1. 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
- Author
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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, Basso, Monica, Lazzarin, Adriano, Morsica, Giulia, Mian, Peter, Pristerà, Raffael, Teresa Santantonio, Massimo Fasano, Evangelista Sagnelli, Paolo Tundo, Sergio Babudieri, Paolo Fabri, Mario Toti, Giovanni Di Perri, Nicoletta Marino, Eligio Pizzigallo, Gioacchino Angarano, the Acute Hepatitis C Study Group: [.., Gabriella Verucchi, and ]
- Subjects
Adult ,Male ,medicine.medical_specialty ,CLEARANCE ,Combination therapy ,Adolescent ,MONOTHERAPY ,VIRUS-INFECTION ,Gastroenterology ,Antiviral Agents ,law.invention ,Medication Adherence ,Polyethylene Glycols ,ALPHA-INTERFERON ,chemistry.chemical_compound ,Young Adult ,Pharmacotherapy ,Randomized controlled trial ,Drug Therapy ,law ,Multicenter trial ,Internal medicine ,Ribavirin ,medicine ,Clinical endpoint ,Humans ,Hepatology ,business.industry ,Interferon-alpha ,Middle Aged ,Hepatitis C ,Recombinant Proteins ,Surgery ,Acute Disease ,Drug Therapy, Combination ,Female ,Treatment Outcome ,Clinical trial ,chemistry ,Combination ,business - 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. © 2014 by the American Association for the Study of Liver Diseases.
- Published
- 2014