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

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

doi: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

Floriano Rosina
, Maria Elena Tosti
, Elisabetta Borghesio
, Maria Masocco
, Alfonso Mele
, Carmine Coppola
, Michele Milella
, Guglielmo Borgia
, Pietro Andreone
, Maurizio Koch
, Anna Linda Zignego
, Mario Romano
, Maurizio Carrara
, Piero Luigi Almasio
, Emilio Azzola
, Gerardo Nardone
, Antonio Benedetti
, Giampiero Carosi
, Francesco Mazzotta
, Evangelista Sagnelli

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

Department of Translational Medicine

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	826-832
Number of pages	7
Journal	Digestive and Liver Disease
Volume	46
Issue number	9
DOIs	https://doi.org/10.1016/j.dld.2014.05.014
Publication status	Published - 1 Sept 2014

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Ribavirin
Sustained virological response (SVR)
Treatment

Access to Document

10.1016/j.dld.2014.05.014

Cite this

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., ... Rizzo, S. (2014). Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency. Digestive and Liver Disease, 46(9), 826-832. https://doi.org/10.1016/j.dld.2014.05.014

@article{39f2717aff804023a00189fe5b4803d0,

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

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.",

keywords = "Ribavirin, Sustained virological response (SVR), Treatment",

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

note = "Funding Information: The study was designed by the three major Italian hepato-gastroenterological scientific societies: the Italian Association of Hospital Gastroenterologists (AIGO), the Italian Association for the Study of the Liver (AISF), and the Italian Society of Gastroenterology (SIGE); by the Italian Society for Infectious and Tropical Diseases (SIMIT); it was supervised by the Italian Institute of Health (ISS) and financially supported by the Italian Drug Agency (AIFA). Funding Information: Source of support: The study was funded by the Governmental Italian Drug Agency (Associazione Italiana per il FArmaco (AIFA)). ",

year = "2014",

month = sep,

day = "1",

doi = "10.1016/j.dld.2014.05.014",

language = "English",

volume = "46",

pages = "826--832",

journal = "Digestive and Liver Disease",

issn = "1590-8658",

publisher = "Elsevier BV",

number = "9",

}

Rosina, F, Tosti, ME, Borghesio, E, Masocco, M, Mele, A, Coppola, C, Milella, M, Borgia, G, Andreone, P, Koch, M, Zignego, AL, Romano, M, Carrara, M, Almasio, PL, Azzola, E, Nardone, G, Benedetti, A, Carosi, G, Mazzotta, F, Sagnelli, E, Rizzetto, M, Mascolo, MC, Cursaro, C, Scuteri, A, Crespi, C, Gianstefani, A, Ranieri, J, Monti, M, Corti, G, Blanc, PL, Baragli, F, Bellentani, S, Gasbarrini, A, Pompili, M, Mecenate, F, Picardi, A, Vespasiani, U, Nosotti, Mecenate, F, A.Picardi, Nosotti, Ricci, GL, Paffetti, A, Mastropietro, C, Moretti, A, Spagnolo, AL, 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, Calì, A, Civitavecchia, G, Pirisi, M , Smirne, C, Andreoletti, M, Morisco, F, Caporaso, N, Gentile, I, Brancaccio, G, Gaeta, GB, Liberti, A, Iannece, MD, Rocco, A, Federico, A, Loguercio, C, Riegler, G, Esposito, P, Fargion, S, Fatta, E, Masutti, F, Bonaventura, ME, Autolitano, A, Russello, M, Bellia, A, Toniutto, P, Bitetto, D, Pasulo, L, Lucà, MG, Grattagliano, I, Palasciano, G, Romagno, D, Giannelli, G, Napoli, N, Plattella, MS, Cassano, P, Gobbo, G, Monti, V, Raspanti, A, Cuccorese, Colombo, AE, Mandelli, G, Spinzi, GC, Floridia, Messina, V, Bonfante, S, Bellissima, P, Toti, M, Vecchiet, J, Falasca, K, Portelli, V, Stefano, GD, Pietromatera, G, Viganò, P, Re, T, Andreoni, M, G.Raineri, Grossi, PA, Caputo, S, Cassola, G, Feasi, M, Biagio, AD, Nicolini, L, Giannini, EG, 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, MA, Simone, L, Tacconi, D, Caremani, M, Almi, P, Chimenti, M, Cosco, Messeri, D, Esperti, FC, Lomonaco, L, Pazzi, P, Fornari, F, Comparato, G, Casetti, T, Foschi, FG, Samori, A, Ferretti, E, Marin, R, Campo, N, Testa, R & Rizzo, S 2014, 'Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency', Digestive and Liver Disease, vol. 46, no. 9, pp. 826-832. https://doi.org/10.1016/j.dld.2014.05.014

TY - JOUR

T1 - Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C

T2 - A multicentre independent study supported by the Italian Drug Agency

AU - Rosina, Floriano

AU - Tosti, Maria Elena

AU - Borghesio, Elisabetta

AU - Masocco, Maria

AU - Mele, Alfonso

AU - Coppola, Carmine

AU - Milella, Michele

AU - Borgia, Guglielmo

AU - Andreone, Pietro

AU - Koch, Maurizio

AU - Zignego, Anna Linda

AU - Romano, Mario

AU - Carrara, Maurizio

AU - Almasio, Piero Luigi

AU - Azzola, Emilio

AU - Nardone, Gerardo

AU - Benedetti, Antonio

AU - Carosi, Giampiero

AU - Mazzotta, Francesco

AU - Sagnelli, Evangelista

AU - Rizzetto, Mario

AU - Mascolo, M. C.

AU - Cursaro, C.

AU - Scuteri, A.

AU - Crespi, C.

AU - Gianstefani, A.

AU - Ranieri, J.

AU - Monti, M.

AU - Corti, G.

AU - Blanc, P. L.

AU - Baragli, F.

AU - Bellentani, S.

AU - Gasbarrini, A.

AU - Pompili, M.

AU - Mecenate, F.

AU - Picardi, A.

AU - Vespasiani, U.

AU - Nosotti,

AU - Mecenate, F.

AU - A.Picardi,

AU - Nosotti,

AU - Ricci, G. L.

AU - Paffetti, A.

AU - Mastropietro, C.

AU - Moretti, A.

AU - Spagnolo, A. L.

AU - Puoti, C.

AU - Bellis, L.

AU - Regazzetti, A.

AU - Maffezzini, E.

AU - Pietrangelo, A.

AU - Abbati, G.

AU - Borghi, A.

AU - Sardini, C.

AU - Raimondo, G.

AU - Scribano, L.

AU - Martines, D.

AU - Svegliati Baroni, G.

AU - Faraci, G.

AU - Schi-anchi, S.

AU - Fornaciari, G.

AU - Massari, M.

AU - Fabris, P.

AU - Bertin, T.

AU - Salvagnini, M.

AU - Madonia, S.

AU - Calì, A.

AU - Civitavecchia, G.

AU - Pirisi, M.

AU - Smirne, C.

AU - Andreoletti, M.

AU - Morisco, F.

AU - Caporaso, N.

AU - Gentile, I.

AU - Brancaccio, G.

AU - Gaeta, G. B.

AU - Liberti, A.

AU - Iannece, M. D.

AU - Rocco, A.

AU - Federico, A.

AU - Loguercio, C.

AU - Riegler, G.

AU - Esposito, P.

AU - Fargion, S.

AU - Fatta, E.

AU - Masutti, F.

AU - Bonaventura, M. E.

AU - Autolitano, A.

AU - Russello, M.

AU - Bellia, A.

AU - Toniutto, P.

AU - Bitetto, D.

AU - Pasulo, L.

AU - Lucà, M. G.

AU - Grattagliano, I.

AU - Palasciano, G.

AU - Romagno, D.

AU - Giannelli, G.

AU - Napoli, N.

AU - Plattella, M. S.

AU - Cassano, P.

AU - Gobbo, G.

AU - Monti, V.

AU - Raspanti, A.

AU - Cuccorese,

AU - Colombo, A. E.

AU - Mandelli, G.

AU - Spinzi, G. C.

AU - Floridia,

AU - Messina, V.

AU - Bonfante, S.

AU - Bellissima, P.

AU - Toti, M.

AU - Vecchiet, J.

AU - Falasca, K.

AU - Portelli, V.

AU - Stefano, G. De

AU - Pietromatera, G.

AU - Viganò, P.

AU - Re, T.

AU - Andreoni, M.

AU - G.Raineri,

AU - Grossi, P. A.

AU - Caputo, S.

AU - Cassola, G.

AU - Feasi, M.

AU - Biagio, A. Di

AU - Nicolini, L.

AU - Giannini, E. G.

AU - Corbo, M.

AU - Foti, G.

AU - Kunkar, A.

AU - Caterini, L.

AU - Migliorini, D.

AU - Chiodera, A.

AU - Calleri, G.

AU - Spezia, C.

AU - Framarin, L.

AU - M.Berrutti,

AU - Ciancio, A.

AU - Baiguera, C.

AU - Puoti, M.

AU - Vento, S.

AU - Contini, C.

AU - Boccia, S.

AU - Casiraghi, M. A.

AU - Simone, L.

AU - Tacconi, D.

AU - Caremani, M.

AU - Almi, P.

AU - Chimenti, M.

AU - Cosco,

AU - Messeri, D.

AU - Esperti, F. C.

AU - Lomonaco, L.

AU - Pazzi, P.

AU - Fornari, F.

AU - Comparato, G.

AU - Casetti, T.

AU - Foschi, F. G.

AU - Samori, A.

AU - Ferretti, E.

AU - Marin, R.

AU - Campo, N.

AU - Testa, R.

AU - Rizzo, S.

N1 - Funding Information: The study was designed by the three major Italian hepato-gastroenterological scientific societies: the Italian Association of Hospital Gastroenterologists (AIGO), the Italian Association for the Study of the Liver (AISF), and the Italian Society of Gastroenterology (SIGE); by the Italian Society for Infectious and Tropical Diseases (SIMIT); it was supervised by the Italian Institute of Health (ISS) and financially supported by the Italian Drug Agency (AIFA). Funding Information: Source of support: The study was funded by the Governmental Italian Drug Agency (Associazione Italiana per il FArmaco (AIFA)).

PY - 2014/9/1

Y1 - 2014/9/1

N2 - 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.

AB - 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.

KW - Ribavirin

KW - Sustained virological response (SVR)

KW - Treatment

UR - https://www.scopus.com/pages/publications/84906309220

U2 - 10.1016/j.dld.2014.05.014

DO - 10.1016/j.dld.2014.05.014

M3 - Article

SN - 1590-8658

VL - 46

SP - 826

EP - 832

JO - Digestive and Liver Disease

JF - Digestive and Liver Disease

IS - 9

ER -

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

Abstract

UN SDGs

Keywords

Access to Document

Other files and links

Fingerprint

Cite this