Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin

Teresa Santantonio, Massimo Fasano, Evangelista Sagnelli, Paolo Tundo, Sergio Babudieri, Paolo Fabris, Mario Toti, Giovanni Di Perri, Nicoletta Marino, Eligio Pizzigallo, Gioacchino Angarano, Giuseppe Pastore, Angela Guastadisegni, Anna Volpe, Francesca Stano, Donato Tommasi, Annamaria Maci, Francesco Resta, Pietro Loperfido, Roberto EspositoVanni Borghi, Tommaso Fontana, Ruggiero Francavilla, Michele Mazzola, Antonella Pipoli, Marinella Stanzione, Pietro Amoroso, Gennaro Lettieri, Vincenzo Messina, Giorgio Antonucci, Silvia Rosati, Andrea Giacometti, Chiara Costa, Carlo Biagio De Stefano, Giuseppe Cariti, Giulia Tositti, M. Piera Riccardi, Gabriella Verucchi, Daniela Francisci, Enzo Petrelli, Laura Stoppini, Giovanni Raimondo, Giovanni Squadrito, Gaia Caccamo, Picciotto Antonino, Basso Monica, Adriano Lazzarin, Giulia Morsica, Peter Mian, Raffael Pristerà

Research output: Contribution to journalArticle

Abstract

Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 μg/kg/week) for 24 or 12 weeks (arm 1, n = 44 and arm 2, n = 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n = 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 43 (72.1%) patients in arms 1, 2, and 3, respectively (P = 0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6%, 81.6%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated. Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration.

Original languageEnglish
Pages (from-to)2101-2109
Number of pages9
JournalHepatology
Volume59
Issue number6
DOIs
Publication statusPublished - 2014

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Ribavirin
Hepatitis C
Therapeutics
RNA
Lost to Follow-Up
peginterferon alfa-2b
Multicenter Studies
Limit of Detection
Real-Time Polymerase Chain Reaction
Multivariate Analysis
Safety

ASJC Scopus subject areas

  • Hepatology

Cite this

Santantonio, T., Fasano, M., Sagnelli, E., Tundo, P., Babudieri, S., Fabris, P., ... Pristerà, R. (2014). Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin. Hepatology, 59(6), 2101-2109. https://doi.org/10.1002/hep.26991

Acute hepatitis C : A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin. / Santantonio, Teresa; Fasano, Massimo; Sagnelli, Evangelista; Tundo, Paolo; Babudieri, Sergio; Fabris, Paolo; Toti, Mario; Di Perri, Giovanni; Marino, Nicoletta; Pizzigallo, Eligio; Angarano, Gioacchino; Pastore, Giuseppe; Guastadisegni, Angela; Volpe, Anna; Stano, Francesca; Tommasi, Donato; Maci, Annamaria; Resta, Francesco; Loperfido, Pietro; Esposito, Roberto; Borghi, Vanni; Fontana, Tommaso; Francavilla, Ruggiero; Mazzola, Michele; Pipoli, Antonella; Stanzione, Marinella; Amoroso, Pietro; Lettieri, Gennaro; Messina, Vincenzo; Antonucci, Giorgio; Rosati, Silvia; Giacometti, Andrea; Costa, Chiara; De Stefano, Carlo Biagio; Cariti, Giuseppe; Tositti, Giulia; Piera Riccardi, M.; Verucchi, Gabriella; Francisci, Daniela; Petrelli, Enzo; Stoppini, Laura; Raimondo, Giovanni; Squadrito, Giovanni; Caccamo, Gaia; Antonino, Picciotto; Monica, Basso; Lazzarin, Adriano; Morsica, Giulia; Mian, Peter; Pristerà, Raffael.

In: Hepatology, Vol. 59, No. 6, 2014, p. 2101-2109.

Research output: Contribution to journalArticle

Santantonio, T, Fasano, M, Sagnelli, E, Tundo, P, Babudieri, S, Fabris, P, Toti, M, Di Perri, G, Marino, N, Pizzigallo, E, Angarano, G, Pastore, G, Guastadisegni, A, Volpe, A, Stano, F, Tommasi, D, Maci, A, Resta, F, Loperfido, P, Esposito, R, Borghi, V, Fontana, T, Francavilla, R, Mazzola, M, Pipoli, A, Stanzione, M, Amoroso, P, Lettieri, G, Messina, V, Antonucci, G, Rosati, S, Giacometti, A, Costa, C, De Stefano, CB, Cariti, G, Tositti, G, Piera Riccardi, M, Verucchi, G, Francisci, D, Petrelli, E, Stoppini, L, Raimondo, G, Squadrito, G, Caccamo, G, Antonino, P, Monica, B, Lazzarin, A, Morsica, G, Mian, P & Pristerà, R 2014, 'Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin', Hepatology, vol. 59, no. 6, pp. 2101-2109. https://doi.org/10.1002/hep.26991
Santantonio, Teresa ; Fasano, Massimo ; Sagnelli, Evangelista ; Tundo, Paolo ; Babudieri, Sergio ; Fabris, Paolo ; Toti, Mario ; Di Perri, Giovanni ; Marino, Nicoletta ; Pizzigallo, Eligio ; Angarano, Gioacchino ; Pastore, Giuseppe ; Guastadisegni, Angela ; Volpe, Anna ; Stano, Francesca ; Tommasi, Donato ; Maci, Annamaria ; Resta, Francesco ; Loperfido, Pietro ; Esposito, Roberto ; Borghi, Vanni ; Fontana, Tommaso ; Francavilla, Ruggiero ; Mazzola, Michele ; Pipoli, Antonella ; Stanzione, Marinella ; Amoroso, Pietro ; Lettieri, Gennaro ; Messina, Vincenzo ; Antonucci, Giorgio ; Rosati, Silvia ; Giacometti, Andrea ; Costa, Chiara ; De Stefano, Carlo Biagio ; Cariti, Giuseppe ; Tositti, Giulia ; Piera Riccardi, M. ; Verucchi, Gabriella ; Francisci, Daniela ; Petrelli, Enzo ; Stoppini, Laura ; Raimondo, Giovanni ; Squadrito, Giovanni ; Caccamo, Gaia ; Antonino, Picciotto ; Monica, Basso ; Lazzarin, Adriano ; Morsica, Giulia ; Mian, Peter ; Pristerà, Raffael. / Acute hepatitis C : A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin. In: Hepatology. 2014 ; Vol. 59, No. 6. pp. 2101-2109.
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abstract = "Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 μg/kg/week) for 24 or 12 weeks (arm 1, n = 44 and arm 2, n = 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n = 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5{\%}. In particular, an SVR was achieved in 31 of 44 (70.5{\%}), 31 of 43 (72.1{\%}), and 31 of 43 (72.1{\%}) patients in arms 1, 2, and 3, respectively (P = 0.898). Sixteen patients (12.3{\%}) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6{\%}, 81.6{\%}, and 81.6{\%} for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated. Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration.",
author = "Teresa Santantonio and Massimo Fasano and Evangelista Sagnelli and Paolo Tundo and Sergio Babudieri and Paolo Fabris and Mario Toti and {Di Perri}, Giovanni and Nicoletta Marino and Eligio Pizzigallo and Gioacchino Angarano and Giuseppe Pastore and Angela Guastadisegni and Anna Volpe and Francesca Stano and Donato Tommasi and Annamaria Maci and Francesco Resta and Pietro Loperfido and Roberto Esposito and Vanni Borghi and Tommaso Fontana and Ruggiero Francavilla and Michele Mazzola and Antonella Pipoli and Marinella Stanzione and Pietro Amoroso and Gennaro Lettieri and Vincenzo Messina and Giorgio Antonucci and Silvia Rosati and Andrea Giacometti and Chiara Costa and {De Stefano}, {Carlo Biagio} and Giuseppe Cariti and Giulia Tositti and {Piera Riccardi}, M. and Gabriella Verucchi and Daniela Francisci and Enzo Petrelli and Laura Stoppini and Giovanni Raimondo and Giovanni Squadrito and Gaia Caccamo and Picciotto Antonino and Basso Monica and Adriano Lazzarin and Giulia Morsica and Peter Mian and Raffael Prister{\`a}",
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language = "English",
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TY - JOUR

T1 - Acute hepatitis C

T2 - A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin

AU - Santantonio, Teresa

AU - Fasano, Massimo

AU - Sagnelli, Evangelista

AU - Tundo, Paolo

AU - Babudieri, Sergio

AU - Fabris, Paolo

AU - Toti, Mario

AU - Di Perri, Giovanni

AU - Marino, Nicoletta

AU - Pizzigallo, Eligio

AU - Angarano, Gioacchino

AU - Pastore, Giuseppe

AU - Guastadisegni, Angela

AU - Volpe, Anna

AU - Stano, Francesca

AU - Tommasi, Donato

AU - Maci, Annamaria

AU - Resta, Francesco

AU - Loperfido, Pietro

AU - Esposito, Roberto

AU - Borghi, Vanni

AU - Fontana, Tommaso

AU - Francavilla, Ruggiero

AU - Mazzola, Michele

AU - Pipoli, Antonella

AU - Stanzione, Marinella

AU - Amoroso, Pietro

AU - Lettieri, Gennaro

AU - Messina, Vincenzo

AU - Antonucci, Giorgio

AU - Rosati, Silvia

AU - Giacometti, Andrea

AU - Costa, Chiara

AU - De Stefano, Carlo Biagio

AU - Cariti, Giuseppe

AU - Tositti, Giulia

AU - Piera Riccardi, M.

AU - Verucchi, Gabriella

AU - Francisci, Daniela

AU - Petrelli, Enzo

AU - Stoppini, Laura

AU - Raimondo, Giovanni

AU - Squadrito, Giovanni

AU - Caccamo, Gaia

AU - Antonino, Picciotto

AU - Monica, Basso

AU - Lazzarin, Adriano

AU - Morsica, Giulia

AU - Mian, Peter

AU - Pristerà, Raffael

PY - 2014

Y1 - 2014

N2 - Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 μg/kg/week) for 24 or 12 weeks (arm 1, n = 44 and arm 2, n = 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n = 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 43 (72.1%) patients in arms 1, 2, and 3, respectively (P = 0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6%, 81.6%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated. Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration.

AB - Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 μg/kg/week) for 24 or 12 weeks (arm 1, n = 44 and arm 2, n = 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n = 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 43 (72.1%) patients in arms 1, 2, and 3, respectively (P = 0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6%, 81.6%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated. Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration.

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