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3. 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

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, 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. 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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, 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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. Corrigendum to “Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV” [J Hepatol 68 (2018) 33–41](S0168827817322596)(10.1016/j.jhep.2017.08.019)

Author

Karampatou A., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou A., Han X., Kondili L. A., Taliani G., Ciancio A., Morisco F., Critelli R. M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A. S., Bruno S., Bao Y., Gonzalez Y. S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M. C., Bigliotti E., Tamburrini F., Montalto G., Capitano A. R., Ieluzzi D., Fattovich G., Zignego A. L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F. P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D. C., Andreone P., Simonetti G., Gaeta G. B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L. E., Quaranta M. G., Falzano L., Mallano A., Karampatou A., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou A., Han X., Kondili L. A., Taliani G., Ciancio A., Morisco F., Critelli R. M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A. S., Bruno S., Bao Y., Gonzalez Y. S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M. C., Bigliotti E., Tamburrini F., Montalto G., Capitano A. R., Ieluzzi D., Fattovich G., Zignego A. L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F. P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D. C., Andreone P., Simonetti G., Gaeta G. B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L. E., Quaranta M. G., Falzano L., and Mallano A.

Abstract

It has come to our attention that the PITER framework investigator, Alessandro Federico, was incorrectly listed as F. Alessandro in the original manuscript. Please note that the correct name of this author is Alessandro Federico (2nd University of Naples). The correct list of PITER investigators is in the footnote below.

Published
2018

7. Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV

Author

Karampatou, Aimilia, Han, Xue, Kondili, Loreta A., Taliani, Gloria, Ciancio, Alessia, Morisco, Filomena, Critelli, Rosina Maria, Baraldi, Enrica, Bernabucci, Veronica, Troshina, Giulia, Guarino, Maria, Tagliavini, Simonetta, D'Ambrosio, Federica, Bristot, Laura, Turco, Laura, Rosato, Stefano, Vella, Stefano, Trenti, Tommaso, Neri, Isabella, La Marca, Antonio, Manthena, Shivaji, Goldstein, Andrea S., Bruno, Savino, Bao, Yanjun, Gonzalez, Yuri Sanchez, Villa, Erica, Craxì, A., Petta, S., Calvaruso, V., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Federico, A., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Karampatou, A., Han, X., Kondili, L., Taliani, G., Ciancio, A., Morisco, F., Critelli, R., Baraldi, E., Bernabucci, V., Troshina, G., Guarino, M., Tagliavini, S., D'Ambrosio, F., Bristot, L., Turco, L., Rosato, S., Vella, S., Trenti, T., Neri, I., La Marca, A., Manthena, S., Goldstein, A., Bruno, S., Bao, Y., Gonzalez, Y., Villa, E., Craxi, A., Petta, S., Calvaruso, V., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou, Aimilia, Han, Xue, Kondili, Loreta A., Taliani, Gloria, Ciancio, Alessia, Morisco, Filomena, Critelli, Rosina Maria, Baraldi, Enrica, Bernabucci, Veronica, Troshina, Giulia, Guarino, Maria, Tagliavini, Simonetta, D'Ambrosio, Federica, Bristot, Laura, Turco, Laura, Rosato, Stefano, Vella, Stefano, Trenti, Tommaso, Neri, Isabella, La Marca, Antonio, Manthena, Shivaji, Goldstein, Andrea S., Bruno, Savino, Bao, Yanjun, Gonzalez, Yuri Sanchez, Villa, Erica, Craxì, A., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Pasetto, M.C., Capitano, A.R., Zignego, A.L., Russo, F.P., Amoruso, D.C., Gaeta, G.B., Weimer, L.E., Quaranta, M.G., Craxã¬, A., and Federico, A.

Subjects
Anti-Mullerian hormone, Antiviral therapy, HBV, HCV, Sustained viral response, Hepatology, Infertility, medicine.medical_specialty, media_common.quotation_subject, Fertility, Anti-Müllerian hormone, Miscarriage, 03 medical and health sciences, 0302 clinical medicine, Medicine, Prospective cohort study, media_common, Gynecology, Anti-Müllerian hormone, Antiviral therapy, HBV, HCV, Sustained viral response, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics, medicine.disease, Anti-Müllerian hormone, Gestational diabetes, Cohort, 030211 gastroenterology & hepatology, business, Live birth, Cell aging
Abstract

Background & Aims Premenopausal women who are HCV positive (HCV+) have failing ovarian function, which is likely to impact their fertility. Thus, we investigated the reproductive history, risk of infertility, and pregnancy outcomes in women of childbearing age who were HCV+. Methods Three different groups were studied: (1) Clinical cohort: 100 women who were HCV+ and also had chronic liver disease (CLD), age matched with 50 women who were HBV+ with CLD and with 100 healthy women; all women were consecutively observed in three gastroenterology units in hospitals in Italy; (2) 1,998 women who were HCV+ and enrolled in the Italian Platform for the Study of Viral Hepatitis Therapies (PITER); (3) 6,085 women, who were mono-infected with HCV, and 20,415 women, who were HCV−, from a large de-identified insurance database from the USA. Measurements: total fertility rate (TFR) defined as the average number of children that a woman would bear during her lifetime. To define the reproductive stage of each participant, levels of anti-Müllerian hormone (AMH) and 17β-estradiol were measured. Results Clinical cohort: women who were either HCV+ or HBV+ had similar CLD severity and age at first pregnancy. Based on a multivariate analysis, women who were HCV+ had a higher risk of miscarriage than those who were HBV+ (odds ratio [OR] 6,905; 95% CI 1.771–26.926). Among women who were HCV+, incidence of miscarriage was correlated with median AMH level (1.0 ng/ml). Achieving a sustained virologic response (SVR) after antiviral treatment reduced the risk of miscarriage (OR 0.255; 95% CI 0.090–0.723). In the PITER-HCV cohort, miscarriage occurred in 42.0% of women (44.6% had multiple miscarriages). TFR for women who were HCV+ and between 15 and 49 years of age was 0.7 vs. 1.37 of Italian population of the same age range. In the US cohort: compared with women who were HCV−, women who were HCV+ positive were significantly more likely to have infertility (OR 2.439; 95% CI 2.130–2.794), premature birth (OR 1.34; 95% CI 1.060–1.690), gestational diabetes (OR 1.24; 95% CI 1.020–1.510), and pre-eclampsia (OR 1.206; 95% CI 0.935–1.556), and were less likely to have a live birth (OR 0.754; 95% CI 0.622–0.913). Conclusions Ovarian senescence in women of childbearing age who are HCV+ is associated with a lower chance of live birth, greater risk of infertility, gestational diabetes, pre-eclampsia and miscarriage. Such risks could be positively influenced by successful HCV cure. Lay summary Most new cases of HCV infection are among people who inject drugs, many of whom are young women in their childbearing years. Women of reproductive age who are HCV+ display markers of ovarian senescence. This is associated with an increased burden in terms of infertility and adverse pregnancy outcomes, including stillbirth, miscarriage, fewer live births, and gestational diabetes. Early viral suppression with therapy is likely to mitigate these risks.

Published
2017

9. Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study

Author

Kondili, L, Gaeta, G, Ieluzzi, D, Zignego, A, Monti, M, Gori, A, Soria, A, Raimondo, G, Filomia, R, Leo, A, Iannone, A, Massari, M, Corsini, R, Gulminetti, R, Comini, A, Toniutto, P, Dissegna, D, Russo, F, Zanetto, A, Rumi, M, Brancaccio, G, Danieli, E, Brunetto, M, Weimer, L, Quaranta, M, Vella, S, Puoti, M, Kondili L. A., Gaeta G. B., Ieluzzi D., Zignego A. L., Monti M., Gori A., Soria A., Raimondo G., Filomia R., Leo A. D., Iannone A., Massari M., Corsini R., Gulminetti R., Comini A. G., Toniutto P., Dissegna D., Russo F. P., Zanetto A., Rumi M. G., Brancaccio G., Danieli E., Brunetto M. R., Weimer L. E., Quaranta M. G., Vella S., Puoti M., Kondili, L, Gaeta, G, Ieluzzi, D, Zignego, A, Monti, M, Gori, A, Soria, A, Raimondo, G, Filomia, R, Leo, A, Iannone, A, Massari, M, Corsini, R, Gulminetti, R, Comini, A, Toniutto, P, Dissegna, D, Russo, F, Zanetto, A, Rumi, M, Brancaccio, G, Danieli, E, Brunetto, M, Weimer, L, Quaranta, M, Vella, S, Puoti, M, Kondili L. A., Gaeta G. B., Ieluzzi D., Zignego A. L., Monti M., Gori A., Soria A., Raimondo G., Filomia R., Leo A. D., Iannone A., Massari M., Corsini R., Gulminetti R., Comini A. G., Toniutto P., Dissegna D., Russo F. P., Zanetto A., Rumi M. G., Brancaccio G., Danieli E., Brunetto M. R., Weimer L. E., Quaranta M. G., Vella S., and Puoti M.

Abstract

Background There are few real-life data on the potential drug-drug interactions (DDIs) between anti-HCV direct-acting antivirals (DAAs) and the comedications used. Aim To assess the potential DDIs of DAAs in HCV-infected outpatients, according to the severity of liver disease and comedication used in a prospective multicentric study. Methods Data from patients in 15 clinical centers who had started a DAA regimen and were receiving comedications during March 2015 to March 2016 were prospectively evaluated. The DDIs for each regimen and comedication were assigned according to HepC Drug Interactions (www.hep-druginteractions.org). Results Of the 449 patients evaluated, 86 had mild liver disease and 363 had moderate-to-severe disease. The use of a single comedication was more frequent among patients with mild liver disease (p = 0.03), whereas utilization of more than three drugs among those with moderate-to-severe disease (p = 0.05). Of the 142 comedications used in 86 patients with mild disease, 27 (20%) may require dose adjustment/closer monitoring, none was contraindicated. Of the 322 comedications used in 363 patients with moderate-to-severe liver disease, 82 (25%) were classified with potential DDIs that required only monitoring and dose adjustments; 10 (3%) were contraindicated in severe liver disease. In patients with mild liver disease 30% (26/86) used at least one drug with a potential DDI whereas of the 363 patients with moderate-to-severe liver disease, 161 (44%) were at risk for one or more DDI. Conclusions Based on these results, we can estimate that 30-44% of patients undergoing DAA and taking comedications are at risk of a clinically significant DDI. This data indicates the need for increased awareness of potential DDI during DAA therapy, especially in patients with moderate-to-severe liver disease. For several drugs, the recommendation related to the DDI changes from "dose adjustment/closer monitoring" in mild to moderate liver disease, to "the use is co

Published
2017

11. Corrigendum to 'Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV' [J Hepatol 68 (2018) 33–41](S0168827817322596)(10.1016/j.jhep.2017.08.019)

Author

Karampatou, A., Han, X., Kondili, L. A., Taliani, G., Ciancio, A., Morisco, F., Critelli, R. M., Baraldi, E., Bernabucci, V., Troshina, G., Guarino, M., Tagliavini, S., D'Ambrosio, F., Bristot, L., Turco, L., Rosato, S., Vella, S., Trenti, T., Neri, I., La Marca, A., Manthena, S., Goldstein, A. S., Bruno, S., Bao, Y., Gonzalez, Y. S., Villa, E., Craxi, A., Petta, S., Calvaruso, V., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Karampatou A., Han X., Kondili L.A., Taliani G., Ciancio A., Morisco F., Critelli R.M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A.S., Bruno S., Bao Y., Gonzalez Y.S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M.C., Bigliotti E., Tamburrini F., Montalto G., Capitano A.R., Ieluzzi D., Fattovich G., Zignego A.L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F.P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D.C., Andreone P., Simonetti G., Gaeta G.B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L.E., Quaranta M.G., Falzano L., and Mallano A.

Subjects
Hepatology, Hepatitis B, EASL guidelines, Treatment, Interferon, Entecavir, Tenofovir, TAF, HBsAg, Hepatocellular carcinoma, HBV DNA, HBV reactivation, Mother to child transmission, EASL guideline
Abstract

It has come to our attention that the PITER framework investigator, Alessandro Federico, was incorrectly listed as F. Alessandro in the original manuscript. Please note that the correct name of this author is Alessandro Federico (2nd University of Naples). The correct list of PITER investigators is in the footnote below.

Published
2018

12. L'Italia come modello per l'Europa e per il mondo nelle politiche sanitarie per il trattamento dell'epatite cronica da HCV

Author

Kondili, L. A., Vella, S., Quaranta, M. G., Rosato, S., Tosti, M. E., Weimer, L. E., Ferrigno, L., D'Angelo, F., Falzano, L., Mattei, A., Olivieri, E., Terlizzi, R., Benedetti, A., Faraci, M. G., Giacometti, A., Brescini, L., Castelli, P., Castelletti, S., Drenaggi (Ancona), D., C. Mazzaro (Aviano, P N), Angarano, G., Milella, M., Di Leo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza (Bari), F., M. Rizzi, G. Cologni (Bergamo), Bolondi, L., Benevento, F., Gianstefani, A., Serio, I., Vaccà, A., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati (Bologna), V., P. Mian, G. Rimenti (Bolzano), Rossini, A., Contessi, G. B., Castelli, F., Zaltron, S., Spinetti, A., Odolini (Brescia), S., Leandr o, G., Cozzolongo, R., Zappimbulso (Castellana Grotte, M., BA), Russello, M., Benigno, R., Coco (Catania), C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, L., Quintieri, F., De Siena, M., Giancotti (Catanzaro), F., Vecchiet, J., Pizzigallo, E., Falasca (Chieti), K., Mastroianni, A., Apuzzo, G., Luciani (Cosenza), F., F. G. Foschi, A. C. Dall’Aglio (Faenza), Libanore, M., Segala, D., Sighinolfi (Ferrara), L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., Del Pin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, L., Monti, M., Madia, F., Xheka (Firenze), A., Cela, E. M., Santantonio, T. A., Bruno, S., Giammario (Foggia), A., Viscoli, C., Alessandrini, A. I., Curti, C., Di Biagio, A., Nicolini, L. A., Balletto (Genova), E., C. Mastroian ni, K. Blerta (Latina), Prati, D., Raffaele, L., Andreoletti (Lecco), M., Perboni, G., Costa, P., Manzini (Mantova), L., G. Raimondo, R. Filomia (Messina), Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Rumi, M. R., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D'Arminio Monfort e, A., Debona, A., Solaro, S., Fargion, S., Borroni, V., Valenti, L., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, M., D’Ambrosio, R., Degasperi, E., Vinci (Milano), M., Villa, E., Bernabucci, V., Bristot, L., Pereira (Modena), F., Chessa, L., Pasetto, M. C., Loi (Monserrato, M., CA), Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma (Monza), M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abresci a, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Coppola, N., Martini, S., Federico, A., Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Rizzo, V., Nardone, G., Sgamato (Napoli), C., G. D'Adamo (Nocera Inferiore, SA), Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Angeli, P., Cavalletto, L., Pontisso, P., Gatta, A., Erne, E. M., Castelli, E., Flo reani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet (Padova), E., Madonia, S., Cannizzaro, M., Montalto, G., Licata, A., Capita no, A. R., Craxì, A., Petta, S., Calvaruso (Palermo), V., Ferrari, C., Negri, E., Orlandini, A., Pesci (Parma), M., Bruno, R., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi (Pavia), S., F. Baldelli, F. Di Candilo (Perugia), Parruti, G., Di Stefano, P., Sozio (Pescara), F., Bru netto, M. R., Colombatto, P., Coco, B., Surace (Pisa), L., G. Foti, S. Pellicano (Reggio Calabria), Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Cor sini, R., Garlassi (Reggio Emilia), E., Ballardini (Rimini), G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, A., Siciliano, M., Nosotti, L., Taliani, G., Bi liotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D’Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, R., Cingolani, A., Lam onica, 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 (Roma), C., Aghemo, A., Gatti C omini (Rozzano, A., MI), M. Persico, M. Masarone (Salerno), Anselmo, M., De Leo, P., Marturano (Savona), M., Brunelli, E., Ridolfi, F., Schimizzi (Senigallia, A. M., AN), Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio (Torino), A., P. Toniutto, G. Alterini (U dine), and F. Capra, D. Ieluzzi (Verona).

Subjects
Hepatitis C, antiviral therapy, cost-effectiveness, NO
Published
2018

14. Nusinersen versus sham control in infantile-onset spinal muscular atrophy

Author

Finkel, RS, Mercuri, E, Darras, BT, Connolly, AM, Kuntz, NL, Kirschner, J, Chiriboga, CA, Saito, K, Servais, L, Tizzano, E, Topaloglu, H, Tulinius, M, Montes, J, Glanzman, AM, Bishop, K, Zhong, ZJ, Gheuens, S, Bennett, CF, Schneider, E, Farwell, W, De Vivo, DC, Bradley, WG, Schroth, MK, Bodensteriner, JB, Davis, CS, Shell, R, Hen, J, Austin, ED, Aziz-Zaman, S, Cappell, J, Constantinescu, A, Cruz, R, Dastgir, J, Dunaway, S, Engelstad, K, Gormley, M, Holuba La Marca, N, Khandji, A, Kramer, S, Marra, J, Ortiz-Miller, C, Popolizio, M, Salazar, R, Sanabria, L, Weimer, L, Anand, P, Gadeken, R, Golumbek, PT, Siener, C, Zaidman, CM, Al-Ghamdi, F, Berde, C, Ghosh, P, Graham, R, Harrington, T, Koka, A, Laine, R, Liew, W, Mirek, E, Ordonez, G, Pasternak, A, Quigley, J, Sethna, N, Souris, M, Szelag, H, Wand, L, Day, JW, D'Souza, G, Duong, TT, Gee, R, Kitsuwa-Lowe, J, McFall, D, Patnaik, S, Paulose, S, Perez, J, Proud, C, Purse, B, Ramamurthi, RJ, Sakamuri, S, Sampson, J, Sanjanwala, B, Tesi Rocha, AC, Watson, K, Welsh, L, Pena, LDM, Case, L, Coates, J, DeArmey, S, Homi, MM, Milleson, C, Nelson, N, Ross, A, Smith, E, Taicher, B, Wootton, J, Finanger, E, Benjamin, D, Frank, A, Roberts, C, Russman, B, Finkel, RS, Mercuri, E, Darras, BT, Connolly, AM, Kuntz, NL, Kirschner, J, Chiriboga, CA, Saito, K, Servais, L, Tizzano, E, Topaloglu, H, Tulinius, M, Montes, J, Glanzman, AM, Bishop, K, Zhong, ZJ, Gheuens, S, Bennett, CF, Schneider, E, Farwell, W, De Vivo, DC, Bradley, WG, Schroth, MK, Bodensteriner, JB, Davis, CS, Shell, R, Hen, J, Austin, ED, Aziz-Zaman, S, Cappell, J, Constantinescu, A, Cruz, R, Dastgir, J, Dunaway, S, Engelstad, K, Gormley, M, Holuba La Marca, N, Khandji, A, Kramer, S, Marra, J, Ortiz-Miller, C, Popolizio, M, Salazar, R, Sanabria, L, Weimer, L, Anand, P, Gadeken, R, Golumbek, PT, Siener, C, Zaidman, CM, Al-Ghamdi, F, Berde, C, Ghosh, P, Graham, R, Harrington, T, Koka, A, Laine, R, Liew, W, Mirek, E, Ordonez, G, Pasternak, A, Quigley, J, Sethna, N, Souris, M, Szelag, H, Wand, L, Day, JW, D'Souza, G, Duong, TT, Gee, R, Kitsuwa-Lowe, J, McFall, D, Patnaik, S, Paulose, S, Perez, J, Proud, C, Purse, B, Ramamurthi, RJ, Sakamuri, S, Sampson, J, Sanjanwala, B, Tesi Rocha, AC, Watson, K, Welsh, L, Pena, LDM, Case, L, Coates, J, DeArmey, S, Homi, MM, Milleson, C, Nelson, N, Ross, A, Smith, E, Taicher, B, Wootton, J, Finanger, E, Benjamin, D, Frank, A, Roberts, C, and Russman, B

Abstract

BACKGROUND: Spinal muscular atrophy is an autosomal recessive neuromuscular disorder that is caused by an insufficient level of survival motor neuron (SMN) protein. Nusinersen is an antisense oligonucleotide drug that modifies pre–messenger RNA splicing of the SMN2 gene and thus promotes increased production of full-length SMN protein. METHODS: We conducted a randomized, double-blind, sham-controlled, phase 3 efficacy and safety trial of nusinersen in infants with spinal muscular atrophy. The primary end points were a motor-milestone response (defined according to results on the Hammersmith Infant Neurological Examination) and event-free survival (time to death or the use of permanent assisted ventilation). Secondary end points included overall survival and subgroup analyses of event-free survival according to disease duration at screening. Only the first primary end point was tested in a prespecified interim analysis. To control the overall type I error rate at 0.05, a hierarchical testing strategy was used for the second primary end point and the secondary end points in the final analysis. RESULTS: In the interim analysis, a significantly higher percentage of infants in the nusinersen group than in the control group had a motor-milestone response (21 of 51 infants [41%] vs. 0 of 27 [0%], P<0.001), and this result prompted early termination of the trial. In the final analysis, a significantly higher percentage of infants in the nusinersen group than in the control group had a motor-milestone response (37 of 73 infants [51%] vs. 0 of 37 [0%]), and the likelihood of event-free survival was higher in the nusinersen group than in the control group (hazard ratio for death or the use of permanent assisted ventilation, 0.53; P=0.005). The likelihood of overall survival was higher in the nusinersen group than in the control group (hazard ratio for death, 0.37; P=0.004), and infants with a shorter disease duration at screening were more likely than those with a longer disea

Published
2017

15. HCV-related mixed cryoglobulinemia: Data from PITER, a nationwide Italian HCV cohort study

Author

Weimer, L. E., Vinci, M., Borgia, G., Brunetto, M., Sturace, L., Gaeta, G. B., Chemello, L., Buggio, A., Andreone, P., Raimondo, G., Filomia, R., Persico, M., Puoti, M., Rumi, M. G., Benedetti, A., Fargion, S., Ieluzzi, D., Nardone, G., Foti, G., Ciancio, A., Taliani, G., Biliotti, E., Madonia, S., Stagno, B., Alberti, A., Massari, M., Rosina, F., Mazzella, G., Di Leo, A., Iannone, A., Ferrari, C., Orlandini, A., Gragnani, L., Santantonio, T. A., Chessa, L., Erne, E. M., Coppola, C., Andreoni, M., Baldelli, F., Mondelli, M., Blanc, P., Gasbarrini, A., D’Aversa, F., Verucchi, G., Colombo, M., Borghi, M., Craxì, A., Petta, S., Villa, E., Patti, O., Russo, F. P., Strazzabosco, M., Mallano, A., Fucili, L., Massella, M., Kondili, L., Vella, S., Zignego, A. L., and it/piter), ISS & AISF & SIMIT collaborating - Group in PITER (available in www. iss.

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Mixed cryoglobulinemia, Gastroenterology, medicine, business, Cohort study
Published
2016

16. Response to raltegravir-based salvage therapy in HIV-infected patients with hepatitis C virus or hepatitis B virus coinfection

Author

Weimer, L. E., Fragola, V., Floridia, M., Guaraldi, G., Ladisa, N., Francisci, D., Bellagamba, R., Degli Antoni, A., Parruti, G., Giacometti, A., Manconi, P. E., Vivarelli, A., D'Ettorre, G., Mura, M. S., Cicalini, S., Preziosi, R., Sighinolfi, L., Verucchi, G., Libertone, R., Tavio, M., Sarmati, L., Bucciardini, R., Angarano, G., Volpe, A., Vullo, V., Ceccarelli, G., Andreoni, M., Delle Rose, D., Tozzi, V., Narciso, P., Petrosillo, N., Pucillo, V., Tommasi, C., Segala, D., Armignacco, O., Ferrari, C., Cavalli, A., Sozio, F., Cosentino, L., Ortu, F., Viale, P., Tedeschi, S., Manfredi, R., Mannazzu, M., Cattari, G., Del Gobbo, R., Mataloni Paggi, A., Cirioni, O., Marchionni, E., Silvestri, C., Brescini, L., Sebastianelli, S., Baldelli, F., Mercuri, A., Bastianelli, S., Nardini, G., Massella, M., Baroncelli, S., Galluzzo, C. M., Pirillo, M. F., Mancini, M. G., Amici, R., Cara, A., Bona, R., Leone, P., Filati, P., Franco, M., Donnini, S., Weimer LE, Fragola V, Floridia M, Guaraldi G, Ladisa N, Francisci D, Bellagamba R, Degli Antoni A, Parruti G, Giacometti A, Manconi PE, Vivarelli A, D'Ettorre G, Mura MS, Cicalini S, Preziosi R, Sighinolfi L, Verucchi G, Libertone R, Tavio M, Sarmati L, and Bucciardini R on behalf of the ISS-NIA Study Group

Subjects
Male, HAART, maraviroc, viruses, HIV Infections, darunavir, hiv-1, Hepacivirus, medicine.disease_cause, Cohort Studies, hiv resistance, Pharmacology (medical), cd4 response, Original Research, Aged, 80 and over, Coinfection, virus diseases, Hepatitis C, Middle Aged, Hepatitis B, viral load, Treatment Outcome, integrase inhibitors, Infectious Diseases, hbv, Female, liver disease, Viral hepatitis, Viral load, medicine.drug, Adult, Microbiology (medical), Hepatitis B virus, Hepatitis C virus, HIV infection, HCV infection, HBV infection, antiretroviral therapy, viral hepatitis, etravirine, hcv, NO, Young Adult, Antiretroviral therapy, CD4 response, Darunavir, Etravirine, HBV, HCV, HIV resistance, HIV-1, Integrase inhibitors, Liver disease, Maraviroc, medicine, Humans, Aged, Salvage Therapy, Pharmacology, business.industry, Raltegravir, HIV, medicine.disease, Virology, digestive system diseases, Immunology, business, Follow-Up Studies
Abstract

OBJECTIVES: To define the impact of coinfection with hepatitis B virus (HBV) or hepatitis C virus (HCV) on viroimmunological response to raltegravir-based salvage regimens that also include new HIV inhibitors such as maraviroc, darunavir and etravirine. METHODS: We used data from a national observational study of patients starting raltegravir-based regimens to compare virological suppression and CD4 cell change from baseline in patients with and without concomitant HBV or HCV infection. RESULTS: Overall, 275 patients (107 coinfected and 168 non-coinfected) were evaluated. Coinfected patients were more commonly former intravenous drug users and had a longer history of HIV infection and higher baseline aminotransferase levels. Both HIV-RNA and CD4 response were similar in the two groups. Mean time to first HIV-RNA copy number

Published
2012

17. Limited occurrence of new grade 3-4 toxicity events with salvage regimens based on raltegravir and /or maraviroc: 96 weeks data from the ISS NIA cohort study

Author

Weimer, L. E., Floridia, M., Bucciardini, R., Baroncelli, S., Galluzzo, C. M., Pirillo, M. F., Fragola, V., Donnini, S., Mirra, M., Di Gragorio, M., Lucattini, S., Fucili, L., Angarano, G., Ladisa, N., Volpe, A., Vullo, V., D’Ettorre, G., Ceccarelli, G., Andreoni, M., Sarmati, L., Delle Rose, D., Tozzi, V., Petrosillo, N., Bellagamba, R., Libertone, R., Cicalini, S., Sighinolfi, L., Segala, D., Armignacco, O., Preziosi, R., Ferrari, C., Degli Antoni, A., Cavalli, A., Parruti, G., Sozio, F., Cosentino, L., Vivarelli, A., Manconi, Pe, Ort, F., Di Martino, M. L., Viale, P., Verucchi, G., Tedeschi, S., Mura, M. S., Mannazzu, M., Cattari, G., Tavio, M., Del Gobbo, R., Mataloni Paggi, A., Giacometti, A., Cirioni, O., Marchionni, E., Silvestri, C., Sebastianelli, S., Brescini, L., Baldelli, F., Francisci, D., Schiaroli, E., Bastianelli, S., Guaraldi, Giovanni, Nardini, Giulia, Stentarelli, Chiara, and Beghetto, Barbara

Subjects
HIV infection, antiretroviral therapy
Published
2013

19. Determinants of virologic and immunologic outcomes in chronically HIV-infected subjects undergoing repeated treatment interruptions: the Istituto Superiore di Sanità-Pulsed Antiretroviral Therapy (ISS-PART) Study

Author

Palmisano, L., Giuliano, M., Bucciardini, R., Fragola, V., Andreotti, M., Galluzzo, C. M., Pirillo, M. F., Weimer, L. E., Arcieri, R., Germinario, E. A., Amici, R., Mancini, M. G., d’Arminio Monforte, A., Castelli, F., Caramello, P., Vella, S., the Italian ISS PART Clinical Centers, and Murdaca, Giuseppe

Published
2007

22. Virological failure at one year in triple-class experienced patients switching to raltegravir-based regimens is not predicted by baseline factors

Author

Bucciardini, R, primary, D'ettorre, G, additional, Baroncelli, S, additional, Ceccarelli, G, additional, Parruti, G, additional, Weimer, L E, additional, Fragola, V, additional, Galluzzo, C M, additional, Pirillo, M F, additional, Lucattini, S, additional, Bellagamba, R, additional, Francisci, D, additional, Ladisa, N, additional, Antoni, A Degli, additional, Guaraldi, G, additional, Manconi, P E, additional, Vullo, V, additional, Preziosi, R, additional, Cirioni, O, additional, Verucchi, G, additional, and Floridia, M, additional

Published
2012
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24. Evolution of proviral DNA HIV-1 tropism under selective pressure of maraviroc-based therapy

Author

Baroncelli, S., primary, Galluzzo, C. M., additional, Weimer, L. E., additional, Pirillo, M. F., additional, Volpe, A., additional, Mercuri, A., additional, Cavalli, A., additional, Fragola, V., additional, Monno, L., additional, Degli Antoni, A., additional, Ladisa, N., additional, Francisci, D., additional, Bucciardini, R., additional, and Floridia, M., additional

Published
2012
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27. A Simplified HAART Regimen with Raltegravir and Lamivudine, and Pharmacokinetic Interactions with a Combined Immunosuppressive Therapy with Tacrolimus and Everolimus in an HIV/HCV/HBV/HDV Patient after Liver Transplantation.

Author

Cirioni, O., Weimer, L. E., Fragola, V., Giacometti, A., Ancarani, F., Maracci, M., Gabrielli, E., Marchionni, E., Pirillo, M. F., and Vella, S.

Abstract

Copyright of West Indian Medical Journal is the property of West Indian Medical Journal (WIMJ) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2014
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28. Randomized controlled phase II trial of glatiramer acetate in ALS

Author

Gordon, P. H., primary, Doorish, C., additional, Montes, J., additional, Mosley, R. L., additional, Diamond, B., additional, MacArthur, R. B., additional, Weimer, L. H., additional, Kaufmann, P., additional, Hays, A. P., additional, Rowland, L. P., additional, Gendelman, H. E., additional, Przedborski, S., additional, and Mitsumoto, H., additional

Published
2006
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32. A Randomized, Double-Blind Trial on the Use of a Triple Combination Including Nevirapine, a Nonnucleoside Reverse Transcriptase HIV Inhibitor, in Antiretroviral-Naive Patients With Advanced Disease

Author

Floridia, M., primary, Bucciardini, R., additional, Ricciardulli, D., additional, Fragola, V., additional, Pirillo, M. F., additional, Weimer, L. E., additional, Tomino, C., additional, Giannini, G., additional, Galluzzo, C. M., additional, Andreotti, M., additional, Cargnel, A., additional, Alberici, F., additional, De Rienzo, B., additional, Leoncini, F., additional, Fiaccadori, F., additional, Francisci, D., additional, Grillone, W., additional, Ortona, L., additional, Piazza, M., additional, Scalzini, A., additional, Nigra, E., additional, Tumietto, F., additional, and Vella, S., additional

Published
1999
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33. Microstrip Discontinuity Models to 60 GHz

Author

PLESSEY RESEARCH (CASWELL) LTD TOWCESTER (UNITED KINGDOM), Arnold, R. G., Jansen, R. H., Weimer, L., PLESSEY RESEARCH (CASWELL) LTD TOWCESTER (UNITED KINGDOM), Arnold, R. G., Jansen, R. H., and Weimer, L.

Abstract

A new modeling concept, in which discontinuities are coupled to package modes, has been formulated. Analytical expressions describing the electrical behavior of various gallium arsenide microstrip discontinuities for frequencies up to 60 GHz are derived. These are suitable for use in Computer Aided Design (CAD) of Monolithic Microwave and Millimeter Wave Integrated Circuits (MMICs). The discontinuities modelled are the Open End, Gap, 90 degree Bend and T-Junction. A physics related modeling approach was used to obtain equivalent circuits representing the microstrip and first package LSM mode and their interaction at the discontinuity. The main section explains the modeling approach undertaken and provides a description of the discontinuity models. An appendix provides details of a 3-D full wave analysis method based on a spectral operator expansion technique. This was used to check numerical results needed for the modeling. (Author), No software available for this document.

Published
1991

34. A Randomized Trial (ISS 902) of Didanosine versus Zidovudine in Previously Untreated Patients with Mildly Symptomatic Human Immunodeficiency Virus Infection

Author

Floridia, M., primary, Vella, S., additional, Seeber, A. C., additional, Tomlno, C., additional, Fragola, V., additional, Weimer, L. E., additional, Ricciardulli, D., additional, Milazzo, F., additional, Gritti, F. M., additional, Mazzotta, F., additional, Ranieri, S., additional, Chiodo, F., additional, Moroni, M., additional, Cargnel, A., additional, Bassetti, D., additional, Giannini, V., additional, Crernoni, L., additional, Concia, E., additional, Sinicco, A., additional, Carosi, G., additional, Alberici, F., additional, and Dianzani, F., additional

Published
1997
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36. A Reduced Grade of Liver Fibro-steatosis after Raltegravir, Maraviroc and Fosamprenavir in an HIV/HCV Co-infected Patient with Chronic Hepatitis, Cardiomyopathy, Intolerance to Nelfinavir and a Marked Increase of Serum Creatine Phosphokinase Levels...

Author

Antoni, A Degli, Weimer, L. E., Manfredi, R., Fragola, V., and Ferrari, C.

Abstract

Copyright of West Indian Medical Journal is the property of West Indian Medical Journal (WIMJ) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2012
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39. A Reduction Grade of Lipodystrophy and Limited Side Effects after HAART Regimen with Raltegravir, Lamivudine, Darunavir and Ritonavir in an HIV-1 Infected Patient after Six Years of Antiretroviral Therapy.

Author

Degli Antoni, A., Weimer, L. E., Fragola, V., Giacometti, A., and Sozio, F.

Abstract

Copyright of West Indian Medical Journal is the property of West Indian Medical Journal (WIMJ) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2015
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40. Long-term Maraviroc Therapy and Limited Side Effects in an HIV-1 Experienced Patient: Six Years of Antiretroviral Observation.

Author

Cirioni, O., Weimer, L. E., Fragola, V., Giacometti, A., and Sozio, F.

Abstract

The article presents a case study of a heterosexual 46-year old female with HIV-1 infection who presented without co-infections at the Hospital ofAncona. Topics discussed include the modification of the medication of the patient to tenofovir (TFV) and emtricitabine in April 2008, the efficacy of maraviroc against CCR5-tropic virus, and the alternative therapy provided by maraviroc for treatment-experienced patients.

Published
2014
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42. Secretion of proinflammatory cytokines by human conjunctival epithelial cells.

Author

Gamache, Daniel A., Dimitrijevich, S. Dan, Weimer, Lori K., Lang, Laura S., Spellman, Joan M., Graff, Gustav, Yanni, John M., Gamache, D A, Dimitrijevich, S D, Weimer, L K, Lang, L S, Spellman, J M, Graff, G, and Yanni, J M

Subjects
CYTOKINES, CONJUNCTIVITIS, EPITHELIAL cells, PROTEIN metabolism, CARCINOGENS, CELL culture, COMPARATIVE studies, CONJUNCTIVA, CULTURE media (Biology), DOSE-effect relationship in pharmacology, ENZYME-linked immunosorbent assay, EPITHELIUM, ESCHERICHIA coli, FLUORESCENT antibody technique, HETEROCYCLIC compounds, INTERLEUKIN-1, RESEARCH methodology, MEDICAL cooperation, RESEARCH, TIME, EVALUATION research, LIPOPOLYSACCHARIDES
Abstract

The production of cytokines by human conjunctival epithelial cells following stimulation was investigated. Primary cultures of human conjunctival epithelial cells were characterized by morphology and keratin expression. Cultured epithelial cells were treated with varying concentrations of lipopolysaccharide, interleukin (IL)-1 beta, calcium ionophore A23187, or phorbol myristate acetate, and cytokine secretion was determined over specified intervals. Culture supernatants and cell lysates were analyzed by ELISA for IL-1 beta, IL-3, IL-4, IL-5, IL-6, IL-8, IL-11, IL-1 receptor antagonist (IL-1ra), tumor necrosis factor-alpha (TNF-alpha), and granulocyte-macrophage colony stimulating factor (GM-CSF). With the exception of IL-1ra, unstimulated conjunctival epithelial cells produced cytokines at relatively low or undetectable levels. IL-1ra was detected in both culture supernatants and cell lysates under basal conditions. In response to stimuli, conjunctival epithelial cells secreted the proinflammatory cytokines TNF-alpha, IL-6, IL-8, and GM-CSF in a dose- and time-dependent fashion. After stimulation, the intracellular levels of IL-1ra increased in these cells but the supernatant-associated levels remained unchanged. None of the other cytokines evaluated (IL-1 beta, IL-3, IL-4, IL-5, and IL-11) were detected in supernatants or lysates of resting or stimulated cells. These findings suggest that conjunctival epithelial cells may contribute to the pathogenesis of human ocular diseases by production of proinflammatory cytokines. Further evaluation of these cells as targets of therapy is warranted. [ABSTRACT FROM AUTHOR]

Published
1997
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46. Sustained Increase of Serum Creatine Phosphokinase Levels and Progressive Muscle Abnormalities Associated with Raltegravir Use during a 32-week Follow-up in an HIV-1 Experienced Patient on Simplified HAART Regimen, Intolerant to Protease Inhibitors...

Author

Cirioni, O., Weimer, L. E., Fragola, V., Giacometti, A., Gabrielli, E., Marchionni, E., Massella, M., and Barchiesi, F.

Abstract

Copyright of West Indian Medical Journal is the property of West Indian Medical Journal (WIMJ) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2013

48. Three-years follow up of raltegravir and/or maraviroc-based regimens in patients experienced to PI, NRTI, NNRTI. Update from the ISS-NIA cohort

Author

Weimer, L. E., Floridia, M., Bucciardini, R., Baroncelli, S., Galluzzo, C. M., Pirillo, M. F., Fragola, V., Donnini, S., Mirra, M., Di Gregori, M., Lucattini, S., Fucili, L., Baldelli, F., Francisci, D., Schiarol, E., Bastianelli, S., Angarano, G., Ladisa, N., Volpe, A., Vullo, V., D’ettore, G., Ceccarelli, G., Andreoni, M., Sarmati, L., Delle Rose, D., Tozzi, V., Libertone, R., Pucillo, L., Bellagamba, R., Petrosillo, N., Cicalini, S., Sighinolfi, L., Daniela Segala, Armignacco, O., Preziosi, R., Ferrari, C., Degli Antoni, A., Cavalli, A., Parruti, G., Sozio, F., Cosentino, L., Vivarelli, A., Manconi, P. E., Ortu, F., Di Marti, L., Viale, P., Verucchi, G., Tedeschi, S., Tavio, M., Del Gobbo, R., Mataloni Paggi, A., Giacometti, A., Cirioni, O., Marchionni, E., Barchiesi, F., Brescini, L., Morone, P., Mazzocato, S., Mura, M. S., Mannazzu, M., Guaraldi, G., Beghetto, B., and Nardini, G.

Subjects
NO

49. Virological response to treatment in patient who start raltegravir in combination with newer agents in current clinical practice

Author

Weimer, L. E., Floridia, M., Bucciardini, R., Baroncelli, S., Galluzzo, C., Pirillo, M. F., Fragola, V., D Ettorre, G., Ceccarelli, G., Baldelli, F., Francisci, D., Angarano, G., Ladisa, N., Vullo, V., Andreoni, M., Delle Rose, D., Tozzi, V., Narciso, P., Petrosillo, N., Bellagamba, R., Libertone, R., Cicalini, S., Tommasi, C., Ghinelli, F., Sighinolfi, L., Daniela Segala, Armignacco, O., Preziosi, R., Ferrari, C., Degli Antoni, A., Parruti, G., Sozio, F., Vivarelli, A., Manconi, P. E., Ortu, F., Verucchi, G., Mura, M. S., Mannazzu, M., Cattari, G., Tavio, M., Mataloni Paggi, A., Giacometti, A., Cirioni, O., Guaraldi, G., Nardini, G., Beghetto, B., Mirra, M., Di Gregorio, M., Lucattini, S., and Fucili, L.

Subjects
NO

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