34 results on '"Tundo, Paolo"'
Search Results
2. HepaDisk – A new quality of life questionnaire for HCV patients
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Fagiuoli, Stefano, Caporaso, Nicola, Morisco, Filomena, Buelli, Fabio, Gualberti, Giuliana, Saragaglia, Valeria, Chessa, Luchino, Corti, Giampaolo, Maida, Ivana, Mastroianni, Claudio M., Pirisi, Mario, Russo, Francesco P., Farina, Francesca, Giannitrapani, Lydia, Toniutto, Pierluigi, Tarquini, Pierluigi, Tundo, Paolo, Vecchiet, Jacopo, Vinci, Maria, and Taliani, Gloria
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- 2019
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3. Apulian infectious diseases network: survey on the prevalence of delta infection among chronic HBV carriers in Apulia
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Fasano, Massimo, primary, Milella, Michele, additional, Carbonara, Sergio, additional, Tundo, Paolo, additional, Minniti, Salvatore, additional, Buccoliero, Giovanni, additional, Maci, Anna Maria, additional, Lo Caputo, Sergio, additional, and Santantonio, Teresa Antonia, additional
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- 2023
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4. HCV clearance after direct-acting antivirals in patients with cirrhosis by stages of liver impairment: The ITAL-C network study
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Ippolito, Antonio Massimo, Milella, Michele, Messina, Vincenzo, Conti, Fabio, Cozzolongo, Raffaele, Morisco, Filomena, Brancaccio, Giuseppina, Barone, Michele, Santantonio, Teresa, Masetti, Chiara, Tundo, Paolo, Smedile, Antonina, Carretta, Vito, Gatti, Pietro, Termite, Antonio Patrizio, Valvano, Maria Rosa, Bruno, Giuseppe, Fabrizio, Claudia, Andreone, Pietro, Zappimbulso, Marianna, Gaeta, Giovanni Battista, Napoli, Nicola, Fontanella, Luca, Lauletta, Gianfranco, Cuccorese, Giuseppe, Metrangolo, Antonio, Francavilla, Ruggiero, Ciracì, Emanuela, Rizzo, Salvatore, and Andriulli, Angelo
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- 2017
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5. An a priori prediction model of response to peginterferon plus ribavirin dual therapy in naïve patients with genotype 1 chronic hepatitis C
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Raimondo, Giovanni, Milella, Michele, Morisco, Filomena, Fattovich, Giovanna, Felder, Martina, Smedile, Antonina, Fasano, Massimo, Gatti, Pietro, Andriulli, Nicola, Tundo, Paolo, Barone, Michele, Cozzolongo, Raffaele, D’Andrea, Giovanna, Mazzella, Giuseppe, Santantonio, Teresa, Andriulli, Angelo, Nardi, Alessandra, Di Marco, Vito, Ippolito, Antonio Massimo, Gavrila, Caius, Aghemo, Alessio, Di Paolo, Daniele, Squadrito, Giovanni, Grassi, Eleonora, Calvaruso, Vincenza, Valvano, Maria Rosa, Brancaccio, Giuseppina, Craxi, Antonio, and Angelico, Mario
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- 2014
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6. Identification of naïve HCV-1 patients with chronic hepatitis who may benefit from dual therapy with peg-interferon and ribavirin
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Andriulli, Angelo, Di Marco, Vito, Margaglione, Maurizio, Ippolito, Antonio Massimo, Fattovich, Giovanna, Smedile, Antonina, Valvano, Maria Rosa, Calvaruso, Vincenza, Gioffreda, Domenica, Milella, Michele, Morisco, Filomena, Felder, Martina, Brancaccio, Giuseppina, Fasano, Massimo, Gatti, Pietro, Tundo, Paolo, Barone, Michele, Cozzolongo, Raffaele, Angelico, Mario, D’Andrea, Giovanna, Andriulli, Nicola, Abate, Maria Lorena, Mazzella, Giuseppe, Gaeta, Giovanni Battista, Craxi, Antonio, and Santantonio, Teresa
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- 2014
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7. Compositional Data Analysis of 16S rRNA Gene Sequencing Results from Hospital Airborne Microbiome Samples
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Perrone, Maria Rita, primary, Romano, Salvatore, additional, De Maria, Giuseppe, additional, Tundo, Paolo, additional, Bruno, Anna Rita, additional, Tagliaferro, Luigi, additional, Maffia, Michele, additional, and Fragola, Mattia, additional
- Published
- 2022
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8. Virologic and Immunologic Response to Regimens Containing Nevirapine or Efavirenz in Combination with 2 Nucleoside Analogues in the Italian Cohort Naive Antiretrovirals (I.Co.N.A.) Study
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Italian Cohort Naive Antiretrovirals (I.Co.N.A.) Study Group, Cozzi-Lepri, Alessandro, Phillips, Andrew N., d' Arminio Monforte, Antonella, Piersantelli, Nicoló, Orani, Anna, Petrosillo, Nicola, Leoncini, Francesco, Scerbo, Antonio, Tundo, Paolo, Abrescia, Nicola, and Moroni, Mauro
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- 2002
9. Variation in genes encoding for interferon λ-3 and λ-4 in the prediction of HCV-1 treatment-induced viral clearance
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Palmieri, Orazio, Ippolito, Antonio M., Margaglione, Maurizio, Valvano, Maria R., Gioffreda, Domenica, Fasano, Massimo, DʼAndrea, Giovanna, Corritore, Giuseppe, Milella, Michele, Andriulli, Nicola, Morisco, Filomena, Giannitrapani, Lydia, Latiano, Anna, Fontana, Rosanna, Gatti, Pietro, Tundo, Paolo, Barone, Michele, Cozzolongo, Raffaele, Santantonio, Teresa, and Andriulli, Angelo
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- 2014
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10. Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin
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Santantonio, Teresa, Fasano, Massimo, Sagnelli, Evangelista, Tundo, Paolo, Babudieri, Sergio, Fabris, Paolo, Toti, Mario, Di Perri, Giovanni, Marino, Nicoletta, Pizzigallo, Eligio, and Angarano, Gioacchino
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- 2014
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11. Interruption of highly active antiretroviral therapy in HIV clinical practice
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Monforte, Antonella d'Arminio, Cozzi-Lepri, Alessandro, Luca, Andrea De, Mussinni, Cristina, Murri, Rita, Grossi, Paolo, Phillips, Andrew, Galli, Andrea, Zauli, Tiziano, Montroni, Maria, Tundo, Paolo, and Moroni, Mauro
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HIV infection -- Drug therapy ,Highly active antiretroviral therapy -- Health aspects ,Health - Abstract
The frequency of a first therapy interruption (TI) (more than or equal to) 12 weeks is investigated, to identify factors associated with TI and with therapy resumption, and the risk of developing clinical events during TI and during continuous therapy is compared. TI occurring in clinical practice is associated with an increased risk of clinical progression, and hence it should be discouraged outside strictly experimental settings.
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- 2005
12. Factors Enhancing Treatment of Hepatitis C Virus–Infected Italian People Who Use Drugs: The CLEO-GRECAS Experience
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Rinaldi, Luca, primary, Messina, Vincenzo, additional, Di Marco, Vito, additional, Iovinella, Vincenzo, additional, Claar, Ernesto, additional, Cariti, Giuseppe, additional, Sacco, Rodolfo, additional, De Luca, Massimo, additional, Scifo, Gaetano, additional, Gatti, Pietro, additional, Barbarini, Giorgio, additional, Pace Palitti, Valeria, additional, Quartini, Mariano, additional, Tundo, Paolo, additional, D'Offizi, Gianpiero, additional, Parruti, Giustino, additional, di Rosolini, Maria Antonietta, additional, Garrucciu, Giovanni, additional, Cosco, Lucio, additional, Benanti, Francesco, additional, Gimignani, Giancarlo, additional, Vespasiani Gentilucci, Umberto, additional, Di Lorenzo, Francesco, additional, D'Antò, Maria, additional, Nevola, Riccardo, additional, Lupia, Tommaso, additional, Rosato, Valerio, additional, Morbiducci, Valeria, additional, Luzzitelli, Ilaria, additional, Sozio, Federica, additional, Di Stefano, Marco, additional, Ciraci, Emanuela, additional, Bulla, Fabio, additional, Guarisco, Riccardo, additional, Cangiano, Cecilia, additional, Imparato, Michele, additional, Maggi, Paolo, additional, Ascione, Antonio, additional, Craxì, Antonio, additional, and Izzi, Antonio, additional
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- 2021
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13. Characterization of nontraumatic focal splenic lesions using contrast-enhanced sonography
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Chiavaroli, Roberto, Grima, Pierfrancesco, and Tundo, Paolo
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- 2011
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14. Virologic and immunologic response to regimens containing nevirapine or efavirenz in combination with 2 nucleoside analogues in the Italian cohort naive antiretrovirals (I.Co.N.A.) study
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Cozzi-Lepri, Alessandro, Phillips, Andrew N., Monforte, Antonella d'Arminio, Piersantelli, Nicolo, Orani, Anna, Petrosillo, Nicola, Leoncini, Francesco, Scerbo, Antonio, Tundo, Paolo, Abrescia, Nicola, and Moroni, Mauro
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Nevirapine -- Evaluation ,Anti-HIV agents -- Evaluation ,HIV infection -- Research ,Health ,Sustiva (Medication) -- Evaluation - Published
- 2002
15. Effectiveness of new generation DAAs for HCV infection in a large cohort of Italian people who use drugs (PWID): the cleo-grecas real-world experience
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Vincenzo Messina, Vincenzo Iovinella, Ernesto Claar, Valerio Rosato, Massimo De Luca, Giorgio Barbarini, Giuseppe Cariti, Tommaso Lupia, Mariano Quartini, Gianpiero D’Offizi, Ilaria Luzzitelli, Giustino Parruti, Federica Sozio, Gaetano Scifo, Marco Distefano, Tundo Paolo, Francesco Benanti, Lucio Cosco, Fabio Bulla, Giancarlo Gimignani, Maria Antonietta Di Rosolini, Valeria Pace Palitti, Umberto Vespasiani Gentilucci, Antonio Ascione, Michele Imparato, Luca Rinaldi, Riccardo Nevola, Vito Di Marco, Antonio Craxì, Valeria Morbiducci, Francesco Di Lorenzo, Riccardo Guarisco, Rodolfo Sacco, and Antonio Izzi
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Hepatology - Published
- 2020
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16. Real‐life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study
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Persico, Marcello, primary, Aglitti, Andrea, additional, Milella, Michele, additional, Coppola, Carmine, additional, Messina, Vincenzo, additional, Claar, Ernesto, additional, Gentile, Ivan, additional, Sogari, Fernando, additional, Pierri, Paola, additional, Surace, Lorenzo A., additional, Morisco, Filomena, additional, Tundo, Paolo, additional, Brancaccio, Giuseppina, additional, Serviddio, Gaetano, additional, Gatti, Pietro, additional, Termite, Antonio P., additional, Di Costanzo, Giovan G., additional, Caroleo, Benedetto, additional, Cozzolongo, Raffaele, additional, Coppola, Nicola, additional, Longo, Annamaria, additional, Fontanella, Luca, additional, Federico, Alessandro, additional, Rosato, Valerio, additional, Terrenato, Irene, additional, and Masarone, Mario, additional
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- 2019
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17. Is Europe ready to reach tuberculosis elimination? An outbreak report from Southern Italy
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Gillini, Laura, primary, Centis, Rosella, additional, D'Ambrosio, Lia, additional, Fedele, Alberto, additional, Aprile, Valerio, additional, Pasanisi, Giancarlo, additional, Donateo, Leonardo, additional, Costa, Danila, additional, Migliori, Giovanni Battista, additional, and Tundo, Paolo, additional
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- 2015
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18. An a priori prediction model of response to peginterferon plus ribavirin dual therapy in naïve patients with genotype 1 chronic hepatitis C
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Andriulli, Angelo, primary, Nardi, Alessandra, additional, Di Marco, Vito, additional, Ippolito, Antonio Massimo, additional, Gavrila, Caius, additional, Aghemo, Alessio, additional, Di Paolo, Daniele, additional, Squadrito, Giovanni, additional, Grassi, Eleonora, additional, Calvaruso, Vincenza, additional, Valvano, Maria Rosa, additional, Brancaccio, Giuseppina, additional, Craxi, Antonio, additional, Angelico, Mario, additional, Raimondo, Giovanni, additional, Milella, Michele, additional, Morisco, Filomena, additional, Fattovich, Giovanna, additional, Felder, Martina, additional, Smedile, Antonina, additional, Fasano, Massimo, additional, Gatti, Pietro, additional, Andriulli, Nicola, additional, Tundo, Paolo, additional, Barone, Michele, additional, Cozzolongo, Raffaele, additional, D’Andrea, Giovanna, additional, Mazzella, Giuseppe, additional, and Santantonio, Teresa, additional
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- 2014
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19. Optimization of direct anti-viral agent treatment schedule: Focus on HCV genotype 3
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Morisco, Filomena, Granata, Rocco, Camera, Silvia, Ippolito, Antonio, Milella, Michele, Conti, Fabio, Masetti, Chiara, Smedile, Antonella, Tundo, Paolo, Santantonio, Teresa, Valvano, Maria Rosa, Termite, Antonio, Gatti, Pietro, Messina, Vincenzo, Iacobellis, Angelo, Librandi, Marta, Caporaso, Nicola, and Andriulli, Angelo
- Abstract
Background and aim Direct antiviral agents (DAAs) have led to high sustained virological responses (SVR) in hepatitis C virus (HCV) patients. However, genotype 3 patients respond to treatment in a suboptimal way. This study aims to identify which of the several treatment schedules recommended for genotype 3 would constitute the best option.Methods Twenty-four Italian centers were involved in this real-life study of HCV genotype 3 patients treated with DAAs. To expand the number of cases, we conducted a systematic review of the literature on the outcome of genotype 3 patients treated with DAAs.Results A total of 233 patients with HCV genotype 3 were enrolled. Cirrhotic patients accounted for 83.7%. Overall, the SVR12 rate was achieved by 205 patients (88.0%); the SVR rates were 78.8% after sofosbuvir/ribavirin, 92.5% after sofosbuvir/daclatasvir ± ribavirin, and 100% after sofosbuvir/ledipasvir (seven patients). No difference in rate of SVR was observed in cirrhotic and non-cirrhotic patients (92.2 vs 94.4) using a combination regimen of NS5A and NS5B inhibitors. The systematic review of the literature provided data of 3311 patients: The mean weighted SVR12 rate was 84.4% (CI: 80.4–87.8); the rates varied from 79.0% (CI: 70.9–85.3) with sofosbuvir/ribavirin, to 83.7% (CI: 66.2–93.1) with sofosbuvir/ledispavir, and to 88.2% (CI: 83.3–91.7) with sofosbuvir/daclatasvir.Conclusions Our results reinforce the concept that patients with HCV genotype 3 should no longer be considered difficult-to-treat individuals. The optimal therapeutic regimen for these patients appears to be the combination sofosbuvir/daclatasvir, administered for 12 weeks without the use of RBV in non-cirrhotic patients. In cirrhotics the meta-analytic approach suggests extending therapy to 24 weeks.
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- 2018
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20. Variation in genes encoding for interferon λ-3 and λ-4 in the prediction of HCV-1 treatment-induced viral clearance
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Palmieri, Orazio, primary, Ippolito, Antonio M., additional, Margaglione, Maurizio, additional, Valvano, Maria R., additional, Gioffreda, Domenica, additional, Fasano, Massimo, additional, D'Andrea, Giovanna, additional, Corritore, Giuseppe, additional, Milella, Michele, additional, Andriulli, Nicola, additional, Morisco, Filomena, additional, Giannitrapani, Lydia, additional, Latiano, Anna, additional, Fontana, Rosanna, additional, Gatti, Pietro, additional, Tundo, Paolo, additional, Barone, Michele, additional, Cozzolongo, Raffaele, additional, Santantonio, Teresa, additional, and Andriulli, Angelo, additional
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- 2013
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21. Altered phosphate metabolism in HIV-1-infected patients with metabolic syndrome
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Grima, Pierfrancesco, primary, Guido, Marcello, additional, Chiavaroli, Roberto, additional, Stano, Francesca, additional, Tundo, Paolo, additional, Tana, Mariangela, additional, de Donno, Antonella, additional, and Zizza, Antonella, additional
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- 2011
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22. Association of visceral adiposity with increased intrarenal artery resistive index in HIV-1-infected patients receiving highly active antiretroviral therapy
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Grima, Pierfrancesco, primary, Zizza, Antonella, additional, Guido, Marcello, additional, Tundo, Paolo, additional, and Chiavaroli, Roberto, additional
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- 2010
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23. Severe hepatitis with autoimmune features following a HHV-6: a case report
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Grima, Pierfrancesco, primary, Chiavaroli, Roberto, additional, Calabrese, Paola, additional, Tundo, Paolo, additional, and Grima, Piero, additional
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- 2008
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24. Altered phosphate metabolism in HIV-1-infected patients with metabolic syndrome.
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Grima, Pierfrancesco, Guido, Marcello, Chiavaroli, Roberto, Stano, Francesca, Tundo, Paolo, Tana, Mariangela, de Donno, Antonella, and Zizza, Antonella
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KIDNEY tubules ,METABOLIC syndrome diagnosis ,PHOSPHATE metabolism ,ANALYSIS of variance ,CONFIDENCE intervals ,STATISTICAL correlation ,EPIDEMIOLOGY ,HIV infections ,HIV-positive persons ,KIDNEY function tests ,LONGITUDINAL method ,MULTIVARIATE analysis ,PHOSPHATES ,STATISTICS ,LOGISTIC regression analysis ,DATA analysis ,METABOLIC syndrome ,HIGHLY active antiretroviral therapy ,CROSS-sectional method ,DATA analysis software ,DESCRIPTIVE statistics ,PHYSIOLOGY - Abstract
Background: Metabolic syndrome (MS) represents a cluster of cardiovascular risk factors that has become a serious problem for HIV-1-infected patients. It has been proposed that disturbance of phosphate metabolism may represent a key feature of MS. Thus, we undertook the present study to investigate the relationship between phosphate levels and the presence of the characteristics of MS. Methods: One hundred and twenty-one HIV-1-infected patients were consecutively enrolled in a prospective, cross-sectional, single-centre study. Kidney tubular function was examined using tubular resorption of phosphate and normalized renal threshold phosphate concentration. Results: Univariate analysis showed that serum phosphate levels correlated negatively with systolic and diastolic blood pressure, glucose values, waist circumference, insulin, and triglycerides. Moreover, there was a positive relationship between phosphate and high-density lipoprotein (HDL) cholesterol. Multivariate analysis showed that insulin levels were correlated with serum phosphate concentration ( r == − 0.24, p == 0.01). Conclusions: Our data show that HIV-1-infected patients with MS have lower phosphate levels. [ABSTRACT FROM AUTHOR]
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- 2012
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25. The Management of Hepatitis B Virus/HIV-1 Co-Infected Patients Starting Their First Haart Regimen. Treating Two Infections for the Price of One Drug?
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Puoti, Massimo, Cozzi-Lepri, Alessandro, Ancarani, Fausto, Bruno, Raffaele, Ambu, Silvia, Ferraro, Teresa, Tundo, Paolo, Santantonio, Teresa, Toti, Mario, Bonasso, Marino, Monforte, Antonella d'Arminio, Ancarani, F, Antonucci, G, Bonasso, M, Bruno, R, Cozzi-Lepri, A, Monforte, A d'Arminio, Luca, A De, Galli, M, Gennero, L, Girardi, E, Lipani, F, Marino, N, Milazzo, L, Morsica, G, Narciso, P, Pizzaferri, P, Puoti, M, Santantonio, T, Verucchi, G, Montroni, M, Scalise, G, Zoli, A, Prete, MS Del, Tirelli, U, Di Gennaro, G, Pastore, G, Ladisa, N, Minafra, G, Suter, F, Arici, C, Chiodo, F, Colangeli, V, Fiorini, C, Coronado, O, Carosi, G, Cadeo, GP, Castelli, F, Minardi, C, Vangi, D, Rizzardini, G, Migliorino, G, Manconi, PE, Piano, P, Ferraro, T, Scerbo, A, Pizzigallo, E, D'Alessandro, M, Santoro, D, Pusterla, L, Carnevale, G, Galloni, D, Viganò, P, Mena, M, Ghinelli, F, Sighinolfi, L, Leoncini, F, Mazzotta, F, Pozzi, M, Lo Caputo, S, Angarano, G, Grisorio, B, Ferrara, S, Grima, P, Tundo, P, Pagano, G, Piersantelli, N, Alessandrini, A, Piscopo, R, Toti, M, Chigiotti, S, Soscia, F, Tacconi, L, Orani, A, Perini, P, Scasso, A, Vincenti, A, Chiodera, F, Castelli, P, Scalzini, A, Fibbia, G, Moroni, M, Lazzarin, A, Cargnel, A, Vigevani, GM, Caggese, L, d'Arminio Monforte, A, Repetto, D, Novati, R, Galli, A, Merli, S, Pastecchia, C, Moioli, MC, Esposito, R, Mussini, C, Abrescia, N, Chirianni, A, Izzo, C, Piazza, M, De Marco, M, Montesarchio, V, Manzillo, E, Graf, M, Colomba, A, Abbadessa, V, Prestileo, T, Mancuso, S, Ferrari, C, Pizzaferri, P, Filice, G, Minoli, L, Bruno, R, Novati, S, Balzelli, F, Loso, K, Petrelli, E, Cioppi, A, Alberici, F, Ruggieri, A, Menichetti, F, Martinelli, C, De Stefano, C, La Gala, A, Ballardini, G, Briganti, E, Magnani, G, Ursitti, MA, Arlotti, M, Ortolani, P, Ortona, L, Dianzani, F, Ippolito, G, Antinori, A, Antonucci, G, D'Elia, S, Narciso, P, Petrosillo, N, Vullo, V, De Luca, A, Del Forno, L, Zaccarelli, M, Acinapura, R, De Longis, P, Ciardi, M, D'Offizi, G, Trotta, MP, Noto, P, Lichtner, M, Capobianchi, MR, Girardi, E, Pezzotti, P, Rezza, G, Mura, MS, Mannazzu, M, Caramello, P, Sinicco, A, Soranzo, ML, Gennero, L, Sciandra, M, Bonasso, M, Grossi, PA, Basilico, C, Poggio, A, Bottari, G, Raise, E, Pasquinucci, S, De Lalla, F, Tositti, G, Resta, F, Chimienti, A, and Cozzi-Lepri, A
- Abstract
We examined the impact of a lamivudine-containing highly active antiretroviral therapy (HAART) regimen on 164 hepatitis B virus/HIV co-infected individuals starting their first HAART. Lamivudine-treated patients (accounting for 73% of the study population) showed a significantly lower level of alanine aminotransferase over follow-up [–81.1 mU/ml mean difference; 95% confidence intervals (95% CI): –30.3; –131.7, P=0.003] and a significantly reduced risk of liver-related morbidity/mortality [Relative hazard (RH)=0.07; 95% CI: 0.01–0.38, P=0.002] than those starting a lamivudine sparing-regimen.
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- 2004
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26. Compositional Data Analysis of 16S rRNA Gene Sequencing Results from Hospital Airborne Microbiome Samples
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Maria Rita Perrone, Salvatore Romano, Giuseppe De Maria, Paolo Tundo, Anna Rita Bruno, Luigi Tagliaferro, Michele Maffia, Mattia Fragola, Perrone, Maria Rita, Romano, Salvatore, De Maria, Giuseppe, Tundo, Paolo, Bruno, Anna Rita, Tagliaferro, Luigi, Maffia, Michele, and Fragola, Mattia
- Subjects
Data Analysis ,Bacteria ,Aitchison distance ,16S rRNA gene sequencing ,CLR transformation ,singular value decomposition ,alpha-diversity ,airborne microbiome ,compositional data ,ρ metrics ,Microbiota ,Health, Toxicology and Mutagenesis ,Public Health, Environmental and Occupational Health ,COVID-19 ,Genes, rRNA ,Hospitals ,Hospital ,Data Analysi ,RNA, Ribosomal, 16S ,Humans ,ρ metric ,Human - Abstract
The compositional analysis of 16S rRNA gene sequencing datasets is applied to characterize the bacterial structure of airborne samples collected in different locations of a hospital infection disease department hosting COVID-19 patients, as well as to investigate the relationships among bacterial taxa at the genus and species level. The exploration of the centered log-ratio transformed data by the principal component analysis via the singular value decomposition has shown that the collected samples segregated with an observable separation depending on the monitoring location. More specifically, two main sample clusters were identified with regards to bacterial genera (species), consisting of samples mostly collected in rooms with and without COVID-19 patients, respectively. Human pathogenic genera (species) associated with nosocomial infections were mostly found in samples from areas hosting patients, while non-pathogenic genera (species) mainly isolated from soil were detected in the other samples. Propionibacterium acnes, Staphylococcus pettenkoferi, Corynebacterium tuberculostearicum, and jeikeium were the main pathogenic species detected in COVID-19 patients’ rooms. Samples from these locations were on average characterized by smaller richness/evenness and diversity than the other ones, both at the genus and species level. Finally, the ρ metrics revealed that pairwise positive associations occurred either between pathogenic or non-pathogenic taxa.
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- 2022
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27. Factors Enhancing Treatment of Hepatitis C Virus-Infected Italian People Who Use Drugs: The CLEO-GRECAS Experience
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Giuseppe Cariti, Valerio Rosato, Giustino Parruti, Luca Rinaldi, Maria Antonietta Di Rosolini, Valeria Morbiducci, Lucio Cosco, Maria D'Antò, Emanuela Ciracì, Giovanni Garrucciu, Giorgio Barbarini, Massimo De Luca, Rodolfo Sacco, Riccardo Nevola, Pietro Gatti, Antonio Ascione, F. Benanti, Cecilia Cangiano, Paolo Maggi, Paolo Tundo, Gianpiero D'Offizi, Riccardo Guarisco, Giancarlo Gimignani, Michele Imparato, Fabio Bulla, Vincenzo Messina, G. Scifo, Ilaria Luzzitelli, Valeria Pace Palitti, Vito Di Marco, Francesco Di Lorenzo, Ernesto Claar, Antonio Izzi, Mariano Quartini, Tommaso Lupia, Umberto Vespasiani Gentilucci, Vincenzo Iovinella, Marco Di Stefano, Federica Sozio, Antonio Craxì, Rinaldi, Luca, Messina, Vincenzo, Di Marco, Vito, Iovinella, Vincenzo, Claar, Ernesto, Cariti, Giuseppe, Sacco, Rodolfo, De Luca, Massimo, Scifo, Gaetano, Gatti, Pietro, Barbarini, Giorgio, Pace Palitti, Valeria, Quartini, Mariano, Tundo, Paolo, D'Offizi, Gianpiero, Parruti, Giustino, di Rosolini, Maria Antonietta, Garrucciu, Giovanni, Cosco, Lucio, Benanti, Francesco, Gimignani, Giancarlo, Vespasiani Gentilucci, Umberto, Di Lorenzo, Francesco, D'Antò, Maria, Nevola, Riccardo, Lupia, Tommaso, Rosato, Valerio, Morbiducci, Valeria, Luzzitelli, Ilaria, Sozio, Federica, Di Stefano, Marco, Ciraci, Emanuela, Bulla, Fabio, Guarisco, Riccardo, Cangiano, Cecilia, Imparato, Michele, Maggi, Paolo, Ascione, Antonio, Craxì, Antonio, Izzi, Antonio, Rinaldi L., Messina V., Di Marco V., Iovinella V., Claar E., Cariti G., Sacco R., de Luca M., Scifo G., Gatti P., Barbarini G., Palitti V.P., Quartini M., Tundo P., D'Offizi G., Parruti G., di Rosolini M.A., Garrucciu G., Cosco L., Benanti F., Gimignani G., Gentilucci U.V., Di Lorenzo F., D'Anto M., Nevola R., Lupia T., Rosato V., Morbiducci V., Luzzitelli I., Sozio F., Di Stefano M., Ciraci E., Bulla F., Guarisco R., Cangiano C., Imparato M., Maggi P., Ascione A., Craxi A., and Izzi A.
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Adult ,Male ,Elbasvir ,medicine.medical_specialty ,Sofosbuvir ,Sustained Virologic Response ,Intention to Treat Analysi ,Substance-Related Disorders ,Hepatitis C virus ,medicine.disease_cause ,Antiviral Agents ,Medication Adherence ,03 medical and health sciences ,0302 clinical medicine ,Retrospective Studie ,Internal medicine ,medicine ,Humans ,Prospective Studies ,Retrospective Studies ,Antiviral Agent ,Hepatology ,business.industry ,Gastroenterology ,virus diseases ,Glecaprevir ,Odds ratio ,Hepatitis C, Chronic ,Middle Aged ,Substance-Related Disorder ,Pibrentasvir ,digestive system diseases ,Intention to Treat Analysis ,Prospective Studie ,Grazoprevir ,Italy ,030220 oncology & carcinogenesis ,Cohort ,030211 gastroenterology & hepatology ,Female ,business ,medicine.drug ,Human - Abstract
INTRODUCTION: We assessed the performance of direct-acting antivirals (DAAs) in hepatitis C virus (HCV)-infected people who use drugs (PWUDs) in terms of sustained virological response (SVR) and adherence rates in comparison to a location-matched cohort of non-PWUD HCV patients. METHODS: All consecutive HCV RNA-positive PWUDs were enrolled between 2015 and 2019. All subjects underwent DAA treatment according to international guidelines and then followed, at least, up to 12 weeks after the end of treatment (SVR12). The SVR and adherence to treatment was compared with that of non-PWUD HCV patients observed at hepatological units of the CLEO platform. Intention-to-treat analysis was performed. RESULTS: A total of 1,786 PWUDs who were followed up were available for assessment. Most PWUDs (85.4%) were managed inside the specialized outpatient addiction clinics (SerDs). The overall SVR rate was 95.4%. The SerDs group achieved an SVR rate of 96.2% compared with 91.6% of the non-SerDs group (P < 0.001). Comparison with the non-SerDs group and the control HCV group showed a significant difference in the dropout rate (0.6% in the SerDs group versus 2.8% in the non-SerDs group and 1.2% in the control group; P < 0.001). At multivariate analysis, factors independently associated with SVR were use of the most recent regimens (elbasvir/grazoprevir, glecaprevir/pibrentasvir, and sofosbuvir/ velpatasvir; odds ratio: 3.126; P 5 0.000) and belonging to the SerDs group (odds ratio: 2.356; P 5 0.002). DISCUSSION: The performance of DAAs in PWUD is excellent, if 2 conditions are met: (i) that the latest generation drugs are used and (ii) that the patients are managed within the SerDs.
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- 2020
28. Real-life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study
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Marcello Persico, Andrea Aglitti, Pietro Gatti, Antonio Patrizio Termite, Benedetto Caroleo, Carmine Coppola, Michele Milella, Paolo Tundo, Vincenzo Messina, Alessandro Federico, Filomena Morisco, Luca Fontanella, Fernando Sogari, Giovan Giuseppe Di Costanzo, Irene Terrenato, Giuseppina Brancaccio, Gaetano Serviddio, Lorenzo Surace, Paola Pierri, Raffaele Cozzolongo, Annamaria Longo, Mario Masarone, Valerio Rosato, Ivan Gentile, Nicola Coppola, Ernesto Claar, Persico, Marcello, Aglitti, Andrea, Milella, Michele, Coppola, Carmine, Messina, Vincenzo, Claar, Ernesto, Gentile, Ivan, Sogari, Fernando, Pierri, Paola, Surace, Lorenzo A, Morisco, Filomena, Tundo, Paolo, Brancaccio, Giuseppina, Serviddio, Gaetano, Gatti, Pietro, Termite, Antonio P, Di Costanzo, Giovan G, Caroleo, Benedetto, Cozzolongo, Raffaele, Coppola, Nicola, Longo, Annamaria, Fontanella, Luca, Federico, Alessandro, Rosato, Valerio, Terrenato, Irene, Masarone, Mario, Persico, M., Aglitti, A., Milella, M., Coppola, C., Messina, V., Claar, E., Gentile, I., Sogari, F., Pierri, P., Surace, L. A., Morisco, F., Tundo, P., Brancaccio, G., Serviddio, G., Gatti, P., Termite, A. P., Di Costanzo, G. G., Caroleo, B., Cozzolongo, R., Coppola, N., Longo, A., Fontanella, L., Federico, A., Rosato, V., Terrenato, I., and Masarone, M.
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METAVIR Fibrosis Score ,Cyclopropanes ,Liver Cirrhosis ,Male ,Longitudinal study ,Aminoisobutyric Acids ,Pyrrolidines ,Sustained Virologic Response ,efficacy ,Hepacivirus ,0302 clinical medicine ,substance abuse ,Longitudinal Studies ,Prospective Studies ,Substance Abuse, Intravenous ,Aged, 80 and over ,Sulfonamides ,Hepatitis C ,Middle Aged ,Pibrentasvir ,Italy ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,Drug Therapy, Combination ,Female ,Adult ,medicine.medical_specialty ,Genotype ,Proline ,Lactams, Macrocyclic ,Antiviral Agents ,Direct-acting antiviral ,HCV genotype ,cirrhosis ,03 medical and health sciences ,Young Adult ,Leucine ,Internal medicine ,Quinoxalines ,medicine ,Humans ,Adverse effect ,Aged ,Hepatitis ,direct-acting antiviral ,Hepatology ,business.industry ,Glecaprevir ,Hepatitis C, Chronic ,medicine.disease ,Benzimidazoles ,business ,Kidney disease ,cirrhosi - Abstract
BACKGROUND AND AIMS It is paramount to identify predictors of treatment failure with direct antiviral agents in 'field-practice' patients, including people who inject drugs (PWID). Data on the efficacy of glecaprevir/pibrentasvir (GLE/PIB) in a field-practice scenario are scant. The multicentre MISTRAL study enrolled 1177 patients, including PWID, to assess real-life efficacy and safety of GLE/PIB and to identify the predictive factors for this treatment. METHODS This was a prospective, longitudinal study. The outcome variable was the rate of sustained virological response (SVR) at week 12. RESULTS A total of 123 patients (10%) were infected from hepatitis C virus (HCV) 3. METAVIR fibrosis score was F4 in 104 subjects (9%); 118 patients (10%) were PWID. Overall, 1163/1177 (99%) patients achieved SVR. The baseline clinical factors discriminating between treatment success and treatment failure were age at treatment (P = 0.031) and creatinine level (P = 0.034). SVR rates were not influenced by gender, substance abuse, previous treatment, treatment duration, fibrosis or chronic kidney disease stage. Compared with non-substance users, the 118 PWID exhibited a significantly different genotype pattern distribution (χ2
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- 2019
29. Optimization of direct anti-viral agent treatment schedule: Focus on HCV genotype 3
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Maria Rosa Valvano, Silvia Camera, Angelo Andriulli, Marta Librandi, R. Granata, Vincenzo Messina, A. Iacobellis, Fabio Conti, Michele Milella, Filomena Morisco, Paolo Tundo, Pietro Gatti, Teresa Santantonio, A. Smedile, Nicola Caporaso, C. Masetti, Antonio Patrizio Termite, Antonio Massimo Ippolito, Morisco, Filomena, Granata, Rocco, Camera, Silvia, Ippolito, Antonio, Milella, Michele, Conti, Fabio, Masetti, Chiara, Smedile, Antonella, Tundo, Paolo, Santantonio, Teresa, Valvano, Maria Rosa, Termite, Antonio, Gatti, Pietro, Messina, Vincenzo, Iacobellis, Angelo, Librandi, Marta, Caporaso, Nicola, and Andriulli, Angelo
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Ledipasvir ,medicine.medical_specialty ,Cirrhosis ,Sofosbuvir ,Hepatitis C virus ,medicine.disease_cause ,Gastroenterology ,meta-analysi ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Internal medicine ,Genotype ,medicine ,genotype 3 ,030212 general & internal medicine ,direct antiviral agent ,business.industry ,Ribavirin ,virus diseases ,Original Articles ,medicine.disease ,digestive system diseases ,chemistry ,Oncology ,Treatment Schedule ,Meta-analysis ,HCV ,030211 gastroenterology & hepatology ,business ,medicine.drug ,cirrhosi - Abstract
Direct antiviral agents (DAAs) have led to high sustained virological responses (SVR) in hepatitis C virus (HCV) patients. However, genotype 3 patients respond to treatment in a suboptimal way. This study aims to identify which of the several treatment schedules recommended for genotype 3 would constitute the best option.Twenty-four Italian centers were involved in this real-life study of HCV genotype 3 patients treated with DAAs. To expand the number of cases, we conducted a systematic review of the literature on the outcome of genotype 3 patients treated with DAAs.A total of 233 patients with HCV genotype 3 were enrolled. Cirrhotic patients accounted for 83.7%. Overall, the SVR12 rate was achieved by 205 patients (88.0%); the SVR rates were 78.8% after sofosbuvir/ribavirin, 92.5% after sofosbuvir/daclatasvir ± ribavirin, and 100% after sofosbuvir/ledipasvir (seven patients). No difference in rate of SVR was observed in cirrhotic and non-cirrhotic patients (92.2 vs 94.4) using a combination regimen of NS5A and NS5B inhibitors.The systematic review of the literature provided data of 3311 patients: The mean weighted SVR12 rate was 84.4% (CI: 80.4-87.8); the rates varied from 79.0% (CI: 70.9-85.3) with sofosbuvir/ribavirin, to 83.7% (CI: 66.2-93.1) with sofosbuvir/ledispavir, and to 88.2% (CI: 83.3-91.7) with sofosbuvir/daclatasvir.Our results reinforce the concept that patients with HCV genotype 3 should no longer be considered difficult-to-treat individuals. The optimal therapeutic regimen for these patients appears to be the combination sofosbuvir/daclatasvir, administered for 12 weeks without the use of RBV in non-cirrhotic patients. In cirrhotics the meta-analytic approach suggests extending therapy to 24 weeks.
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- 2017
30. HCV clearance after direct-acting antivirals in patients with cirrhosis by stages of liver impairment: The ITAL-C network study
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Nicola Napoli, Vincenzo Messina, Marianna Zappimbulso, Angelo Andriulli, Gianfranco Lauletta, Giuseppe Bruno, Teresa Santantonio, Raffaele Cozzolongo, Antonio Patrizio Termite, Salvatore Rizzo, C. Masetti, Antonina Smedile, Giuseppina Brancaccio, Antonio Massimo Ippolito, Pietro Gatti, Paolo Tundo, Fabio Conti, Claudia Fabrizio, Giovanni Battista Gaeta, Luca Fontanella, Michele Barone, Antonio Metrangolo, Giuseppe Cuccorese, Michele Milella, Ruggiero Francavilla, Filomena Morisco, Emanuela Ciracì, Vito Carretta, Maria Rosa Valvano, Pietro Andreone, Ippolito, Antonio Massimo, Milella, Michele, Messina, Vincenzo, Conti, Fabio, Cozzolongo, Raffaele, Morisco, Filomena, Brancaccio, Giuseppina, Barone, Michele, Santantonio, Teresa, Masetti, Chiara, Tundo, Paolo, Smedile, Antonina, Carretta, Vito, Gatti, Pietro, Termite, Antonio Patrizio, Valvano, Maria Rosa, Bruno, Giuseppe, Fabrizio, Claudia, Andreone, Pietro, Zappimbulso, Marianna, Gaeta, Giovanni Battista, Napoli, Nicola, Fontanella, Luca, Lauletta, Gianfranco, Cuccorese, Giuseppe, Metrangolo, Antonio, Francavilla, Ruggiero, Ciracì, Emanuela, Rizzo, Salvatore, and Andriulli, Angelo
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Male ,Cirrhosis ,Databases, Factual ,Sustained Virologic Response ,Hepacivirus ,Antiviral therapy ,Direct-acting antivirals ,HCV ,Hepatitis C ,Liver cirrhosis ,Hepatology ,Gastroenterology ,Direct-acting antiviral ,Severity of Illness Index ,0302 clinical medicine ,Prospective Studies ,Stage (cooking) ,Prospective cohort study ,Multivariate Analysi ,biology ,Middle Aged ,Italy ,Liver ,030220 oncology & carcinogenesis ,Drug Therapy, Combination ,Female ,030211 gastroenterology & hepatology ,Human ,medicine.medical_specialty ,Logistic Model ,Liver Cirrhosi ,Antiviral Agents ,03 medical and health sciences ,Internal medicine ,Severity of illness ,medicine ,Humans ,Aged ,Antiviral Agent ,Hepaciviru ,business.industry ,medicine.disease ,biology.organism_classification ,Prospective Studie ,Logistic Models ,Multivariate Analysis ,Varices ,business - Abstract
Background Sustained virological response (SVR12) rates at 12 weeks after treatment for HCV-infected patients with decompensated cirrhosis are used when referring to those with moderate functional impairment, while few data are available for those with more severe impairment. The use of the cirrhosis staging system proposed by D’Amico might provide new insights on timing for antiviral therapy. Methods We investigated efficacy (SVR12), safety, and post-treatment variations in clinical and laboratory parameters in 2612 patients with advanced fibrosis (n = 575) or cirrhosis (n = 2037). Cirrhosis was in the compensated phase (without/with varices) or had previously been in the decompensated stage. Different direct-acting antiviral (DAA) regimens were administered in accordance with scientific guidelines. Results The SVR12 rate was 97.6% in patients with advanced fibrosis. For patients with cirrhosis, the rate was 96.5% in stage 1, 95.1% in stage 2, 100% in stage 3, 95.7% in stage 4, and 93.6% in stage 5. These rates were independent of gender, age, HCV genotype, and treatment schedule. Positive changes in biochemical parameters and CPT classes following therapy were evident in compensated and previously decompensated patients. Conclusion Our findings support the use of DAAs in patients with advanced cirrhosis (stages 3–5) who are at greatest risk and have the most to gain from therapy.
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- 2017
31. An a priori prediction model of response to peginterferon plus ribavirin dual therapy in naïve patients with genotype 1 chronic hepatitis C
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Daniele Di Paolo, Vito Di Marco, C. Gavrila, Giovanni Raimondo, Pietro Gatti, Michele Milella, Giovanna D'Andrea, Antonio Craxì, Filomena Morisco, Michele Barone, Martina Felder, Alessio Aghemo, Giuseppe Mazzella, Giovanna Fattovich, Mario Angelico, Teresa Santantonio, Giuseppina Brancaccio, Antonina Smedile, Eleonora Grassi, Giovanni Squadrito, Antonio Massimo Ippolito, Alessandra Nardi, Nicola Andriulli, Angelo Andriulli, Raffaele Cozzolongo, Maria Rosa Valvano, Vincenza Calvaruso, Massimo Fasano, Paolo Tundo, Andriulli, Angelo, Nardi, Alessandra, Di Marco, Vito, Ippolito, Antonio Massimo, Gavrila, Caiu, Aghemo, Alessio, Di Paolo, Daniele, Squadrito, Giovanni, Grassi, Eleonora, Calvaruso, Vincenza, Valvano, Maria Rosa, Brancaccio, Giuseppina, Craxi, Antonio, Angelico, Mario, Raimondo, Giovanni, Milella, Michele, Morisco, Filomena, Fattovich, Giovanna, Felder, Martina, Smedile, Antonina, Fasano, Massimo, Santantonio, Teresa, Gatti, Pietro, Nicolaandriulli, Null, Tundo, Paolo, Barone, Michele, Cozzolongo, Raffaele, Giovanna D'andrea, Null, Mazzella, Giuseppe, Giovanna D'Andrea, Null, Andriulli, A, Nardi, A, Di Marco, V, Ippolito, Am, Gavrila, C, Aghemo, A, Di Paolo, D, Squadrito, G, Grassi, E, Calvaruso, V, Valvano, Mr, Brancaccio, G, Craxi, A, Angelico, M, Collaborator, S., and Collaborators
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Oncology ,Male ,Hepacivirus ,Predictive Value of Test ,chronic hepatitis C ,prediction model of response ,peginterferon plus ribavirin dual therapy ,Polyethylene Glycol ,Polyethylene Glycols ,chemistry.chemical_compound ,Genotype ,Viral ,Chronic ,Rapid virological response ,Drug Carrier ,Chronic hepatitis ,Settore MED/12 - Gastroenterologia ,Drug Carriers ,biology ,Gastroenterology ,Recombinant Protein ,Middle Aged ,Viral Load ,Prognosis ,Hepatitis C ,Recombinant Proteins ,HCV infection ,Treatment Outcome ,Predictive value of tests ,Combination ,RNA, Viral ,Drug Therapy, Combination ,Female ,Peg-interferon and ribavirin treatment ,Predictors of sustained virological response, rapid virological response ,Adult ,Antiviral Agents ,Hepatitis C, Chronic ,Humans ,Interferon-alpha ,Predictive Value of Tests ,Real-Time Polymerase Chain Reaction ,Ribavirin ,Hepatology ,Viral load ,Human ,medicine.medical_specialty ,Prognosi ,Alpha interferon ,Drug Therapy ,Internal medicine ,Predictors of sustained virological response ,Linear regression ,medicine ,Antiviral Agent ,Predictors of sustained virological response, Rapid virological response ,Hepaciviru ,business.industry ,biology.organism_classification ,chemistry ,Immunology ,Chronic hepatiti ,RNA ,business - Abstract
none 29 no Background: Aim was to select naïve patients with genotype 1 chronic hepatitis C having a high probability of response to Peg-interferon. +. ribavirin therapy. Methods: In 1073 patients (derivation cohort), predictors of rapid and sustained virological response were identified by logistic analysis; regression coefficients were used to generate prediction models for sustained virological response. Probabilities at baseline and treatment week 4 were utilized to develop a decision rule to select patients with high likelihood of response. The model was then validated in 423 patients (validation cohort). Results: In the derivation cohort, 257 achieved rapid virological response and 818 did not, with sustained virological response rates of 80.2% and 25.4%, respectively; interleukin-28B polymorphisms, fibrosis staging, gamma-glutamyl transferase, and viral load predicted sustained virological response. Assuming a
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- 2014
32. Resistance Associated Mutations in HCV Patients Failing DAA Treatment.
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Di Stefano M, Faleo G, Farhan Mohamed AM, Morella S, Bruno SR, Tundo P, Fiore JR, and Santantonio TA
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- Drug Resistance, Viral genetics, Genotype, Hepacivirus genetics, Humans, Mutation, Treatment Failure, Viral Nonstructural Proteins genetics, Antiviral Agents pharmacology, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy
- Abstract
Currently, treatment of chronic hepatitis C is based on a combination of direct-acting antiviral agents (DAAs) which achieve HCV clearance in more than 95% of patients. Despite this high rate of cure, treatment failures can occur in about 3-5% of treated patients. Resistance associated substitutions (RAS) are commonly detected after virological failure, although their role in real-life DAA failures is still debated. This study aimed to evaluate in real-life DAA-failing patients the prevalence of clinically relevant RASs for the different DAA classes and to identify possible predictors. Fifty consecutive HCV-infected patients who experienced a virological failure to a DAA-containing regimen were included in the study. Direct sequencing of HCV regions involved in DAA resistance (NS3, NS5A and NS5B) was performed with Sanger-based homemade protocols. The presence of mutations in the NS3 and NS5A regions was statistically associated with regimens containing protease inhibitors (p<0.0032) and NS5A inhibitors (p<0.0006), respectively. On the contrary, for the NS5B region, the known mutations associated with the NS5B RNA polymerase inhibitors were detected in treated HCV patients, although there was no statistical significance (p>0.5). A significant correlation was found between the presence of RASs and advanced fibrosis/cirrhosis, but not with age, sex and viral load. Our study demonstrates a high frequency of RASs in patients with DAA failure, thus highlighting the usefulness of genotypic tests in this setting. The identification of RASs may guide the choice of the most appropriate drugs for HCV re-treatment.
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- 2021
33. Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience.
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Cleo Study Group, Ascione A, Adinolfi LE, 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, 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 A, Leo P, Lettieri G, Luppino I, Marrone A, Mazzoni E, Messina V, 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
- 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.
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- 2016
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34. Acute hepatitis C: a 24-week course of pegylated interferon α-2b versus a 12-week course of pegylated interferon α-2b alone or with ribavirin.
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Santantonio T, Fasano M, Sagnelli E, Tundo P, Babudieri S, Fabris P, Toti M, Di Perri G, Marino N, Pizzigallo E, and Angarano G
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- Acute Disease, Adolescent, Adult, Antiviral Agents adverse effects, Drug Therapy, Combination, Female, Humans, Interferon alpha-2, Interferon-alpha adverse effects, Male, Medication Adherence, Middle Aged, Polyethylene Glycols adverse effects, Recombinant Proteins administration & dosage, Recombinant Proteins adverse effects, Ribavirin adverse effects, Treatment Outcome, Young Adult, Antiviral Agents administration & dosage, Hepatitis C drug therapy, Interferon-alpha administration & dosage, Polyethylene Glycols administration & dosage, Ribavirin administration & dosage
- Abstract
Unlabelled: Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 μg/kg/week) for 24 or 12 weeks (arm 1, n = 44 and arm 2, n = 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n = 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 43 (72.1%) patients in arms 1, 2, and 3, respectively (P = 0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6%, 81.6%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated., Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration., (© 2014 by the American Association for the Study of Liver Diseases.)
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- 2014
- Full Text
- View/download PDF
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