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1. Clinical features and comorbidity pattern of HCV infected migrants compared to native patients in care in Italy: A real-life evaluation of the PITER cohort

Author: Quaranta, M, Ferrigno, L, Tata, X, D'Angelo, F, Massari, M, Coppola, C, Biliotti, E, Giorgini, A, Laccabue, D, Ciancio, A, Blanc, P, Margotti, M, Ieluzzi, D, Brunetto, M, Barbaro, F, Russo, F, Beretta, I, Morsica, G, Verucchi, G, Saracino, A, Galli, M, Kondili, L, Mazzaro, C, Bertola, M, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Fiorentini, A, Angarano, G, Milella, M, Leo, A, Rendina, M, Salvatore D'ABRAMO, F, Lillo, C, Iannone, A, Piazzolla, M, Badia, L, Piscaglia, F, Benevento, F, Serio, I, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Bruno, R, Mondelli, M, Chessa, L, Loi, M, Torti, C, Costa, C, Mazzitelli, M, Pisani, V, Scaglione, V, Trecarichi, E, Zignego, A, Monti, M, Madia, F, Attala, L, Pierotti, P, Salomoni, E, Mariabelli, E, Santantonio, T, Bruno, S, Cela, E, Bassetti, M, Mazzarello, G, Alessandrini, A, Biagio, A, Nicolini, L, Raimondo, G, Filomia, R, Aghemo, A, Meli, R, Lazzarin, A, Salpietro, S, Fracanzani, A, Fatta, E, Lombardi, R, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Puoti, M, Baiguera, C, D'Amico, F, Vinci, M, Rumi, M, Zuin, M, Zermiani, P, Andreone, P, Caraceni, P, Guarneri, V, Villa, E, Bernabucci, V, Bristot, L, Paradiso, M, Migliorino, G, Gambaro, A, Lapadula, G, Spolti, A, Soria, A, Invernizzi, P, Ciaccio, A, Luca, M, Malinverno, F, Ratti, L, Amoruso, D, Pisano, F, Scarano, F, Staiano, L, Morisco, F, Cossiga, V, Gentile, I, Buonomo, A, Foggia, M, Zappulo, E, Federico, A, Dallio, M, Coppola, N, Sagnelli, C, Martini, S, Monari, C, Nardone, G, Sgamato, C, Chemello, L, Cavalletto, L, Sterrantino, D, Zanetto, A, Zanaga, P, Brancaccio, G, Craxi, A, Petta, S, Calvaruso, V, Crapanzano, L, Madonia, S, Cannizzaro, M, Bruno, E, Licata, A, Amodeo, S, Capitano, A, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Gulminetti, R, Pagnucco, L, Parruti, G, Stefano, P, Coco, B, Corsini, R, Garlassi, E, Andreoni, M, Teti, E, Cerva, C, Baiocchi, L, Grassi, G, Gasbarrini, A, Pompili, M, Siena, M, Taliani, G, Spaziante, M, Persico, M, Masarone, M, Aglitti, A, Calvanese, G, Anselmo, M, Leo, P, Marturano, M, Saracco, G, Quaranta M. G., Ferrigno L., Tata X., D'Angelo F., Massari M., Coppola C., Biliotti E., Giorgini A., Laccabue D., Ciancio A., Blanc P. L., Margotti M., Ieluzzi D., Brunetto M. R., Barbaro F., Russo F. P., Beretta I., Morsica G., Verucchi G., Saracino A., Galli M., Kondili L. A., Mazzaro C., Bertola M., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Fiorentini A., Angarano G., Milella M., Leo A. D., Rendina M., Salvatore D'ABRAMO F., Lillo C., Iannone A., Piazzolla M., Badia L., Piscaglia F., Benevento F., Serio I., Castelli F., Zaltron S., Spinetti A., Odolini S., Bruno R., Mondelli M., Chessa L., Loi M., Torti C., Costa C., Mazzitelli M., Pisani V., Scaglione V., Trecarichi E. M., Zignego A. L., Monti M., Madia F., Attala L., Pierotti P., Salomoni E., Mariabelli E., Santantonio T. A., Bruno S. R., Cela E. M., Bassetti M., Mazzarello G., Alessandrini A. I., Biagio A. D., Nicolini L. A., Raimondo G., Filomia R., Aghemo A., Meli R., Lazzarin A., Salpietro S., Fracanzani A. L., Fatta E., Lombardi R., Lampertico P., Borghi M., D'ambrosio R., Degasperi E., Puoti M., Baiguera C., D'AMICO F., Vinci M., Rumi M. G., Zuin M., Zermiani P., Andreone P., Caraceni P., Guarneri V., Villa E., Bernabucci V., Bristot L., Paradiso M. L., Migliorino G., Gambaro A., Lapadula G., Spolti A., Soria A., Invernizzi P., Ciaccio A., LucA M., Malinverno F., Ratti L., Amoruso D. C., Pisano F., Scarano F., Staiano L., Morisco F., Cossiga V., Gentile I., Buonomo A. R., Foggia M., Zappulo E., Federico A., Dallio M., Coppola N., Sagnelli C., Martini S., Monari C., Nardone G., Sgamato C., Chemello L., Cavalletto L., Sterrantino D., Zanetto A., Zanaga P., Brancaccio G., Craxi A., Petta S., Calvaruso V., Crapanzano L., Madonia S., Cannizzaro M., Bruno E. M., Licata A., Amodeo S., Capitano A. R., Ferrari C., Negri E., Orlandini A., Pesci M., Gulminetti R., Pagnucco L., Parruti G., Stefano P. D., Coco B., Corsini R., Garlassi E., Andreoni M., Teti E., Cerva C., Baiocchi L., Grassi G., Gasbarrini A., Pompili M., Siena M. D., Taliani G., Spaziante M., Persico M., Masarone M., Aglitti A., Calvanese G., Anselmo M., Leo P. D., Marturano M., Saracco G. M., Quaranta, M, Ferrigno, L, Tata, X, D'Angelo, F, Massari, M, Coppola, C, Biliotti, E, Giorgini, A, Laccabue, D, Ciancio, A, Blanc, P, Margotti, M, Ieluzzi, D, Brunetto, M, Barbaro, F, Russo, F, Beretta, I, Morsica, G, Verucchi, G, Saracino, A, Galli, M, Kondili, L, Mazzaro, C, Bertola, M, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Fiorentini, A, Angarano, G, Milella, M, Leo, A, Rendina, M, Salvatore D'ABRAMO, F, Lillo, C, Iannone, A, Piazzolla, M, Badia, L, Piscaglia, F, Benevento, F, Serio, I, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Bruno, R, Mondelli, M, Chessa, L, Loi, M, Torti, C, Costa, C, Mazzitelli, M, Pisani, V, Scaglione, V, Trecarichi, E, Zignego, A, Monti, M, Madia, F, Attala, L, Pierotti, P, Salomoni, E, Mariabelli, E, Santantonio, T, Bruno, S, Cela, E, Bassetti, M, Mazzarello, G, Alessandrini, A, Biagio, A, Nicolini, L, Raimondo, G, Filomia, R, Aghemo, A, Meli, R, Lazzarin, A, Salpietro, S, Fracanzani, A, Fatta, E, Lombardi, R, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Puoti, M, Baiguera, C, D'Amico, F, Vinci, M, Rumi, M, Zuin, M, Zermiani, P, Andreone, P, Caraceni, P, Guarneri, V, Villa, E, Bernabucci, V, Bristot, L, Paradiso, M, Migliorino, G, Gambaro, A, Lapadula, G, Spolti, A, Soria, A, Invernizzi, P, Ciaccio, A, Luca, M, Malinverno, F, Ratti, L, Amoruso, D, Pisano, F, Scarano, F, Staiano, L, Morisco, F, Cossiga, V, Gentile, I, Buonomo, A, Foggia, M, Zappulo, E, Federico, A, Dallio, M, Coppola, N, Sagnelli, C, Martini, S, Monari, C, Nardone, G, Sgamato, C, Chemello, L, Cavalletto, L, Sterrantino, D, Zanetto, A, Zanaga, P, Brancaccio, G, Craxi, A, Petta, S, Calvaruso, V, Crapanzano, L, Madonia, S, Cannizzaro, M, Bruno, E, Licata, A, Amodeo, S, Capitano, A, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Gulminetti, R, Pagnucco, L, Parruti, G, Stefano, P, Coco, B, Corsini, R, Garlassi, E, Andreoni, M, Teti, E, Cerva, C, Baiocchi, L, Grassi, G, Gasbarrini, A, Pompili, M, Siena, M, Taliani, G, Spaziante, M, Persico, M, Masarone, M, Aglitti, A, Calvanese, G, Anselmo, M, Leo, P, Marturano, M, Saracco, G, Quaranta M. G., Ferrigno L., Tata X., D'Angelo F., Massari M., Coppola C., Biliotti E., Giorgini A., Laccabue D., Ciancio A., Blanc P. L., Margotti M., Ieluzzi D., Brunetto M. R., Barbaro F., Russo F. P., Beretta I., Morsica G., Verucchi G., Saracino A., Galli M., Kondili L. A., Mazzaro C., Bertola M., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Fiorentini A., Angarano G., Milella M., Leo A. D., Rendina M., Salvatore D'ABRAMO F., Lillo C., Iannone A., Piazzolla M., Badia L., Piscaglia F., Benevento F., Serio I., Castelli F., Zaltron S., Spinetti A., Odolini S., Bruno R., Mondelli M., Chessa L., Loi M., Torti C., Costa C., Mazzitelli M., Pisani V., Scaglione V., Trecarichi E. M., Zignego A. L., Monti M., Madia F., Attala L., Pierotti P., Salomoni E., Mariabelli E., Santantonio T. A., Bruno S. R., Cela E. M., Bassetti M., Mazzarello G., Alessandrini A. I., Biagio A. D., Nicolini L. A., Raimondo G., Filomia R., Aghemo A., Meli R., Lazzarin A., Salpietro S., Fracanzani A. L., Fatta E., Lombardi R., Lampertico P., Borghi M., D'ambrosio R., Degasperi E., Puoti M., Baiguera C., D'AMICO F., Vinci M., Rumi M. G., Zuin M., Zermiani P., Andreone P., Caraceni P., Guarneri V., Villa E., Bernabucci V., Bristot L., Paradiso M. L., Migliorino G., Gambaro A., Lapadula G., Spolti A., Soria A., Invernizzi P., Ciaccio A., LucA M., Malinverno F., Ratti L., Amoruso D. C., Pisano F., Scarano F., Staiano L., Morisco F., Cossiga V., Gentile I., Buonomo A. R., Foggia M., Zappulo E., Federico A., Dallio M., Coppola N., Sagnelli C., Martini S., Monari C., Nardone G., Sgamato C., Chemello L., Cavalletto L., Sterrantino D., Zanetto A., Zanaga P., Brancaccio G., Craxi A., Petta S., Calvaruso V., Crapanzano L., Madonia S., Cannizzaro M., Bruno E. M., Licata A., Amodeo S., Capitano A. R., Ferrari C., Negri E., Orlandini A., Pesci M., Gulminetti R., Pagnucco L., Parruti G., Stefano P. D., Coco B., Corsini R., Garlassi E., Andreoni M., Teti E., Cerva C., Baiocchi L., Grassi G., Gasbarrini A., Pompili M., Siena M. D., Taliani G., Spaziante M., Persico M., Masarone M., Aglitti A., Calvanese G., Anselmo M., Leo P. D., Marturano M., and Saracco G. M.
Abstract: Background: Direct-acting antivirals are highly effective for the treatment of hepatitis C virus (HCV) infection, regardless race/ethnicity. We aimed to evaluate demographic, virological and clinical data of HCV-infected migrants vs. natives consecutively enrolled in the PITER cohort. Methods: Migrants were defined by country of birth and nationality that was different from Italy. Mann-Whitney U test, Chi-squared test and multiple logistic regression were used. Results: Of 10,669 enrolled patients, 301 (2.8%) were migrants: median age 47 vs. 62 years, (p < 0.001), females 56.5% vs. 45.3%, (p < 0.001), HBsAg positivity 3.8% vs. 1.4%, (p < 0.05). Genotype 1b was prevalent in both groups, whereas genotype 4 was more prevalent in migrants (p < 0.05). Liver disease severity and sustained virologic response (SVR) were similar. A higher prevalence of comorbidities was reported for natives compared to migrants (p < 0.05). Liver disease progression cofactors (HBsAg, HIV coinfection, alcohol abuse, potential metabolic syndrome) were present in 39.1% and 47.1% (p > 0.05) of migrants and natives who eradicated HCV, respectively. Conclusion: Compared to natives, HCV-infected migrants in care have different demographics, HCV genotypes, viral coinfections and comorbidities and similar disease severity, SVR and cofactors for disease progression after HCV eradication. A periodic clinical assessment after HCV eradication in Italians and migrants with cofactors for disease progression is warranted.
Published: 2021

2. Burden of Disease in PWH Harboring a Multidrug-Resistant Virus: Data from the PRESTIGIO Registry

Author: Galli, L, Parisi, M, Poli, A, Menozzi, M, Fiscon, M, Garlassi, E, Francisci, D, DI Biagio, A, Sterrantino, G, Fornabaio, C, Degli Antoni, A, Angarano, G, Fusco, F, D'Arminio Monforte, A, Corbelli, G, Santoro, M, Zazzi, M, Castagna, A, Gianotti, N, Maggiolo, F, Calza, L, Foca, E, Cenderello, G, Rusconi, S, Mussini, C, Antinori, A, Gagliardini, R, Bonora, S, Ferrara, M, Galli, A, Carini, E, Bigoloni, A, Tavio, M, Butini, L, Giacometti, A, Vaccher, E, Martellotta, F, Da Ros, V, Saracino, A, Balena, F, Comi, L, DI Filippo, E, Valenti, D, Suardi, C, Mazzola, B, Viale, P, Del Turco, E, Ramirez, M, Castelli, F, Celotti, A, Brognoli, F, Bonoldi, G, Menzaghi, B, Abeli, C, Farinazzo, M, Ortu, F, Campus, M, Cacopardo, B, Celesia, M, Pan, A, Bartoloni, A, Rinaldi, F, Giache, S, Pierluigi, B, Vichi, F, Santantonio, T, Ferrara, S, Bruno, S, Cassola, G, Marcello, F, Calautti, F, Bassetti, M, Bruzzone, B, Artioli, S, Lazzarin, A, Canetti, D, Galli, M, Formenti, T, Morena, V, Gabrieli, A, Gazzola, L, Merlini, E, Minieri, V, Gori, A, Bandera, A, Pastore, V, Ferroni, V, Puoti, M, Moioli, C, Vassalli, S, Enrica, R, Giulia, N, Beghetto, B, Manzillo, E, Franco, A, Cattelan, A, Marinello, S, Cavinato, S, Macario, A, Cascio, A, Mazzola, G, Antoni, A, Ferrari, C, Laccabue, D, Filice, G, Gulminetti, R, Pagnucco, L, Asti, A, Schiaroli, E, Papalini, C, Italiani, F, DI Pietro, M, Magnani, G, Elisa, G, Barchi, E, Corsini, R, Vergori, A, Cicalini, S, Onnelli, G, Giannetti, A, Cauda, R, Ciccullo, A, La Monica, S, Vullo, V, Dettorre, G, Cavallari, E, Andreoni, M, Malagnino, V, Ceccarelli, L, Viviani, F, Sasset, L, Dentone, C, Rossetti, B, Modica, S, Borgo, V, DI Perri, G, Carcieri, C, Malena, M, Padovani, B, Luzzati, R, Centonze, S, Valentinotti, R, Galli L., Parisi M. R., Poli A., Menozzi M., Fiscon M., Garlassi E., Francisci D., DI Biagio A., Sterrantino G., Fornabaio C., Degli Antoni A., Angarano G., Fusco F. M., D'Arminio Monforte A., Corbelli G. M., Santoro M. M., Zazzi M., Castagna A., Gianotti N., Maggiolo F., Calza L., Foca E., Cenderello G., Rusconi S., Mussini C., Antinori A., Gagliardini R., Bonora S., Ferrara M., Santoro M., Galli A., Carini E., Bigoloni A., Tavio M., Butini L., Giacometti A., Vaccher E., Martellotta F., Da Ros V., Saracino A., Balena F., Comi L., DI Filippo E., Valenti D., Suardi C., Mazzola B., Viale P., Del Turco E. R., Ramirez M. V., Castelli F., Celotti A., Brognoli F., Bonoldi G., Menzaghi B., Abeli C., Farinazzo M., Ortu F., Campus M., Cacopardo B., Celesia M., Pan A., Bartoloni A., Rinaldi F., Giache S., Pierluigi B., Vichi F., Santantonio T., Ferrara S., Bruno S. R., Cassola G., Marcello F., Calautti F., Bassetti M., Bruzzone B., Artioli S., Lazzarin A., Canetti D., Galli M., Formenti T., Morena V., Gabrieli A., Gazzola L., Merlini E., Minieri V., Gori A., Bandera A., Pastore V., Ferroni V., Puoti M., Moioli C., Vassalli S., Enrica R., Giulia N., Beghetto B., Manzillo E., Franco A., Cattelan A. M., Marinello S., Cavinato S., MacArio A., Cascio A., Mazzola G., Antoni A. M. D., Ferrari C., Laccabue D., Filice G., Gulminetti R., Pagnucco L., Asti A., Schiaroli E., Papalini C., Italiani F., DI Pietro M., Magnani G., Elisa G., Barchi E., Corsini R., Vergori A., Cicalini S., Onnelli G., Giannetti A., Cauda R., Ciccullo A., La Monica S., Vullo V., Dettorre G., Cavallari E. N., Andreoni M., Malagnino V., Ceccarelli L., Viviani F., Sasset L., Dentone C., Rossetti B., Modica S., Borgo V., DI Perri G., Carcieri C., Malena M., Padovani B., Luzzati R., Centonze S., Valentinotti R., Galli, L, Parisi, M, Poli, A, Menozzi, M, Fiscon, M, Garlassi, E, Francisci, D, DI Biagio, A, Sterrantino, G, Fornabaio, C, Degli Antoni, A, Angarano, G, Fusco, F, D'Arminio Monforte, A, Corbelli, G, Santoro, M, Zazzi, M, Castagna, A, Gianotti, N, Maggiolo, F, Calza, L, Foca, E, Cenderello, G, Rusconi, S, Mussini, C, Antinori, A, Gagliardini, R, Bonora, S, Ferrara, M, Galli, A, Carini, E, Bigoloni, A, Tavio, M, Butini, L, Giacometti, A, Vaccher, E, Martellotta, F, Da Ros, V, Saracino, A, Balena, F, Comi, L, DI Filippo, E, Valenti, D, Suardi, C, Mazzola, B, Viale, P, Del Turco, E, Ramirez, M, Castelli, F, Celotti, A, Brognoli, F, Bonoldi, G, Menzaghi, B, Abeli, C, Farinazzo, M, Ortu, F, Campus, M, Cacopardo, B, Celesia, M, Pan, A, Bartoloni, A, Rinaldi, F, Giache, S, Pierluigi, B, Vichi, F, Santantonio, T, Ferrara, S, Bruno, S, Cassola, G, Marcello, F, Calautti, F, Bassetti, M, Bruzzone, B, Artioli, S, Lazzarin, A, Canetti, D, Galli, M, Formenti, T, Morena, V, Gabrieli, A, Gazzola, L, Merlini, E, Minieri, V, Gori, A, Bandera, A, Pastore, V, Ferroni, V, Puoti, M, Moioli, C, Vassalli, S, Enrica, R, Giulia, N, Beghetto, B, Manzillo, E, Franco, A, Cattelan, A, Marinello, S, Cavinato, S, Macario, A, Cascio, A, Mazzola, G, Antoni, A, Ferrari, C, Laccabue, D, Filice, G, Gulminetti, R, Pagnucco, L, Asti, A, Schiaroli, E, Papalini, C, Italiani, F, DI Pietro, M, Magnani, G, Elisa, G, Barchi, E, Corsini, R, Vergori, A, Cicalini, S, Onnelli, G, Giannetti, A, Cauda, R, Ciccullo, A, La Monica, S, Vullo, V, Dettorre, G, Cavallari, E, Andreoni, M, Malagnino, V, Ceccarelli, L, Viviani, F, Sasset, L, Dentone, C, Rossetti, B, Modica, S, Borgo, V, DI Perri, G, Carcieri, C, Malena, M, Padovani, B, Luzzati, R, Centonze, S, Valentinotti, R, Galli L., Parisi M. R., Poli A., Menozzi M., Fiscon M., Garlassi E., Francisci D., DI Biagio A., Sterrantino G., Fornabaio C., Degli Antoni A., Angarano G., Fusco F. M., D'Arminio Monforte A., Corbelli G. M., Santoro M. M., Zazzi M., Castagna A., Gianotti N., Maggiolo F., Calza L., Foca E., Cenderello G., Rusconi S., Mussini C., Antinori A., Gagliardini R., Bonora S., Ferrara M., Santoro M., Galli A., Carini E., Bigoloni A., Tavio M., Butini L., Giacometti A., Vaccher E., Martellotta F., Da Ros V., Saracino A., Balena F., Comi L., DI Filippo E., Valenti D., Suardi C., Mazzola B., Viale P., Del Turco E. R., Ramirez M. V., Castelli F., Celotti A., Brognoli F., Bonoldi G., Menzaghi B., Abeli C., Farinazzo M., Ortu F., Campus M., Cacopardo B., Celesia M., Pan A., Bartoloni A., Rinaldi F., Giache S., Pierluigi B., Vichi F., Santantonio T., Ferrara S., Bruno S. R., Cassola G., Marcello F., Calautti F., Bassetti M., Bruzzone B., Artioli S., Lazzarin A., Canetti D., Galli M., Formenti T., Morena V., Gabrieli A., Gazzola L., Merlini E., Minieri V., Gori A., Bandera A., Pastore V., Ferroni V., Puoti M., Moioli C., Vassalli S., Enrica R., Giulia N., Beghetto B., Manzillo E., Franco A., Cattelan A. M., Marinello S., Cavinato S., MacArio A., Cascio A., Mazzola G., Antoni A. M. D., Ferrari C., Laccabue D., Filice G., Gulminetti R., Pagnucco L., Asti A., Schiaroli E., Papalini C., Italiani F., DI Pietro M., Magnani G., Elisa G., Barchi E., Corsini R., Vergori A., Cicalini S., Onnelli G., Giannetti A., Cauda R., Ciccullo A., La Monica S., Vullo V., Dettorre G., Cavallari E. N., Andreoni M., Malagnino V., Ceccarelli L., Viviani F., Sasset L., Dentone C., Rossetti B., Modica S., Borgo V., DI Perri G., Carcieri C., Malena M., Padovani B., Luzzati R., Centonze S., and Valentinotti R.
Abstract: Background: Currently, no data are available on the burden of morbidity and mortality in people with HIV-1 (PWH) harboring a 4-class drug-resistant (4DR) virus (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors). The study aimed to assess the incidence of clinical events and death in this population. Methods: This was a cohort study on PWH from the PRESTIGIO Registry with a documented 4DR virus. Burden of disease was defined as the occurrence of any new event including an AIDS-defining event (ADE) or non-AIDS-defining event (NADE) or death from any cause after 4DR evidence (baseline). Cox regression models evaluated factors associated with the risk of new clinical events/death. Results: Among 148 PWH followed for a median (interquartile range) of 47 (32-84) months after 4DR evidence, 38 PWH had 62 new events or died from any cause (incidence rate, 9.12/100 person-years of follow-up; 95% CI = 6.85-11.39): 12 deaths (6 AIDS-related and 6 non-AIDS-related), 18 ADEs, 32 NADEs; 20 of the 38 NADEs (45%) of the incident clinical events were malignancies. The 4-year cumulative incidence of death was 6% (95% CI, 3%-13%), and that of ≥1 event or death was 22% (95% CI, 16%-31%). A higher risk of new clinical events/death was more likely in PWH with previous clinical events (adjusted hazard ratio [aHR], 2.67; 95% CI, 1.07-6.67) and marginally associated with lower baseline CD4+/CD8+ ratio (aHR, 0.82; 95% CI, 0.65-1.02). Conclusions: PWH harboring 4DR have a high burden of disease with a worrying incidence of malignancies, strongly advising for close prevention and monitoring interventions as well as access to innovative therapeutic strategies, especially in people with a history of clinical events and low CD4+/CD8+ ratio.
Published: 2020

3. Burden of Disease in PWH Harboring a Multidrug-Resistant Virus: Data from the PRESTIGIO Registry

Author: Galli, L., Parisi, M. R., Poli, A., Menozzi, M., Fiscon, M., Garlassi, E., Francisci, D., DI Biagio, A., Sterrantino, G., Fornabaio, C., Degli Antoni, A., Angarano, G., Fusco, F. M., D'Arminio Monforte, A., Corbelli, G. M., Santoro, M. M., Zazzi, M., Castagna, A., Gianotti, N., Maggiolo, F., Calza, L., Foca, E., Cenderello, G., Rusconi, S., Mussini, C., Antinori, A., Gagliardini, R., Bonora, S., Ferrara, M., Santoro, M., Galli, A., Carini, E., Bigoloni, A., Tavio, M., Butini, L., Giacometti, A., Vaccher, E., Martellotta, F., Da Ros, V., Saracino, A., Balena, F., Comi, L., DI Filippo, E., Valenti, D., Suardi, C., Mazzola, B., Viale, P., Del Turco, E. R., Ramirez, M. V., Castelli, F., Celotti, A., Brognoli, F., Bonoldi, G., Menzaghi, B., Abeli, C., Farinazzo, M., Ortu, F., Campus, M., Cacopardo, B., Celesia, M., Pan, A., Bartoloni, A., Rinaldi, F., Giache, S., Pierluigi, B., Vichi, F., Santantonio, T., Ferrara, S., Bruno, S. R., Cassola, G., Marcello, F., Calautti, F., Bassetti, M., Bruzzone, B., Artioli, S., Lazzarin, A., Canetti, D., Galli, M., Formenti, T., Morena, V., Gabrieli, A., Gazzola, L., Merlini, E., Minieri, V., Gori, A., Bandera, A., Pastore, V., Ferroni, V., Puoti, M., Moioli, C., Vassalli, S., Enrica, R., Giulia, N., Beghetto, B., Manzillo, E., Franco, A., Cattelan, A. M., Marinello, S., Cavinato, S., Macario, A., Cascio, A., Mazzola, G., Antoni, A. M. D., Ferrari, C., Laccabue, D., Filice, G., Gulminetti, R., Pagnucco, L., Asti, A., Schiaroli, E., Papalini, C., Italiani, F., DI Pietro, M., Magnani, G., Elisa, G., Barchi, E., Corsini, R., Vergori, A., Cicalini, S., Onnelli, G., Giannetti, A., Cauda, R., Ciccullo, A., La Monica, S., Vullo, V., Dettorre, G., Cavallari, E. N., Andreoni, M., Malagnino, V., Ceccarelli, L., Viviani, F., Sasset, L., Dentone, C., Rossetti, B., Modica, S., Borgo, V., DI Perri, G., Carcieri, C., Malena, M., Padovani, B., Luzzati, R., Centonze, S., Valentinotti, R., Galli L., Parisi M.R., Poli A., Menozzi M., Fiscon M., Garlassi E., Francisci D., DI Biagio A., Sterrantino G., Fornabaio C., Degli Antoni A., Angarano G., Fusco F.M., D'Arminio Monforte A., Corbelli G.M., Santoro M.M., Zazzi M., Castagna A., Gianotti N., Maggiolo F., Calza L., Foca E., Cenderello G., Rusconi S., Mussini C., Antinori A., Gagliardini R., Bonora S., Ferrara M., Santoro M., Galli A., Carini E., Bigoloni A., Tavio M., Butini L., Giacometti A., Vaccher E., Martellotta F., Da Ros V., Saracino A., Balena F., Comi L., DI Filippo E., Valenti D., Suardi C., Mazzola B., Viale P., Del Turco E.R., Ramirez M.V., Castelli F., Celotti A., Brognoli F., Bonoldi G., Menzaghi B., Abeli C., Farinazzo M., Ortu F., Campus M., Cacopardo B., Celesia M., Pan A., Bartoloni A., Rinaldi F., Giache S., Pierluigi B., Vichi F., Santantonio T., Ferrara S., Bruno S.R., Cassola G., Marcello F., Calautti F., Bassetti M., Bruzzone B., Artioli S., Lazzarin A., Canetti D., Galli M., Formenti T., Morena V., Gabrieli A., Gazzola L., Merlini E., Minieri V., Gori A., Bandera A., Pastore V., Ferroni V., Puoti M., Moioli C., Vassalli S., Enrica R., Giulia N., Beghetto B., Manzillo E., Franco A., Cattelan A.M., Marinello S., Cavinato S., MacArio A., Cascio A., Mazzola G., Antoni A.M.D., Ferrari C., Laccabue D., Filice G., Gulminetti R., Pagnucco L., Asti A., Frsdi E., Schiaroli E., Papalini C., Italiani F., DI Pietro M., Magnani G., Elisa G., Barchi E., Corsini R., Vergori A., Cicalini S., Onnelli G., Giannetti A., Cauda R., Ciccullo A., La Monica S., Vullo V., Dettorre G., Cavallari E.N., Andreoni M., Malagnino V., Ceccarelli L., Viviani F., Sasset L., Dentone C., Rossetti B., Modica S., Borgo V., DI Perri G., Carcieri C., Malena M., Padovani B., Luzzati R., Centonze S., Valentinotti R., Galli, L, Parisi, M, Poli, A, Menozzi, M, Fiscon, M, Garlassi, E, Francisci, D, DI Biagio, A, Sterrantino, G, Fornabaio, C, Degli Antoni, A, Angarano, G, Fusco, F, D'Arminio Monforte, A, Corbelli, G, Santoro, M, Zazzi, M, Castagna, A, Gianotti, N, Maggiolo, F, Calza, L, Foca, E, Cenderello, G, Rusconi, S, Mussini, C, Antinori, A, Gagliardini, R, Bonora, S, Ferrara, M, Galli, A, Carini, E, Bigoloni, A, Tavio, M, Butini, L, Giacometti, A, Vaccher, E, Martellotta, F, Da Ros, V, Saracino, A, Balena, F, Comi, L, DI Filippo, E, Valenti, D, Suardi, C, Mazzola, B, Viale, P, Del Turco, E, Ramirez, M, Castelli, F, Celotti, A, Brognoli, F, Bonoldi, G, Menzaghi, B, Abeli, C, Farinazzo, M, Ortu, F, Campus, M, Cacopardo, B, Celesia, M, Pan, A, Bartoloni, A, Rinaldi, F, Giache, S, Pierluigi, B, Vichi, F, Santantonio, T, Ferrara, S, Bruno, S, Cassola, G, Marcello, F, Calautti, F, Bassetti, M, Bruzzone, B, Artioli, S, Lazzarin, A, Canetti, D, Galli, M, Formenti, T, Morena, V, Gabrieli, A, Gazzola, L, Merlini, E, Minieri, V, Gori, A, Bandera, A, Pastore, V, Ferroni, V, Puoti, M, Moioli, C, Vassalli, S, Enrica, R, Giulia, N, Beghetto, B, Manzillo, E, Franco, A, Cattelan, A, Marinello, S, Cavinato, S, Macario, A, Cascio, A, Mazzola, G, Antoni, A, Ferrari, C, Laccabue, D, Filice, G, Gulminetti, R, Pagnucco, L, Asti, A, Schiaroli, E, Papalini, C, Italiani, F, DI Pietro, M, Magnani, G, Elisa, G, Barchi, E, Corsini, R, Vergori, A, Cicalini, S, Onnelli, G, Giannetti, A, Cauda, R, Ciccullo, A, La Monica, S, Vullo, V, Dettorre, G, Cavallari, E, Andreoni, M, Malagnino, V, Ceccarelli, L, Viviani, F, Sasset, L, Dentone, C, Rossetti, B, Modica, S, Borgo, V, DI Perri, G, Carcieri, C, Malena, M, Padovani, B, Luzzati, R, Centonze, S, Valentinotti, R, Galli, Laura, Parisi, Maria Rita, Poli, Andrea, Menozzi, Marianna, Fiscon, Marta, Garlassi, Elisa, Francisci, Daniela, Di Biagio, Antonio, Sterrantino, Gaetana, Fornabaio, Chiara, Degli Antoni, Anna, Angarano, Gioacchino, Fusco, Francesco Maria, D'Arminio Monforte, Antonella, Corbelli, Giulio Maria, Santoro, Maria Mercede, Zazzi, Maurizio, and Castagna, Antonella
Subjects: 0301 basic medicine, medicine.medical_specialty, 4-class drug resistance, AIDS-defining event, cancer, death, non-AIDS-defining event, Population, Major Articles, Settore MED/07, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Internal medicine, medicine, Cumulative incidence, 030212 general & internal medicine, education, Disease burden, education.field_of_study, Proportional hazards model, business.industry, Incidence (epidemiology), Hazard ratio, 030112 virology, AcademicSubjects/MED00290, Infectious Diseases, Oncology, business, Cohort study
Abstract: BackgroundCurrently, no data are available on the burden of morbidity and mortality in people with HIV-1 (PWH) harboring a 4-class drug-resistant (4DR) virus (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors). The study aimed to assess the incidence of clinical events and death in this population.MethodsThis was a cohort study on PWH from the PRESTIGIO Registry with a documented 4DR virus. Burden of disease was defined as the occurrence of any new event including an AIDS-defining event (ADE) or non-AIDS-defining event (NADE) or death from any cause after 4DR evidence (baseline). Cox regression models evaluated factors associated with the risk of new clinical events/death.ResultsAmong 148 PWH followed for a median (interquartile range) of 47 (32–84) months after 4DR evidence, 38 PWH had 62 new events or died from any cause (incidence rate, 9.12/100 person-years of follow-up; 95% CI = 6.85–11.39): 12 deaths (6 AIDS-related and 6 non-AIDS-related), 18 ADEs, 32 NADEs; 20 of the 38 NADEs (45%) of the incident clinical events were malignancies. The 4-year cumulative incidence of death was 6% (95% CI, 3%–13%), and that of ≥1 event or death was 22% (95% CI, 16%–31%). A higher risk of new clinical events/death was more likely in PWH with previous clinical events (adjusted hazard ratio [aHR], 2.67; 95% CI, 1.07–6.67) and marginally associated with lower baseline CD4+/CD8+ ratio (aHR, 0.82; 95% CI, 0.65–1.02).ConclusionsPWH harboring 4DR have a high burden of disease with a worrying incidence of malignancies, strongly advising for close prevention and monitoring interventions as well as access to innovative therapeutic strategies, especially in people with a history of clinical events and low CD4+/CD8+ ratio.
Published: 2020

4. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author: Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., Ieluzzi D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., and Ieluzzi D.
Abstract: Objective: We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy. Methods: A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered. Results: The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively. Conclusions: This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.
Published: 2019

5. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author: Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L. A., Vella, S., Quaranta, M. G., Rosato, S., Tosti, M. E., Weimer, L. E., Ferrigno, L., D’Angelo, F., Falzano, L., Benedetti, A., Schiadà, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Di Leo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, Peter, Rimenti, G., Rossini, A., Contessi, G. B., Castelli, Fulvio, Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, Lucia, Quintieri, F., De Siena, Martina, Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall’Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., DelundefinedPin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, Francesca, Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., DiundefinedBiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, Chiara, Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D’ArminioundefinedMonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, Margherita, D’Ambrosio, R., Degasperi, E., Vinci, Maria Rosaria, Villa, E., Bernabucci, V., Bristot, Luca, Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, Alex, Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D’Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, Enrico, Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, Maria Chiara, Montalto, G., Licata, A., Capitano, A. R., Craxì, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, Paolo, Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, Antonio, Siciliano, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D’Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, Roberto, Cingolani, Antonella, Lamonica, S., D’Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, Antonio, D’Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, Patrizia, Dell’Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, Monia, Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Kondili LA, Vella S, Quaranta MG, Rosato S, Tosti ME, Weimer LE, Ferrigno L, D'Angelo F, Falzano L, Benedetti A, Schiadà L, Cucco M, Giacometti A, Brescini L, Castelletti S, Drenaggi D, Mazzaro C, Angarano G, Milella M, Di Leo A, Rendina M, Contaldo A, Iannone A, La Fortezza F, Rizzi M, Cologni G, Bolondi L, Benevento F, Serio I, Andreone P, Caraceni P, Guarneri V, Margotti M, Simonetti G, Mazzella G, Verucchi G, Donati V, Mian P, Rimenti G, Rossini A, Contessi GB, Castelli F, Zaltron S, Spinetti A, Odolini S, Leandro G, Cozzolongo R, Zappimbulso M, Russello M, Benigno R, Coco C, Torti C, Costa C, Greco G, Mazzitelli M, Pisani V, Cosco L, Quintieri F, De Siena M, Giancotti F, Vecchiet J, Falasca K, Mastroianni A, Apuzzo G, Chidichimo L, Foschi FG, Dall'Aglio AC, Libanore M, Segala D, Sighinolfi L, Bartolozzi D, Salomoni E, Blanc P, Baragli F, Del Pin B, Mariabelli E, Mazzotta F, Poggi A, Zignego AL, Monti M, Madia F, Xheka A, Cela EM, Santantonio TA, Bruno SR, Viscoli C, Alessandrini AI, Curti C, Di Biagio A, Nicolini LA, Balletto E, Mastroianni C, Blerta K, Prati D, Raffaele L, Andreoletti M, Perboni G, Costa P, Manzini L, Raimondo G, Filomia R, Lazzarin A, Morsica G, Salpietro S, Puoti M, Baiguera C, Vassalli S, Rumi MG, Labanca S, Zuin M, Giorgini A, Orellana D, D'Arminio Monforte A, Debona A, Solaro S, Fargion S, Valenti L, Periti G, Pelusi S, Galli M, Calvi E, Milazzo L, Peri A, Lampertico P, Borghi M, D'Ambrosio R, Degasperi E, Vinci M, Villa E, Bernabucci V, Bristot L, Pereira F, Chessa L, Pasetto MC, Loi M, Gori A, Beretta I, Pastore V, Soria A, Strazzabosco M, Ciaccio A, Gemma M, Borgia G, Foggia A, Zappulo E, Gentile I, Buonomo AR, Abrescia N, Maddaloni A, Caporaso N, Morisco F, Camera S, Donnarumma L, Coppola C, Amoruso DC, Staiano L, Saturnino MR, Coppola N, Martini S, Monari C, Federico A, Dallio M, Loguercio C, Gaeta GB, Brancaccio G, Nardone G, Sgamato C, D'Adamo G, Alberti A, Gonzo M, Piovesan S, Chemello L, Buggio A, Cavalletto L, Barbaro F, Castelli E, Floreani A, Cazzagon N, Franceschet I, Russo FP, Zanetto A, Franceschet E, Madonia S, Cannizzaro M, Montalto G, Licata A, Capitano AR, Craxì A, Petta S, Calvaruso V, Rini F, Ferrari C, Negri E, Orlandini A, Pesci M, Bruno R, Lombardi A, Zuccaro V, Gulminetti R, Asti A, Villaraggia M, Mondelli M, Ludovisi S, Baldelli F, Di Candilo F, Parruti G, Di Stefano P, Sozio F, Gizzi MC, Brunetto MR, Colombatto P, Coco B, Surace L, Foti G, Pellicano S, Fornaciari G, Schianchi S, Vignoli P, Massari M, Corsini R, Garlassi E, Ballardini G, Andreoni M, Cerva C, Angelico M, Gasbarrini A, Siciliano M, De Siena M, Nosotti L, Taliani G, Biliotti E, Santori M, Spaziante M, Tamburini F, Vullo V, D'Ettorre G, Cavallari EN, Gebremeskel TS, Pavone P, Cauda R, Cingolani A, Lamonica S, D'Offizi G, Lionetti R, Visco Comandini U, Grieco A, D'Aversa F, Picardi A, De Vincentis A, Galati G, Gallo P, Dell'Unto C, Aghemo A, Gatti Comini A, Persico M, Masarone M, Anselmo M, De Leo P, Marturano M, Brunelli E, Ridolfi F, Schimizzi AM, Ayoubi Khajekini M, Framarin L, Di Perri G, Cariti G, Boglione L, Cardellino C, Marinaro L, Saracco GM, Ciancio A, Toniutto P, Alterini G, Capra F, Ieluzzi D., Marcellusi, A., Viti, R., Kondili, L. A., Rosato, S., Vella, S., Mennini, F. S., Quaranta, M. G., Tosti, M. E., Weimer, L. E., Ferrigno, L., D'Angelo, F., Falzano, L., Benedetti, A., Schiada, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Dileo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, P., Rimenti, G., Rossini, A., Contessi, G. B., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, L., Quintieri, F., Desiena, M., Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall'Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., Delpin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, F., Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., Dibiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, C., Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D'Arminiomonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, M., D'Ambrosio, R., Degasperi, E., Vinci, M., Villa, E., Bernabucci, V., Bristot, L., Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, A., Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D'Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, E., Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, M., Montalto, G., Licata, A., Capitano, A. R., Craxi, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, P., Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, A., Siciliano, M., De Siena, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D'Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, R., Cingolani, A., Lamonica, S., D'Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, A., D'Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, P., Dell'Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, M., Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L.A., Quaranta, M.G., Tosti, M.E., Weimer, L.E., D’Angelo, F., Schiadà, L., Di&nbsp, Leo, A., Contessi, G.B., De&nbsp, Siena, M., Foschi, F.G., Dall’Aglio, A.C., Del&nbsp, Pin, B., Zignego, A.L., Cela, E.M., Santantonio, T.A., Bruno, S.R., Alessandrini, A.I., Biagio, A., Nicolini, L.A., Rumi, M.G., D’Arminio&nbsp, Monforte, A., D’Ambrosio, R., Pasetto, M.C., Buonomo, A.R., Amoruso, D.C., Saturnino, M.R., Gaeta, G.B., D’Adamo, G., Russo, F.P., Capitano, A.R., Craxì, A., Gizzi, M.C., Brunetto, M.R., D’Ettorre, G., Cavallari, E.N., Gebremeskel, T.S., D’Offizi, G., D’Aversa, F., Dell’Unto, C., Schimizzi, A.M., Saracco, G.M., Cosco, Alfredo, Dall’Aglio, A. C., Salomoni, Valentina, Nicolini, Elvira, Calvi, Marta, Soria, Giovanni, D'Adamo, Danilo, ALONSO ALBERTI, MARIA PALOMA CARMEN, Orlandini, Giovanni, DE ASTIS, Fabio, Sozio, Concetta, Terzini, Angelico, DE SIENA, ANDREA URIEL, Taliani, Sabrina, Spaziante, Agata, Lamonica, Emilia, and Capra, Carlo
Subjects: Liver Cirrhosis, Pediatrics, Time Factors, Settore MED/09 - Medicina Interna, National Health Programs, ERADICATION, OUTBREAK, antiviral treatment, anti HCV, economic consequences, Hepacivirus, LIVER FIBROSIS, Severity of Illness Index, Health Services Accessibility, COST-EFFECTIVENESS, Indirect costs, 0302 clinical medicine, Epidemiology, virus infection, 030212 general & internal medicine, health care economics and organizations, cost effectiveness, 030503 health policy & services, Health Policy, Health services research, health, Hepatitis C, Markov Chains, chronic hepatitis C, virus infection, fibrosis progression, cost effectiveness, liver fibrosis, Italy, Pharmacology, Public Health, Environmental and Occupational Health, Cohort, Settore SECS-P/03 - Scienza delle Finanze, Disease Progression, Public Health, 0305 other medical science, Viral hepatitis, Anti-HCV antiviral treatment, CHRONIC HEPATITIS-C, medicine.medical_specialty, Genotype, Settore MED/12 - GASTROENTEROLOGIA, VIRUS-INFECTION, Antiviral Agents, NO, 03 medical and health sciences, Cost Savings, Humans, medicine, MANAGEMENT, chronic hepatitis C, INDUCED DISEASES, METAANALYSIS, Health economics, business.industry, Public health, Environmental and Occupational Health, medicine.disease, FIBROSIS PROGRESSION, business
Abstract: OBJECTIVE:\ud We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy.\ud \ud METHODS:\ud A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered.\ud \ud RESULTS:\ud The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively.\ud \ud CONCLUSIONS:\ud This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.
Published: 2019

6. Clinical features and comorbidity pattern of HCV infected migrants compared to native patients in care in Italy: A real-life evaluation of the PITER cohort

Author: Quaranta, M. G., Ferrigno, L., Tata, X., D'Angelo, Francesca Bice, Massari, Massimo, Coppola, C., Biliotti, E., Giorgini, A., Laccabue, D., Ciancio, A., Blanc, P. L., Margotti, M., Ieluzzi, D., Brunetto, M. R., Barbaro, Federico, Russo, F. P., Beretta, I., Morsica, G., Verucchi, G., Saracino, A., Galli, M., Kondili, L. A., Mazzaro, C., Bertola, M., Benedetti, A., Schiada, L., Cucco, Marco, Giacometti, A., Brescini, L., Castelletti, S., Fiorentini, A., Angarano, G., Milella, M., Leo, A. D., Rendina, Marco, Salvatore D'ABRAMO, F., Lillo, C., Iannone, A., Piazzolla, M., Badia, L., Piscaglia, F., Benevento, F., Serio, I., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Bruno, Rosa Anna, Mondelli, M., Chessa, L., Loi, M., Torti, Carlo, Costa, C., Mazzitelli, M., Pisani, V., Scaglione, V., Trecarichi, Enrico Maria, Zignego, A. L., Monti, M., Madia, Francesca, Attala, L., Pierotti, P., Salomoni, E., Mariabelli, E., Santantonio, T. A., Bruno, S. R., Cela, E. M., Bassetti, M., Mazzarello, G., Alessandrini, A. I., Biagio, A. D., Nicolini, L. A., Raimondo, G., Filomia, R., Aghemo, A., Meli, R., Lazzarin, A., Salpietro, S., Fracanzani, A. L., Fatta, E., Lombardi, Roberto, Lampertico, P., Borghi, Margherita, D'Ambrosio, Roberto, Degasperi, E., Puoti, M., Baiguera, C., D'Amico, F., Vinci, Maria Rosaria, Rumi, M. G., Zuin, M., Zermiani, P., Andreone, P., Caraceni, P., Guarneri, V., Villa, E., Bernabucci, V., Bristot, Luca, Paradiso, M. L., Migliorino, G., Gambaro, A., Lapadula, G., Spolti, A., Soria, A., Invernizzi, P., Ciaccio, A., Luca, M., Malinverno, F., Ratti, L., Amoruso, D. C., Pisano, Francesco, Scarano, F., Staiano, L., Morisco, F., Cossiga, V., Gentile, I., Buonomo, A. R., Foggia, M., Zappulo, E., Federico, A., Dallio, M., Coppola, N., Sagnelli, C., Martini, Simone, Monari, C., Nardone, G., Sgamato, C., Chemello, L., Cavalletto, L., Sterrantino, D., Zanetto, A., Zanaga, P., Brancaccio, G., Craxi, A., Petta, S., Calvaruso, V., Crapanzano, L., Madonia, S., Cannizzaro, Maria Chiara, Bruno, E. M., Licata, Maria Angela Vittoria Anna Chiara, Amodeo, Silvia, Capitano, A. R., Ferrari, C., Negri, Erica, Orlandini, A., Pesci, M., Gulminetti, R., Pagnucco, L., Parruti, G., Stefano, P. D., Coco, B., Corsini, R., Garlassi, E., Andreoni, M., Teti, E., Cerva, C., Baiocchi, Luca, Grassi, G., Gasbarrini, Antonio, Pompili, Maurizio, Siena, M. D., Taliani, G., Spaziante, M., Persico, M., Masarone, M., Aglitti, A., Calvanese, G., Anselmo, M., Leo, P. D., Marturano, Monia, Saracco, G. M., D'Angelo F., Massari M. (ORCID:0000-0001-7048-6374), Barbaro F., Cucco M., Rendina M., Bruno R., Torti C., Trecarichi E. M., Madia F., Lombardi R., Borghi M., D'ambrosio R., Vinci M., Bristot L., Pisano F., Martini S., Cannizzaro M., Licata A., Amodeo S., Negri E., Baiocchi L., Gasbarrini A. (ORCID:0000-0002-7278-4823), Pompili M. (ORCID:0000-0001-6699-7980), Marturano M., Quaranta, M. G., Ferrigno, L., Tata, X., D'Angelo, Francesca Bice, Massari, Massimo, Coppola, C., Biliotti, E., Giorgini, A., Laccabue, D., Ciancio, A., Blanc, P. L., Margotti, M., Ieluzzi, D., Brunetto, M. R., Barbaro, Federico, Russo, F. P., Beretta, I., Morsica, G., Verucchi, G., Saracino, A., Galli, M., Kondili, L. A., Mazzaro, C., Bertola, M., Benedetti, A., Schiada, L., Cucco, Marco, Giacometti, A., Brescini, L., Castelletti, S., Fiorentini, A., Angarano, G., Milella, M., Leo, A. D., Rendina, Marco, Salvatore D'ABRAMO, F., Lillo, C., Iannone, A., Piazzolla, M., Badia, L., Piscaglia, F., Benevento, F., Serio, I., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Bruno, Rosa Anna, Mondelli, M., Chessa, L., Loi, M., Torti, Carlo, Costa, C., Mazzitelli, M., Pisani, V., Scaglione, V., Trecarichi, Enrico Maria, Zignego, A. L., Monti, M., Madia, Francesca, Attala, L., Pierotti, P., Salomoni, E., Mariabelli, E., Santantonio, T. A., Bruno, S. R., Cela, E. M., Bassetti, M., Mazzarello, G., Alessandrini, A. I., Biagio, A. D., Nicolini, L. A., Raimondo, G., Filomia, R., Aghemo, A., Meli, R., Lazzarin, A., Salpietro, S., Fracanzani, A. L., Fatta, E., Lombardi, Roberto, Lampertico, P., Borghi, Margherita, D'Ambrosio, Roberto, Degasperi, E., Puoti, M., Baiguera, C., D'Amico, F., Vinci, Maria Rosaria, Rumi, M. G., Zuin, M., Zermiani, P., Andreone, P., Caraceni, P., Guarneri, V., Villa, E., Bernabucci, V., Bristot, Luca, Paradiso, M. L., Migliorino, G., Gambaro, A., Lapadula, G., Spolti, A., Soria, A., Invernizzi, P., Ciaccio, A., Luca, M., Malinverno, F., Ratti, L., Amoruso, D. C., Pisano, Francesco, Scarano, F., Staiano, L., Morisco, F., Cossiga, V., Gentile, I., Buonomo, A. R., Foggia, M., Zappulo, E., Federico, A., Dallio, M., Coppola, N., Sagnelli, C., Martini, Simone, Monari, C., Nardone, G., Sgamato, C., Chemello, L., Cavalletto, L., Sterrantino, D., Zanetto, A., Zanaga, P., Brancaccio, G., Craxi, A., Petta, S., Calvaruso, V., Crapanzano, L., Madonia, S., Cannizzaro, Maria Chiara, Bruno, E. M., Licata, Maria Angela Vittoria Anna Chiara, Amodeo, Silvia, Capitano, A. R., Ferrari, C., Negri, Erica, Orlandini, A., Pesci, M., Gulminetti, R., Pagnucco, L., Parruti, G., Stefano, P. D., Coco, B., Corsini, R., Garlassi, E., Andreoni, M., Teti, E., Cerva, C., Baiocchi, Luca, Grassi, G., Gasbarrini, Antonio, Pompili, Maurizio, Siena, M. D., Taliani, G., Spaziante, M., Persico, M., Masarone, M., Aglitti, A., Calvanese, G., Anselmo, M., Leo, P. D., Marturano, Monia, Saracco, G. M., D'Angelo F., Massari M. (ORCID:0000-0001-7048-6374), Barbaro F., Cucco M., Rendina M., Bruno R., Torti C., Trecarichi E. M., Madia F., Lombardi R., Borghi M., D'ambrosio R., Vinci M., Bristot L., Pisano F., Martini S., Cannizzaro M., Licata A., Amodeo S., Negri E., Baiocchi L., Gasbarrini A. (ORCID:0000-0002-7278-4823), Pompili M. (ORCID:0000-0001-6699-7980), and Marturano M.
Abstract: Background: Direct-acting antivirals are highly effective for the treatment of hepatitis C virus (HCV) infection, regardless race/ethnicity. We aimed to evaluate demographic, virological and clinical data of HCV-infected migrants vs. natives consecutively enrolled in the PITER cohort. Methods: Migrants were defined by country of birth and nationality that was different from Italy. Mann-Whitney U test, Chi-squared test and multiple logistic regression were used. Results: Of 10,669 enrolled patients, 301 (2.8%) were migrants: median age 47 vs. 62 years, (p < 0.001), females 56.5% vs. 45.3%, (p < 0.001), HBsAg positivity 3.8% vs. 1.4%, (p < 0.05). Genotype 1b was prevalent in both groups, whereas genotype 4 was more prevalent in migrants (p < 0.05). Liver disease severity and sustained virologic response (SVR) were similar. A higher prevalence of comorbidities was reported for natives compared to migrants (p < 0.05). Liver disease progression cofactors (HBsAg, HIV coinfection, alcohol abuse, potential metabolic syndrome) were present in 39.1% and 47.1% (p > 0.05) of migrants and natives who eradicated HCV, respectively. Conclusion: Compared to natives, HCV-infected migrants in care have different demographics, HCV genotypes, viral coinfections and comorbidities and similar disease severity, SVR and cofactors for disease progression after HCV eradication. A periodic clinical assessment after HCV eradication in Italians and migrants with cofactors for disease progression is warranted.
Published: 2021

7. Hyperhomocysteinaemia in HIV-infected patients: determinants of variability and correlations with predictors of cardiovascular disease

Author: Guaraldi, G, Ventura, P, Garlassi, E, Orlando, G, Squillace, N, Nardini, G, Stentarelli, C, Zona, S, Marchini, S, Moriondo, V, and Tebas, P
Published: 2009

8. Nuove frontiere diagnostiche nel controllo della tossicità cardiovascolare

Author: Guaraldi, Giovanni, Garlassi, E., Maggi, P., Guaraldi, G, Garlassi, E, and Maggi, P
Subjects: rischio cardiovascolare, HIV, terapia antiretrovirale
Published: 2011

9. Multidrug-resistant tuberculosis outbreak in an Italian prison: tolerance of pyrazinamide plus levofloxacin prophylaxis and serial interferon gamma release assays

Author: Bedini, A., primary, Garlassi, E., additional, Stentarelli, C., additional, Petrella, S., additional, Meacci, M., additional, Meccugni, B., additional, Meschiari, M., additional, Franceschini, E., additional, Cerri, S., additional, Brasacchio, A., additional, Rumpianesi, F., additional, Richeldi, L., additional, and Mussini, C., additional
Published: 2016
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10. HIGH PREVALENCE OF VITAMIN D DEFICIENCY IN A COHORT OF HIV INFECTED PREGNANT WOMEN AND ITS IMPACT ON PREGNANCY OUTCOME

Author: Stentarelli, Chiara, Zona, Stefano, Garlassi, E., Menozzi, Marianna, Trenti, T., Baroncelli, S., Pinnetti, C., Degli Antoni, A., Floridia, M., and Guaraldi, Giovanni
Subjects: HIV infection, pregnancy, vitamin D
Published: 2013

11. HIGH PREVALENCE OF VITAMIN D DEFICIENCY IN A COHORT OF HIV INFECTED PREGNANT AND NON-PREGNANT WOMEN OF CHILDBEARING AGE

Author: Stentarelli, Chiara, Zona, Stefano, Garlassi, E., Menozzi, Marianna, Trenti, T., Baroncelli, S., Pinnetti, C., Degli Antoni, A., Floridia, M., and Guaraldi, Giovanni
Subjects: HIV infection, pregnancy, vitamin D
Published: 2013

12. Vitamin D3 supplementation decreases the risk of diabetes mellitus among patients with HIV infection

Author: Guaraldi, Giovanni, Zona, Stefano, Orlando, Gabriella, Carli, Federica, Ligabue, Guido, Stentarelli, C., Menozzi, M., Garlassi, E., Giovanardi, C., and Tebas, P.
Subjects: vitamin D3, HIV, DIABETES MELLITUS, Diabetes, Vitamin D3
Published: 2011

13. HIV infection and survival in patients with HCC and liver cirrhosis

Author: Ventura, Garlassi, E., Cacopardo, Bruno Santi, DI GANGI, P., Ferrari, M. C., Venturelli, G., Tirelli, U., Guaraldi, G., Pietrangelo, A., and Berretta, M.
Published: 2010

14. Polypharmacology for polypathology in HIV infected patients

Author: Guaraldi, Giovanni, Menozzi, M., Zona, S., Garlassi, E., Berti, A., Rossi, E., Orlando, G., Carli, F., Roverato, A., Cocchi, S., and Palella, Fj
Subjects: HIV infection, polypathology
Published: 2010

15. Hepatocellular carcinoma in HIV infected patients: check early, treat hard

Author: Garlassi, E., Ventura, P., Berretta, M., Cocchi, S., Cacopardo, B., Stentarelli, C., Di Gangi, P., Antonello Pietrangelo, Tirelli, U., and Guaraldi, G.
Subjects: HIV, hepatocellular carcinoma
Published: 2010

16. La valutazione del rischio cardiovascolare nel paziente con infezione da HIV

Author: Guaraldi, Giovanni, Garlassi, E., and Rossi, Rosario
Subjects: rischio cardiovascolare, HIV, terapia antiretrovirale
Published: 2009

17. Combined use of waist and thigh circumference to identify high-risk, abdominally obese HIV+ patients

Author: O'Neil, T, primary, Ross, R, additional, Zona, S, additional, Orlando, G, additional, Carli, F, additional, Garlassi, E, additional, Stentarelli, C, additional, Mussini, C, additional, and Guaraldi, G, additional
Published: 2012
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18. Tenofovir accelerates bone mass loss of the lumbar spine in the first years of menopause in HIV‐infected women

Author: Garlassi, E, primary, Zona, S, additional, Vescini, F, additional, Domingues da Silva, A, additional, Berardi, C, additional, Orlando, G, additional, Carli, F, additional, Menozzi, M, additional, Santoro, A, additional, Mussini, C, additional, and Guaraldi, G, additional
Published: 2012
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19. Premature Age-Related Comorbidities Among HIV-Infected Persons Compared With the General Population

Author: Guaraldi, G., primary, Orlando, G., additional, Zona, S., additional, Menozzi, M., additional, Carli, F., additional, Garlassi, E., additional, Berti, A., additional, Rossi, E., additional, Roverato, A., additional, and Palella, F., additional
Published: 2011
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20. Unexpected identification of bilateral masses in an asymptomatic heavy smoker

Author: Garlassi, E., primary, Rossi, G., additional, Bedini, A., additional, and Richeldi, L., additional
Published: 2010
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21. Clinical outcomes and survival in patients with hepatocellular carcinoma and HIV infection.

Author: Berretta, M., primary, Garlassi, E., additional, Ventura, P., additional, Cacopardo, B., additional, Lleshi, A., additional, Cocchi, S., additional, Guaraldi, G., additional, Pietrangelo, A., additional, and Tirelli, U., additional
Published: 2010
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22. 30 HIV INFECTION AND SURVIVAL IN PATIENTS WITH HCC AND LIVER CIRRHOSIS

Author: Ventura, P., primary, Garlassi, E., additional, Cacopardo, B., additional, Di Gangi, P., additional, Ferrari, M.C., additional, Venturelli, G., additional, Tirelli, U., additional, Guaraldi, G., additional, Pietrangelo, A., additional, and Beretta, M., additional
Published: 2010
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23. Metabolic alterations in HIV-infected pregnant women: Moving to metabolic tailoring of antiretroviral drugs

Author: Guaraldi, G., Stentarelli, C., Da Silva, A. D., Luzi, K., Isabella NERI, Cellini, M., Petrella, E., Garlassi, E., Menozzi, M., Facchinetti, F., and Mussini, C.
Subjects: Metabolism, prevention, Anti-HIV Agents, Pregnancy, antiretroviral therapy, Infant, Newborn, Humans, pregnancy, HIV infection, Female, HIV Infections
Abstract: The most striking effect of increased survival and improved quality of life in HIV-infected women undergoing antiretroviral therapy is the feasibility of motherhood-desire satisfaction. However, such advantages are often associated with drug-related metabolic toxicities, particularly relevant in the pregnancy context. Recent guidelines provide recommendations and trends for the use of antiretroviral therapy in pregnant women, but current literature falls short of providing specific insights on the need for metabolic monitoring and treatment in HIV-infected pregnant women. In this review we provide specific insight into the state-of-the-art of: detection, evaluation, and management of metabolic alterations in this special population. Pregnancy is in fact a metabolic transition process, potentially associated with specific diseases in the mother, in the newborn, and in the adulthood of the child. We will not simply discuss antiretroviral therapy metabolic toxicities, but rather their interaction with the physiological metabolic changes occurring during pregnancy. Close monitoring is needed to diagnose metabolic alterations that can lead to adverse outcomes in the mother, in the newborn, and potentially in adulthood. Lifestyle interventions and an appropriate metabolic tailoring of antiretroviral therapy drugs need to be considered in the prevention and treatment of metabolic alteration during pregnancy.

24. Lipodystrophy and quality of life of HIV-infected persons

Author: Guaraldi, G., Rita Murri, Orlando, G., Squillace, N., Stentarelli, C., Zona, S., Garlassi, E., and Martinez, E.
Subjects: Body image, Lipodystrophy, Body changes, Health-related quality of life, Lipodystrophy case definition, Anti-HIV Agents, HIV-Associated Lipodystrophy Syndrome, Body Image, Quality of Life, Body Fat Distribution, Humans, HIV Infections
Abstract: Morphological changes induced by HIV-related lipodystrophy profoundly affect body image and influence health-related quality of life. Measurements of health-related quality of life in patients with lipodystrophy are complex due to a lack of consensus on the definition of lipodystrophy, a lack of appropriate methods to capture the impact of body fat changes, and the subjective perception of those changes by patients. This review describes the different tools that have been used to assess quality of life in patients with lipodystrophy, and critically analyzes published papers on health-related quality of life. With regard to facial lipoatrophy, the most stigmatizing condition of lipodystrophy, we have analyzed the impact of reconstructive plastic surgery on patient-related outcomes and health-related quality of life. A better knowledge of the associations between lipodystrophy and health-related quality of life will allow us to understand the burden of long-term toxicities of antiretroviral therapies as well as to identify novel patient-related endpoints useful in assessing the efficacy of lipodystrophy treating programs.

25. Clinical features and comorbidity pattern of HCV infected migrants compared to native patients in care in Italy: A real-life evaluation of the PITER cohort

Author: Maria Giovanna Quaranta, Luigina Ferrigno, Xhimi Tata, Franca D'Angelo, Marco Massari, Carmine Coppola, Elisa Biliotti, Alessia Giorgini, Diletta Laccabue, Alessia Ciancio, Pier Luigi Blanc, Marzia Margotti, Donatella Ieluzzi, Maurizia Rossana Brunetto, Francesco Barbaro, Francesco Paolo Russo, Ilaria Beretta, Giulia Morsica, Gabriella Verucchi, Annalisa Saracino, Massimo Galli, Loeta A. Kondili, Cesare Mazzaro, Manuela Bertola, Ornella Schioppa, Antonio Benedetti, Laura Schiadà, Monica Cucco, Andrea Giacometti, Laura Brescini, Sefora Castelletti, Alessandro Fiorentini, Gioacchino Angarano, Michele Milella, Alfredo Di Leo, Maria Rendina, Fulvio Salvatore D'abramo, Chiara Lillo, Andrea Iannone, Mariano Piazzolla, Lorenzo Badia, Fabio Piscaglia, Francesca Benevento, Ilaria Serio, Francesco Castelli, Serena Zaltron, Angiola Spinetti, Silvia Odolini, Raffaele Bruno, Mario Mondelli, Luchino Chessa, Martina Loi, Carlo Torti, Chiara Costa, Maria Mazzitelli, Vincenzo Pisani, Vincenzo Scaglione, Enrico Maria Trecarichi, Anna Linda Zignego, Monica Monti, Francesco Madia, Letizia Attala, Piera Pierotti, Elena Salomoni, Elisa Mariabelli, Teresa Antonia Santantonio, Serena Rita Bruno, Ester Marina Cela, Matteo Bassetti, Giovanni Mazzarello, Anna Ida Alessandrini, Antonio Di Biagio, Laura Ambra Nicolini, Giovanni Raimondo, Roberto Filomia, Alessio Aghemo, Rossella Meli, Adriano Lazzarin, Stefania Salpietro, Anna Ludovica Fracanzani, Erika Fatta, Rosa Lombardi, Pietro Lampertico, Marta Borghi, Roberta D'ambrosio, Elisabetta Degasperi, Massimo Puoti, Chiara Baiguera, Federico D'amico, Maria Vinci, Maria Grazia Rumi, Massimo Zuin, Paola Zermiani, Pietro Andreone, Paolo Caraceni, Valeria Guarneri, Erica Villa, Veronica Bernabucci, Laura Bristot, Maria Luisa Paradiso, Guglielmo Migliorino, Alessandra Gambaro, Giuseppe Lapadula, Anna Spolti, Alessandro Soria, Pietro Invernizzi, Antonio Ciaccio, Martina LucÀ, Federica Malinverno, Laura Ratti, Daniela Caterina Amoruso, Federica Pisano, Ferdinando Scarano, Laura Staiano, Filomena Morisco, Valentina Cossiga, Ivan Gentile, Antonio Riccardo Buonomo, Maria Foggia, Emanuela Zappulo, Alessandro Federico, Marcello Dallio, Nicola Coppola, Caterina Sagnelli, Salvatore Martini, Caterina Monari, Gerardo Nardone, Costantino Sgamato, Liliana Chemello, Luisa Cavalletto, Daniela Sterrantino, Alberto Zanetto, Paola Zanaga, Giuseppina Brancaccio, Antonio Craxì, Salvatore Petta, Vincenza Calvaruso, Luciano Crapanzano, Salvatore Madonia, Marco Cannizzaro, Erica Maria Bruno, Anna Licata, Simona Amodeo, Adele Rosaria Capitano, Carlo Ferrari, Elisa Negri, Alessandra Orlandini, Marco Pesci, Roberto Gulminetti, Layla Pagnucco, Giustino Parruti, Paola Di Stefano, Barbara Coco, Romina Corsini, Elisa Garlassi, Massimo Andreoni, Elisabetta Teti, Carlotta Cerva, Lorenzo Baiocchi, Giuseppe Grassi, Antonio Gasbarrini, Maurizio Pompili, Martina De Siena, Gloria Taliani, Martina Spaziante, Marcello Persico, Mario Masarone, Andrea Aglitti, Gemma Calvanese, Marco Anselmo, Pasqualina De Leo, Monica Marturano, Giorgio Maria Saracco, Quaranta M.G., Ferrigno L., Tata X., D'Angelo F., Massari M., Coppola C., Biliotti E., Giorgini A., Laccabue D., Ciancio A., Blanc P.L., Margotti M., Ieluzzi D., Brunetto M.R., Barbaro F., Russo F.P., Beretta I., Morsica G., Verucchi G., Saracino A., Galli M., Kondili L.A., Mazzaro C., Bertola M., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Fiorentini A., Angarano G., Milella M., Leo A.D., Rendina M., Salvatore D'ABRAMO F., Lillo C., Iannone A., Piazzolla M., Badia L., Piscaglia F., Benevento F., Serio I., Castelli F., Zaltron S., Spinetti A., Odolini S., Bruno R., Mondelli M., Chessa L., Loi M., Torti C., Costa C., Mazzitelli M., Pisani V., Scaglione V., Trecarichi E.M., Zignego A.L., Monti M., Madia F., Attala L., Pierotti P., Salomoni E., Mariabelli E., Santantonio T.A., Bruno S.R., Cela E.M., Bassetti M., Mazzarello G., Alessandrini A.I., Biagio A.D., Nicolini L.A., Raimondo G., Filomia R., Aghemo A., Meli R., Lazzarin A., Salpietro S., Fracanzani A.L., Fatta E., Lombardi R., Lampertico P., Borghi M., D'ambrosio R., Degasperi E., Puoti M., Baiguera C., D'AMICO F., Vinci M., Rumi M.G., Zuin M., Zermiani P., Andreone P., Caraceni P., Guarneri V., Villa E., Bernabucci V., Bristot L., Paradiso M.L., Migliorino G., Gambaro A., Lapadula G., Spolti A., Soria A., Invernizzi P., Ciaccio A., LucA M., Malinverno F., Ratti L., Amoruso D.C., Pisano F., Scarano F., Staiano L., Morisco F., Cossiga V., Gentile I., Buonomo A.R., Foggia M., Zappulo E., Federico A., Dallio M., Coppola N., Sagnelli C., Martini S., Monari C., Nardone G., Sgamato C., Chemello L., Cavalletto L., Sterrantino D., Zanetto A., Zanaga P., Brancaccio G., Craxi A., Petta S., Calvaruso V., Crapanzano L., Madonia S., Cannizzaro M., Bruno E.M., Licata A., Amodeo S., Capitano A.R., Ferrari C., Negri E., Orlandini A., Pesci M., Gulminetti R., Pagnucco L., Parruti G., Stefano P.D., Coco B., Corsini R., Garlassi E., Andreoni M., Teti E., Cerva C., Baiocchi L., Grassi G., Gasbarrini A., Pompili M., Siena M.D., Taliani G., Spaziante M., Persico M., Masarone M., Aglitti A., Calvanese G., Anselmo M., Leo P.D., Marturano M., Saracco G.M., Quaranta, M, Ferrigno, L, Tata, X, D'Angelo, F, Massari, M, Coppola, C, Biliotti, E, Giorgini, A, Laccabue, D, Ciancio, A, Blanc, P, Margotti, M, Ieluzzi, D, Brunetto, M, Barbaro, F, Russo, F, Beretta, I, Morsica, G, Verucchi, G, Saracino, A, Galli, M, Kondili, L, Mazzaro, C, Bertola, M, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Fiorentini, A, Angarano, G, Milella, M, Leo, A, Rendina, M, Salvatore D'ABRAMO, F, Lillo, C, Iannone, A, Piazzolla, M, Badia, L, Piscaglia, F, Benevento, F, Serio, I, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Bruno, R, Mondelli, M, Chessa, L, Loi, M, Torti, C, Costa, C, Mazzitelli, M, Pisani, V, Scaglione, V, Trecarichi, E, Zignego, A, Monti, M, Madia, F, Attala, L, Pierotti, P, Salomoni, E, Mariabelli, E, Santantonio, T, Bruno, S, Cela, E, Bassetti, M, Mazzarello, G, Alessandrini, A, Biagio, A, Nicolini, L, Raimondo, G, Filomia, R, Aghemo, A, Meli, R, Lazzarin, A, Salpietro, S, Fracanzani, A, Fatta, E, Lombardi, R, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Puoti, M, Baiguera, C, D'Amico, F, Vinci, M, Rumi, M, Zuin, M, Zermiani, P, Andreone, P, Caraceni, P, Guarneri, V, Villa, E, Bernabucci, V, Bristot, L, Paradiso, M, Migliorino, G, Gambaro, A, Lapadula, G, Spolti, A, Soria, A, Invernizzi, P, Ciaccio, A, Luca, M, Malinverno, F, Ratti, L, Amoruso, D, Pisano, F, Scarano, F, Staiano, L, Morisco, F, Cossiga, V, Gentile, I, Buonomo, A, Foggia, M, Zappulo, E, Federico, A, Dallio, M, Coppola, N, Sagnelli, C, Martini, S, Monari, C, Nardone, G, Sgamato, C, Chemello, L, Cavalletto, L, Sterrantino, D, Zanetto, A, Zanaga, P, Brancaccio, G, Craxi, A, Petta, S, Calvaruso, V, Crapanzano, L, Madonia, S, Cannizzaro, M, Bruno, E, Licata, A, Amodeo, S, Capitano, A, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Gulminetti, R, Pagnucco, L, Parruti, G, Stefano, P, Coco, B, Corsini, R, Garlassi, E, Andreoni, M, Teti, E, Cerva, C, Baiocchi, L, Grassi, G, Gasbarrini, A, Pompili, M, Siena, M, Taliani, G, Spaziante, M, Persico, M, Masarone, M, Aglitti, A, Calvanese, G, Anselmo, M, Leo, P, Marturano, M, Saracco, G, Quaranta, M. G., Ferrigno, L., Tata, X., D'Angelo, F., Massari, M., Coppola, C., Biliotti, E., Giorgini, A., Laccabue, D., Ciancio, A., Blanc, P. L., Margotti, M., Ieluzzi, D., Brunetto, M. R., Barbaro, F., Russo, F. P., Beretta, I., Morsica, G., Verucchi, G., Saracino, A., Galli, M., Kondili, L. A., Mazzaro, C., Bertola, M., Benedetti, A., Schiada, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Fiorentini, A., Angarano, G., Milella, M., Leo, A. D., Rendina, M., Salvatore D'ABRAMO, F., Lillo, C., Iannone, A., Piazzolla, M., Badia, L., Piscaglia, F., Benevento, F., Serio, I., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Bruno, R., Mondelli, M., Chessa, L., Loi, M., Torti, C., Costa, C., Mazzitelli, M., Pisani, V., Scaglione, V., Trecarichi, E. M., Zignego, A. L., Monti, M., Madia, F., Attala, L., Pierotti, P., Salomoni, E., Mariabelli, E., Santantonio, T. A., Bruno, S. R., Cela, E. M., Bassetti, M., Mazzarello, G., Alessandrini, A. I., Biagio, A. D., Nicolini, L. A., Raimondo, G., Filomia, R., Aghemo, A., Meli, R., Lazzarin, A., Salpietro, S., Fracanzani, A. L., Fatta, E., Lombardi, R., Lampertico, P., Borghi, M., D'Ambrosio, R., Degasperi, E., Puoti, M., Baiguera, C., D'Amico, F., Vinci, M., Rumi, M. G., Zuin, M., Zermiani, P., Andreone, P., Caraceni, P., Guarneri, V., Villa, E., Bernabucci, V., Bristot, L., Paradiso, M. L., Migliorino, G., Gambaro, A., Lapadula, G., Spolti, A., Soria, A., Invernizzi, P., Ciaccio, A., Luca, M., Malinverno, F., Ratti, L., Amoruso, D. C., Pisano, F., Scarano, F., Staiano, L., Morisco, F., Cossiga, V., Gentile, I., Buonomo, A. R., Foggia, M., Zappulo, E., Federico, A., Dallio, M., Coppola, N., Sagnelli, C., Martini, S., Monari, C., Nardone, G., Sgamato, C., Chemello, L., Cavalletto, L., Sterrantino, D., Zanetto, A., Zanaga, P., Brancaccio, G., Craxi, A., Petta, S., Calvaruso, V., Crapanzano, L., Madonia, S., Cannizzaro, M., Bruno, E. M., Licata, A., Amodeo, S., Capitano, A. R., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Gulminetti, R., Pagnucco, L., Parruti, G., Stefano, P. D., Coco, B., Corsini, R., Garlassi, E., Andreoni, M., Teti, E., Cerva, C., Baiocchi, L., Grassi, G., Gasbarrini, A., Pompili, M., Siena, M. D., Taliani, G., Spaziante, M., Persico, M., Masarone, M., Aglitti, A., Calvanese, G., Anselmo, M., Leo, P. D., Marturano, M., and Saracco, G. M.
Subjects: Male, HCV genotypes, Ethnic group, Linked-to-care patient, Comorbidity, Hepacivirus, Logistic regression, medicine.disease_cause, Comorbidities, Direct acting antivirals, HCV Cohort, Linked-to-care patients, Aged, Antiviral Agents, Coinfection, Female, Hepatitis C, Chronic, Humans, Italy, Middle Aged, Transients and Migrants, 0302 clinical medicine, Medicine, Chronic, Gastroenterology, virus diseases, Hepatitis C, Life evaluation, 030220 oncology & carcinogenesis, Cohort, 030211 gastroenterology & hepatology, Comorbiditie, Human, Hepatitis C virus, Settore MED/12 - GASTROENTEROLOGIA, 03 medical and health sciences, Disease severity, Antiviral Agent, Hepaciviru, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, digestive system diseases, Direct acting antiviral, business, Demography
Abstract: Background: Direct-acting antivirals are highly effective for the treatment of hepatitis C virus (HCV) infection, regardless race/ethnicity. We aimed to evaluate demographic, virological and clinical data of HCV-infected migrants vs. natives consecutively enrolled in the PITER cohort. Methods: Migrants were defined by country of birth and nationality that was different from Italy. Mann-Whitney U test, Chi-squared test and multiple logistic regression were used. Results: Of 10,669 enrolled patients, 301 (2.8%) were migrants: median age 47 vs. 62 years, (p < 0.001), females 56.5% vs. 45.3%, (p < 0.001), HBsAg positivity 3.8% vs. 1.4%, (p < 0.05). Genotype 1b was prevalent in both groups, whereas genotype 4 was more prevalent in migrants (p < 0.05). Liver disease severity and sustained virologic response (SVR) were similar. A higher prevalence of comorbidities was reported for natives compared to migrants (p < 0.05). Liver disease progression cofactors (HBsAg, HIV coinfection, alcohol abuse, potential metabolic syndrome) were present in 39.1% and 47.1% (p > 0.05) of migrants and natives who eradicated HCV, respectively. Conclusion: Compared to natives, HCV-infected migrants in care have different demographics, HCV genotypes, viral coinfections and comorbidities and similar disease severity, SVR and cofactors for disease progression after HCV eradication. A periodic clinical assessment after HCV eradication in Italians and migrants with cofactors for disease progression is warranted.
Published: 2021

26. Premature Age-Related Comorbidities Among HIV-Infected Persons Compared With the General Population

Author: Frank J. Palella, Marianna Menozzi, Alessandra Berti, Elisa Garlassi, Gabriella Orlando, Federica Carli, Alberto Roverato, Stefano Zona, Elisa Rossi, Giovanni Guaraldi, Guaraldi G., Orlando G., Zona S., Menozzi M., Carli F., Garlassi E., Berti A., Rossi E., Roverato A., and Palella F.
Subjects: Adult, Male, Microbiology (medical), medicine.medical_specialty, Anti-HIV Agents, antiretroviral therapy, Population, HIV Infections, Disease, comorbidities, Logistic regression, Fractures, Bone, Risk Factors, Antiretroviral Therapy, Highly Active, Internal medicine, Diabetes mellitus, Diabetes Mellitus, Prevalence, Humans, Medicine, HIV–infected patients, Ageing, comorbidity, Renal Insufficiency, education, HIV–infected patient, education.field_of_study, business.industry, Age Factors, Case-control study, Odds ratio, Middle Aged, HIV infection, medicine.disease, ageing, Comorbidity, Surgery, Infectious Diseases, Italy, Cardiovascular Diseases, Case-Control Studies, Hypertension, Cohort, Female, business
Abstract: Background. Human immunodeficiency virus (HIV)‐infected patients may have a greater risk of noninfectious comorbidities (NICMs) compared with the general population. We assessed the prevalence and risk factors for NICMs in a large cohort of HIV-infected adults and compared these findings with data from matched control subjects. Methods. We performed a case-control study involving antiretroviral therapy (ART)‐experienced HIVinfected patients treated at Modena University, Italy, from 2002 through 2009. These patients were compared with age-, sex-, and race-matched adults (control subjects) from the general population included in the CINECA ARNO database. NICMs included cardiovascular disease, hypertension, diabetes mellitus, bone fractures, and renal failure. Polypathology (Pp) was defined as the concurrent presence of $2 NICMs. Logistic regression models were constructed to evaluate associated predictors of NICMs and Pp. Results. There were 2854 patients and 8562 control subjects. The mean age was 46 years, and 37% were women. Individual NICM and Pp prevalences in each age stratum were higher among patients than among controls (all P ,.001). Pp prevalence among patients aged 41‐50 years was similar to that among controls aged 51‐60 years (P value was not statistically significant); diabetes mellitus, cardiovascular disease, bone fractures, and renal failure were statistically independent after adjustment for sex, age, and hypertension. Logistic regression models showed that independent predictors of Pp in the overall cohort were (all P , .001) age (odds ratio [OR], 1.11), male sex (OR, 1.77), nadir CD4 cell count ,200 cells/lL (OR, 4.46), and ART exposure (OR, 1.01). Conclusions. Specific age-related NICMs and Pp were more common among HIV-infected patients than in the general population. The prevalence of Pp in HIV-infected persons anticipated Pp prevalence observed in the general population among persons who were 10 years older, and HIV-specific cofactors (lower nadir CD4 cell count and more prolonged ART exposure) were identified as risk factors. These data support the need for earlier screening for NICMs in HIV-infected patients.
Published: 2011

27. Polypharmacy, anticholinergic burden and drug-drug interaction assessment in people with four-class-resistant HIV: data from the PRESTIGIO registry.

Author: Mazzitelli M, Pontillo D, Clemente T, Di Biagio A, Cenderello G, Rusconi S, Menzaghi B, Fornabaio C, Garlassi E, Zazzi M, Castagna A, and Cattelan AM
Subjects: Humans, Male, Female, Middle Aged, Cross-Sectional Studies, Drug Resistance, Viral, Adult, Drug Interactions, Polypharmacy, HIV Infections drug therapy, Anti-HIV Agents therapeutic use, Registries, Cholinergic Antagonists administration & dosage
Abstract: Objectives: To evaluate polypharmacy, anticholinergic burden (ACB) and drug-drug interactions (DDIs) in people with four-class-resistant HIV (4DR-PWH)., Methods: We performed a cross-sectional study, including 4DR-PWH from the PRESTIGIO Registry taking at least one non-antiretroviral drug. Polypharmacy was defined as taking five or more non-antiretroviral drugs. ACB was calculated using the ACB scale: 0 = no AC effect, 1-2 = low/moderate risk, ≥3 = high AC risk. Participants' characteristics by ACB score were compared using the Kruskal-Wallis test, and Spearman's correlation coefficient was used to assess linear relationships. DDIs were evaluated using the Liverpool database., Results: Overall, 172 4DR-PLWH were evaluated: 75.6% males, median age 49.9 years (IQR = 45.6-56), 62 (27.1%) on polypharmacy, 124 (72.1%) using a boosting agent and 72 (41.8%) with four or more antiretrovirals. Based on ACB, 128 (74.45%), 33 (19.2%) and 11 (6.4%) had a no, low/moderate and high AC risk, respectively. The most common AC drugs were β-blockers (12.2%), diuretics (8.7%) and antidepressants (8.7%). The high ACB was significantly related to the number of drugs/person (r = 0.33, P < 0.0001) and the number of clinical events (r = 0.222, P = 0.004). Overall, 258 DDIs were found between antiretrovirals and co-medications in 115 (66.8%) PWH, and 14 (8.1%) PWH received contraindicated drug combinations., Conclusions: In 4DR-PWH, polypharmacy, DDIs and the proportion of people with moderate/high AC burden were high. In 4DR-PWH undetectability achievement and maintenance is the priority and use of boosted PIs is common. A strict collaboration (infectious diseases specialists, virologists, pharmacologists) is needed to limit the risk of ACB and DDIs and to explore the advantages of new antiretrovirals., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
Published: 2024
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28. Burden of Disease in PWH Harboring a Multidrug-Resistant Virus: Data From the PRESTIGIO Registry.

Author: Galli L, Parisi MR, Poli A, Menozzi M, Fiscon M, Garlassi E, Francisci D, Di Biagio A, Sterrantino G, Fornabaio C, Degli Antoni A, Angarano G, Fusco FM, D'Arminio Monforte A, Corbelli GM, Santoro MM, Zazzi M, and Castagna A
Abstract: Background: Currently, no data are available on the burden of morbidity and mortality in people with HIV-1 (PWH) harboring a 4-class drug-resistant (4DR) virus (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors). The study aimed to assess the incidence of clinical events and death in this population., Methods: This was a cohort study on PWH from the PRESTIGIO Registry with a documented 4DR virus. Burden of disease was defined as the occurrence of any new event including an AIDS-defining event (ADE) or non-AIDS-defining event (NADE) or death from any cause after 4DR evidence (baseline). Cox regression models evaluated factors associated with the risk of new clinical events/death., Results: Among 148 PWH followed for a median (interquartile range) of 47 (32-84) months after 4DR evidence, 38 PWH had 62 new events or died from any cause (incidence rate, 9.12/100 person-years of follow-up; 95% CI = 6.85-11.39): 12 deaths (6 AIDS-related and 6 non-AIDS-related), 18 ADEs, 32 NADEs; 20 of the 38 NADEs (45%) of the incident clinical events were malignancies. The 4-year cumulative incidence of death was 6% (95% CI, 3%-13%), and that of ≥1 event or death was 22% (95% CI, 16%-31%). A higher risk of new clinical events/death was more likely in PWH with previous clinical events (adjusted hazard ratio [aHR], 2.67; 95% CI, 1.07-6.67) and marginally associated with lower baseline CD4+/CD8+ ratio (aHR, 0.82; 95% CI, 0.65-1.02)., Conclusions: PWH harboring 4DR have a high burden of disease with a worrying incidence of malignancies, strongly advising for close prevention and monitoring interventions as well as access to innovative therapeutic strategies, especially in people with a history of clinical events and low CD4+/CD8+ ratio., (© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Published: 2020
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29. Secukinumab in an HIV-positive patient with psoriasis.

Author: Di Lernia V, Casanova DM, and Garlassi E
Subjects: AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome drug therapy, Antibodies, Monoclonal, Humanized administration & dosage, Antiretroviral Therapy, Highly Active, Candidiasis etiology, Drug Administration Schedule, Esophagitis microbiology, Female, HIV Seropositivity complications, Humans, Middle Aged, Psoriasis complications, Remission Induction, Severity of Illness Index, Viral Load, Acquired Immunodeficiency Syndrome complications, Antibodies, Monoclonal, Humanized therapeutic use, Psoriasis drug therapy
Published: 2019
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30. Secukinumab bei einer HIV-positiven Patientin mit Psoriasis.

Author: Di Lernia V, Casanova DM, and Garlassi E
Published: 2019
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31. HIV-related non-Hodgkin Lymphoma. Case report and review of the literature.

Author: Giordano D, Castellucci A, Merli F, Garlassi E, and Pernice C
Subjects: Burkitt Lymphoma therapy, HIV Infections therapy, Humans, Male, Oropharyngeal Neoplasms therapy, Young Adult, Burkitt Lymphoma diagnosis, Burkitt Lymphoma virology, HIV Infections complications, HIV Infections diagnosis, Oropharyngeal Neoplasms diagnosis, Oropharyngeal Neoplasms virology
Abstract: Background: HIV-related Burkitt's lymphoma with initial oropharyngeal presentation is rarely reported. The aim of this paper is to report the clinical findings of an unusual case of a patient with extranodal oropharyngeal Burkitt's lymphoma as presenting disease of an unknown HIV positivity and acquired immunodeficiency syndrome., Methods: We reported the case of a hispanic patient with extranodal oropharyngeal Burkitt's lymphoma as presenting disease of an unknown HIV positivity and acquired immunodeficiency syndrome. We describe the diagnostic work-up and treatment of this rare case of extranodal oropharyngeal Burkitt's lymphoma., Results: Histological exam on oropharyngeal incision biopsy documented a Burkitt's lymphoma. The patient underwent highly active antiretroviral therapy and chemotherapy. After two years of follow-up the patient shows no signs of recurrence from disease., Conclusions: HIV-related Burkitt's lymphoma presenting with primary oropharyngeal involvement is rare, with rapidly progressing dysphagia, and does not respond to antibiotherapy. Patients should undergo incision biopsy to rule out a malignancy. In young adults, diagnosis of Burkitt's lymphoma should suggest HIV infection. The importance of a prompt diagnosis in such cases is essential to correctly adequately staging the disease to start highly active antiretroviral therapy and chemotherapy as soon as possible.
Published: 2019
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32. Correlates of infection and molecular characterization of blood-borne HIV, HCV, and HBV infections in HIV-1 infected inmates in Italy: An observational cross-sectional study.

Author: Sanarico N, D'Amato S, Bruni R, Rovetto C, Salvi E, Di Zeo P, Chionne P, Madonna E, Pisani G, Costantino A, Equestre M, Tosti ME, Cenci A, Maggiorella MT, Sernicola L, Pontali E, Pansera A, Quattrocchi R, Carbonara S, Signorile F, Surace LA, Federzoni G, Garlassi E, Starnini G, Monarca R, Babudieri S, Rapicetta M, Pompa MG, Caraglia A, Ensoli B, Ciccaglione AR, and Buttò S
Subjects: Adult, Aged, Cross-Sectional Studies, Female, HIV Infections diagnosis, HIV Infections epidemiology, HIV Infections virology, Hepatitis B diagnosis, Hepatitis B epidemiology, Hepatitis B virology, Hepatitis C diagnosis, Hepatitis C epidemiology, Hepatitis C virology, Humans, Italy, Male, Middle Aged, Prevalence, Blood-Borne Pathogens, HIV Infections blood, HIV-1 genetics, Hepacivirus genetics, Hepatitis B blood, Hepatitis B virus genetics, Hepatitis C blood
Abstract: Coinfection of blood-borne hepatitis B and hepatitis C viruses (HBV and HCV, respectively) in human immunodeficiency virus type 1 (HIV-1)-positive individuals frequently occurs in inmate population and peculiar viral strains and patterns of virological markers may be observed.Plasma from 69 HIV-1-positive inmates was obtained from 7 clinical centers connected with correctional centers in different towns in Italy. HIV, HBV, and HCV markers were tested by commercial assays. Virus genotyping was carried out by sequencing the protease and reverse transcriptase-encoding region (PR-RT region) for HIV and a region encompassing the NS5B gene for HCV and subsequent phylogenetic analysis.Twelve over 14 HIV-subtyped inmates were infected with HIV-1 subtype B strains. The 2 non-B strains belonged to subtype G and CRF02_AG, in an Italian and a Gambian patient, respectively. Variants carrying the K103N and Y181C resistance mutations to non-nucleoside reverse transcriptase inhibitors (NNRTIs) were found in 2 out of 9 patients naive for combined antiretroviral therapy (cART) (22.2%). Most HIV-positive patients (92.8%) showed evidence of past or present HBV and/or HCV infection. Prevalence of HBV and HCV was 81.2% for both viruses, whereas prevalence of HBV/HCV coinfection was 69.6%. A significantly higher presence of HCV infection was found in Italians [odds ratio (OR) 11.0; interval 1.7-80.9] and in drug users (OR 27.8; interval 4.9-186.0). HCV subtypes were determined in 42 HCV or HBV/HCV-coinfected individuals. HCV subtypes 1a, 3a, 4d, and 1b were found in 42.9%, 40.5%, 14.3%, and 2.4% of inmates, respectively. Low titers of HBV DNA in HBV DNA positive subjects precluded HBV subtyping.The high prevalence of HBV and HCV coinfections in HIV-infected inmates, as well as the heterogeneity of HIV and HCV subtypes suggest the need to adopt systematic controls in prisons to monitor both the burden and the genetic forms of blood-borne viral infections, in order to apply targeted therapeutic interventions.
Published: 2016
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33. Contrast-enhanced ultrasound (CEUS) appearance of hepatic myelolipoma.

Author: Menozzi G, Maccabruni V, Marini G, Froio E, and Garlassi E
Subjects: Aged, Contrast Media, Diagnosis, Differential, Female, Humans, Image-Guided Biopsy, Incidental Findings, Liver Neoplasms pathology, Magnetic Resonance Imaging, Myelolipoma pathology, Phospholipids, Sulfur Hexafluoride, Tomography, X-Ray Computed, Ultrasonography, Liver Neoplasms diagnostic imaging, Myelolipoma diagnostic imaging
Abstract: The case report is a description of a single case of hepatic myelolipoma, a very rare benign hepatic tumor, evaluated with contrast sonography, in a 72-year-old female. It was previously reported as hyperechoic lesions at sonography. CEUS features of the lesion were: homogeneous hyperenhancement in the arterial phase and a slight hyperenhancement in the portal venous phase typical of benign tumors. The case report shows CEUS may help in differential diagnosis between benign and malignant lesions, but only the biopsy of the tumor and the pathological evaluation allows the diagnosis.
Published: 2014
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34. Evaluation with contrast ultrasound of the prevalence of splenic infarction in left-sided infective endocarditis.

Author: Menozzi G, Maccabruni V, Gabbi E, Magnani G, and Garlassi E
Abstract: Purpose: To prospectively evaluate the prevalence of the embolization of the spleen in patients with definite left-sided infective endocarditis (IE) using a contrast-enhanced ultrasound (CEUS)., Methods: From March 2012 through September 2013, 18 consecutive patients (9 females and 9 males, aged 21-83 years) evaluated at our hospital and with definite left-sided IE according to the revised Duke criteria were enrolled. All of the patients gave informed written consent and the study was performed in conformity with the ethical guidelines of the Declaration of Helsinki. All of the patients were submitted to a CEUS of the spleen within 10 days after the definite diagnosis of IE. For the CEUS, a blood pool second-generation contrast agent and an ultrasound machine with a contrast harmonic imaging technology were used., Results: The splenic CEUS showed infarctions in 11 patients (61 %) and resulted positive in the 2 patients with negative echocardiography., Conclusions: In this study, CEUS of the spleen, a repeatable and low-cost imaging technique, easily allowed the bedside detection of asymptomatic and even tiny infarctions and showed a high rate of embolization in patients with definite left-sided IE. Therefore, in the setting of IE (possible or definite), CEUS of the spleen has the potential to better define or accelerate the diagnosis itself.
Published: 2014
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35. Switching to darunavir/ritonavir monotherapy vs. triple-therapy on body fat redistribution and bone mass in HIV-infected adults: the Monarch randomized controlled trial.

Author: Guaraldi G, Zona S, Cossarizza A, Vernacotola L, Carli F, Lattanzi A, Nardini G, Orlando G, Garlassi E, Termini R, and Garau M
Subjects: Adult, Antiretroviral Therapy, Highly Active, Darunavir, Female, HIV Infections physiopathology, HIV Protease Inhibitors adverse effects, Humans, Male, Middle Aged, Reverse Transcriptase Inhibitors administration & dosage, Ritonavir adverse effects, Sulfonamides adverse effects, Treatment Outcome, Body Fat Distribution, Bone Density drug effects, HIV Infections drug therapy, HIV Protease Inhibitors administration & dosage, HIV-Associated Lipodystrophy Syndrome chemically induced, Ritonavir administration & dosage, Sulfonamides administration & dosage
Abstract: Changes in body fat distribution and bone mass in HIV-infected patients may be associated with long-term use of nucleoside reverse transcriptase inhibitors (NRTIs). The Monarch trial recruited 30 patients receiving non-nucleoside reverse transcriptase inhibitor or protease inhibitor-based highly active antiretroviral therapy, with HIV RNA <40 copies/mL. Patients were randomized to either darunavir/ritonavir 800/100 mg once daily monotherapy or darunavir/ritonavir 800/100 mg once daily + two NRTIs. Bone mass, peripheral lipoatrophy and central fat accumulation were assessed using dual-energy X-ray absorptiometry scanning, supplemented by computed tomography scans. Median age was 43 years, 77% were men. Visceral adipose tissue remained stable from baseline to Week 48 in the whole group (p = 0.261) with no significant difference between arms (p = 0.56). There was a significant reduction in insulin resistance (HOMA-IR, p = 0.013) over 48 weeks in the whole group, but not of body mass index (p = 0.24). In the darunavir/ritonavir monotherapy arm, there was a small but significant increase in both lumbar and femur bone mineral density at 48 weeks and was observed after correction for baseline values. The absolute change in lumbar bone mineral density at 48 weeks was more pronounced in the darunavir/ritonavir arm compared with the darunavir/ritonavir + 2NRTIs arm. In this study, discontinuing nucleoside analogues and switching to darunavir/ritonavir monotherapy was associated with a small but statistically significant increase in bone mineral density, but stable levels of limb fat and visceral adipose tissue.
Published: 2014
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36. Life expectancy in the immune recovery era: the evolving scenario of the HIV epidemic in northern Italy.

Author: Guaraldi G, Cossarizza A, Franceschi C, Roverato A, Vaccher E, Tambussi G, Garlassi E, Menozzi M, Mussini C, and Dʼarminio Monforte A
Subjects: Adult, Female, HIV Infections drug therapy, HIV Infections epidemiology, Humans, Italy epidemiology, Male, Middle Aged, Retrospective Studies, Young Adult, Anti-Retroviral Agents therapeutic use, Epidemics, HIV Infections immunology, HIV Infections mortality, Life Expectancy
Abstract: Introduction: National cohort and intercohort studies have been set to describe the differences of life expectancy (LE) of HIV-infected individuals., Objective: The aim of this study was to assess the impact of immune recovery (IR) on LE of patients with HIV undergoing combination antiretroviral therapy., Methods: In this retrospective observational study, outcome measure was LE of patients with HIV compared with LE of northern Italian population. Group categorizations were as follows: patients with no immune recovery (nIR), patients with IR, patients who are immune maintained, and pre-highly active antiretroviral therapy (HAART) and post-HAART. Abridged life tables were constructed from age-specific mortality rates (per 1000 person years) to estimate LE from the age of 20-55 years., Results: A total of 9671 patients, 71% men, were included. After 2005, we assisted to a rapid increase in the overall rate of patients attaining IR in the community coupled with a progressive decrease of AIDS death, but not of non-AIDS deaths. In a 40-year-old patient, LE was 38.10 years [standard error (SE) = 2.60], 30.08 years (SE = 0.98), and 22.9 (SE = 0.69) in the IR, post-HAART group and nIR, respectively, compared with 41.38 years of the general Italian population. An approximately 5-year gap in LE was observed in IR patients., Discussion: We describe IR at a "community" level, related to calendar year and apparent 10 years after HAART introduction. HAART community IR is significantly influencing LE and is associated with the changing clinical picture of HIV disease. An increasing gradient of LE exists between nIR, post-HAART, and IR groups, with the latter, above the age of 40 years only, reaching LE of general population.
Published: 2014
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37. Metabolic alterations in HIV-infected pregnant women: moving to metabolic tailoring of antiretroviral drugs.

Author: Guaraldi G, Stentarelli C, Da Silva AD, Luzi K, Neri I, Cellini M, Petrella E, Garlassi E, Menozzi M, Facchinetti F, and Mussini C
Subjects: Female, Humans, Infant, Newborn, Pregnancy, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV Infections metabolism
Abstract: The most striking effect of increased survival and improved quality of life in HIV-infected women undergoing antiretroviral therapy is the feasibility of motherhood-desire satisfaction. However, such advantages are often associated with drug-related metabolic toxicities, particularly relevant in the pregnancy context. Recent guidelines provide recommendations and trends for the use of antiretroviral therapy in pregnant women, but current literature falls short of providing specific insights on the need for metabolic monitoring and treatment in HIV-infected pregnant women. In this review we provide specific insight into the state-of-the-art of: detection, evaluation, and management of metabolic alterations in this special population. Pregnancy is in fact a metabolic transition process, potentially associated with specific diseases in the mother, in the newborn, and in the adulthood of the child. We will not simply discuss antiretroviral therapy metabolic toxicities, but rather their interaction with the physiological metabolic changes occurring during pregnancy. Close monitoring is needed to diagnose metabolic alterations that can lead to adverse outcomes in the mother, in the newborn, and potentially in adulthood. Lifestyle interventions and an appropriate metabolic tailoring of antiretroviral therapy drugs need to be considered in the prevention and treatment of metabolic alteration during pregnancy.
Published: 2014

38. CD8 T-cell activation is associated with lipodystrophy and visceral fat accumulation in antiretroviral therapy-treated virologically suppressed HIV-infected patients.

Author: Guaraldi G, Luzi K, Bellistrì GM, Zona S, Domingues da Silva AR, Bai F, Garlassi E, Marchetti G, Capeau J, and Monforte Ad
Subjects: Adipose Tissue, Adult, Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Phosphorylation, STAT5 Transcription Factor genetics, STAT5 Transcription Factor metabolism, Viral Load, Viremia, Anti-HIV Agents therapeutic use, CD8-Positive T-Lymphocytes physiology, HIV Infections drug therapy, HIV-Associated Lipodystrophy Syndrome metabolism, Lymphocyte Activation physiology
Abstract: Objective: HIV-infected patients receiving antiretroviral treatment frequently accumulate fat at the abdominal level. It is unknown whether T-cell activation and immune phenotypes are associated with fat accumulation. Thus, the aim of the study was to search for an association between the presence of clinical lipodystrophy (LD), visceral and subcutaneous abdominal adipose tissue amount (VAT and SAT), and peripheral T-cell immune phenotypes., Design: Cross-sectional study including 87 HIV-infected antiretroviral therapy-treated virologically suppressed and immune-reconstituted patients., Methods: The patients were evaluated for clinical LD, VAT, SAT, homeostasis model of insulin resistance, and coronary artery calcium score (>10). T-cell activation (CD8/CD38), differentiation (CD4/CD8/CCR7/CD45RA), and expression/activation of the interleukin-7 (IL-7)/IL-7R system (CD4/CD8/CD127, IL-7, and CD4/CD8/pStat-5) were assessed by cytometry., Results: In multivariable analyses, CD8 T-cell activation (CD38) was associated with lipoatrophy and central fat accumulation (respectively, β = 5.63, P = 0.005, and β = 4.19, P = 0.020). This was also the case for IL-7R expressing CD8⁺ T cells (CD127⁺) for lipoatrophy β = 12.8, P = 0.003, and for central fat accumulation β = 9.45, P = 0.016. CD8⁺ T-cell activation was also associated with VAT/total adipose tissue (β = 0.01, P = 0.002) and SAT/VAT ratios (β = -0.014, P = 0.015). As expected, VAT/total adipose tissue was an independent risk factor for homeostasis model of insulin resistance (r = 0.364, P = 0.028) and cardiovascular risk (coronary artery calcium, r = 0.406, P = 0.002)., Conclusions: CD8⁺ T-cell activation was associated with LD and the relative amount of VAT in antiretroviral therapy-controlled, virologically suppressed, HIV-infected patients. We propose that CD8 activation may be involved in the accumulation of central fat frequently observed in these patients, with resulting increased cardiometabolic risk.
Published: 2013
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39. Combined use of waist and hip circumference to identify abdominally obese HIV-infected patients at increased health risk.

Author: O'Neill T, Guaraldi G, Orlando G, Carli F, Garlassi E, Zona S, Després JP, and Ross R
Subjects: Adult, Body Mass Index, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 epidemiology, Female, HIV Infections complications, HIV Infections epidemiology, Hip pathology, Humans, Hypertension complications, Hypertension diagnosis, Hypertension epidemiology, Insulin Resistance, Intra-Abdominal Fat pathology, Male, Middle Aged, Multivariate Analysis, Obesity, Abdominal complications, Obesity, Abdominal epidemiology, Risk Factors, HIV Infections pathology, Obesity, Abdominal diagnosis, Waist Circumference
Abstract: Objectives: To determine whether for a given waist circumference (WC), a larger hip circumference (HC) was associated with a reduced risk of insulin resistance, type 2 diabetes (T2D), hypertension and cardiovascular disease (CVD) in HIV-infected patients. A second objective was to determine whether, for a given WC, the addition of HC improved upon estimates of abdominal adiposity, in particular visceral adipose tissue (VAT), compared to those obtained by WC alone., Methods: HIV-infected men (N = 1481) and women (N = 841) were recruited between 2005 and 2009. WC and HC were obtained using standard techniques and abdominal adiposity was measured using computed tomography., Results: After control for WC and covariates, HC was negatively associated with risk of insulin resistance (p<0.05) and T2D [Men: OR = 0.91 (95% CI: 0.86-0.96); Women: OR = 0.91 (95% CI: 0.84-0.98)]. For a given WC, HC was also negatively associated with a lower risk of hypertension (p<0.05) and CVD [OR = 0.94 (95% CI: 0.88-0.99)] in men, but not women. Although HC was negatively associated with VAT in men and women after control for WC (p<0.05), the addition of HC did not substantially improve upon the prediction of VAT compared to WC alone., Conclusions: The identification of HIV-infected individuals at increased health risk by WC alone is substantially improved by the addition of HC. Estimates of visceral adipose tissue by WC are not substantially improved by the addition of HC and thus variation in visceral adiposity may not be the conduit by which HC identifies increased health risk.
Published: 2013
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40. Sorafenib for the treatment of unresectable hepatocellular carcinoma in HIV-positive patients.

Author: Berretta M, Di Benedetto F, Dal Maso L, Cacopardo B, Nasti G, Facchini G, Bearz A, Spina M, Garlassi E, De Re V, Fiorica F, Lleshi A, and Tirelli U
Subjects: Adult, Aged, Antineoplastic Agents adverse effects, Antiretroviral Therapy, Highly Active methods, Disease Progression, Female, HIV Infections drug therapy, Humans, Male, Middle Aged, Niacinamide adverse effects, Niacinamide therapeutic use, Phenylurea Compounds adverse effects, Retrospective Studies, Sorafenib, Treatment Outcome, Antineoplastic Agents therapeutic use, Carcinoma, Hepatocellular drug therapy, Carcinoma, Hepatocellular virology, HIV Infections complications, Liver Neoplasms drug therapy, Liver Neoplasms virology, Niacinamide analogs & derivatives, Phenylurea Compounds therapeutic use
Abstract: Few data are available on the safety and efficacy of sorafenib in HIV-infected patients with unresectable hepatocellular carcinoma (HIV-u-HCC) and concomitant highly active antiretroviral therapy (HAART). Between July 2007 and October 2010, 27 consecutive HIV-u-HCC patients were treated with sorafenib and concomitant HAART within the Gruppo Italiano Cooperativo AIDS e Tumori (GICAT). Three patients achieved a partial response, 12 achieved a stable disease, and 12 showed progression. The median time to progression and overall survival was 5.1 (range 0.5-13.3) and 12.8 (range 1.1-23.5) months, respectively. Grades 3-4 toxicities included diarrhea (four patients, 14.8%), hypertension (three patients, 11%), and hand-and-foot skin reaction (four patients, 14.9%). Most drug-related side effects were low grade and manageable. This retrospective study shows favorable survival data among HIV-u-HCC patients treated with sorafenib together with a reasonable safety profile.
Published: 2013
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41. Nonmelanoma skin cancers among HIV-infected persons in the HAART era.

Author: Garlassi E, Harding V, Weir J, Francis N, Nelson M, Newsom-Davis T, and Bower M
Subjects: Adult, Aged, Female, Humans, Male, Middle Aged, Retrospective Studies, Antiretroviral Therapy, Highly Active, Carcinoma, Basal Cell epidemiology, Carcinoma, Squamous Cell epidemiology, HIV Infections complications, HIV Infections drug therapy, Skin Neoplasms epidemiology
Published: 2012
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42. Morphological and metabolic components of lipodystrophy in various nevirapine-based highly active antiretroviral therapy (HAART) regimens: a cross-sectional, observational study.

Author: Guaraldi G, Zona S, Orlando G, Carli F, Stentarelli C, Luzi K, Garlassi E, Menozzi M, Bagni P, and Adorni F
Subjects: Adult, Aged, Anti-HIV Agents adverse effects, Anti-HIV Agents pharmacology, Antiretroviral Therapy, Highly Active adverse effects, Body Composition drug effects, Body Fat Distribution, Cross-Sectional Studies, Drug Combinations, Dyslipidemias complications, Dyslipidemias drug therapy, Dyslipidemias metabolism, Dyslipidemias pathology, Female, HIV Infections epidemiology, HIV Infections metabolism, HIV-1 drug effects, Humans, Insulin Resistance physiology, Italy, Lipodystrophy epidemiology, Lipodystrophy metabolism, Lipodystrophy pathology, Male, Middle Aged, Nevirapine adverse effects, Nevirapine pharmacology, Outpatients, Protease Inhibitors adverse effects, Protease Inhibitors pharmacology, Protease Inhibitors therapeutic use, Reverse Transcriptase Inhibitors adverse effects, Reverse Transcriptase Inhibitors pharmacology, Reverse Transcriptase Inhibitors therapeutic use, Universities, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, Lipodystrophy drug therapy, Nevirapine therapeutic use
Abstract: Background: Morphological abnormalities (lipoatrophy and central fat accumulation) and metabolic changes (dyslipidaemia and glucose regulation impairment) have emerged as components of lipodystrophy and as major tolerability issues with long-term use of highly active antiretroviral therapy (HAART) in HIV-positive patients. Protease inhibitors (PIs) are recognized as having the greatest impact in terms of metabolic complications, followed by nucleoside reverse transcriptase inhibitors, while the non-nucleoside reverse transcriptase inhibitors (NNRTIs) have the least impact. In particular, regimens based on the NNRTI nevirapine have been shown to achieve significant metabolic benefits and may help to improve dyslipidaemia. Improvements in body shape changes associated with lipodystrophy have also been reported when nevirapine replaced a PI in long-term triple therapy., Objective: The objective of this cross-sectional observational ('real-world') study was to investigate the effect of three HAART regimens plus stable nevirapine therapy on morphological and metabolic components of lipodystrophy in HIV-infected patients., Methods: Consecutive patients (aged >18 years) with serologically documented HIV infection, who had received HAART for at least 2 years and who had been diagnosed with lipodystrophy, were followed up as outpatients at the metabolic clinic of the University of Modena and Reggio Emilia, Modena, Italy. Patients received stable nevirapine therapy plus fixed-dose combinations of tenofovir disoproxil fumarate plus emtricitabine (Truvada(®); TVD), zidovudine plus lamivudine (3TC) [Combivir(®); CBV], or abacavir plus lamivudine (Kivexa(®); KVX). Multivariate regression analyses were performed to analyse predictors of four components of lipodystrophy: lipoatrophy using leg fat mass measured by dual-emission x-ray absorptiometry (DXA), fat accumulation using waist circumference, dyslipidaemia using apolipoprotein (Apo)B/ApoA1 ratio, and glucose intolerance using the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)., Results: Overall, 101 patients were enrolled (TVD group = 61, CBV group = 20, KVX group = 20); 191 observations were analysed. Male sex was associated with reduced leg fat mass, while age and body mass index (BMI) were associated with increased leg fat mass (all p < 0.05). Leg fat mass and male sex were associated with increased waist circumference (p < 0.001 for both). Leg fat mass predicted reduced ApoB/ApoA1 ratio, while age and BMI predicted increased ApoB/ApoA1 ratio (all p < 0.05). BMI predicted HOMA-IR increase (p = 0.0017). No differences in lipoatrophy, central fat accumulation, dyslipidaemia or glucose metabolism were observed among any of the three different nevirapine plus nucleoside backbone groups (TVD, CBV or KVX)., Conclusion: HAART including nevirapine has a limited impact on components of lipodystrophy in patients with HIV infection. Further studies are needed to verify if nevirapine overcomes the expected distinct lipodystrophy risk profile associated with different nucleoside backbone therapies.
Published: 2011
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43. Hepatocellular carcinoma in HIV-infected patients: check early, treat hard.

Author: Berretta M, Garlassi E, Cacopardo B, Cappellani A, Guaraldi G, Cocchi S, De Paoli P, Lleshi A, Izzi I, Torresin A, Di Gangi P, Pietrangelo A, Ferrari M, Bearz A, Berretta S, Nasti G, Di Benedetto F, Balestreri L, Tirelli U, and Ventura P
Subjects: Adult, Aged, Aged, 80 and over, Carcinoma, Hepatocellular pathology, Carcinoma, Hepatocellular therapy, Female, HIV Infections pathology, Humans, Liver Neoplasms pathology, Liver Neoplasms therapy, Male, Middle Aged, Prognosis, Retrospective Studies, Treatment Outcome, Carcinoma, Hepatocellular virology, HIV, HIV Infections complications, Liver Neoplasms virology
Abstract: Purpose: Hepatocellular carcinoma (HCC) is an increasing cause of mortality in HIV-infected patients in the highly active antiretroviral therapy (HAART) era. The aims of this study were to describe HCC tumor characteristics and different therapeutic approaches, to evaluate patient survival time from HCC diagnosis, and to identify clinical prognostic predictors in patients with and without HIV infection., Patients and Methods: A multicenter observational retrospective comparison of 104 HIV-infected patients and 484 uninfected patients was performed in four Italian centers. HCC was staged according to the Barcelona Clinic Liver Cancer (BCLC) criteria., Results: Tumor characteristics of patients with and without HIV were significantly different for age, Eastern Cooperative Oncology Group performance status (PS) score ≤1, and etiology of chronic liver disease. Despite the similar potentially curative option rate and better BCLC stage at diagnosis, the median survival time was significantly shorter in HIV(+) patients. HIV(+) patients were less frequently retreated at relapse. Independent predictors of survival were: BCLC stage, potentially effective HCC therapy, tumor dimension ≤3 cm, HCC diagnosis under a screening program, HCC recurrence, and portal vein thrombosis. Restricting the analysis to HIV(+) patients only, all positive prognostic factors were confirmed together with HAART exposure., Conclusion: This study confirms a significantly shorter survival time in HIV(+) HCC patients. The less aggressive retreatment at recurrence approach does not balance the benefit of younger age and better BCLC stage and PS score of HIV(+) patients. Thus, considering the prognosis of HIV(+) HCC patients, effective screening techniques, programs, and specific management guidelines are urgently needed.
Published: 2011
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44. Oxaliplatin based chemotherapy and concomitant highly active antiretroviral therapy in the treatment of 24 patients with colorectal cancer and HIV infection.

Author: Berretta M, Lleshi A, Cappellani A, Bearz A, Spina M, Talamini R, Cacopardo B, Nunnari G, Montesarchio V, Izzi I, Lanzafame M, Nasti G, Basile F, Berretta S, Fisichella R, Schiantarelli C C, Garlassi E, Ridolfo A, Guella L, and Tirelli U
Subjects: Adult, Anti-HIV Agents adverse effects, Antineoplastic Agents adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antiretroviral Therapy, Highly Active adverse effects, Antiretroviral Therapy, Highly Active methods, Colorectal Neoplasms secondary, Drug Therapy methods, Drug-Related Side Effects and Adverse Reactions, Female, Fluorouracil adverse effects, Fluorouracil therapeutic use, Humans, Italy, Leucovorin adverse effects, Leucovorin therapeutic use, Male, Middle Aged, Organoplatinum Compounds adverse effects, Organoplatinum Compounds therapeutic use, Treatment Outcome, Anti-HIV Agents therapeutic use, Antineoplastic Agents therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Colorectal Neoplasms complications, Colorectal Neoplasms drug therapy, HIV Infections complications, HIV Infections drug therapy
Abstract: Background: Although FOLFOX4 is considered the standard chemotherapy regimen for colorectal cancer (CRC), few data are available on its results in human immunodeficiency (HIV)-related CRC. The results were analyzed to evaluate feasibility and activity of FOLFOX4 plus highly active antiretroviral therapy (HAART) in metastatic CRC (mCRC) HIV-seropositive patients., Patients and Methods: From January 2002 to March 2007, 24 patients were selected among the CRC HIV-seropositive patients treated with FOLFOX4 and concomitant HAART within the Italian Cooperative Group on AIDS and Tumors (GICAT)., Results: Four median cycles of chemotherapy were administered; the most common severe toxicity was neutropenia (37.5%). An overall response rate of 50% was observed; 4.2% of patients achieved complete response and 45.8% partial response. No opportunistic infections occurred during or immediately after chemotherapy. The median CD4+ count was 380 (range 220-570) at diagnosis., Conclusions: To our knowledge, this is the largest study describing activity and tolerability of FOLFOX4 and HAART, in this setting. FOLFOX4 plus concomitant HAART resulted feasible and active also in HIV-seropositive patients. Moreover, the concomitant use of HAART did not to seem to increase the FOLFOX4 toxicity. This study suggests the good tolerability of the FOLFOX4, making it a reasonable option for combination with HAART.
Published: 2010
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45. Lipodystrophy and quality of life of HIV-infected persons.

Author: Guaraldi G, Murri R, Orlando G, Squillace N, Stentarelli C, Zona S, Garlassi E, and Martínez E
Subjects: Anti-HIV Agents therapeutic use, Body Fat Distribution, Body Image, HIV Infections psychology, HIV-Associated Lipodystrophy Syndrome etiology, HIV-Associated Lipodystrophy Syndrome therapy, Humans, HIV Infections complications, HIV-Associated Lipodystrophy Syndrome psychology, Quality of Life
Abstract: Morphological changes induced by HIV-related lipodystrophy profoundly affect body image and influence health-related quality of life. Measurements of health-related quality of life in patients with lipodystrophy are complex due to a lack of consensus on the definition of lipodystrophy, a lack of appropriate methods to capture the impact of body fat changes, and the subjective perception of those changes by patients. This review describes the different tools that have been used to assess quality of life in patients with lipodystrophy, and critically analyzes published papers on health-related quality of life. With regard to facial lipoatrophy, the most stigmatizing condition of lipodystrophy, we have analyzed the impact of reconstructive plastic surgery on patient-related outcomes and health-related quality of life. A better knowledge of the associations between lipodystrophy and health-related quality of life will allow us to understand the burden of long-term toxicities of antiretroviral therapies as well as to identify novel patient-related endpoints useful in assessing the efficacy of lipodystrophy treating programs.
Published: 2008

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