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

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

doi:10.1016/j.dld.2014.05.014

Background: Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in "real world" chronic hepatitis C patients in Italy. Methods: Independent observational multicentre study including consecutive patients receiving Peg-interferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study. Results: 4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase.Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%).During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and γ-glutamil-transpeptidase >2 times the normal limit were associated with poorer response. Conclusions: The response to Peg-interferon/ribavirin therapy in "real world" clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-to-treat than among difficult-to-treat hepatitis C virus genotypes. © 2014 Editrice Gastroenterologica Italiana S.r.l.

Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency / Rosina, F., Tosti, M.E., Borghesio, E., Masocco, M., Mele, A., Coppola, C., Milella, M., Borgia, G., Andreone, P., Koch, M., Zignego, A.L., Romano, M., Carrara, M., Almasio, P.L., Azzola, E., Nardone, G., Benedetti, A., Carosi, G., Mazzotta, F., Sagnelli, E., et al.. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1590-8658. - 46:9(2014), pp. 826-832. [10.1016/j.dld.2014.05.014]

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

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

2014

Abstract

Background: Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in "real world" chronic hepatitis C patients in Italy. Methods: Independent observational multicentre study including consecutive patients receiving Peg-interferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study. Results: 4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase.Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%).During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and γ-glutamil-transpeptidase >2 times the normal limit were associated with poorer response. Conclusions: The response to Peg-interferon/ribavirin therapy in "real world" clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-to-treat than among difficult-to-treat hepatitis C virus genotypes. © 2014 Editrice Gastroenterologica Italiana S.r.l.

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Scheda completa

Scheda completa (DC)

	Anno di pubblicazione
	
				2014
			
	Rivista
	
				DIGESTIVE AND LIVER DISEASE
			
	N° del Volume
	
				46
			
	Fascicolo
	
				9
			
	Pagina iniziale
	
				826
			
	Pagina finale
	
				832
			
	Codice DOI
	
				https://dx.doi.org/10.1016/j.dld.2014.05.014
			
	Codice WoS
	
				WOS:000341154000012
			
	Codice Scopus
	
				2-s2.0-84906309220
			
	Codice PubMed
	
				24986781
			
	Citazione
	
				Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency / Rosina, F., Tosti, M.E., Borghesio, E., Masocco, M., Mele, A., Coppola, C., Milella, M., Borgia, G., Andreone, P., Koch, M., Zignego, A.L., Romano, M., Carrara, M., Almasio, P.L., Azzola, E., Nardone, G., Benedetti, A., Carosi, G., Mazzotta, F., Sagnelli, E., et al.. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1590-8658. - 46:9(2014), pp. 826-832. [10.1016/j.dld.2014.05.014]
			
	Tutti gli autori
	
						Rosina, F.; Tosti, M. E.; Borghesio, E.; Masocco, M.; Mele, A.; Coppola, C.; Milella, M.; Borgia, G.; Andreone, P.; Koch, M.; Zignego, A. L.; Romano, ...espandi
						
	Tipologia
	
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