah, Borroto-Esoda, Katyna, Brosgart, Carol, Chuck, Steven, Shakil, Ahmad Obaid, Fung, Jhon, Alberti, Alfredo, Lok, Anna, Picciotto, Antonio, Torre, Francesco, Riely, Caroline, Trepo, Christian, Bizollon, Thierry, Bottaa-Fridlund, Danielle, Gerolami, Rene, Douglas, David, Ranjan, Dinesh, Faust, Dominik, Trojan, Joerg, Gane, Edward, Villa, Erica, Boarino, Modentina, Sokal, Etienne, Starkel, Peter, Bonino, Ferruccio, Maurizio, Brunetto, Gordon, Fred, Pratt, JoAnne, Berr, Frieder, Schiefke, Ingolf, McCaughan, Geoff, Strasser, Simone, Dusheiko, Geoffrey, Pageaux, Georges Philipp, Larrey, Dominique, Pastore, Giuseppe, Santantonio, Teresa, Alexander, Graeme, Woodall, Tracy, Van Vlierberghe, Han, Colle, Isabelle, Harley, Hugh, Guggenheim, Jean, Myx-Staccini, Aline, Metreau, Jean Michel, Mavier, Philippe, Vierling, John, Tran, Tram, Girgrah, Nigel, Nyberg, Lisa, Yuen, Man-Fung, Ma, Mang, Balnco, Manuel Delgado, Merli, Manuela, Tanzilli, Paola, Angelico, Mario, Di Paolo, Daniele, Rizzetto, Mario, Marzano, Alfredo, Lampertico, Pietro, Prieto, Martin, Berenguer, Marina, Felder, Martina, Sterneck, Martina, Willems, Marc, Charlton, Michael, Gunneson, Timothy, Ritter, Michael, Voight, Michael, Swift, Judy, Shiffman, Mitchell, Tassopoulos, Nicholas, Klissas, Isidoros, Naourmov, Nikolai, Chamouard, Patrick, Marcellin, Patrick, Durand, Francois, Angus, Peter, Nathan, Connelly, Toniutto, Pierluigi, Fumo, Elisabetta, Andreone, Pietro, Cursaro, Carmela, Barcena, Rafael, Hoz, Fernando Garcia, Zachoval, Reinhard, Christina, Maria, De Man, Robert Auke, Metselaar, Herold, UCL - SSS/IREC - Institut de recherche expérimentale et clinique, Schiff, Eugene, Lai, Cjing-Lung, Hadziyannis, Stephanos, Nuehaus, Peter, Terrault, Norah, Colombo, Massimo, Tillmann, Hans, Samuel, Didler, Zuezem, Stefan, Villenueve, Jean-Pierre, Arteburn, Sarah, Borroto-Esoda, Katyna, Brosgart, Carol, Chuck, Steven, Shakil, Ahmad Obaid, Fung, Jhon, Alberti, Alfredo, Lok, Anna, Picciotto, Antonio, Torre, Francesco, Riely, Caroline, Trepo, Christian, Bizollon, Thierry, Bottaa-Fridlund, Danielle, Gerolami, Rene, Douglas, David, Ranjan, Dinesh, Faust, Dominik, Trojan, Joerg, Gane, Edward, Villa, Erica, Boarino, Modentina, Sokal, Etienne, Starkel, Peter, Bonino, Ferruccio, Maurizio, Brunetto, Gordon, Fred, Pratt, JoAnne, Berr, Frieder, Schiefke, Ingolf, McCaughan, Geoff, Strasser, Simone, Dusheiko, Geoffrey, Pageaux, Georges Philipp, Larrey, Dominique, Pastore, Giuseppe, Santantonio, Teresa, Alexander, Graeme, Woodall, Tracy, Van Vlierberghe, Han, Colle, Isabelle, Harley, Hugh, Guggenheim, Jean, Myx-Staccini, Aline, Metreau, Jean Michel, Mavier, Philippe, Vierling, John, Tran, Tram, Girgrah, Nigel, Nyberg, Lisa, Yuen, Man-Fung, Ma, Mang, Balnco, Manuel Delgado, Merli, Manuela, Tanzilli, Paola, Angelico, Mario, Di Paolo, Daniele, Rizzetto, Mario, Marzano, Alfredo, Lampertico, Pietro, Prieto, Martin, Berenguer, Marina, Felder, Martina, Sterneck, Martina, Willems, Marc, Charlton, Michael, Gunneson, Timothy, Ritter, Michael, Voight, Michael, Swift, Judy, Shiffman, Mitchell, Tassopoulos, Nicholas, Klissas, Isidoros, Naourmov, Nikolai, Chamouard, Patrick, Marcellin, Patrick, Durand, Francois, Angus, Peter, Nathan, Connelly, Toniutto, Pierluigi, Fumo, Elisabetta, Andreone, Pietro, Cursaro, Carmela, Barcena, Rafael, Hoz, Fernando Garcia, Zachoval, Reinhard, Christina, Maria, De Man, Robert Auke, and Metselaar, Herold
Abstract: Wait-listed (n = 226) or post-liver transplantation (n = 241) chronic hepatitis B (CHB) patients with lamivudine-resistant hepatitis B virus (HBV) were treated with adefovir dipivoxil for a median of 39 and 99 weeks, respectively. Among wait-listed patients, serum HBV DNA levels became undetectable (
Published: 2007

42. Terapia di combinazione con Micofenolato Mofetile ed inibitori della calcineurina a basse dosi: utilità della riduzione della concentrazione ematica pre-dose in pazienti sottoposti a trapianto di fegato con insufficienza renale cronica

Author: Andreone, Pietro, Scuteri, Alessandra <1971>, Andreone, Pietro, and Scuteri, Alessandra <1971>
Published: 2007

43. Terapia di combinazione con Micofenolato Mofetile ed inibitori della calcineurina a basse dosi: utilità della riduzione della concentrazione ematica pre-dose in pazienti sottoposti a trapianto di fegato con insufficienza renale cronica

Author: Andreone, Pietro, Scuteri, Alessandra <1971>, Andreone, Pietro, and Scuteri, Alessandra <1971>
Published: 2007

44. Range of normal liver stiffness and factors associated with increased stiffness measurements in apparently healthy individuals

Author: Bazerbachi, Fateh, Haffar, Samir, Wang, Zhen, Cabezas, Joaquín, Arias-Loste, Maria Teresa, Crespo, Javier, Darwish-Murad, Sarwa, Ikram, M. Arfan, Olynyk, John K., Gan, Eng, Petta, Salvatore, Berzuini, Alessandra, Prati, Daniele, de Lédinghen, Victor, Wong, Vincent W., Del Poggio, Paolo, Chávez-Tapia, Norberto C., Chen, Yong-Peng, Cheng, Pin-Nan, Yuen, Man-Fung, Das, Kausik, Chowdhury, Abhijit, Caballeria, Llorenç, Fabrellas, Núria, Ginès, Pere, Kumar, Manoj, Sarin, Shiv Kumar, Conti, Fabio, Andreone, Pietro, Sirli, Roxana, Cortez-Pinto, Helena, Carvalhana, Sofia, Sugihara, Takaaki, Kim, Seung Up, Parikh, Pathik, Chayama, Kazuaki, Corpechot, Christophe, Kim, Kang Mo, Papatheodoridis, George, Alsebaey, Ayman, Kamath, Patrick S., Murad, M. Hassan, Watt, Kymberly D., Bazerbachi, Fateh, Haffar, Samir, Wang, Zhen, Cabezas, Joaquín, Arias-Loste, Maria Teresa, Crespo, Javier, Darwish-Murad, Sarwa, Ikram, M. Arfan, Olynyk, John K., Gan, Eng, Petta, Salvatore, Berzuini, Alessandra, Prati, Daniele, de Lédinghen, Victor, Wong, Vincent W., Del Poggio, Paolo, Chávez-Tapia, Norberto C., Chen, Yong-Peng, Cheng, Pin-Nan, Yuen, Man-Fung, Das, Kausik, Chowdhury, Abhijit, Caballeria, Llorenç, Fabrellas, Núria, Ginès, Pere, Kumar, Manoj, Sarin, Shiv Kumar, Conti, Fabio, Andreone, Pietro, Sirli, Roxana, Cortez-Pinto, Helena, Carvalhana, Sofia, Sugihara, Takaaki, Kim, Seung Up, Parikh, Pathik, Chayama, Kazuaki, Corpechot, Christophe, Kim, Kang Mo, Papatheodoridis, George, Alsebaey, Ayman, Kamath, Patrick S., Murad, M. Hassan, and Watt, Kymberly D.
Abstract: Bazerbachi, F., Haffar, S., Wang, Z., Cabezas, J., Arias-Loste, M. T., Crespo, J., ... & Petta, S. (2019). Range of normal liver stiffness and factors associated with increased stiffness measurements in apparently healthy individuals. Clinical Gastroenterology and Hepatology, 17(1), 54-64. Available here.

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