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14 results on '"Piai G"'

1. The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes

Author

Carrai, P, Morelli, C, Cordone, G, Romano, A, Tamé, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, the ITACOPS study group, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A. L., Carrai, P, Morelli, C, Cordone, G, Romano, A, Tame, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A, Carrai, Paola, Cristina, Morelli, Cordone, Gabriella, Romano, Antonietta, Tamã©, Mariarosa, Lionetti, Raffaella, Pietrosi, Giada, Lenci, Ilaria, Piai, Guido, Russo, Francesco Paolo, Coppola, Carmine, Melazzini, Mario, Montilla, Simona, Pani, Luca, Petraglia, Sandra, Russo, Pierluigi, Trotta, Maria Paola, Martini, Silvia, Toniutto, Pierluigi, Bandiera, Francesco, Bhoori, Sherrie, Brillanti, Stefano, Burra, Patrizia, Corsale, Sveva, De Luca, Andrea, Fagiuoli, Stefano, Fattovich, Giovanna, Fava, Gianmarco, Felder, Martina, Forte, Paolo, Galeota-Lanza, Alfonso, Gitto, Stefano, Grieco, Antonio, Grossi, Paolo, Ialungo, A. M., Iemmolo, Rosa Maria, Loiacono, Laura, Mangia, Alessandra, Merli, Manuela, Piacentini, A., Pellicelli, Adriano, Rigamonti, Cristina, Gabriella, Verucchi, and Zignego, Anna Linda

Subjects
Compassionate Use Trials, Liver Cirrhosis, Male, 0301 basic medicine, Simeprevir, cholestatic hepatiti, cholestatic hepatitis, hepatitis C, liver transplantation, sofosbuvir, Analysis of Variance, Antiviral Agents, Cohort Studies, Confidence Intervals, Disease Progression, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, Hepatitis C, Chronic, Humans, Italy, Liver Function Tests, Logistic Models, Multivariate Analysis, Prognosis, Recurrence, Ribavirin, Risk Assessment, Severity of Illness Index, Sofosbuvir, Treatment Outcome, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Chronic, Hepatitis C, Combination, 030211 gastroenterology & hepatology, Drug, Viral hepatitis, medicine.drug, medicine.medical_specialty, Daclatasvir, Transplantation, Dose-Response Relationship, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, business.industry, medicine.disease, digestive system diseases, Surgery, 030104 developmental biology, chemistry, Liver function, business
Abstract

Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score

Published
2017

2. Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program

Author

Stefano Fagiuoli, Mario Angelico, Paola Carrai, Marzia Montalbano, Marco Biolato, Teresa Santantonio, Luisa Pasulo, Luca S. Belli, Gabriella Verucchi, Gianpiero D'Offizi, Lorenzo Badia, Elena Angeli, Erica Villa, Marcello Persico, Chiara Mazzarelli, Guido Piai, Raffaella Lionetti, Giovanni Guaraldi, Vanni Borghi, Vincenza Calvaruso, Laura Milazzo, Martina Felder, Antonio Grieco, Massimo Puoti, Antonio Craxì, Alfredo Alberti, Rossella Letizia Mancusi, Calvaruso, Vincenza, Mazzarelli, Chiara, Milazzo, Laura, Badia, Lorenzo, Pasulo, Luisa, Guaraldi, Giovanni, Lionetti, Raffaella, Villa, Erica, Borghi, Vanni, Carrai, Paola, Alberti, Alfredo, Biolato, Marco, Piai, Guido, Persico, Marcello, Santantonio, Teresa, Felder, Martina, Angelico, Mario, Montalbano, Marzia, Mancusi, Rossella Letizia, Grieco, Antonio, Angeli, Elena, D'Offizi, Gianpiero, Fagiuoli, Stefano, Belli, Luca, Verucchi, Gabriella, Puoti, Massimo, Craxì, Antonio, Calvaruso V, Mazzarelli C, Milazzo L, Badia L, Pasulo L, Guaraldi G, Lionetti R, Villa E, Borghi V, Carrai P, Alberti A, Biolato M, Piai G, Persico M, Santantonio T, Felder M, Angelico M, Montalbano M, Mancusi RL, Grieco A, Angeli E, D'Offizi G, Fagiuoli S, Belli L, Verucchi G, Puoti M, Craxì A., Calvaruso, V, Mazzarelli, C, Milazzo, L, Badia, L, Pasulo, L, Guaraldi, G, Lionetti, R, Villa, E, Borghi, V, Carrai, P, Alberti, A, Biolato, M, Piai, G, Persico, M, Santantonio, T, Felder, M, Angelico, M, Montalbano, M, Mancusi, R, Grieco, A, Angeli, E, D'Offizi, G, Fagiuoli, S, Belli, L, Verucchi, G, Puoti, M, and Craxi, A

Subjects
0301 basic medicine, Simeprevir, Liver Cirrhosis, Male, Pyrrolidines, Sofosbuvir, Sustained Virologic Response, lcsh:Medicine, Settore MED/05, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Liver Function Tests, INFECTION, Medicine, PLUS SOFOSBUVIR, lcsh:Science, Sulfonamides, Multidisciplinary, Imidazoles, Valine, Hepatitis C, Middle Aged, Treatment Outcome, Italy, SAFETY, HCV, SUSTAINED VIROLOGICAL RESPONSE, Drug Therapy, Combination, Female, RIBAVIRIN, Settore BIO/19 - MICROBIOLOGIA GENERALE, CHRONIC HEPATITIS-C, medicine.drug, Adult, medicine.medical_specialty, Daclatasvir, Drug-Related Side Effects and Adverse Reactions, Antiviral Agents, Article, 03 medical and health sciences, Internal medicine, Humans, Aged, ADVANCED LIVER-DISEASE, business.industry, Ribavirin, VIRUS GENOTYPE 3, lcsh:R, Hepatitis C, Chronic, HCV HIV Daclatasvir, medicine.disease, Isoquinolines, EFFICACY, Regimen, 030104 developmental biology, chemistry, Asunaprevir, lcsh:Q, Liver function, Carbamates, business, 030217 neurology & neurosurgery
Abstract

We reported the efficacy and safety data for daclatasvir (DCV)-based all-oral antiviral therapy in patients treated in the Italian compassionate-use program. 275 patients were included (202 male-73.5%, mean age: 57.4 years, 62 HIV-coinfected, 94 with recurrence of hepatitis C post-OLT). Forty-nine patients (17.8%) had Child-Pugh B, Genotype(G) distribution was: G1a:72 patients (26.2%), G1b:137 (49.8%); G3:40 (14.5%) and G4:26 (9.5%). Patients received DCV with sofosbuvir(SOF) (n = 221, 129 with ribavirin(RBV) or with simeprevir (SMV) or asunaprevir (ASU) (n = 54, 19 with RBV) for up to 24 weeks. Logistic regression was used to identify baseline characteristics associated with sustained virological response at week 12 post-treatment (SVR12). Liver function changes between baseline and follow up were assessed in 228 patients. 240 patients achieved SVR12 (87.3%), post transplant and HIV co-infected patients were equally distributed among SVR and no SVR (35% vs 34.3%; p = 0.56 and 24.2% vs 11.4%, p = 0.13, respectively). SVR rate was significantly higher with the combination DCV + SOF compared with DCV + SIM or ASU (93.2% vs 63.0%, p

Published
2019

3. Toward Zero Hepatitis C Virus-Related Mortality as a Prerequisite for the Release of Resources in a Center for Follow-up of Liver Transplant

Author

Luca Rinaldi, Tommaso Sgueglia, Giovanna Valente, Guido Piai, Lucia Miglioresi, Valente, G., Miglioresi, L., Sgueglia, T., Rinaldi, L., and Piai, G.

Subjects
Male, medicine.medical_specialty, Sustained Virologic Response, medicine.medical_treatment, Hepacivirus, Hepatitis C virus, Population, medicine.disease_cause, Antiviral Agents, Follow-Up Studie, Retrospective Studie, Internal medicine, Humans, Medicine, education, Retrospective Studies, Antiviral Agent, Excess mortality, Transplantation, education.field_of_study, Hepaciviru, biology, business.industry, Immunosuppression, Retrospective cohort study, Hepatitis C, Hepatitis C, Chronic, medicine.disease, biology.organism_classification, Liver Transplantation, Virologic response, Female, Surgery, business, Follow-Up Studies, Human
Abstract

Taking charge of a liver transplanted (LT) patient implies not only to follow up the transplanted organ (eg, immunosuppression and cancer risk) but also to deal with the prevailing patient’s active problems. The recurrence of hepatitis C on the graft has historically been one of the main active problems to be addressed, leading to 30% to 40% mortality per se in these patients and has involved many resources in the hepatological centers responsible for the follow-up. We verified how much the availability of the new drugs with direct-acting antiviral agents (DAAs) against hepatitis C virus (HCV) has impacted the mortality within the assisted population, changing its characteristics and addressing new clinical issues in the LT-patients. We performed a retrospective comparison between 230 LT patients followed up during pre-DAA era (group 1, with 88 HCV RNA-positive) and 244 patients observed from 2014 onward when DAAs became available (group 2, with 79 HCV RNA-positive). Fifty-two antiviral therapies were performed in group 1 with 18 sustained virologic response (SVR) (35%) and 53 treatments, of which 37 were retreatments, in group 2 with 51 SVR (96%), P = .0001. Deaths for HCV-related causes were 19 of 33 (57%) in group 1 and 7 of 24 (24%) in group 2, P = .01. The Kaplan-Meier showed a dramatic reduction in excess mortality in HCV-LT patients after the availability of DAAs. These results suggest that HCV is no longer the main active problem of follow-up in liver transplants, therefore the resources can be relocated to take care of other clinical aspects.

Published
2019

4. Influence of antiviral therapy on the liver stiffness in chronic HBV hepatitis

Author

Rosa Zampino, Valerio Rosato, Vincenzo Messina, Giovanna Valente, Luigi Elio Adinolfi, Pasquale Orabona, Carmela Buonomo, Luca Rinaldi, Antonio Chirianni, Nicolina de Rosa, Vincenzo Sangiovanni, Antonio Ascione, Guido Piai, Luca Fontanella, Aldo Marrone, Rinaldi, L, Ascione, A, Messina, V, Rosato, V, Valente, G, Sangiovanni, V, Zampino, R, Marrone, A, Fontanella, L, de Rosa, N, Orabona, P, Buonomo, C, Chirianni, A, Adinolfi, Le, and Piai, G.

Subjects
Adult, Liver Cirrhosis, Male, Microbiology (medical), medicine.medical_specialty, Cirrhosis, Antiviral Agents, Gastroenterology, 03 medical and health sciences, Hepatitis B, Chronic, 0302 clinical medicine, Liver stiffness, Fibrosis, Internal medicine, medicine, Humans, Prospective Studies, Aged, Hepatitis, medicine.diagnostic_test, business.industry, General Medicine, Entecavir, Middle Aged, medicine.disease, Infectious Diseases, 030220 oncology & carcinogenesis, Liver biopsy, Elasticity Imaging Techniques, Female, 030211 gastroenterology & hepatology, Hepatic fibrosis, Transient elastography, business, medicine.drug
Abstract

Purpose: The aim of this study was to evaluate the effects of antiviral therapy on liver stiffness measurement (LSM). Methods: Two hundred HBV patients were enrolled from four hospital centers in southern Italy; median age was 50.7 (25–75) males were 68%; 171 patients underwent to liver biopsy and 200 patients had LSM at baseline and 189 at the end of follow-up. One hundred and forty-nine patients were treated with nucleos(t)ide analogs, while 51 patients were untreated. The cutoffs of the LSM, related to the fibrosis stages, were as follows: non-advanced fibrosis ≤ 8.1 kPa and advanced fibrosis ≥ 8.2 Kpa. Results: At baseline, the median value of LSM was 14.1 kPa for advanced fibrosis/cirrhosis and 6.9 kPa for non-advanced fibrosis. LSM was performed at 24 months from the start of therapy. The treated patients (68% received Entecavir and 32% Tenofovir) showed a decrease in liver stiffness measurement of 1.5 kPa (p < 0.001) in non-advanced fibrosis and of 6 kPa (p < 0.001) in advanced fibrosis/cirrhosis. In the patients not undergoing antiviral treatment, no statistically significant change of the LSM was observed (p = 0.26). A logistic binary regression model showed that the only independent factor associated with a significant change in the LSM was the liver stiffness value at baseline (odd ratio 2.855; 95% CI 1.456–5.788; (p = 0.007). Conclusion: Long-term antiviral therapy induced a significant reduction of liver stiffness measurement and this result may be related to the reduction of liver fibrosis. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature.

Published
2018

5. Role of Liver Stiffness Measurement in Predicting HCC Occurrence in Direct-Acting Antivirals Setting: A Real-Life Experience

Author

Giovanna Valente, Alessio Trabucco, Barbara Guerrera, Ferdinando Carlo Sasso, Maria Guarino, Luigi Elio Adinolfi, Michele Imparato, Pia Clara Pafundi, Luca Rinaldi, Riccardo Nevola, Antonio Ascione, Natalina Iuliano, Alessandro Perrella, Filomena Morisco, Guido Piai, Luca Fontanella, Rinaldi, Luca, Guarino, Maria, Perrella, Alessandro, Pafundi, Pia Clara, Valente, Giovanna, Fontanella, Luca, Nevola, Riccardo, Guerrera, Barbara, Iuliano, Natalina, Imparato, Michele, Trabucco, Alessio, Sasso, Ferdinando Carlo, Morisco, Filomena, Ascione, Antonio, Piai, Guido, Adinolfi, Luigi Elio, Rinaldi, L., Guarino, M., Perrella, A., Pafundi, P. C., Valente, G., Fontanella, L., Nevola, R., Guerrera, B., Iuliano, N., Imparato, M., Trabucco, A., Sasso, F. C., Morisco, F., Ascione, A., Piai, G., and Adinolfi, L. E.

Subjects
Liver Cirrhosis, Male, medicine.medical_specialty, Carcinoma, Hepatocellular, Cirrhosis, Transient elastography, Physiology, Direct-acting antiviral, Antiviral Agents, Risk Assessment, Sensitivity and Specificity, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Elastic Modulus, Internal medicine, Humans, Medicine, HCC, business.industry, Liver Neoplasms, Liver stiffne, Reproducibility of Results, Hepatitis C, Hepatitis C, Chronic, Middle Aged, Hepatology, medicine.disease, digestive system diseases, HCV cirrhosi, Liver, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Elasticity Imaging Techniques, Female, 030211 gastroenterology & hepatology, business, Risk assessment, Viral hepatitis
Abstract

The aim of this study was to evaluate the relationship between the liver stiffness measurement and the risk of developing hepatocellular carcinoma (HCC) in HCV cirrhotic patients undergoing new direct-acting antivirals.From April 2015 to April 2017, all consecutive HCV cirrhotic patients treated by direct-acting antivirals were enrolled. A liver stiffness measurement was computed at baseline, and an ultrasound evaluation was provided for all patients at baseline and every 6 months until 1 year after the stopping of the antiviral therapy. The diagnosis of HCC was performed according to international guidelines by imaging technique workup.Two hundred and fifty-eight HCV patients with a diagnosis of cirrhosis were identified. The median liver stiffness was 25.5 kPa. Thirty-five patients developed HCC. Patients were divided into three groups, based on their liver stiffness: 20 kPa (n = 72), between 20 and 30 kPa (n = 92) and 30 kPa (n = 94). Compared to the 20 kPa and 20-30 kPa groups, the 30 kPa group showed a statistically significant increased risk of HCC (p = 0.019; HR 0.329; 95% CI 0.131-0.830). A ROC curve analysis to assess the overall predictive performance of liver stiffness measurement on the HCC risk was performed. The results allow us to identify a cutoff value of liver stiffness measurement equal to 27.8 kPa, which guarantees the highest sensitivity and specificity (respectively, 72% and 65%).The data underline that the baseline liver stiffness measurement and ultrasound surveillance is a valuable tool for assessing the risk of HCC in cirrhotic patients undergoing the direct-acting antivirals treatment.

Published
2019

6. Incidence and risk factors of early HCC occurrence in HCV patients treated with direct acting antivirals: a prospective multicentre study

Author

Maria Guarino, Nicola Coppola, Luigi Elio Adinolfi, Guido Piai, Massimo De Luca, Antonio Izzi, Morena Fasano, Luca Rinaldi, Fortunato Ciardiello, Ferdinando Carlo Sasso, Riccardo Nevola, Filomena Morisco, Giovanna Valente, Alessandro Perrella, Caterina Monari, Pia Clara Pafundi, Lucia Miglioresi, Erika Martinelli, Barbara Guerrera, Massimiliano Berretta, Rinaldi, Luca, Perrella, Alessandro, Guarino, Maria, De Luca, Massimo, Piai, Guido, Coppola, Nicola, Pafundi, Pia Clara, Ciardiello, Fortunato, Fasano, Morena, Martinelli, Erika, Valente, Giovanna, Nevola, Riccardo, Monari, Caterina, Miglioresi, Lucia, Guerrera, Barbara, Berretta, Massimiliano, Sasso, Ferdinando Carlo, Morisco, Filomena, Izzi, Antonio, Adinolfi, Luigi Elio, Rinaldi, L., Perrella, A., Guarino, M., De Luca, M., Piai, G., Coppola, N., Pafundi, P. C., Ciardiello, F., Fasano, M., Martinelli, E., Valente, G., Nevola, R., Monari, C., Miglioresi, L., Guerrera, B., Berretta, M., Sasso, F. C., Morisco, F., Izzi, A., and Adinolfi, L. E.

Subjects
Liver Cirrhosis, Male, 0301 basic medicine, Cirrhosis, Sustained Virologic Response, Sofosbuvir, lcsh:Medicine, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Medicine, Cumulative incidence, Prospective Studies, HCC, Incidence, Incidence (epidemiology), HCV cirrhosis, Liver Neoplasms, General Medicine, Middle Aged, 030220 oncology & carcinogenesis, Female, Immune-surveillance, Off Treatment, medicine.drug, medicine.medical_specialty, Carcinoma, Hepatocellular, Antiviral Agents, General Biochemistry, Genetics and Molecular Biology, Direct acting antivirals, 03 medical and health sciences, Diabetes mellitus, Internal medicine, Humans, Aged, business.industry, Research, Ribavirin, lcsh:R, Hepatitis C, Chronic, medicine.disease, digestive system diseases, Regimen, HCV cirrhosi, Logistic Models, 030104 developmental biology, chemistry, Multivariate Analysis, Direct acting antiviral, business
Abstract

Background An unexpected increased HCC recurrence and occurrence rate among HCV patients treated with direct acting antivirals combination has been reported. Aim of the study was the evaluation of early HCC occurrence rate and its risk factors in a HCV infected population, treated with direct-acting-antivirals. Methods According to the Italian ministerial guidelines for direct-acting-antivirals treatment, 1022 consecutive HCV patients treated with direct-acting-antivirals were enrolled. Patients either with active HCC at imaging or history of previous treated HCC, HBV or HIV co-infection, or liver transplant recipients were excluded. The SVR, defined as the persistent absence of detectable serum HCV-RNA 12 weeks after the end of treatment (SVR12), was assessed for all enrolled patients. Abdominal ultrasound was performed before starting antiviral therapy, and repeated every 6 months. HCC was diagnosed according to the international guidelines. Patients showing either nodular patterns suggestive of HCC or with uncertain dynamic vascular behaviour were excluded from a further follow-up. Results Nine hundred and eighty-five patients completed the 48 weeks follow-up after the end of treatment. A Sofosbuvir-based regimen was administered in the 74.9% of patients, among whom, the 71.6% underwent a simultaneous Ribavirin administration. A sustained virological response at 12 weeks off treatment was documented in 966 patients (98.2%). During the post treatment follow-up HCC was detected in 35 patients, with a cumulative incidence rate of the 3.55%. At multivariate analysis, four variables resulted independently associated with HCC development, both in a cirrhosis based and a class B Child based model, respectively: cirrhosis/class B Child, therapeutic schedule including Sofosbuvir without Ribavirin, liver stiffness values, male gender and presence of diabetes. A multivariate analysis performed on Child A cirrhotic patients, showed that Sofosbuvir based therapeutic treatment without Ribavirin had a HCC occurrence 5.7 higher than Ribavirin-based schedules with or without Sofosbuvir (p

Published
2019

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

Author

Giada Carolo, Veronica Bernabucci, Luchino Chessa, Maria Luisa Russo, Giorgio Maria Saracco, Marzia Montalbano, Barbara Menzaghi, Giovanni Di Perri, Adriano Lazzarin, Silvia La Monica, Raffaele Bruno, Gian Ludovico Rapaccini, Mario U. Mondelli, Anna Maria Schimizzi, Caterina Pasquazzi, Maurizia Rossana Brunetto, Antonio Craxì, Filomena Morisco, Carmela Lo Guercio, Vania Giacomet, Alessia Giorgini, Mario Masarone, Francesca Paolo Russo, T. Zolfino, Vincenzo Sangiovanni, Alessia Ciancio, Antonella d'Arminio Monforte, Savino Bruno, E.M. Erne, Antonio Gasbarrini, Francesco Castelli, Sergio Novara, G. Nardone, Andrea De Luca, Claudio Maria Mastroianni, Gioacchino Angarano, Chiara Dentone, Renato Maserati, Anna Maria Piscaglia, Tiziana Quirino, Giuseppe Tarantino, M. Lichtner, Antonio Chirianni, Giuseppina Brancaccio, S. Paganin, Alfredo Alberti, Silvia Corradori, Edoardo G. Giannini, Carlo Torti, Chiara Boarini, Raffaele Cozzolongo, Marco Di Stefano, Alessandro Soria, Paolo Tundi, Giovanni Cassola, Debora Angrisani, Antonio Grieco, Cecilia Pravadelli, Giuliano Rizzardini, Roberto Gulminetti, Vincenzo Messina, Maria Rendina, Massimo Pirisi, Irene Cacciola, Roberto Ganga, Raffaella Lionetti, Paolo Calabrese, Laura Ponti, Filomena Simeone, Maurizio Russello, Monica Monti, Nicola Boffa, Pierluigi Tarquini, Franco Capra, Ivo Avancini, Domenico Sansonno, Stefano Fagiuoli, Michele Barone, Giacomo Vecchiet, Salvatore Rizzo, Carlo Federico Perno, Teresa Santantonio, Pierluigi Toniutto, Massimo Zuin, Nicola Caporaso, Alessandra Orlandini, Grazielle Marie Pigozzi, Martina Felder, Antonio Cristaudo, Roberto Cecere, Massimo Marignani, Vincenza Calvaruso, G. Abbati, Domenico Potenza, Maria Chiara Piras, Mario Rizzetto, Serena Cima, Marco delle Monache, Alessio Aghemo, D. Ieluzzi, Guglielmo Borgia, Giampaolo Corti, Paolo Poggio, Manuela Merli, Elena Danieli, Andrea Giacometti, Massimo Andreoni, Antonino Picciotto, Mario Angelico, Benedetta Canovari, Sara Piovesan, Anna Linda Zignego, Antonio Benedetti, Emanuele Durante, Erica Villa, Marcello Persico, Antonio Patrizio Termite, Barbara Coco, Maria Vinci, Lucio Boglione, Cristina Rossi, Paolo Angeli, Massimo Memoli, Maria Teresa Giordani, Massimo De Luca, Luisa Pasulo, Vincenzo Vullo, Mario Melazzini, Attilio Solinas, Pietro Gatti, Michele Guerra, Silvia Martini, Antonio Ascione, Massimo Puoti, Roberto Cauda, Giovanna Onnelli, Silvia Magnani, Salvatore Madonna, Giovanni Raimondo, Marco Tabone, Gloria Taliani, Dante Romagnoli, Aldo Marrone, Umberto Vespasiani Gentilucci, Luca Miele, Marcello Tavio, Andrea Antinori, Giampiero D'Offizi, Mirella Onofrio, Valentina Iodice, Lucio Cosco, Guido Piai, Luca Pani, Francesca Ceccherini Silberstein, Simona Montilla, Marco Lenzi, Luca Fontanella, Alessandro Federico, Carlo Ferrari, Giustino Parruti, Antonio Di Biagio, Gabriella Verucchi, Fabio Marsetti, Michele Milella, Maria Grazia Rumi, Antonio Izzi, Marco Marzioni, Francesca Donato, Vanni Borghi, Mariano Quartini, Massimo Colombo, Michele Imparato, Giovanni Battista Gaeta, P.L. Blanc, Alfredo Di Leo, Nicola Coppola, Alessandro Chiodera, Ivana Maida, Davide Campagnolo, Cinzia Antonini, Antonietta Romano, A. Gianstefani, Katia Falasca, Massimo Levrero, Gaetano Serviddio, Maria Paola Trotta, Olivia Morelli, Salvatore Petta, Elisabetta Teti, Maria Rita Parisi, Pietro Andreone, 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, Ascione, A, De Luca, M, Melazzini, M, Montilla, S, Trotta, M, Petta, S, Puoti, M, Sangiovanni, V, Messina, V, Bruno, S, Izzi, A, Villa, E, Aghemo, A, Zignego, A, Orlandini, A, Fontanella, L, Gasbarrini, A, Marzioni, M, Giannini, E, Craxi, A, Abbati, G, Alberti, A, Andreone, P, Andreoni, M, Angeli, P, Angelico, M, Angarano, G, Angrisani, D, Antinori, A, Antonini, C, Avancini, I, Barone, M, Bruno, R, Benedetti, A, Bernabucci, V, Blanc, P, Boarini, C, Boffa, N, Boglione, L, Borghi, V, Borgia, G, Brancaccio, G, Brunetto, M, Cacciola, I, Calabrese, P, Calvaruso, V, Campagnolo, D, Canovari, B, Caporaso, N, Capra, F, Carolo, G, Cassola, G, Castelli, F, Cauda, R, Silberstein, F, Cecere, R, Chessa, L, Chiodera, A, Chirianni, A, Ciancio, A, Cima, S, Coco, B, Colombo, M, Coppola, N, Corti, G, Cosco, L, Corradori, S, Cozzolongo, R, Cristaudo, A, Danieli, E, Monforte, A, Monache, M, Del Poggio, P, de Luca, A, Dentone, C, Di Biagio, A, Di Leo, A, Di Perri, G, Di Stefano, M, D'Offizi, G, Donato, F, Durante, E, Erne, E, Fagiuoli, S, Falasca, K, Federico, A, Felder, M, Ferrari, C, Gaeta, G, Ganga, R, Gatti, P, Giacomet, V, Giacometti, A, Gianstefani, A, Giordani, M, Giorgini, A, Grieco, A, Guerra, M, Gulminetti, R, Ieluzzi, D, Imparato, M, Iodice, V, La Monica, S, Lazzarin, A, Lenzi, M, Levrero, M, Lichtner, M, Lionetti, R, Guercio, C, Madonna, S, Magnani, S, Maida, I, Marignani, M, Marrone, A, Marsetti, F, Martini, S, Masarone, M, Maserati, R, Mastroianni, C, Memoli, M, Menzaghi, B, Merli, M, Miele, L, Milella, M, Mondelli, M, Montalbano, M, Monti, M, Morelli, O, Morisco, F, Nardone, G, Novara, S, Onnelli, G, Onofrio, M, Paganin, S, Pani, L, Parisi, M, Parruti, G, Pasquazzi, C, Pasulo, L, Perno, C, Persico, M, Piai, G, Picciotto, A, Pigozzi, G, Piovesan, S, Piras, M, Pirisi, M, Piscaglia, A, Ponti, L, Potenza, D, Pravadelli, C, Quartini, M, Quirino, T, Raimondo, G, Rapaccini, G, Rendina, M, Rizzardini, G, Rizzetto, M, Rizzo, S, Romagnoli, D, Romano, A, Rossi, C, Rumi, M, Russello, M, Russo, F, Russo, M, Sansonno, D, Santantonio, T, Saracco, G, Schimizzi, A, Serviddio, G, Simeone, F, Solinas, A, Soria, A, Tabone, M, Taliani, G, Tarantino, G, Tarquini, P, Tavio, M, Termite, A, Teti, E, Toniutto, P, Torti, C, Tundi, P, Vecchiet, G, Verucchi, G, Gentilucci, U, Vinci, M, Vullo, V, Zolfino, T, and Zuin, M

Subjects
Cyclopropanes, Liver Cirrhosis, Male, Cirrhosis, Dasabuvir, Elderly, Ombitasvir, Paritaprevir, Aged, 80 and over, Anilides, Antiviral Agents, Biomarkers, Carbamates, Female, Hepacivirus, Hepatitis C, Chronic, Humans, Macrocyclic Compounds, Ribavirin, Ritonavir, Sulfonamides, Treatment Outcome, Uracil, Drug Therapy, Combination, Genotype, Cirrhosis, Dasabuvir, Elderly, Ombitasvir, Paritaprevir, Microbiology (medical), Infectious Diseases, Aged, 80 and over, Hepatitis C, Chronic, Drug Therapy, Combination, Microbiology (medical), Infectious Diseases, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, 2-Naphthylamine, Medicine, 030212 general & internal medicine, Valine, General Medicine, 030211 gastroenterology & hepatology, Macrocyclic Compound, medicine.drug, Human, medicine.medical_specialty, Proline, Lactams, Macrocyclic, Settore MED/12 - GASTROENTEROLOGIA, Liver Cirrhosi, Sulfonamide, 03 medical and health sciences, Internal medicine, Decompensation, Hepatitis, Antiviral Agent, Cirrhosi, Hepaciviru, business.industry, Settore MED/09 - MEDICINA INTERNA, Anilide, Biomarker, medicine.disease, chemistry, Carbamate, business
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 65years. 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 (25/150/100mg) and twice-daily dasabuvir (250mg) 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 12weeks 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 < 3.5g/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 < 2mg/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

8. Prevalent use of combined prophylaxis of hepatitis B after liver transplantation in Italy: results of a national survey in a large cohort

Author

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, Ispheb, Group, 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, Lotti Suffredini, Anna, 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, 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, and Vukotic, R

Subjects
0106 biological sciences, Prophylaxis reinfection, Hepatitis B virus-liver transplantation, Immunoglobulins, Chemoprevention, Health Care Surveys, Hepatitis B, Hepatitis B Core Antigens, Humans, Italy, Postoperative Complications, Practice Patterns, Physicians', Retrospective Studies, Tissue Donors, Liver Transplantation, Internal Medicine, Endocrinology, Diabetes and Metabolism, Nutrition and Dietetics, Gastroenterology, medicine.medical_treatment, Practice Patterns, Liver transplantation, 01 natural sciences, 0302 clinical medicine, Endocrinology, Epidemiology, Nutrition and Dietetic, Hepatitis B virus, virus diseases, Entecavir, Diabetes and Metabolism, Hepatocellular carcinoma, Coinfection, 030211 gastroenterology & hepatology, medicine.drug, medicine.medical_specialty, Virus, 03 medical and health sciences, 010608 biotechnology, Internal medicine, medicine, Immunoglobulin, Liver Transplantation, Hepatitis B, Prophylaxis reinfection, Physicians', business.industry, Retrospective cohort study, medicine.disease, digestive system diseases, Settore MED/18, business
Abstract

BACKGROUND Prophylaxis of hepatitis B after liver transplantation with antiviral(s) and immunoglobulins efficiently 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 confirm: 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

9. DAA-based regimens in HBsAg/anti-HCV positive patients: The need to control HBV replication to avoid HBV reactivation

Author

G.B. Gaeta, S. De Pascalis, G. Stornaiuolo, Vincenzo Sangiovanni, Giuseppe D'Adamo, Vincenzo Messina, Nicola Coppola, Ivan Gentile, Margherita Macera, Maria Stanzione, Guido Piai, Luca Fontanella, Macera, M., Stanzione, M., Messina, V., D’Adamo, G., Sangiovanni, V., Fontanella, L., De Pascalis, S., Stornaiuolo, G., Piai, G., Gaeta, G. B., Gentile, Ivan, and Coppola, N.

Subjects
HBsAg, Hepatology, business.industry, Anti hiv, Gastroenterology, Hbv reactivation, Medicine, business, Hbv replication, Virology
Published
2017

10. Sorafenib plus octreotide is an effective and safe treatment in advanced hepatocellular carcinoma: multicenter phase II So.LAR. study

Author

Antonio Febbraro, Agata Pisano, Elena Capasso, Raffaele Addeo, Vincenzo Faiola, Rosanna Mamone, M. Bianco, Alberto D’Agostino, Vincenzo Montesarchio, Clementina Savastano, Luciano Tarantino, Michele Caraglia, Salvatore Del Prete, Antonietta Sabia, Gregorio Cennamo, Giovannella Palmieri, Luigi Maiorino, Guido Piai, Rosario Guarrasi, Liliana Montella, Bruno Vincenzi, Prete, Sd, Montella, Liliana, Caraglia, M, Maiorino, L, Cennamo, G, Montesarchio, V, Piai, G, Febbraro, A, Tarantino, L, Capasso, E, Palmieri, Giovannella, Guarrasi, R, Bianco, M, Mamone, R, Savastano, C, Pisano, A, Vincenzi, B, Sabia, A, D'Agostino, A, Faiola, V, Addeo, R., DEL PRETE, Sd, Montella, L, Caraglia, Michele, and Palmieri, G

Subjects
Diarrhea, Male, Niacinamide, Sorafenib, Cancer Research, medicine.medical_specialty, Carcinoma, Hepatocellular, Survival, Pyridines, medicine.drug_class, Population, Octreotide, Toxicology, Gastroenterology, Tyrosine-kinase inhibitor, Multikinase inhibitor, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Pharmacology (medical), education, Aged, Aged, 80 and over, Pharmacology, education.field_of_study, business.industry, Phenylurea Compounds, Benzenesulfonates, Liver Neoplasms, Cancer, hepatocellular carcinoma, Middle Aged, medicine.disease, digestive system diseases, Surgery, Treatment Outcome, Oncology, Hepatocellular carcinoma, Hypertension, Disease Progression, Female, Liver cancer, business, octreotide, medicine.drug
Abstract

PURPOSE: Advanced hepatocellular carcinoma (HCC) not eligible for local therapies has limited chances of cure. Sorafenib is a multikinase inhibitor with proven activity in advanced HCC. Octreotide is used in this setting with conflicting results. Treatment with sorafenib and long-acting octreotide was tested in advanced HCC to evaluate safety and activity. METHODS: Fifty patients with advanced HCC, Child-Pugh A or B, received sorafenib at a dosage of 800 mg/day for 28 days with a following week of rest and long-acting octreotide at a dose of 40 mg, administered every 28 days. RESULTS: All patients were assessable for safety and efficacy. Sixteen patients out of 50 (34%) were naïve from other therapies, while all the others were previously treated with local and/or systemic treatments. We achieved 5 partial responses (10%), 33 stable diseases (66%) and 12 progressions of disease (24%). Median time to progression was 7.0 months (95% CI, 3.0-10.9 months), and median overall survival was 12 months (95% CI, 6.3-17.4 months). Treatment was well tolerated. Diarrhoea (6%) and hypertension (4%) were the most frequent grade 3 toxicities. CONCLUSIONS: Our data suggest that the combination between sorafenib and long-acting octreotide is active and well tolerated in patients with advanced HCC and could represent another efficacious chance for the management of this population.

Published
2009

11. Diagnosis and clinical impact of occult hepatitis B infection in patients with biopsy proven chronic hepatitis C: A multicenter study

Author

Imparato Michele, Moggio Giovanni, Del Vecchio Blanco Camillo, Sagnelli Evangelista, Coppola Nicola, Caprio Nunzio, Bruno Marika, Piai Guido, Pasquale Giuseppe, Stanzione Maria, Pisapia Raffaella, Sagnelli Caterina, Messina Vincenzo, Sagnelli, E., Imparato, M., Coppola, Nicola, Pisapia, R., Sagnelli, Caterina, Messina, V., Piai, G., Stanzione, M., Bruno, M., Maggio, G., Caprio, N., Pasquale, Giuseppe, and DEL VECCHIO BLANCO, C.

Subjects
Adult, Liver Cirrhosis, Male, liver diseases, Biopsy, Hepatitis C virus, Hepacivirus, medicine.disease_cause, Polymerase Chain Reaction, Severity of Illness Index, Plasma, Flaviviridae, Virology, Prevalence, medicine, Humans, Aged, DNA Primers, Hepatitis B virus, biology, medicine.diagnostic_test, business.industry, occult HBV infection, virus diseases, Hepatitis C, Chronic, Middle Aged, Hepatitis B, biology.organism_classification, medicine.disease, Occult, digestive system diseases, Infectious Diseases, Liver, HCV genotype, HCV, DNA, Viral, Immunology, Leukocytes, Mononuclear, Female, Viral disease, business
Abstract

Occult hepatitisB virus (HBV) infection in patients with chronic hepatitis C has been found associated with severe liver damage, low response to interferon treatment and increased risk of developing HCC. However, doubts remain on its clinical impact and the sensitivity and specificity of its detection. HBV-DNA was sought by PCR in plasma, peripheral blood mononuclear cells (PBMCs) and liver compartments of 89 patients with biopsy proven chronic hepatitis C, using sets of primers for core (‘‘c’’), surface (‘‘s’’), and x (‘‘x’’) regions of HBV genome. Occult HBV infection was defined by the presence of HBVDNA in at least two different PCRs in at least one compartment. Occult HBV infection was detected in 37 (41.6%) of the 89 patients investigated. It was more frequent (80.8%) in 26 anti- HBs negative/anti-HBc positive patients than in 18 anti-HBs/anti-HBc positive (61.1%, P

Published
2008

12. Conversion From Twice-Daily to Once-Daily Tacrolimus in Stable Liver Transplant Patients: Effectiveness in a Real-World Setting

Author

M. Sgambato, Guido Piai, Luca Rinaldi, G. Valente, Valente, G., Rinaldi, L., Sgambato, M., and Piai, G.

Subjects
Adult, Male, medicine.medical_specialty, Urology, Renal function, Drug Administration Schedule, Tacrolimus, Humans, Medicine, Dosing, Adverse effect, Aged, Transplantation, business.industry, Middle Aged, Liver Transplantation, Surgery, Regimen, Treatment Outcome, surgical procedures, operative, Trough level, Female, Transplant patient, business, Immunosuppressive Agents
Abstract

Background The prolonged-release once-daily (QD) tacrolimus is a formulation developed to improve adherence to immunosuppressant (IS) regimen, reducing the frequency of dosing, and to increase safety, avoiding toxic peak concentrations. We evaluated efficiency and quality of conversion from twice-daily (BID) to QD tacrolimus formulation in stable liver transplant (LT) recipients in the real-setting of a gastrohepatology team peripheral to LT centers. Patients and methods Thirty-four LT recipients (median age 60 years, range 33–69) were switched from BID tacrolimus to QD tacrolimus (1:1 dose) at a median of 38 months (range 8–211) after transplantation. Tacrolimus levels and laboratory analyses were recorded before and postconversion. Adherence to IS treatment was measured by a modified “Basel Assessment of Adherence Scale to Immunosuppressives.” Results Median postconversion follow-up was 21 months (range 6–35, at least 12 months in 30 patients). Mean total tacrolimus daily dose and mean tacrolimus trough level were not significantly different before and after the switch (3.1 ± 2.3 preconversion versus 3.1 ± 2.5 and 3.0 ± 2.5 mg at 6 and 12 months postconversion, respectively; and 5.3 ± 1.8 preconversion versus 4.6 ± 1.4 and 4.5 ± 1.8 ng/mL at 6 and 12 months postconversion, respectively). All patients maintained stable liver and metabolic parameters. Renal function by glomerular filtration rate increased (67 ± 17 preconversion versus 73 ± 19 and 73 ± 20 mL/min at 6 and 12 months postconversion, respectively; P = .003). No acute rejection episode or major severe adverse events occurred postconversion. Patient-reported outcome showed a reduction of missed IS doses. Conclusion We observed that in a real-world setting far from LT centers, the switch from BID tacrolimus to QD tacrolimus in stable LT recipients is efficient (safe and effective) to improve quality of medical care, with possibly better IS adherence and improvement of renal function.

Published
2013

13. Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience

Author

Antonio Ascione, null CLEO Study Group, Luigi Elio Adinolfi, Pietro Amoroso, Angelo Andriulli, Orlando Armignacco, Tiziana Ascione, Sergio Babudieri, Giorgio Barbarini, Michele Brogna, Francesco Cesario, Vincenzo Citro, Ernesto Claar, Raffaele Cozzolongo, Giuseppe D’Adamo, Emilio D’Amico, Pellegrino Dattolo, Massimo De Luca, Vincenzo De Maria, Massimo De Siena, Giuseppe De Vita, Antonio Di Giacomo, Rosanna De Marco, Giorgio De Stefano, Giulio De Stefano, Sebastiano Di Salvo, Raffaele Di Sarno, Nunzia Farella, Laura Felicioni, Basilio Fimiani, Luca Fontanella, Giuseppe Foti, Caterina Furlan, Francesca Giancotti, Giancarlo Giolitto, Tiziana Gravina, Barbara Guerrera, Roberto Gulminetti, Angelo Iacobellis, Michele Imparato, Angelo Iodice, Vincenzo Iovinella, Antonio Izzi, Alfonso Liberti, Pietro Leo, Gennaro Lettieri, Ileana Luppino, Aldo Marrone, Ettore Mazzoni, Vincenzo Messina, Roberto Monarca, Vincenzo Narciso, Lorenzo Nosotti, Adriano Maria Pellicelli, Alessandro Perrella, Guido Piai, Antonio Picardi, Paola Pierri, Grazia Pietromatera, Francesco Resta, Luca Rinaldi, Mario Romano, Angelo Rossini, Maurizio Russello, Grazia Russo, Rodolfo Sacco, Vincenzo Sangiovanni, Antonio Schiano, Antonio Sciambra, Gaetano Scifo, Filomena Simeone, Annarita Sullo, Pierluigi Tarquini, Paolo Tundo, Alfredo Vallone, Ascione, A, Adinolfi, Luigi Elio, Amoroso, P, Andriulli, A, Armignacco, O, Ascione, T, Babudieri, S, Barbarini, G, Brogna, M, Cesario, F, Citro, V, Claar, E, Cozzolongo, R, D'Adamo, G, D'Amico, E, Dattolo, P, De Luca, M, De Maria, V, De Siena, M, De Vita, G, Di Giacomo, A, De Marco, R, De Stefano, G, Di Salvo, S, Di Sarno, R, Farella, N, Felicioni, L, Fimiani, B, Fontanella, L, Foti, G, Furlan, C, Giancotti, F, Giolitto, G, Gravina, T, Guerrera, B, Gulminetti, R, Iacobellis, A, Imparato, M, Iodice, A, Iovinella, V, Izzi, A, Liberti, 1, Leo, P, Lettieri, G, Luppino, I, Marrone, Aldo, Mazzoni, E, Messina, V1, Monarca, R, Narciso, V, Nosotti, L, Pellicelli, Am, Perrella, A, Piai, G, Picardi, A, Pierri, P, Pietromatera, G, Resta, F, Rinaldi, L, Romano, M, Rossini, A, Russello, M, Russo, G, Sacco, R, Sangiovanni, V, Schiano, A, Sciambra, A, Scifo, G, Simeone, F, Sullo, A, Tarquini, P, Tundo, P, and Vallone, A.

Subjects
viruses, Hepatitis C virus, Observational Study, Antiviral therapy, Boceprevir, Chronic hepatitis, Peg-interferon, Ribavirin, Telaprevir, Hepatology, medicine.disease_cause, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Medicine, 030212 general & internal medicine, Telaprevi, business.industry, Virology, Peg interferon, Chronic infection, chemistry, Chronic hepatiti, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

AIM:To check the safety and efficacy of boceprevir/telaprevir with peginterferon/ribavirin for hepatitis C virus (HCV) genotype 1 in the real-world settings. METHODS: This study was a non-randomized, observational, prospective, multicenter. This study involved 47 centers in Italy. A database was prepared for the homogenous collection of the data, was used by all of the centers for data collection, and was updated continuously. All of the patients enrolled in this study were older than 18 years of age and were diagnosed with chronic infection due to HCV genotype 1. The HCV RNA testing was performed using COBAS-TaqMan2.0 (Roche, LLQ 25 IU/mL). RESULTS: All consecutively treated patients were included. Forty-seven centers enrolled 834 patients as follows: Male 64%; median age 57 (range 18-78), of whom 18.3% were over 65; mean body mass index 25.6 (range 16-39); genotype 1b (79.4%); diagnosis of cirrhosis (38.2%); and fibrosis F3/4 (71.2%). The following drugs were used: Telaprevir (66.2%) and PEG-IFN-alpha2a (67.6%). Patients were naïve (24.4%), relapsers (30.5%), partial responders (14.8%) and null responders (30.3%). Overall, adverse events (AEs) occurred in 617 patients (73.9%) during the treatment. Anemia was the most frequent AE (52.9% of cases), especially in cirrhotic. The therapy was stopped for 14.6% of the patients because of adverse events or virological failure (15%). Sustained virological response was achieved in 62.7% of the cases, but was 43.8% in cirrhotic patients over 65 years of age. CONCLUSION: In everyday practice, triple therapy is safe but has moderate efficacy, especially for patients over 65 years of age, with advanced fibrosis, non-responders to peginterferon + ribavirin.

Published
2016

14. Survival after Locoregional Treatments for Hepatocellular Carcinoma: A Cohort Study in Real-World Patients

Author

Paolo Chiodini, Francesco Perrone, Mario Fusco, Nicola Lama, Vincenzo Castaldo, F. Calise, Massimo Di Maio, Ilario de Sio, Graziano Olivieri, Ciro Gallo, Bruno Daniele, Giovanni Battista Gaeta, Giovanni G. Di Costanzo, Guido Piai, Giuseppe Signoriello, Simona Signoriello, Giampiero Marone, Mario Visconti, Rosario Lanzetta, Annalisa Annunziata, Signoriello, Simona, Annunziata, A, Lama, N, Signoriello, Giuseppe, Chiodini, Paolo, De Sio, I, Daniele, B, Di Costanzo, Gg, Calise, F, Olivieri, G, Castaldo, V, Lanzetta, R, Piai, G, Marone, G, Visconti, M, Fusco, M, Di Maio, M, Perrone, F, Gallo, Ciro, and Gaeta, Giovanni Battista

Subjects
Male, medicine.medical_specialty, Carcinoma, Hepatocellular, Article Subject, Radiofrequency ablation, medicine.medical_treatment, lcsh:Medicine, Kaplan-Meier Estimate, lcsh:Technology, Gastroenterology, General Biochemistry, Genetics and Molecular Biology, law.invention, Randomized controlled trial, law, Internal medicine, Medicine, Humans, lcsh:Science, General Environmental Science, Aged, Proportional Hazards Models, Retrospective Studies, Chemotherapy, lcsh:T, business.industry, Proportional hazards model, lcsh:R, Liver Neoplasms, technology, industry, and agriculture, Retrospective cohort study, General Medicine, Middle Aged, medicine.disease, Surgery, surgical procedures, operative, Treatment Outcome, Hepatocellular carcinoma, lcsh:Q, Female, Percutaneous ethanol injection, business, Cohort study, Research Article
Abstract

Evidence of relative effectiveness of local treatments for hepatocellular carcinoma (HCC) is scanty. We investigated, in a retrospective cohort study, whether surgical resection, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI), and transarterial embolization with (TACE) or without (TAE) chemotherapy resulted in different survival in clinical practice. All patients first diagnosed with HCC and treated with any locoregional therapy from 1998 to 2002 in twelve Italian hospitals were eligible. Overall survival (OS) was the unique endpoint. Three main comparisons were planned: RFA versus PEI, surgical resection versus RFA/PEI (combined), TACE/TAE versus RFA/PEI (combined). Propensity score method was used to minimize bias related to non random treatment assignment. Overall 425 subjects were analyzed, with 385 (91%) deaths after a median followup of 7.7 years. OS did not significantly differ between RFA and PEI (HR 1.11, 95% CI 0.79–1.57), between surgery and RFA/PEI (HR 0.95, 95% CI 0.64–1.41) and between TACE/TAE and RFA/PEI (HR 0.88, 95% CI 0.66–1.17). 5-year OS probabilities were 0.14 for RFA, 0.18 for PEI, 0.27 for surgery, and 0.15 for TACE/TAE. No locoregional treatment for HCC was found to be more effective than the comparator. Adequately powered randomized clinical trials are still needed to definitely assess relative effectiveness of locoregional HCC treatment.

Published
2012

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