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

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

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.