HCV clearance after direct-acting antivirals in patients with cirrhosis by stages of liver impairment: The ITAL-C network study

Antonio Massimo Ippolito; Michele Milella; Vincenzo Messina; Fabio Conti; Raffaele Cozzolongo; Filomena Morisco; Giuseppina Brancaccio; Michele Barone; Teresa Santantonio; Chiara Masetti; Paolo Tundo; Antonina Smedile; Vito Carretta; Pietro Gatti; Antonio Patrizio Termite; Maria Rosa Valvano; Giuseppe Bruno; Claudia Fabrizio; Pietro Andreone; Marianna Zappimbulso; Giovanni Battista Gaeta; Nicola Napoli; Luca Fontanella; Gianfranco Lauletta; Giuseppe Cuccorese; Antonio Metrangolo; Ruggiero Francavilla; Emanuela Ciracì; Salvatore Rizzo; Angelo Andriulli

doi:10.1016/j.dld.2017.03.025

HCV clearance after direct-acting antivirals in patients with cirrhosis by stages of liver impairment: The ITAL-C network study

Antonio Massimo Ippolito, Michele Milella, Vincenzo Messina, Fabio Conti, Raffaele Cozzolongo, Filomena Morisco, Giuseppina Brancaccio, Michele Barone, Teresa Santantonio, Chiara Masetti, Paolo Tundo, Antonina Smedile, Vito Carretta, Pietro Gatti, Antonio Patrizio Termite, Maria Rosa Valvano, Giuseppe Bruno, Claudia Fabrizio, Pietro Andreone, Marianna ZappimbulsoGiovanni Battista Gaeta, Nicola Napoli, Luca Fontanella, Gianfranco Lauletta, Giuseppe Cuccorese, Antonio Metrangolo, Ruggiero Francavilla, Emanuela Ciracì, Salvatore Rizzo, Angelo Andriulli

Ente Ospedaliero Specializzato in Gastroenterologia "Saverio de Bellis"

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

Abstract

BACKGROUND: Sustained virological response (SVR12) rates at 12 weeks after treatment for HCV-infected patients with decompensated cirrhosis are used when referring to those with moderate functional impairment, while few data are available for those with more severe impairment. The use of the cirrhosis staging system proposed by D'Amico might provide new insights on timing for antiviral therapy.

METHODS: We investigated efficacy (SVR12), safety, and post-treatment variations in clinical and laboratory parameters in 2612 patients with advanced fibrosis (n=575) or cirrhosis (n=2037). Cirrhosis was in the compensated phase (without/with varices) or had previously been in the decompensated stage. Different direct-acting antiviral (DAA) regimens were administered in accordance with scientific guidelines.

RESULTS: The SVR12 rate was 97.6% in patients with advanced fibrosis. For patients with cirrhosis, the rate was 96.5% in stage 1, 95.1% in stage 2, 100% in stage 3, 95.7% in stage 4, and 93.6% in stage 5. These rates were independent of gender, age, HCV genotype, and treatment schedule. Positive changes in biochemical parameters and CPT classes following therapy were evident in compensated and previously decompensated patients.

CONCLUSION: Our findings support the use of DAAs in patients with advanced cirrhosis (stages 3-5) who are at greatest risk and have the most to gain from therapy.

Original language	English
Pages (from-to)	1022-1028
Number of pages	7
Journal	Digestive and Liver Disease
Volume	49
Issue number	9
DOIs	https://doi.org/10.1016/j.dld.2017.03.025
Publication status	Published - Sep 2017

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Journal Article

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10.1016/j.dld.2017.03.025

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Ippolito, A. M., Milella, M., Messina, V., Conti, F., Cozzolongo, R., Morisco, F., Brancaccio, G., Barone, M., Santantonio, T., Masetti, C., Tundo, P., Smedile, A., Carretta, V., Gatti, P., Termite, A. P., Valvano, M. R., Bruno, G., Fabrizio, C., Andreone, P., ... Andriulli, A. (2017). HCV clearance after direct-acting antivirals in patients with cirrhosis by stages of liver impairment: The ITAL-C network study. Digestive and Liver Disease, 49(9), 1022-1028. https://doi.org/10.1016/j.dld.2017.03.025

Ippolito, AM, Milella, M, Messina, V, Conti, F, Cozzolongo, R, Morisco, F, Brancaccio, G, Barone, M, Santantonio, T, Masetti, C, Tundo, P, Smedile, A, Carretta, V, Gatti, P, Termite, AP, Valvano, MR, Bruno, G, Fabrizio, C, Andreone, P, Zappimbulso, M, Gaeta, GB, Napoli, N, Fontanella, L, Lauletta, G, Cuccorese, G, Metrangolo, A, Francavilla, R, Ciracì, E, Rizzo, S & Andriulli, A 2017, 'HCV clearance after direct-acting antivirals in patients with cirrhosis by stages of liver impairment: The ITAL-C network study', Digestive and Liver Disease, vol. 49, no. 9, pp. 1022-1028. https://doi.org/10.1016/j.dld.2017.03.025

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title = "HCV clearance after direct-acting antivirals in patients with cirrhosis by stages of liver impairment: The ITAL-C network study",

abstract = "BACKGROUND: Sustained virological response (SVR12) rates at 12 weeks after treatment for HCV-infected patients with decompensated cirrhosis are used when referring to those with moderate functional impairment, while few data are available for those with more severe impairment. The use of the cirrhosis staging system proposed by D'Amico might provide new insights on timing for antiviral therapy.METHODS: We investigated efficacy (SVR12), safety, and post-treatment variations in clinical and laboratory parameters in 2612 patients with advanced fibrosis (n=575) or cirrhosis (n=2037). Cirrhosis was in the compensated phase (without/with varices) or had previously been in the decompensated stage. Different direct-acting antiviral (DAA) regimens were administered in accordance with scientific guidelines.RESULTS: The SVR12 rate was 97.6% in patients with advanced fibrosis. For patients with cirrhosis, the rate was 96.5% in stage 1, 95.1% in stage 2, 100% in stage 3, 95.7% in stage 4, and 93.6% in stage 5. These rates were independent of gender, age, HCV genotype, and treatment schedule. Positive changes in biochemical parameters and CPT classes following therapy were evident in compensated and previously decompensated patients.CONCLUSION: Our findings support the use of DAAs in patients with advanced cirrhosis (stages 3-5) who are at greatest risk and have the most to gain from therapy.",

keywords = "Journal Article",

author = "Ippolito, {Antonio Massimo} and Michele Milella and Vincenzo Messina and Fabio Conti and Raffaele Cozzolongo and Filomena Morisco and Giuseppina Brancaccio and Michele Barone and Teresa Santantonio and Chiara Masetti and Paolo Tundo and Antonina Smedile and Vito Carretta and Pietro Gatti and Termite, {Antonio Patrizio} and Valvano, {Maria Rosa} and Giuseppe Bruno and Claudia Fabrizio and Pietro Andreone and Marianna Zappimbulso and Gaeta, {Giovanni Battista} and Nicola Napoli and Luca Fontanella and Gianfranco Lauletta and Giuseppe Cuccorese and Antonio Metrangolo and Ruggiero Francavilla and Emanuela Cirac{\`i} and Salvatore Rizzo and Angelo Andriulli",

year = "2017",

month = sep,

doi = "10.1016/j.dld.2017.03.025",

language = "English",

volume = "49",

pages = "1022--1028",

journal = "Digestive and Liver Disease",

issn = "1590-8658",

publisher = "Elsevier B.V.",

number = "9",

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TY - JOUR

T1 - HCV clearance after direct-acting antivirals in patients with cirrhosis by stages of liver impairment

T2 - The ITAL-C network study

AU - Ippolito, Antonio Massimo

AU - Milella, Michele

AU - Messina, Vincenzo

AU - Conti, Fabio

AU - Cozzolongo, Raffaele

AU - Morisco, Filomena

AU - Brancaccio, Giuseppina

AU - Barone, Michele

AU - Santantonio, Teresa

AU - Masetti, Chiara

AU - Tundo, Paolo

AU - Smedile, Antonina

AU - Carretta, Vito

AU - Gatti, Pietro

AU - Termite, Antonio Patrizio

AU - Valvano, Maria Rosa

AU - Bruno, Giuseppe

AU - Fabrizio, Claudia

AU - Andreone, Pietro

AU - Zappimbulso, Marianna

AU - Gaeta, Giovanni Battista

AU - Napoli, Nicola

AU - Fontanella, Luca

AU - Lauletta, Gianfranco

AU - Cuccorese, Giuseppe

AU - Metrangolo, Antonio

AU - Francavilla, Ruggiero

AU - Ciracì, Emanuela

AU - Rizzo, Salvatore

AU - Andriulli, Angelo

PY - 2017/9

Y1 - 2017/9

N2 - BACKGROUND: Sustained virological response (SVR12) rates at 12 weeks after treatment for HCV-infected patients with decompensated cirrhosis are used when referring to those with moderate functional impairment, while few data are available for those with more severe impairment. The use of the cirrhosis staging system proposed by D'Amico might provide new insights on timing for antiviral therapy.METHODS: We investigated efficacy (SVR12), safety, and post-treatment variations in clinical and laboratory parameters in 2612 patients with advanced fibrosis (n=575) or cirrhosis (n=2037). Cirrhosis was in the compensated phase (without/with varices) or had previously been in the decompensated stage. Different direct-acting antiviral (DAA) regimens were administered in accordance with scientific guidelines.RESULTS: The SVR12 rate was 97.6% in patients with advanced fibrosis. For patients with cirrhosis, the rate was 96.5% in stage 1, 95.1% in stage 2, 100% in stage 3, 95.7% in stage 4, and 93.6% in stage 5. These rates were independent of gender, age, HCV genotype, and treatment schedule. Positive changes in biochemical parameters and CPT classes following therapy were evident in compensated and previously decompensated patients.CONCLUSION: Our findings support the use of DAAs in patients with advanced cirrhosis (stages 3-5) who are at greatest risk and have the most to gain from therapy.

AB - BACKGROUND: Sustained virological response (SVR12) rates at 12 weeks after treatment for HCV-infected patients with decompensated cirrhosis are used when referring to those with moderate functional impairment, while few data are available for those with more severe impairment. The use of the cirrhosis staging system proposed by D'Amico might provide new insights on timing for antiviral therapy.METHODS: We investigated efficacy (SVR12), safety, and post-treatment variations in clinical and laboratory parameters in 2612 patients with advanced fibrosis (n=575) or cirrhosis (n=2037). Cirrhosis was in the compensated phase (without/with varices) or had previously been in the decompensated stage. Different direct-acting antiviral (DAA) regimens were administered in accordance with scientific guidelines.RESULTS: The SVR12 rate was 97.6% in patients with advanced fibrosis. For patients with cirrhosis, the rate was 96.5% in stage 1, 95.1% in stage 2, 100% in stage 3, 95.7% in stage 4, and 93.6% in stage 5. These rates were independent of gender, age, HCV genotype, and treatment schedule. Positive changes in biochemical parameters and CPT classes following therapy were evident in compensated and previously decompensated patients.CONCLUSION: Our findings support the use of DAAs in patients with advanced cirrhosis (stages 3-5) who are at greatest risk and have the most to gain from therapy.

KW - Journal Article

U2 - 10.1016/j.dld.2017.03.025

DO - 10.1016/j.dld.2017.03.025

M3 - Article

C2 - 28487083

VL - 49

SP - 1022

EP - 1028

JO - Digestive and Liver Disease

JF - Digestive and Liver Disease

SN - 1590-8658

IS - 9

ER -

HCV clearance after direct-acting antivirals in patients with cirrhosis by stages of liver impairment: The ITAL-C network study

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