학술논문
Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B
Document Type
Academic Journal
Author
Lampertico, Pietro; Viganò, Mauro; Di Costanzo, Giovan Giuseppe; Sagnelli, Evangelista; Fasano, Massimo; Di Marco, Vito; Boninsegna, Sara; Farci, Patrizia; Fargion, Silvia; Giuberti, Tiziana; Iannacone, Claudio; Regep, Loredana; Massetto, Benedetta; Facchetti, Floriana; Colombo, Massimo; Andreone, Pietro; Riili, Anna; Scuteri, Alessandra; Cursaro, Carmela; Andriulli, Angelo; Anna Niro, Grazia; Angarano, Gioacchino; Fasano, Massimo; Santantonio, Teresa Antonia; Palattella, Maria Stefania; Brunetto, Maurizia; Colombatto, Piero; Coco, Barbara; Ciccorossi, Pietro; Oliveri, Filippo; Sacco, Rodolfo; Bruno, Savino; Bollani, Simona; Chiesa, Alberto; Carosi, Giampiero; Baiguera, Chiara; Rossi, Stefania; Zaltron, Serena; Puoti, Massimo; Colombo, Massimo; Lampertico, Pietro; Cozzolongo, Raffaele; Giannuzzi, Vito; Craxì, Antonio; Di Marco, Vito; Calvaruso, Vincenza; Venezia, Giovanna; Di Costanzo, Giovan Giuseppe; Lanza, Alfonso Galeota; Di Perri, Giovanni; Cariti, Giuseppe; Mollaretti, Oscar; De Blasi, Tiziano; Kulmiye, Cumar; Rostagno, Roberto; Farci, Patrizia; Eliana Lai, Maria; Serra, Giancarlo; Chessa, Luchino; Balestrieri, Cinzia; Cauli, Cristiana; Fargion, Silvia Rossana; Bertelli, Cristina; Fatta, Erika; Fattovich, Giovanna; Pasino, Michela; Zanni, Silvia; Olivari, Nicola; Zagni, Irene; Ferrari, Carlo; Schivazappa, Simona; Giuberti, Tiziana; Laccabue, Diletta; Penna, Amalia; Gaeta, Giovanbattista; Stanzione, Maria; Stornaiuolo, Gianfranca; Martines, Diego; Boninsegna, Sara; Raimondo, Giovanni; Caccamo, Gaia; Squadrito, Giovanni; Isgrò, Graziella; Rizzetto, Mario; Lagget, Marco; Carenzi, Silvia; Ruggiero, Giuseppe; Marrone, Aldo; Sagnelli, Evangelista; Messina, Vincenzo; Ulisse Di Caprio, Domenico Umberto; Selva, Vincenzo; Toniutto, Pierluigi
Source
Gut. Feb 01, 2013 62(2):290-298
Subject
Language
English
ISSN
0017-5749
Abstract
OBJECTIVE: Treatment with peginterferon α-2a (PegIFN) for 48 weeks is the standard of care for selected HBeAg-negative patients chronically infected with hepatitis B virus (HBV), but with limited treatment efficacy. A study was undertaken to investigate whether treatment extension to 96 weeks improves the outcome in this patient population. METHODS: 128 HBeAg-negative patients (120 genotype D) were randomised to weekly 180 μg PegIFN for 48 weeks (group A, n=51), 180 μg PegIFN for 48 weeks followed by 135 μg weekly for an additional 48 weeks (group B, n=52) or 180 μg PegIFN plus lamivudine (100 mg/day) for 48 weeks then 135 μg PegIFN for 48 weeks (group C, n=25). Endpoints were alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (primary), HBV DNA <2000 IU/ml and HBsAg clearance at 48 weeks after treatment. RESULTS: Forty-eight weeks after treatment, six patients in group A and 13 in group B achieved alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (11.8% vs 25.0%, p=0.08), 6 vs 15 patients had HBV DNA <2000 IU/ml (11.8% vs 28.8%, p=0.03), 0 vs 3 achieved HBsAg clearance (0% vs 5.8%, p=0.24) and 0 vs 5 had HBsAg <10 IU/ml (0% vs 9.6%, p=0.06). While extended PegIFN treatment was the strongest independent predictor of response, the combination with lamivudine did not improve responses. Discontinuation rates were similar among the groups (19.6%, 23.1%, 32.0%, p=0.81) and were mostly due to PegIFN-related adverse events. CONCLUSIONS: In HBeAg-negative genotype D patients with chronic hepatitis B, PegIFN treatment for 96 weeks was well tolerated and the post-treatment virological response improved significantly compared with 48 weeks of treatment. TRIAL REGISTRATION NUMBER: http://ClinicalTrials.gov registration number: NCT01095835.