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 journalArticlepeer-review

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

ASJC Scopus subject areas

  • Hepatology

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