Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B. Issue 2 (2nd August 2012)

• Record Type: Journal Article
• Authors: 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
• Other Names: Andreone Pietro author non-byline.; Riili Anna author non-byline.; Scuteri Alessandra author non-byline.; Cursaro Carmela author non-byline.; Andriulli Angelo author non-byline.; Anna Niro Grazia author non-byline.; Angarano Gioacchino author non-byline.; Fasano Massimo author non-byline.; Santantonio Teresa Antonia author non-byline.; Palattella Maria Stefania author non-byline.; Brunetto Maurizia author non-byline.; Colombatto Piero author non-byline.; Coco Barbara author non-byline.; Ciccorossi Pietro author non-byline.; Oliveri Filippo author non-byline.; Sacco Rodolfo author non-byline.; Bruno Savino author non-byline.; Bollani Simona author non-byline.; Chiesa Alberto author non-byline.; Carosi Giampiero author non-byline.; Baiguera Chiara author non-byline.; Rossi Stefania author non-byline.; Zaltron Serena author non-byline.; Puoti Massimo author non-byline.; Colombo Massimo author non-byline.; Lampertico Pietro author non-byline.; Cozzolongo Raffaele author non-byline.; Giannuzzi Vito author non-byline.; Craxì Antonio author non-byline.; Di Marco Vito author non-byline.; Calvaruso Vincenza author non-byline.; Venezia Giovanna author non-byline.; Di Costanzo Giovan Giuseppe author non-byline.; Lanza Alfonso Galeota author non-byline.; Di Perri Giovanni author non-byline.; Cariti Giuseppe author non-byline.; Mollaretti Oscar author non-byline.; De Blasi Tiziano author non-byline.; Kulmiye Cumar author non-byline.; Rostagno Roberto author non-byline.; Farci Patrizia author non-byline.; Eliana Lai Maria author non-byline.; Serra Giancarlo author non-byline.; Chessa Luchino author non-byline.; Balestrieri Cinzia author non-byline.; Cauli Cristiana author non-byline.; Fargion Silvia Rossana author non-byline.; Bertelli Cristina author non-byline.; Fatta Erika author non-byline.; Fattovich Giovanna author non-byline.; Pasino Michela author non-byline.; Zanni Silvia author non-byline.; Olivari Nicola author non-byline.; Zagni Irene author non-byline.; Ferrari Carlo author non-byline.; Schivazappa Simona author non-byline.; Giuberti Tiziana author non-byline.; Laccabue Diletta author non-byline.; Penna Amalia author non-byline.; Gaeta Giovanbattista author non-byline.; Stanzione Maria author non-byline.; Stornaiuolo Gianfranca author non-byline.; Martines Diego author non-byline.; Boninsegna Sara author non-byline.; Raimondo Giovanni author non-byline.; Caccamo Gaia author non-byline.; Squadrito Giovanni author non-byline.; Isgrò Graziella author non-byline.; Rizzetto Mario author non-byline.; Lagget Marco author non-byline.; Carenzi Silvia author non-byline.; Ruggiero Giuseppe author non-byline.; Marrone Aldo author non-byline.; Sagnelli Evangelista author non-byline.; Messina Vincenzo author non-byline.; Ulisse Di Caprio Domenico Umberto author non-byline.; Selva Vincenzo author non-byline.; Toniutto Pierluigi author non-byline.;
• Is Part Of: Gut. Volume 62:Issue 2(2013)
• Page Start: 290
• Page End: 298
• Publication Date: 2012-08-02
• Subjects: Hepatitis B virus -- HBV DNA -- HBsAg -- pegylated interferon -- lamivudine -- hepatitis B -- hepatocellular carcinoma -- cirrhosis -- hepatitis C -- iron overload -- chronic liver disease -- liver -- hepatitis; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2011-301430
• Languages: English
• ISSNs: 0017-5749

Abstract

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 .