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1. Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency

Author

Mascolo, M.C., Cursaro, C., Scuteri, A., Ranieri, J., Monti, M., Bellentani, S., Gasbarrini, A., Pompili, M., Puoti, C., Bellis, L., Regazzetti, A., Maffezzini, E., Pietrangelo, A., Abbati, G., Raimondo, G., Scribano, L., Martines, D., Baroni, G. Svegliati, Faraci, G., Schianchi, S., Fornaciari, G., Fabris, P., Madonia, S., Civitavecchia, G., Pirisi, M., Smirne, C., Borghi, A., Sardini, C., Andreoletti, M., Morisco, F., Caporaso, N., Fargion, S., Fatta, E., Masutti, F., Bonaventura, M.E., Autolitano, A., Russello, M., Bellia, A., Toniutto, P., Bitetto, D., Mecenate, F., Pasulo, L., Lucà, M.G., Picardi, A., Vespasiani, U., Grattagliano, I., Palasciano, G., Romagno, D., Crespi, C., Gianstefani, A., Gobbo, G., Monti, V., Giannelli, G., Napoli, N., Nosotti, Raspanti, A., Cuccorese, Colombo, A.E., Floridia, Plattella, M.S., Cassano, P., Gentile, I., Blanc, P.L., Messina, V., Bonfante, S., Bellissima, P., Toti, M., Vecchiet, J., Falasca, K., Portelli, V., De Stefano, G., Pietromatera, G., Viganò, P., Re, T., Andreoni, M., Raineri, G., Massari, M., Grossi, P.A., Caputo, S., Cassola, G., Feasi, M., Foti, G., Kunkar, A., Corti, G., Baragli, F., Caterini, L., Migliorini, D., Chiodera, A., Calleri, G., Spezia, C., Baiguera, C., Puoti, M., Brancaccio, G., Gaeta, G.B., Vento, S., Di Biagio, A., Nicolini, L., Liberti, A., Iannece, M.D., Contini, C., Tacconi, D., Caremani, M., Almi, P., Chimenti, M., Cosco, Messeri, D., Esperti, F.C., Paffetti, A., Mastropietro, C., Moretti, A., Spagnolo, A.L., Lomonaco, L., Calì, A., Mandelli, G., Spinzi, G.C., Framarin, L., Berrutti, M., Boccia, S., Simone, L., Pazzi, P., Fornari, F., Comparato, G., Casetti, T., Foschi, F.G., Bertin, T., Salvagnini, M., Samori, A., Ferretti, E., Casiraghi, M.A., Marin, R., Ciancio, A., Campo, N., Testa, R., Rocco, A., Federico, A., Loguercio, C., Rizzo, S., Giannini, E.G., Corbo, M., Riegler, G., Esposito, P., Ricci, G.L., Rosina, Floriano, Tosti, Maria Elena, Borghesio, Elisabetta, Masocco, Maria, Mele, Alfonso, Coppola, Carmine, Milella, Michele, Borgia, Guglielmo, Andreone, Pietro, Koch, Maurizio, Zignego, Anna Linda, Romano, Mario, Carrara, Maurizio, Almasio, Piero Luigi, Azzola, Emilio, Nardone, Gerardo, Benedetti, Antonio, Carosi, Giampiero, Mazzotta, Francesco, Sagnelli, Evangelista, and Rizzetto, Mario

Published
2014
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3. Impact of new DAA therapy on real clinical practice: a multicenter region-wide cohort study

Author

Lanini, Simone, Scognamiglio, Paola, Mecozzi, Alessandra, Lombardozzi, Lorella, Vullo, Vincenzo, Angelico, Mario, Gasbarrini, Antonio, Taliani, Gloria, Attili, Adolfo Francesco, Perno, Carlo Federico, De Santis, Adriano, Puro, Vincenzo, Cerqua, Fabio, D'Offizi, Gianpiero, Pellicelli, Adriano, Armignacco, Orlando, Mennini, Francesco Saverio, Siciliano, Massimo, Girardi, Enrico, Panella, Vincenzo, Ippolito, Giuseppe, Sarrecchia, C., Di Paolo, M. D., Francioso, S., Brega, A., Lenci, I., Sarmati, L., Pompili, Maurizio, Grieco, Antonio, Tamburrini, Enrica, Apaccini, R., Miele, Luca, D'Ettorre, G., Mezzaroma, I., Furlan, C., Accapezzato, D., Paoletti, F., Merili, M., Corradini, S., Sereno, S., Fimiani, C., Mastropietro, C., Labbadia, G., Gentile, Giuseppe, Pasquazzi, C., Marignani, M., Guarisco, R., Puoti, C., Spilabotti, L., Montalbano, M., Boumis, E., Visco-Comandini, U., Zaccarelli, M., Ammassari, A., Lionetti, R., Murachelli, S., Loiacono, L., Antinori, Armando, Noto, P., Palmieri, F., Cicalini, S., Cerilli, S., Sampaolesi, A., Vincenzi, L., Bellagamba, R., Galati, V., Abdeddaim, A., Iacomi, F., Iannicelli, G., Mastroianni, Chiara, Lichtner, M., Ridola, L., Coluzzi, T., Mercurio, V., Del Borgo, C., Fondacaro, L., Cerasari, G., Guarascio, P., D'Ambrosio, C., Starnini, G., Caterini, A., Villani, Emanuele Rocco, Sarracino, L., Casinelli, K., Moretti, A., Vespasiani, U., Galati, G., Cecere, R., Bonaventura, M., and Scudieri, M.

Subjects
Male, Cirrhosis, Investigational, chronic hepatitis c, clinical study, direct acting antiviral, hepatitis c virus, liver cirrhosis, liver damage, mixed effect model, multicenter cohort study, new therapy, treatment efficacy, Logistic regression, Chronic hepatitis C, Cohort Studies, 0302 clinical medicine, Clinical study, Direct acting antiviral, Hepatitis C virus, Liver cirrhosis, Liver damage, Mixed effect model, Multicenter cohort study, New therapy, Treatment efficacy, Adult, Aged, Aged, 80 and over, Antiviral Agents, Drug Therapy, Combination, Drugs, Investigational, Female, Follow-Up Studies, Hepatitis C, Chronic, Humans, Liver Cirrhosis, Middle Aged, Therapies, Investigational, 80 and over, 030212 general & internal medicine, Stage (cooking), Chronic, Confounding, Drugs, Hepatitis C, Infectious Diseases, Cohort, Combination, Settore SECS-P/03 - Scienza delle Finanze, 030211 gastroenterology & hepatology, Cohort study, Research Article, medicine.medical_specialty, Side effect, Hepatitis C virus, Chronic hepatitis C, Liver cirrhosis, Direct acting antiviral, Multicenter cohort study, Mixed effect model, Liver damage, Treatment efficacy, Clinical study, New therapy, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, lcsh:RC109-216, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Clinical trial, Therapies, business
Abstract

Background Management of chronic hepatitis C (CHC) has significantly accelerated in the last few years. Currently, second generation direct acting antivirals (DAAs) promise clearance of infection in most of patients. Here we present the results of the first analysis carried out on data of Lazio clinical network for DAAs. Methods The study was designed as a multicenter cohort: a) to assess the evolution of treatment during the first 24 months of the activity of the Clinical Network; b) to report overall efficacy of treatments; c) to analyze potential factors associated with lack of virological response at 12 weeks after therapy (SVR12); d) to evaluate the variation of ALT at baseline and 12 weeks after therapy in those who achieved SVR12 in comparison to those who did not. Analyses of efficacy were carried out with multilevel mixed effect logistic regression model. ALT temporal variation was assessed by mixed effect model mixed models with random intercept at patient’s level and random slope at the level of the time; i.e. either before or after therapy. Results Between 30 December 2014 and 31 December 2016 5279 patients started a DAA treatment; of those, 5127 (in 14 clinical centers) had completed the 12-week follow-up. Overall proportion of SVR12 was 93.41% (N = 4780) with no heterogeneity between the 14 clinical centers. Interruption as the consequence of severe side effect was very low (only 23 patients). Unadjusted analysis indicates that proportion of SVR12 significantly changes according to patient’s baseline characteristics, however after adjusting for potential confounders only adherence to current guidelines, stage of liver diseases, gender, transplant and HIV status were independently associated with the response to therapy. Analysis of ALT temporal variation showed that ALT level normalized in most, but not, all patients who achieved SVR12. Conclusion Our study confirmed the extraordinary efficacy of DAAs outside clinical trials. The advantage of DAAs was particularly significant for those patients who were previously considered as difficult-to-treat and did not have treatment options before DAAs era. Intervention based on network of select centers and prioritization of patients according to diseases severity was successful. Further studies are needed to establish whether clearance of HCV after DAAs therapy can arrest or even revert liver fibrosis in non-cirrhotic patients and/or improve life quality and expectancy in those who achieve SVR12 with cirrhosis.

Published
2018
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9. First-line antiretroviral therapy with efavirenz plus tenofovir disiproxil fumarate/emtricitabine or rilpivirine plus tenofovir disiproxil fumarate/emtricitabine: a durability comparison

Author

Taramasso, L., Biagio, Di, Maggiolo, A., Tavelli, F., Lo Caputo, A., Bonora, S., Zaccarelli, S., Caramello, M., Costantini, P., Viscoli, A., D'Arminio, Monforte, Cozzi-Lepri, A., Andreoni, A., Angarano, M., Antinori, G., Castelli, A., Cauda, F., Perri, Di, Galli, G., Iardino, M., Ippolito, R., Lazzarin, G., Perno, A., C. F., Von, Schloesser, Viale, F., Castagna, P., Ceccherini-Silberstein, A., Girardi, F., Mussini, E., Puoti, C., Ammassari, M., Balotta, A., Bandera, C., Bonfanti, A, Borderi, P., Calcagno, M., Calza, A., Capobianchi, L., Cingolani, M. R., Cinque, A., Luca, De, Gianotti, A., Gori, N., Guaraldi, A., Lapadula, G., Lichtner, G., Madeddu, M., Marchetti, G., Marcotullio, G., Monno, S., Nozza, L., Quiros, Roldan, Rossotti, E., Rusconi, R., Santoro, S., Saracino, M. M., Fanti, A., Galli, I., Lorenzini, L, Rodano, P., Shanyinde, A., Carletti, M., Carrara, F., Caro, Di, Graziano, S., Petrone, F., Prota, G, Quartu, S., Truffa, S., Giacometti, A., Valeriani, C., Santoro, C., Suardi, C., Donati, V., Verucchi, G., Minardi, C., Quirino, T., Abeli, C., Manconi, P. E., Piano, P., Cacopardo, B., Celesia, B., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Vichi, F., Cassola, G., Alessandrini, A., Bobbio, N., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Borgia, G., Di Martino, F., Maddaloni, L., Gentile, I., Orlando, R., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M. A., Vullo, V., Cristaudo, A., Baldin, G., Cicalini, S., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Savinelli, S., Latini, A., Cecchetto, M., Viviani, F., Mura, M. S., Rossetti, B., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Taramasso, L, Di Biagio, A, Maggiolo, F, Tavelli, A, Lo Caputo, S, Bonora, S., Zaccarelli, M, Caramello, P, Costantini, A, Viscoli, C., d'Arminio Monforte, A, Cozzi-Lepri, A, on behalf of the Italian Cohort NaiveAntiretrovirals (ICONA) Foundation Study, Group, Castagna, A, Taramasso, L., Di Biagio, A., Maggiolo, F., Tavelli, A., Lo Caputo, S., Zaccarelli, M., Caramello, P., Costantini, A., d'Arminio Monforte, A., Cozzi-Lepri, A., Andreoni, M., Angarano, G., Antinori, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C.F., von Schloesser, F., Viale, P., Castagna, A., Ceccherini-Silberstein, F., Girardi, E., Mussini, C., Puoti, M., Ammassari, A., Balotta, C., Bandera, A., Bonfanti, P., Borderi, M., Calcagno, A., Calza, L., Capobianchi, M.R., Cingolani, A., Cinque, P., De Luca, A., Gianotti, N., Gori, A., Guaraldi, G., Lapadula, G., Lichtner, M., Madeddu, G., Marchetti, G., Marcotullio, S., Monno, L., Nozza, S., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M.M., Saracino, A., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Shanyinde, M., Carletti, F., Carrara, S., Di Caro, A., Graziano, S., Petrone, F., Prota, G., Quartu, S., Truffa, S., Giacometti, A., Valeriani, C., Santoro, C., Suardi, C., Donati, V., Verucchi, G., Minardi, C., Quirino, T., Abeli, C., Manconi, P.E., Piano, P., Cacopardo, B., Celesia, B., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Vichi, F., Cassola, G., Alessandrini, A., Bobbio, N., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A.P., Rizzardini, G., Ridolfo, A.L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M.C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Borgia, G., Di Martino, F., Maddaloni, L., Gentile, I., Orlando, R., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M.A., Vullo, V., Cristaudo, A., Baldin, G., Cicalini, S., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Savinelli, S., Latini, A., Cecchetto, M., Viviani, F., Mura, M.S., Rossetti, B., Orofino, G.C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Bonora, S, Viscoli, C, Andreoni, M, Angarano, G, Antinori, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, Viale, P, Ceccherini-Silberstein, F, Girardi, E, Mussini, C, Puoti, M, Ammassari, A, Balotta, C, Bandera, A, Bonfanti, P, Borderi, M, Calcagno, A, Calza, L, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Marchetti, G, Marcotullio, S, Monno, L, Nozza, S, Quiros Roldan, E, Rossotti, R, Rusconi, S, Santoro, M, Saracino, A, Fanti, I, Galli, L, Lorenzini, P, Rodano, A, Shanyinde, M, Carletti, F, Carrara, S, Di Caro, A, Graziano, S, Petrone, F, Prota, G, Quartu, S, Truffa, S, Giacometti, A, Valeriani, C, Santoro, C, Suardi, C, Donati, V, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Vichi, F, Cassola, G, Alessandrini, A, Bobbio, N, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Borgia, G, Di Martino, F, Maddaloni, L, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, Cristaudo, A, Baldin, G, Cicalini, S, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Savinelli, S, Latini, A, Cecchetto, M, Viviani, F, Mura, M, Rossetti, B, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Perno, C. F., Capobianchi, M. R., Santoro, M. M., Manconi, P. E., Castelli, A. P., Ridolfo, A. L., Moioli, M. C., Ursitti, M. A., Mura, M. S., and Orofino, G. C.

Subjects
0301 basic medicine, medicine.medical_specialty, Efavirenz, combination antiretroviral therapy, durability, efavirenz, naïve, rilpivirine, Health Policy, Infectious Diseases, Pharmacology (medical), Infectious Disease, Emtricitabine, Gastroenterology, NO, 03 medical and health sciences, chemistry.chemical_compound, Interquartile range, Internal medicine, medicine, business.industry, 030112 virology, Confidence interval, Discontinuation, naive, Regimen, chemistry, combination antiretroviral therapy, durability, efavirenz, naïve, rilpivirine, Rilpivirine, business, Viral load, medicine.drug
Abstract

Objectives: The aim of this study was to compare the durabilities of efavirenz (EFV) and rilpivirine (RPV) in combination with tenofovir/emtricitabine (TDF/FTC) in first-line regimens. Methods: A multicentre prospective and observational study was carried out. We included all patients participating in the Italian Cohort Naive Antiretrovirals (ICONA) Foundation Study who started first-line combination antiretroviral therapy (cART) with TDF/FTC in combination with RPV or EFV, with a baseline viral load < 100 000 HIV-1 RNA copies/mL. Survival analyses using Kaplan–Meier (KM) curves and Cox regression with time-fixed covariates at baseline were employed. Results: Overall, 1490 ART-naïve patients were included in the study, of whom 704 were initiating their first cART with EFV and 786 with RPV. Patients treated with EFV, compared with those on RPV, were older [median 36 (interquartile range (IQR) 30–43) years vs. 33 (IQR 27–39) years, respectively; P < 0.001], were more frequently at Centers for Disease Control and Prevention (CDC) stage C (3.1% vs. 1.4%, respectively; P = 0.024), and had a lower median baseline CD4 count [340 (IQR 257–421) cells/μL vs. 447 (IQR 347–580) cells/μL, respectively; P < 0.001] and a higher median viral load [4.38 (IQR 3.92–4.74) log10 copies/mL vs. 4.23 (IQR 3.81–4.59) log10 copies/mL, respectively], (P = 0.004). A total of 343 patients discontinued at least one drug of those included in the first cART regimen, more often EFV (26%) than RPV (13%), by 2 years (P < 0.0001). After adjustment, patients treated with EFV were more likely to discontinue at least one drug for any cause [relative hazard (RH) 4.09; 95% confidence interval (CI) 2.89–5.80], for toxicity (RH 2.23; 95% CI 1.05–4.73) for intolerance (RH 5.17; 95% CI 2.66–10.07) and for proactive switch (RH 10.96; 95% CI 3.17–37.87) than those starting RPV. Conclusions: In our nonrandomized comparison, RPV was better tolerated, less toxic and showed longer durability than EFV, without a significant difference in rates of discontinuation because of failures.

Published
2018

14. Practice guidelines for the treatment of hepatitis C: recommendations from an AISF/SIMIT/SIMAST Expert Opinion Meeting

Author

Prati, D, Gasbarrini, A, Mazzotta, F, Sagnelli, E, Carosi, G, Abrescia, N, Alberti, Alfredo, Ambu, S, Andreone, P, Andriulli, A, Angelico, M, Antonucci, G, Ascione, A, Belli, Ls, Bruno, R, Bruno, S, Burra, Patrizia, Camma, C, Caporaso, N, Cariti, G, Cillo, U, Coppola, N, Craxi, A, DE LUCA, A, DE MARTIN, E, DI MARCO, V, Fagiuoli, S, Ferrari, C, Gaeta, Gb, Galli, M, Grieco, A, Grossi, P, Licata, A, Maida, I, Mangia, A, Marino, N, Maserati, R, Missale, G, Mondelli, M, Nasta, P, Niro, G, Persico, M, Petrelli, E, Picciotto, A, Piscaglia, F, Pollicino, T, Puoti, C, Puoti, M, Raimondo, G, Rumi, Mg, Santantonio, T, Smedile, A, Squadrito, G, Baroni, Gs, Taliani, G, Tavio, M, Toti, M, Bonino, F, Brunetto, Mr, Cacopardo, B, Caremani, M, Cauda, R, Colombo, M, DI PERRI, G, Donato, F, Farci, P, Fattovich, G, Filice, G, Ghinelli, F, Guadagnino, V, Lazzarin, A, Levrero, M, Licata, G, Orani, A, Paffetti, A, Pastore, G, Piccinino, F, Pizzigallo, E, Pontisso, Patrizia, Portelli, V, Rizzetto, M, Rossi, A, Stroffolini, T, Ubaldi, E, Santantanio, T, Alberti, A., Antonucci, Gf, Craxi, A., Prati D, Gasbarrini A, Mazzotta F, Sagnelli E, Carosi G, Abrescia N, Alberti A, Ambu S, Andreone P, Andriulli A, Angelico M, Antonucci GF, Ascione A, Belli LS, Bruno R, Bruno S, Burra P, Cammà, C, Caporaso N, Cariti G, Cillo U, Coppola N, Craxì, A, De Luca A, De Martin E, Di Marco, V, Fagiuoli S, Ferrari C, Gaeta GB, Galli M, Grieco A, Grossi P, Licata, A, Maida I, Mangia A, Marino N, Maserati R, Missale G, Mondelli M, Nasta P, Niro G, Persico M, Petrelli E, Picciotto A, Piscaglia F, Pollicino T, Prati D, Puoti C, Puoti M, Raimondo G, Rumi MG, Sagnelli E, Santantonio T, Smedile A, Squadrito G, Baroni GS, Taliani G, Tavio M, Toti M, Bonino F, Brunetto MR, Cacopardo B, Caremani M, Cauda R, Colombo M, Di Perri G, Donato F, Farci P, Fattovich G, Filice G, Ghinelli F, Guadagnino V, Lazzarin A, Levrero M, Licata G, Orani A, Paffetti A, Pastore G, Piccinino F, Pizzigallo E, Pontisso P, Portelli V, Rizzetto M, Rossi A, Stroffolini T, Ubaldi E., Italian Association for the Study of the Liver, Italian Society of Infectious, Tropical Disease, Italian Society for the Study of Sexually Transmitted Diseases: Prati D., Gasbarrini A., Mazzotta F., Sagnelli E., Carosi G., Abrescia N., Alberti A., Ambu S., Andreone P., Andriulli A., Angelico M., Antonucci G.F., Ascione A., Belli L.S., Bruno R., Bruno S., Burra P., Cammà C., Caporaso N., Cariti G., Cillo U., Coppola N., Craxì A., De Luca A., De Martin E., Di Marco V., Fagiuoli S., Ferrari C., Gaeta G.B., Galli M., Grieco A., Grossi P., Licata A., Maida I., Mangia A., Marino N., Maserati R., Missale G., Mondelli M., Nasta P., Niro G., Persico M., Petrelli E., Picciotto A., Piscaglia F., Pollicino T., Puoti C., Puoti M., Raimondo G., Rumi M.G., Santantonio T., Smedile A., Squadrito G., Baroni G.S., Taliani G., Tavio M., Toti M., Bonino F., Brunetto M.R., Cacopardo B., Caremani M., Cauda R., Colombo M., Di Perri G., Donato F., Farci P., Fattovich G., Filice G., Ghinelli F., Guadagnino V., Lazzarin A., Levrero M., Licata G., Orani A., Paffetti A., Pastore G., Piccinino F., Pizzigallo E., Pontisso P., Portelli V., Rizzetto M., Rossi A., Stroffolini T., Ubaldi E., Prati, D, Gasbarrini, A, Mazzotta, F, Sagnelli, E, Carosi, G, Abrescia, N, Alberti, A, Ambu, S, Andreone, P, Andriulli, A, Angelico, M, Antonucci, G, Ascione, A, Belli, L, Bruno, R, Bruno, S, Burra, P, Caporaso, N, Cariti, G, Cillo, U, Coppola, N, De Luca, A, De Martin, E, Fagiuoli, S, Ferrari, C, Gaeta, G, Galli, M, Grieco, A, Grossi, P, Maida, I, Mangia, A, Marino, N, Maserati, R, Missale, G, Mondelli, M, Nasta, P, Niro, G, Persico, M, Petrelli, E, Picciotto, A, Piscaglia, F, Pollicino, T, Puoti, C, Puoti, M, Raimondo, G, Rumi, M, Santantonio, T, Smedile, A, Squadrito, G, Baroni, G, Taliani, G, Tavio, M, Toti, M, Bonino, F, Brunetto, M, Cacopardo, B, Caremani, M, Cauda, R, Colombo, M, Di Perri, G, Donato, F, Farci, P, Fattovich, G, Filice, G, Ghinelli, F, Guadagnino, V, Lazzarin, A, Levrero, M, Licata, G, Orani, A, Paffetti, A, Pastore, G, Piccinino, F, Pizzigallo, E, Pontisso, P, Portelli, V, Rizzetto, M, Rossi, A, Stroffolini, T, and Ubaldi, E

Subjects
Liver Cirrhosis, ANTIVIRAL TREATMENT, Human immunodeficiency virus (HIV), HIV Infections, Hepacivirus, ANTIVIRAL THERAPY, PEGYLATED INTERFERON-ALPHA-2B, LIVER-TRANSPLANTATION, PEGINTERFERON ALPHA-2A, HIV-INFECTED PATIENTS, VIRUS-COINFECTED PATIENTS, RAPID VIROLOGICAL RESPONSE, Antiviral therapy, medicine.disease_cause, Gastroenterology, Polyethylene Glycols, HBV, guidelines, Acute hepatitis, Chronic hepatitis, Settore MED/12 - Gastroenterologia, liver transplantation, Hepatitis C, Recombinant Proteins, acute hepatitis, antiviral therapy, chronic hepatitis, cirrhosis, elderly patients, hbv, hcv, hdv, hiv, CLINICAL PRACTICE GUIDELINES, Cirrhosis, HCV, Drug Therapy, Combination, Antiviral therapy Acute hepatitis Chronic hepatitis,Cirrhosis, Elderly patients, HBV, HCV, HDV, HIV Liver transplantation, Elderly patient, Acute hepatiti, medicine.medical_specialty, Genotype, Alpha interferon, Interferon alpha-2, CHRONIC HEPATITIS C, Antiviral Agents, Hepatitis B, Chronic, Internal medicine, HDV, Drug Resistance, Viral, Ribavirin, medicine, Humans, Cirrhosi, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, Interferon-alpha, HIV, Hepatitis C, Chronic, medicine.disease, Elderly patients, Family medicine, Expert opinion, Chronic hepatiti, business
Abstract

It is increasingly clear that a tailored therapeutic approach to patients with hepatitis C virus infection is needed. Success rates in difficult to treat and low-responsive hepatitis C virus patients are not completely satisfactory, and there is the need to optimise treatment duration and intensity in patients with the highest likelihood of response. In addition, the management of special patient categories originally excluded from phase III registration trials needs to be critically re-evaluated. This article reports the recommendations for the treatment of hepatitis C virus infection on an individual basis, drafted by experts of three scientific societies.

Published
2010

15. Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency

Author

Rosina, Floriano, Tosti, Maria Elena, Borghesio, Elisabetta, Masocco, Maria, Mele, Alfonso, Coppola, Carmine, Milella, Michele, Borgia, Guglielmo, Andreone, Pietro, Koch, Maurizio, Zignego, Anna Linda, Romano, Mario, Carrara, Maurizio, Almasio, Piero Luigi, Azzola, Emilio, Nardone, Gerardo, Benedetti, Antonio, Carosi, Giampiero, Mazzotta, Francesco, Sagnelli, Evangelista, Rizzetto, Mario, Mascolo, M. C., Cursaro, C., Scuteri, A., Crespi, C., Gianstefani, A., Ranieri, J., Monti, M., Corti, G., Blanc, P. L., Baragli, F., Bellentani, S., Gasbarrini, A., Pompili, M., Mecenate, F., Picardi, A., Vespasiani, U., Nosotti, Null, Null, A. Picardi, Ricci, G. L., Paffetti, A., Mastropietro, C., Moretti, A., Spagnolo, A. L., Puoti, C., Bellis, L., Regazzetti, A., Maffezzini, E., Pietrangelo, A., Abbati, G., Borghi, A., Sardini, C., Raimondo, G., Scribano, L., Martines, D., Svegliati Baroni, G., Faraci, G., Schi anchi, S., Fornaciari, G., Massari, M., Fabris, P., Bertin, T., Salvagnini, M., Madonia, S., Calì, A., Civitavecchia, G., Pirisi, M., Smirne, C., Andreoletti, M., Morisco, F., Caporaso, N., Gentile, I., Brancaccio, G., Gaeta, G. B., Liberti, A., Iannece, M. D., Rocco, A., Federico, A., Loguercio, C., Riegler, G., Esposito, P., Fargion, S., Fatta, E., Masutti, F., Bonaventura, M. E., Autolitano, A., Russello, M., Bellia, A., Toniutto, P., Bitetto, D., Pasulo, L., Lucà, M. G., Grattagliano, I., Palasciano, G., Romagno, D., Giannelli, G., Napoli, N., Plattella, M. S., Cassano, P., Gobbo, G., Monti, V., Raspanti, A., Cuccorese, Null, Colombo, A. E., Mandelli, G., Spinzi, G. C., Floridia, Null, Messina, V., Bonfante, S., Bellissima, P., Toti, M., Vecchiet, J., Falasca, K., Portelli, V., Stefano, G. De, Pietromatera, G., Viganò, P., Re, T., Andreoni, M., Null, G. Raineri, Grossi, P. A., Caputo, S., Cassola, G., Feasi, M., Biagio, A. Di, Nicolini, LAURA AMBRA, Giannini, EDOARDO GIOVANNI, Corbo, M., Foti, G., Kunkar, A., Caterini, L., Migliorini, D., Chiodera, A., Calleri, G., Spezia, C., Framarin, L., Null, M. Berrutti, Ciancio, A., Baiguera, C., Puoti, M., Vento, S., Contini, C., Boccia, S., Casiraghi, M. A., Simone, L., Tacconi, D., Caremani, M., Almi, P., Chimenti, M., Cosco, Null, Messeri, D., Esperti, F. C., Lomonaco, L., Pazzi, P., Fornari, F., Comparato, G., Casetti, T., Foschi, F. G., Samori, A., Ferretti, E., Marin, R., Campo, N., Testa, R., Rizzo, S., Rosina, F, Tosti, ME, Borghesio, E, Masocco, M, Mele, A, Coppola, C, Milella, M, Borgia, G, Andreone, P, Koch, M, Zignego, AL, Romano, M, Carrara, M, Almasio, PL, Azzola, E, Nardone, G, Benedetti, A, Carosi, G, Mazzotta, F, Sagnelli, E, Rizzetto, M, Rosina, F., Tosti, M. E., Borghesio, E., Masocco, M., Mele, A., Coppola, C., Milella, M., Borgia, Guglielmo, Andreone, P., Koch, M., Zignego, A. L., Romano, M., Carrara, M., Almasio, P. L., Azzola, E., Nardone, GERARDO ANTONIO PIO, Benedetti, A., Carosi, G., Mazzotta, F., Sagnelli, E., Rizzetto, M., Aifa, Aisf, Simit, Aigo, Sige, Gentile, Ivan, Morisco, Filomena, Et, Al, Floriano Rosina, Maria Elena Tosti, Elisabetta Borghesio, Maria Masocco, Alfonso Mele, Carmine Coppola, Michele Milella, Guglielmo Borgia, Pietro Andreone, Maurizio Koch, Anna Linda Zignego, Mario Romano, Maurizio Carrara, Piero Luigi Almasio, Emilio Azzola, Gerardo Nardone, Antonio Benedetti, Giampiero Carosi, Francesco Mazzotta, Evangelista Sagnelli, and Mario Rizzetto

Subjects
Registrie, Male, Cirrhosis, medicine.disease_cause, Polyethylene Glycol, Gastroenterology, Polyethylene Glycols, chemistry.chemical_compound, Hepatitis Viruses, Hepatitis Viruse, Prospective Studies, Viral, Registries, Chronic, Prospective cohort study, Drug Carrier, Drug Carriers, Settore MED/12 - Gastroenterologia, Medicine (all), Recombinant Protein, Middle Aged, Hepatitis C, Recombinant Proteins, Treatment Outcome, Italy, Combination, RNA, Viral, Population study, Drug Therapy, Combination, Female, Human, medicine.medical_specialty, Genotype, Hepatitis C virus, Alpha interferon, Ribavirin, Sustained virological response (SVR), Treatment, Antiviral Agents, Follow-Up Studie, Hepatology, Drug Therapy, Internal medicine, medicine, Humans, Antiviral Agent, business.industry, Interferon-alpha, HCV therapy, Hepatitis C, Chronic, medicine.disease, Clinical trial, Prospective Studie, chemistry, Immunology, RNA, Follow-Up Studies, business
Abstract

a b s t r a c t Background: Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in “real world” chronic hepatitis C patients in Italy. Methods: Independent observational multicentre study including consecutive patients receiving Peginterferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study. Results: 4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase. Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%). During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and -glutamil-transpeptidase >2 times the normal limit were associated with poorer response. Conclusions: The response to Peg-interferon/ribavirin therapy in “real world” clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-totreat than among difficult-to-treat hepatitis C virus genotypes.

Published
2014

16. Vaccine-escape HBsAg mutants circulating among genotype D HBV-infected patients correlate with atypical serological profiles, high viremia and transaminases: Potential impact on vaccination strategies

Author

Salpini, R., primary, Battisti, A., additional, Colagrossi, L., additional, Alteri, C., additional, Bertoli, A., additional, Fabeni, L., additional, Sarrecchia, C., additional, Di Carlo, D., additional, Pollicita, M., additional, Lichtner, M., additional, Mastroianni, C., additional, De Sanctis, G., additional, Paoloni, M., additional, Marignani, M., additional, Pasquazzi, C., additional, Di Paolo, D., additional, Iapadre, N., additional, Mari, T., additional, Puoti, C., additional, Parruti, G., additional, Romano, S., additional, Visca, M., additional, Vecchiet, I., additional, Andreoni, M., additional, Cappiello, G., additional, Spanò, A., additional, Angelico, M., additional, Perno, C.F., additional, and Svicher, V., additional

Published
2016
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17. Trattamento della Epatite da HCV

Author

Alberti A, Bonino F, Bortolotti F, Colombo M, Craxì A, Mele A, Rizzetto M, Almasio P, Androne P, Ascione A, Benvegnù L, Brunetto M, Bruno S, Cammaà C, Di Marco V, Fattovich G, Ferrari C, Ideo G, Levriero M, Pagliaro L, Pastore G, Piccinino F, Pontisso P, Puoti C, Puoti M, Raimondo G, Rumi MG, Saracco G, Santantonio T, Smedile A, Zignego L., BRILLANTI, STEFANO, MAZZELLA, GIUSEPPE, Alberti A, Bonino F, Bortolotti F, Colombo M, Craxì A, Mele A, Rizzetto M, Almasio P, Androne P, Ascione A, Benvegnù L, Brillanti S, Brunetto M, Bruno S, Cammaà C, Di Marco V, Fattovich G, Ferrari C, Ideo G, Levriero M, Mazzella G, Pagliaro L, Pastore G, Piccinino F, Pontisso P, Puoti C, Puoti M, Raimondo G, Rumi MG, Saracco G, Santantonio T, Smedile A, and Zignego L.

Subjects
TERAPIA, HCV, EPATITE
Published
2004

18. Detection of high levels of Survivin-IgM immune complex in sera from hepatitis C virus infected patients with cirrhosis

Author

Matteucci C, Sorrentino R, Bellis L, Ettorre GM, Svicher V, Santoro R, Vennarecci G, Biasiolo A, Pontisso P, Scacciatelli D, Beneduce L, Sarrecchia C, Casalino P, Bernardini S, Pierimarchi P, Garaci E, Puoti C, and Rasi G.

Subjects
Survivin, Hepatocarcinoma Cirrosis, HCV
Abstract

AIM: The identification and surveillance of patients with liver dysfunctions and the discovering of new disease biomarkers with high sensibility and specificity are needed in the clinical practice. Aim of this study was to investigate on the serological presence of circulating Survivin-IgM immune complex (IC) as potential biomarker of diverse phases of chronic liver diseases. METHODS: Serum levels of Survivin-IgM were measured using an ELISA standardized and validated in our laboratory in 262 individuals, including healthy subjects and patients with chronic hepatitis, cirrhosis and HCC. RESULTS: Survivin-IgM IC was lower in healthy subjects (median: 99.39 AU/ml, IQR=73.33-148.27) than in patients with chronic viral hepatitis (median: 148.03 AU/ml, IQR=86.75-333.82; p=0.002) or with cirrhosis (median: 371.00 AU/ml, IQR=106.07-1110.06; p

Published
2013
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21. Longitudinal evaluation reveals a complex spectrum of virological profiles in hepatitis B virus/Hepatitis C virus coinfected patients

Author

Raimondo, G, Brunetto, Mr, Pontisso, P, Smedile, A, Maina, Am, Saitta, C, Squadrito, G, AND ASSOCIAZIONE ITALIANA STUDIO FEGATO AISF COOPERATIVE GROUP OLIVERO A, TONO N., Rosina, F, Sartori, M, Colombo, M, Lampertico, P, Fargion, S, Rossini, A, Fattovich, Giovanna, Ruvoletto, Mg, Villano, M, Croc, L, Picciotto, A, Ferrari, C, Missale, G, Zignego, Al, Moscato, G, Toti, M, Levriero, M, Puoti, C, Caporaso, N, Morisco, F, Gaeta, Gb, Piccinino, F, Sagnelli, E, Persico, M, Andriulli, A, Niro, Ga, Dentico, P, Pastore, G, Santantonio, T, Crax, A, DI MARCO, V, Cacopardo, B, Bruno, S, Smedile, V, Aiello, A, Brancatelli, S, Costantino, L, Pollicino, T, and Raffa, G.

Subjects
hepatitis B, hepatitis c, coinfection, virological profile
Published
2006

24. Effects of ursodeoxycholic acid on serum liver enzymes in patients with hepatitis C virus-related chronic liver disease

Author

Puoti, C, Magrini, A, Filippi, T, Annovazzi, G, and Pannullo, A

Subjects
Adult, Male, gamma-Glutamyltransferase, Humans, Hepatitis C, Female, Ursodeoxycholic Acid, Alanine Transaminase, Settore MED/44 - Medicina del Lavoro
Abstract

To study the effect of ursodeoxycholic acid (UDCA) on serum liver enzyme levels [alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT)] in 101 patients with hepatitis C virus-related chronic liver disease.Forty-nine patients were assigned to receive UDCA (450 mg/day) over a period of 6 months and 52 to receive no treatment.In the UDCA group, serum ALT and GGT levels significantly improved. ALT values decreased from pre-treatment levels of 157.0 +/- 62.6 IU/l to 82.5 +/- 46.4 IU/l (P0.05), and GGT fell from 141.3 +/- 86.2 IU/l to 66.0 +/- 49.5 IU/l (P0.001). No significant change occurred in the mean ALT and GGT levels in the control group.Although our encouraging preliminary results must be validated by double-blind histological trials, UDCA may be an alternative treatment for patients who fail to respond to interferon therapy.

Published
1995

25. Familial environment and HCV infection

Author

Puoti, C, Magrini, A, and Filippi, T

Subjects
Family Health, Disease Transmission, Infectious, Settore MED/44 - Medicina del Lavoro, Humans, Hepatitis C, Disease Transmission, Infectious
Published
1995

31. OC3.10.3 ANTIVIRAL TREATMENT OF HCV CARRIERS WITH NORMAL ALT

Author

Puoti, C., primary, Pellicelli, A.M., additional, Romano, M., additional, Mecenate, F., additional, Barbarini, G., additional, Mazzoni, E., additional, Barlattani, A., additional, Picardi, A., additional, Nosotti, L., additional, Paffetti, A., additional, Bonaventura, M.E., additional, Villani, R., additional, Guarisco, R., additional, Bellis, L., additional, Nicodemo, S., additional, Spilabotti, L., additional, and Soccorsi, F., additional

Published
2008
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32. 826 ANTIVIRAL TREATMENT OF HCV CARRIERS WITH NORMAL ALT

Author

Puoti, C., primary, Pellicelli, A.M., additional, Romano, M., additional, Guarisco, R., additional, Mecenate, F., additional, Barbarini, G., additional, Mazzoni, E., additional, Barlattani, A., additional, Picardi, A., additional, Paffetti, A., additional, Nosotti, L., additional, Bonaventura, M.E, additional, Villani, R., additional, Bellis, L., additional, Nicodemo, S., additional, Spilabotti, L., additional, and Soccorsi, F., additional

Published
2008
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40. Liver histology in anti-HCV positive subjects with normal ALT levels

Author

Puoti, C., Stati, T., Magrini, A., Rigato, P., Romagnoli, G., Piero Rossi, Montagnese, F., and Resta, S.

Subjects
Adult, Male, Hepatitis B Surface Antigens, Alanine Transaminase, Hepacivirus, Middle Aged, Hepatitis C Antibodies, Hepatitis C, Liver, Settore MED/44 - Medicina del Lavoro, Humans, RNA, Viral, Female, RNA, Viral

43. HCV genotype 1a shows a better virological response to antiviral therapy than HCV genotype 1b

Author

Pellicelli Adriano M, Romano Mario, Stroffolini Tommaso, Mazzoni Ettore, Mecenate Fabrizio, Monarca Roberto, Picardi Antonio, Bonaventura Maria, Mastropietro Cristina, Vignally Pascal, Andreoli Arnaldo, Marignani Massimo, D’Ambrosio Cecilia, Miglioresi Lucia, Nosotti Lorenzo, Mitidieri Olga, Gentilucci Umberto, Puoti Claudio, Barbaro Giuseppe, Barlattani Angelo, Furlan Caterina, and Barbarini Giorgio

Subjects
Genotype 1a, HCV genotype 1 subtypes, Sustained virological response, Antiviral therapy, Pegylated interferon, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background The impact of viral subtype on the rate of sustained virological response (SVR) to antiviral therapy in patients chronically infected with hepatitis C genotype 1 subtype 1a and 1b has not been extensively investigated. The aim of this study is to determine whether the HCV genotype 1 subtypes 1a and 1b respond differently to treatment with PEGylated interferon (PEG-IFN) plus ribavirin. Methods For 48 weeks, 388 “naïve”genotype 1 patients were treated weekly with PEG-IFN α-2a or PEG-INF α-2b combined with daily ribavirin (1000–1200 mg/day). The numbers of patients in whom HCV-RNA was undetectable were compared after 4 (rapid virological response, RVR), 12 (early virological response, EVR), and 48 (end treatment virological response, ETR) weeks of treatment as well as 24 weeks after the last treatment (sustained virological response, SVR). Results The rate of SVR was higher in subtype 1a patients than subtype 1b patients (55% vs. 43%; p 10 IU/ml (OR: 3.2; 95% CI: 2.7 to 6.9) and fibrosis score < S3 (OR: 3.8; 95% CI:3.2 to 7.4), were all independent predictors of SVR. Conclusion Dual antiviral therapy is more effective against HCV subtype 1a than against subtype 1b and this difference is independent of other factors that may favour viral clearance. Trial registration ClinicalTrials.gov Identifier: NCT01342003

Published
2012
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44. Ursodeoxycholic acid and chronic hepatitis C infection.

Author

Puoti, C, Pannullo, A, Annovazzi, G, Filippi, T, and Magrini, A

Subjects
*CHRONIC diseases, *CLINICAL trials, *COMPARATIVE studies, *HEPATITIS C, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH, *EVALUATION research, *ALANINE aminotransferase, *RANDOMIZED controlled trials, *GAMMA-glutamyltransferase
Published
1993
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45. Virological response and retention in care according to time of starting ART in Italy: data from the Icona Foundation Study cohort

Author

D'Arminio Monforte, A., Tavelli, A., Cozzi-Lepri, A., Castagna, A., Passerini, S., Francisci, D., Saracino, A., Maggiolo, F., Lapadula, G., Girardi, E., Perno, C. F., Antinori, A., Andreoni, M., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Marchetti, G. C., Rezza, G., Von Schloesser, F., Viale, P., Ceccherini-Silberstein, F., Lo Caputo, S., Mussini, C., Puoti, M., Bai, F., Balotta, C., Bandera, A., Bonora, S., Borderi, M., Calcagno, A., Capetti, A., Capobianchi, M. R., Cicalini, S., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lichtner, M., Madeddu, G., Marchetti, G., Monno, L., Nozza, S., Pinnetti, C., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M. M., Sarmati, L., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Macchia, M., Carletti, F., Carrara, S., Di Caro, A., Graziano, S., Petroni, F., Prota, G., Truffa, S., Giacometti, A., Costantini, A., Barocci, V., Angarano, G., Milano, E., Suardi, C., Donati, V., Verucchi, G., Castelnuovo, F., Minardi, C., Menzaghi, B., Abeli, C., Cacopardo, B., Celesia, B., Vecchiet, J., Falasca, K., Pan, A., Lorenzotti, S., Sighinolfi, L., Segala, D., Blanc, P., Vichi, F., Cassola, G., Viscoli, C., Alessandrini, A., Bobbio, N., Mazzarello, G., Fondaco, L., Bonfanti, P., Molteni, C., Chiodera, A., Milini, P., Nunnari, G., Pellicano, G., Rizzardini, G., Cannizzo, E. S., Moioli, M. C., Piolini, R., Bernacchia, D., Salpietro, S., Tincati, C., Puzzolante, C., Migliorino, C., Sangiovanni, V., Borgia, G., Esposito, V., Di Flumeri, G., Gentile, I., Rizzo, V., Cattelan, A. M., Marinello, S., Cascio, A., Trizzino, M., Schiaroli, E., Parruti, G., Sozio, F., Magnani, G., Ursitti, M. A., Cristaudo, A., Vullo, V., Acinapura, R., Moschese, D., Capozzi, M., Mondi, A., Rivano Capparuccia, M., Iaiani, G., Latini, A., Gagliardini, R., Plazzi, M. M., De Girolamo, G., Vergori, A., Cecchetto, M., Viviani, F., De Vito, A., Rossetti, B., Montagnani, F., Franco, A., Fontana Del Vecchio, R., Di Giuli, C., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Manfrin, V., Battagin, G., Starnini, G., Ialungo, A., D'Arminio Monforte, A., Tavelli, A., Cozzi-Lepri, A., Castagna, A., Passerini, S., Francisci, D., Saracino, A., Maggiolo, F., Lapadula, G., Girardi, E., Perno, C. F., Antinori, A., Andreoni, M., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Marchetti, G. C., Rezza, G., Von Schloesser, F., Viale, P., Ceccherini-Silberstein, F., Lo Caputo, S., Mussini, C., Puoti, M., Bai, F., Balotta, C., Bandera, A., Bonora, S., Borderi, M., Calcagno, A., Capetti, A., Capobianchi, M. R., Cicalini, S., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lichtner, M., Madeddu, G., Marchetti, G., Monno, L., Nozza, S., Pinnetti, C., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M. M., Sarmati, L., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Macchia, M., Carletti, F., Carrara, S., Di Caro, A., Graziano, S., Petroni, F., Prota, G., Truffa, S., Giacometti, A., Costantini, A., Barocci, V., Angarano, G., Milano, E., Suardi, C., Donati, V., Verucchi, G., Castelnuovo, F., Minardi, C., Menzaghi, B., Abeli, C., Cacopardo, B., Celesia, B., Vecchiet, J., Falasca, K., Pan, A., Lorenzotti, S., Sighinolfi, L., Segala, D., Blanc, P., Vichi, F., Cassola, G., Viscoli, C., Alessandrini, A., Bobbio, N., Mazzarello, G., Fondaco, L., Bonfanti, P., Molteni, C., Chiodera, A., Milini, P., Nunnari, G., Pellicano, G., Rizzardini, G., Cannizzo, E. S., Moioli, M. C., Piolini, R., Bernacchia, D., Salpietro, S., Tincati, C., Puzzolante, C., Migliorino, C., Sangiovanni, V., Borgia, G., Esposito, V., Di Flumeri, G., Gentile, I., Rizzo, V., Cattelan, A. M., Marinello, S., Cascio, A., Trizzino, M., Schiaroli, E., Parruti, G., Sozio, F., Magnani, G., Ursitti, M. A., Cristaudo, A., Vullo, V., Acinapura, R., Moschese, D., Capozzi, M., Mondi, A., Rivano Capparuccia, M., Iaiani, G., Latini, A., Gagliardini, R., Plazzi, M. M., De Girolamo, G., Vergori, A., Cecchetto, M., Viviani, F., De Vito, A., Rossetti, B., Montagnani, F., Franco, A., Fontana Del Vecchio, R., Di Giuli, C., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Manfrin, V., Battagin, G., Starnini, G., Ialungo, A., A d'Arminio Monforte, A Antinori, M Andreoni, A Castagna, F Castelli, R Cauda, G Di Perri, M Galli, R Iardino, G Ippolito, A Lazzarin, G C Marchetti, G Rezza, F von Schloesser, F Ceccherini-Silberstein, A Cozzi-Lepri, E Girardi, S Lo Caputo, C Mussini, M Puoti, C F Perno, F Bai, C Balotta, A Bandera, S Bonora, M Borderi, A Calcagno, A Capetti, M R Capobianchi, S Cicalini, A Cingolani, P Cinque, , A Di Biagio, N Gianotti, A Gori, G Guaraldi, G Lapadula, M Lichtner, G Madeddu, F Maggiolo, L Monno, S Nozza, C Pinnetti, E Quiros Roldan, R Rossotti, S Rusconi, M M Santoro, A Saracino, L Sarmati, I Fanti, L Galli, P Lorenzini, A Rodano', M Macchia, A Tavelli, F Carletti, S Carrara, A Di Caro, S Graziano, F Petroni, G Prota, S Truffa, A Giacometti, A Costantini, V Barocci, G Angarano, E Milano, C Suardi, V Donati, G Verucchi, F Castelnuovo, C Minardi, B Menzaghi, C Abeli, B Cacopardo, B Celesia, J Vecchiet, K Falasca, A Pan, S Lorenzotti, L Sighinolfi, D Segala, P Blanc, F Vichi, G Cassola, C Viscoli, A Alessandrini, N Bobbio, G Mazzarello, L Fondaco, P Bonfanti, C Molteni, A Chiodera, P Milini, G Nunnari, G Pellicanò, G Rizzardini, E S Cannizzo, M C Moioli, R Piolini, D Bernacchia, S Salpietro, C Tincati, C Puzzolante, C Migliorino, V Sangiovanni, G Borgia, V Esposito, G Di Flumeri, I Gentile, V Rizzo, A M Cattelan, S Marinello, A Cascio, M Trizzino, D Francisci, E Schiaroli, G Parruti, F Sozio, G Magnani, M A Ursitti, A Cristaudo, V Vullo, R Acinapura, D Moschese, M Capozzi, A Mondi, M Rivano Capparuccia, G Iaiani, A Latini, R Gagliardini, M M Plazzi, G De Girolamo, A Vergori, M Cecchetto, F Viviani, A De Vito, B Rossetti, F Montagnani, A Franco, R Fontana Del Vecchio, C Di Giuli, P Caramello, G C Orofino, M Sciandra, M Bassetti, A Londero, V Manfrin, G Battagin, G Starnini, A Ialungo, D'Arminio Monforte, A, Tavelli, A, Cozzi-Lepri, A, Castagna, A, Passerini, S, Francisci, D, Saracino, A, Maggiolo, F, Lapadula, G, Girardi, E, Perno, C, Antinori, A, Andreoni, M, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Marchetti, G, Rezza, G, Von Schloesser, F, Viale, P, Ceccherini-Silberstein, F, Lo Caputo, S, Mussini, C, Puoti, M, Bai, F, Balotta, C, Bandera, A, Bonora, S, Borderi, M, Calcagno, A, Capetti, A, Capobianchi, M, Cicalini, S, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Lichtner, M, Madeddu, G, Monno, L, Nozza, S, Pinnetti, C, Quiros Roldan, E, Rossotti, R, Rusconi, S, Santoro, M, Sarmati, L, Fanti, I, Galli, L, Lorenzini, P, Rodano, A, Macchia, M, Carletti, F, Carrara, S, Di Caro, A, Graziano, S, Petroni, F, Prota, G, Truffa, S, Giacometti, A, Costantini, A, Barocci, V, Angarano, G, Milano, E, Suardi, C, Donati, V, Verucchi, G, Castelnuovo, F, Minardi, C, Menzaghi, B, Abeli, C, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Lorenzotti, S, Sighinolfi, L, Segala, D, Blanc, P, Vichi, F, Cassola, G, Viscoli, C, Alessandrini, A, Bobbio, N, Mazzarello, G, Fondaco, L, Bonfanti, P, Molteni, C, Chiodera, A, Milini, P, Nunnari, G, Pellicano, G, Rizzardini, G, Cannizzo, E, Moioli, M, Piolini, R, Bernacchia, D, Salpietro, S, Tincati, C, Puzzolante, C, Migliorino, C, Sangiovanni, V, Borgia, G, Esposito, V, Di Flumeri, G, Gentile, I, Rizzo, V, Cattelan, A, Marinello, S, Cascio, A, Trizzino, M, Schiaroli, E, Parruti, G, Sozio, F, Magnani, G, Ursitti, M, Cristaudo, A, Vullo, V, Acinapura, R, Moschese, D, Capozzi, M, Mondi, A, Rivano Capparuccia, M, Iaiani, G, Latini, A, Gagliardini, R, Plazzi, M, De Girolamo, G, Vergori, A, Cecchetto, M, Viviani, F, De Vito, A, Rossetti, B, Montagnani, F, Franco, A, Fontana Del Vecchio, R, Di Giuli, C, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Manfrin, V, Battagin, G, Starnini, G, Ialungo, A, D'Arminio Monforte A., Tavelli A., Cozzi-Lepri A., Castagna A., Passerini S., Francisci D., Saracino A., Maggiolo F., Lapadula G., Girardi E., Perno C.F., Antinori A., Andreoni M., Castelli F., Cauda R., Di Perri G., Galli M., Iardino R., Ippolito G., Lazzarin A., Marchetti G.C., Rezza G., Von Schloesser F., Viale P., Ceccherini-Silberstein F., Lo Caputo S., Mussini C., Puoti M., Bai F., Balotta C., Bandera A., Bonora S., Borderi M., Calcagno A., Capetti A., Capobianchi M.R., Cicalini S., Cingolani A., Cinque P., De Luca A., Di Biagio A., Gianotti N., Gori A., Guaraldi G., Lichtner M., Madeddu G., Marchetti G., Monno L., Nozza S., Pinnetti C., Quiros Roldan E., Rossotti R., Rusconi S., Santoro M.M., Sarmati L., Fanti I., Galli L., Lorenzini P., Rodano A., MacChia M., Carletti F., Carrara S., Di Caro A., Graziano S., Petroni F., Prota G., Truffa S., Giacometti A., Costantini A., Barocci V., Angarano G., Milano E., Suardi C., Donati V., Verucchi G., Castelnuovo F., Minardi C., Menzaghi B., Abeli C., Cacopardo B., Celesia B., Vecchiet J., Falasca K., Pan A., Lorenzotti S., Sighinolfi L., Segala D., Blanc P., Vichi F., Cassola G., Viscoli C., Alessandrini A., Bobbio N., Mazzarello G., Fondaco L., Bonfanti P., Molteni C., Chiodera A., Milini P., Nunnari G., Pellicano G., Rizzardini G., Cannizzo E.S., Moioli M.C., Piolini R., Bernacchia D., Salpietro S., Tincati C., Puzzolante C., Migliorino C., Sangiovanni V., Borgia G., Esposito V., Di Flumeri G., Gentile I., Rizzo V., Cattelan A.M., Marinello S., Cascio A., Trizzino M., Schiaroli E., Parruti G., Sozio F., Magnani G., Ursitti M.A., Cristaudo A., Vullo V., Acinapura R., Moschese D., Capozzi M., Mondi A., Rivano Capparuccia M., Iaiani G., Latini A., Gagliardini R., Plazzi M.M., De Girolamo G., Vergori A., Cecchetto M., Viviani F., De Vito A., Rossetti B., Montagnani F., Franco A., Fontana Del Vecchio R., Di Giuli C., Caramello P., Orofino G.C., Sciandra M., Bassetti M., Londero A., Manfrin V., Battagin G., Starnini G., and Ialungo A.

Subjects
0301 basic medicine, diagnosis, hiv, communicable diseases, HIV Infections, Logistic regression, Virological response, Cohort Studies, 0302 clinical medicine, Retention in Care, Medicine, Pharmacology (medical), HIV Infection, 030212 general & internal medicine, Prospective cohort study, cd4 count determination procedure, drug, suppression, Viral Load, CD4 Lymphocyte Count, Humans, Italy, Anti-HIV Agents, virology, Infectious Diseases, blood hiv rna, Cohort, hiv, cd4 count determination procedure, communicable diseases, incomeitaly, diagnosis, virology, blood hiv rna, retention in care, incomeitaly, Viral load, HIV, ART, Cohort study, Human, Microbiology (medical), medicine.medical_specialty, antiretroviral therapy, Settore MED/17 - MALATTIE INFETTIVE, NO, 03 medical and health sciences, HIV viral load, Internal medicine, HIV, CD4, ART, Pharmacology, business.industry, double blind, Anti-HIV Agent, HIV viral load, antiretroviral therapy, double blind, initiation, suppression, infection, Retention in care, 030112 virology, infection, initiation, Observational study, Cohort Studie, business
Abstract

Objectives To describe: (i) factors associated with rapid and delayed ART initiation; (ii) rates of 12 week virological response; and (iii) virologically controlled retention in care by 1 year from ART initiation according to timing of start in a real-life setting. Methods All individuals in the Icona cohort diagnosed with HIV in 2016–17 who initiated ART were grouped according to the time between HIV diagnosis and ART initiation: Group 1, ≤7 days; Group 2, 8–14 days; Group 3, 15–30 days; Group 4, 31–120 days; and Group 5, >120 days. Multivariable logistic regression models were used to identify factors associated with: (i) the probability of rapid (Group 1) and very delayed (Group 5) ART initiation; (ii) the 12 week virological response (by a modified snapshot algorithm); and (iii) the probability of retention in care at 1 year (on ART with HIV-RNA Results A total of 1247 individuals were included [82 (6.6%) in Group 1, 115 (9.2%) in Group 2, 267 (21.4%) in Group 3, 641 (51.4%) in Group 4 and 142 (11.4%) in Group 5]. Main predictors of rapid ART start (Group 1) were low CD4 cell count and high HIV-RNA at first contact with the infectious diseases centre. There was no association between probability of virological response and timing of ART initiation. Overall, 90% of individuals remained on ART after 1 year, 91% with undetectable HIV-RNA. Participants of Italian nationality, those with higher CD4 cell count and lower HIV-RNA at ART initiation were more likely to be retained in care after 1 year. Conclusions In our high-income observational setting, we did not observe differences in the 1 year rate of virological response and retention in care according to timing of ART initiation.

Published
2020

46. Incidence and risk factors for liver enzyme elevation among naive HIV-1-infected patients receiving ART in the ICONA cohort

Author

Taramasso, L., Lorenzini, P., Di Biagio, A., Lichtner, M., Marchetti, G., Rossotti, R., Lapadula, G., Cozzi-Lepri, A., Vichi, F., Antinori, A., Bonora, S., D'Arminio Monforte, A., ICONA Foundation Study Group:, A d'Arminio Monforte, Antinori, A, Andreoni, M, Castagna, A, Castelli, F, Cauda, R, G Di Perri, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, C Marchetti, G, Rezza, G, F von Schloesser, Viale, P, A d'Arminio Monforte, Ceccherini-Silberstein, F, Cozzi-Lepri, A, Girardi, E, S Lo Caputo, Mussini, C, Puoti, M, F Perno, C, Bai, F, Balotta, C, Bandera, A, Bonora, S, Borderi, M, Calcagno, A, Capetti, A, R Capobianchi, M, Cicalini, S, Cingolani, A, Cinque, P, A De Luca, A Di Biagio, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Monno, L, Nozza, S, Pinnetti, C, QUIROS ROLDAN, Maria Eugenia, Rossotti, R, Rusconi, S, M Santoro, M, Saracino, A, Sarmati, L, Fanti, I, Galli, L, Lorenzini, P, Rodano', A, Macchia, M, Tavelli, A, Carletti, F, Carrara, S, A Di Caro, Graziano, S, Petroni, F, Prota, G, Truffa, S, Giacometti, A, Costantini, A, Barocci, V, Angarano, G, Milano, E, Suardi, C, Donati, V, Verucchi, G, Castelnuovo, F, Minardi, C, Menzaghi, B, Abeli, C, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Lorenzotti, S, Sighinolfi, L, Segala, D, Blanc, P, Vichi, F, Cassola, G, Viscoli, C, Alessandrini, A, Bobbio, N, Mazzarello, G, Vita, S, Bonfanti, P, Molteni, C, Chiodera, A, Milini, P, Nunnari, G, Pellicanò, G, Rizzardini, G, S Cannizzo, E, C Moioli, M, Piolini, R, Bernacchia, D, Salpietro, S, Tincati, C, Puzzolante, C, Migliorino, C, Sangiovanni, V, Borgia, G, Esposito, V, F Di Martino, Gentile, I, Rizzo, V, M Cattelan, A, Marinello, S, Cascio, A, Trizzino, M, Baldelli, F, Schiaroli, E, Parruti, G, Sozio, F, Magnani, G, A Ursitti, M, Cristaudo, A, Vullo, V, Acinapura, R, Moschese, D, Capozzi, M, Mondi, A, M Rivano Capparuccia, Iaiani, G, Latini, A, Gagliardini, R, M Plazzi, M, Savinelli, S, Vergori, A, Cecchetto, M, Viviani, F, A De Vito, Rossetti, B, Montagnani, F, Franco, A, R Fontana Del Vecchio, Francisci, D, C Di Giuli, Caramello, P, C Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Starnini, G, Ialungo, A, Taramasso, L, Lorenzini, P, Di Biagio, A, Lichtner, M, Marchetti, G, Rossotti, R, Lapadula, G, Cozzi-Lepri, A, Vichi, F, Antinori, A, Bonora, S, D'Arminio Monforte, A, d'Arminio Monforte, A, Andreoni, M, Castagna, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Marchetti, Gc, Rezza, G, von Schloesser, F, Viale, P, Ceccherini-Silberstein, F, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Perno, Cf, Bai, F, Balotta, C, Bandera, A, Borderi, M, Calcagno, A, Capetti, A, Capobianchi, Mr, Cicalini, S, Cingolani, A, Cinque, P, De Luca, A, Gianotti, N, Gori, A, Guaraldi, G, Madeddu, G, Maggiolo, F, Monno, L, Nozza, S, Pinnetti, C, Quiros Roldan, E, Rusconi, S, Santoro, Mm, Saracino, A, Sarmati, L, Fanti, I, Galli, L, Rodano', A, Macchia, M, Tavelli, A, Carletti, F, Carrara, S, Di Caro, A, Graziano, S, Petroni, F, Prota, G, Truffa, S, Giacometti, A, Costantini, A, Barocci, V, Angarano, G, Milano, E, Suardi, C, Donati, V, Verucchi, G, Castelnuovo, F, Minardi, C, Menzaghi, B, Abeli, C, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Lorenzotti, S, Sighinolfi, L, Segala, D, Blanc, P, Cassola, G, Viscoli, C, Alessandrini, A, Bobbio, N, Mazzarello, G, Vita, S, Bonfanti, P, Molteni, C, Chiodera, A, Milini, P, Nunnari, G, Pellicanò, G, Rizzardini, G, Cannizzo, E, Moioli, Mc, Piolini, R, Bernacchia, D, Salpietro, S, Tincati, C, Puzzolante, C, Migliorino, C, Sangiovanni, V, Borgia, G, Esposito, V, Di Martino, F, Gentile, I, Rizzo, V, Cattelan, Am, Marinello, S, Cascio, A, Trizzino, M, Baldelli, F, Schiaroli, E, Parruti, G, Sozio, F, Magnani, G, Ursitti, Ma, Cristaudo, A, Vullo, V, Acinapura, R, Moschese, D, Capozzi, M, Mondi, A, Capparuccia, Mr, Iaiani, G, Latini, A, Gagliardini, R, Plazzi, Mm, Savinelli, S, Vergori, A, Cecchetto, M, Viviani, F, De Vito, A, Rossetti, B, Montagnani, F, Franco, A, Fontana Del Vecchio, R, Francisci, D, Di Giuli, C, Caramello, P, Orofino, Gc, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Starnini, G, Ialungo, A, Taramasso L., Lorenzini P., Di Biagio A., Lichtner M., Marchetti G., Rossotti R., Lapadula G., Cozzi-Lepri A., Vichi F., Antinori A., Bonora S., Cascio A., D'Arminio Monforte A., Cascio A. in ICONA Foundation Study Group., Taramasso, L., Lorenzini, P., Di Biagio, A., Lichtner, M., Marchetti, G., Rossotti, R., Lapadula, G., Cozzi-Lepri, A., Vichi, F., Antinori, A., Bonora, S., D'Arminio Monforte, A., Castagna, A., and A d'Arminio Monforte,i, M Andreoni, A Castagna, F Castelli, R Cauda, G Di Perri, M Galli, R Iardino, G Ippolito, A Lazzarin, G Rezza, F von Schloesser, F Ceccherini-Silberstein, E Girardi, S Lo Caputo, C Mussini, M Puoti, C F Perno, F Bai, C Balotta, A Bandera, M Borderi, A Calcagno, A Capetti, M R Capobianchi, S Cicalini, A Cingolani, P Cinque, A De Luca, E Girardi, N Gianotti, A Gori, G Guaraldi, G Madeddu, F Maggiolo, L Monno, S Nozza, C Pinnetti, E Quiros Roldan, S Rusconi, M M Santoro, A Saracino, L Sarmati, I Fanti, A Rodano', M Macchia, A Tavelli, F Carletti, S Carrara, A Di Caro, S Graziano, F Petroni, G Prota, S Truffa, A Giacometti, A Costantini, V Barocci, G Angarano, L Monno, E Milano, F Maggiolo, C Suardi, P Viale, V Donati, G Verucchi, F Castelnuovo, C Minardi, B Menzaghi, C Abeli, B Cacopardo, B Celesia, J Vecchiet, K Falasca, A Pan, S Lorenzotti, L Sighinolfi, D Segala, P Blanc, G Cassola, C Viscoli, A Alessandrini, N Bobbio, G Mazzarello, S Vita, P Bonfanti, C Molteni, A Chiodera, P Milini, G Nunnari, G Pellicanò, G Rizzardini, E S Cannizzo, M C Moioli, R Piolini, D Bernacchia, S Salpietro, C Tincati, C Puzzolante, C Migliorino, V Sangiovanni, G Borgia, V Esposito, F Di Martino, I Gentile, V Rizzo, A M Cattelan, S Marinello, A Cascio, M Trizzino, F Baldelli, E Schiaroli, G Parruti, F Sozio, G Magnani, M A Ursitti, A Cristaudo, V Vullo, R Acinapura, D Moschese, M Capozzi, A Mondi, M Rivano Capparuccia, G Iaiani, A Latini, R Gagliardini, M M Plazzi, S Savinelli, A Vergori, M Cecchetto, F Viviani, G Madeddu, A De Vito, B Rossetti, F Montagnani, A Franco, R Fontana Del Vecchio, D Francisci, C Di Giuli, P Caramello, G C Orofino, M Sciandra, M Bassetti, A Londero, G Pellizzer, V Manfrin, G Starnini, A Ialungo

Subjects
0301 basic medicine, Male, Integrase inhibitor, Hepatitis B Surface Antigen, HIV Infections, 0302 clinical medicine, Risk Factors, hivh epatitis c rna surface antigens follow-up homosexuality integrase inhibitors hepatitis b virus hepatitis b virus measurement hiv infections hepatotoxicity hepatitis c virus coinfection nucleoside reverse transcriptase inhibitors non-nucleoside reverse transcriptase inhibitors cox proportional hazards models baseline value liver enzyme raltegravir, Pharmacology (medical), HIV Infection, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Coinfection, Incidence (epidemiology), Liver Disease, Incidence, Liver Diseases, virus diseases, Hepatitis C, Middle Aged, Reverse Transcriptase Inhibitor, Infectious Diseases, Cohort, Population study, Regression Analysis, Reverse Transcriptase Inhibitors, Female, medicine.drug, Human, Microbiology (medical), Adult, medicine.medical_specialty, Anti-HIV Agents, Regression Analysi, NO, 03 medical and health sciences, Internal medicine, medicine, Humans, HIV Integrase Inhibitors, HIV Protease Inhibitor, Pharmacology, Hepatitis B Surface Antigens, business.industry, Anti-HIV Agent, HIV, ART, HIV Protease Inhibitors, medicine.disease, Raltegravir, 030112 virology, HIV Integrase Inhibitor, Prospective Studie, HIV-1, business, Adult, Anti-HIV Agents, Coinfection, Female, Hepatitis B Surface Antigens, Hepatitis C, HIV Infections, HIV Integrase Inhibitors, HIV Protease Inhibitors, HIV-1, Humans, Incidence, Liver Diseases, Male, Middle Aged, Prospective Studies, Regression Analysis, Reverse Transcriptase Inhibitors, Risk Factors
Abstract

ObjectivesTo evaluate the incidence and risk factors for liver enzyme elevations (LEE) in patients initiating first-line ART in the ICONA prospective observational cohort, between June 2009 and December 2017.Patients and methodsIn total, 6575 ART-naive patients were selected, initiating two NRTIs with the third drug being a boosted PI (n=2436; 37.0%), an NNRTI (n=2384; 36.3%) or an integrase strand transfer inhibitor (INSTI) (n=1755; 26.7%). HBV surface antigen and HCV RNA were detected in 3.9% and 5.8% of the study population. Inverse probability weighted Cox regression analysis was used to calculate the HRs, according to first-line regimen, for LEE, defined as ALT or AST increases of ≥2.5× upper limit of normal (ULN) for patients with normal baseline values or ≥2.5× baseline for patients with higher baseline values.ResultsOne hundred and eighty-three LEE occurred over 20722 patient-years of follow-up. After adjusting for the main confounders, the risk of LEE halved with INSTIs compared with NNRTIs (HR 0.46, 95% CI 0.25–0.86), with a significant reduction in the raltegravir group (HR 0.11, 95% CI 0.02–0.84 using the NNRTI class as reference). HRs for LEE were significantly higher in subjects with HBV or HCV coinfection, in patients with poorly controlled HIV infection and in those who acquired HIV through homosexual transmission.ConclusionsIn our study, INSTI use almost halved the risk of LEE compared with other regimens. This finding could be particularly important for choosing ART in patients with risk factors for liver toxicity such as HCV and HBV coinfections.

Published
2019

47. Histological and virological features and follow-up of hepatitis C virus carriers with normal aminotransferase levels: the Italian prospective study of the asymptomatic C carriers (ISACC)

Author

Giovanni Battista Gaeta, Roberto Castellacci, Nicoletta Bergami, Fabrizio Montagnese, Serena Zaltron, Claudio Puoti, Paolo Corvisieri, Davide F Precone, Eliseo Minola, Gianfranca Stornaiuolo, Lia Bellis, Massimo Puoti, Puoti, C, Castellacci, R, Montagnese, F, Zaltron, S, Stornaiuolo, G, Bergami, N, Bellis, L, Precone, Df, Corvisieri, P, Puoti, M, Minola, E, and Gaeta, Giovanni Battista

Subjects
Adult, Male, medicine.medical_specialty, Cirrhosis, Genotype, Biopsy, Hepacivirus, Hepatitis C virus, medicine.disease_cause, Chronic liver disease, Asymptomatic, Gastroenterology, Internal medicine, medicine, Humans, Prospective Studies, Prospective cohort study, Hepatitis, Hepatology, biology, Alanine Transaminase, Hepatitis C, Chronic, Middle Aged, medicine.disease, biology.organism_classification, digestive system diseases, Italy, Alanine transaminase, Carrier State, Immunology, biology.protein, Female, medicine.symptom, Follow-Up Studies
Abstract

Background/Aims : To evaluate demographic characteristics, liver histology and virological features of hepatitis C virus (HCV) carriers with normal alanine transaminase (ALT) levels. Methods : A nationwide prospective study was started in 1997. Four Italian centres have participated in this study. Results : Eight hundred and eighty subjects entered the study. One hundred and eighty-nine (21.5%) were excluded during the follow-up because of ALT increase. Among the 691 patients with persistent ALT normality, 72% were females. An overall prevalence of genotype 2 was found (52%). Normal liver was found in 17% of the patients; 34% had minimal chronic hepatitis, 44% mild hepatitis, 4% moderate to severe hepatitis, and 1% had cirrhosis. Clinical and virological features did not differ between subjects with ALT flares and those with persistently normal ALT. Baseline ALT levels have no effects on liver histology and clinical outcome. Conclusions : Many HCV carriers have significant chronic liver damage, although in the majority of them liver lesions are minimal or mild. Up to 60% of HCV carriers in Italy harbour non-1 HCV types. Current definition of HCV carriers with persistently normal ALT levels, based upon three normal ALT values over a 6-month period, is not adequate to discriminate between carriers with persistent ALT normality and those with transient biochemical remission. Longer follow-ups are needed.

Published
2002

49. Liver steatosis: The new epidemic of the Third Millennium. Benign liver state or silent killer?

Author

Puoti C, Elmo MG, Ceccarelli D, and Ditrinco M

Subjects
Diabetes Mellitus, Type 2 complications, Humans, Obesity complications, Prognosis, Risk Factors, Liver pathology, Non-alcoholic Fatty Liver Disease diagnosis, Non-alcoholic Fatty Liver Disease physiopathology, Non-alcoholic Fatty Liver Disease therapy
Abstract

Until the end of the 90's of the last century, rather little attention was paid to the issue of the non-alcoholic fatty liver disease (NAFLD), perhaps due to the fact that the newly discovered hepatitis C virus did attract a paramount interest of hepatologists and researchers. On the other side, fatty liver was considered a relatively uncommon cause of liver damage, occurring almost exclusively in obese females, often associated with non-insulin dependent diabetes mellitus (NIDDM), and with a relatively benign prognosis. Due to the complexity of international available guidelines, we decide to approach the main unsolved issues on this topic in the form of a dialog between a hepatologist and a man suffering from NAFLD, trying to give evidence-based answers to the more frequently asked questions from patients and their GPs. This is the third instalment of the Trilogy of Dr. Calm, a skilled hepatologist who will try to clearly explain to his patient Mr. Frightened the natural history of NAFLD, the diagnostic workup, indications for liver biopsy and suggested medical treatments, advicing him on the importance of dietary intervention and lifestyle modifications., (Copyright © 2017. Published by Elsevier B.V.)

Published
2017
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50. Occurrence of hepatocellular carcinoma 13 years after successful antiviral treatment for HCV infection.

Author

Puoti C, Lanzetta G, and Scotti E

Subjects
Adult, Antiviral Agents adverse effects, Drug Therapy, Combination, Hepatitis C complications, Hepatitis C diagnosis, Humans, Interferon-alpha adverse effects, Male, Polyethylene Glycols adverse effects, Recombinant Proteins adverse effects, Recombinant Proteins therapeutic use, Ribavirin adverse effects, Risk Factors, Time Factors, Treatment Outcome, Viral Load, Antiviral Agents therapeutic use, Carcinoma, Hepatocellular virology, Hepatitis C drug therapy, Interferon-alpha therapeutic use, Liver Neoplasms virology, Polyethylene Glycols therapeutic use, Ribavirin therapeutic use
Published
2016
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