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.

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.

altro

Rizzo S.

2014

journal article

Periodico

DIGESTIVE AND LIVER DISEASE

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.