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 mg PegIFN for 48 weeks (group A, n=51), 180 μg PegIFN for 48 weeks followed by 135 mg 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.
Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B / Lampertico, P.; Vigano, M.; Di Costanzo, G. G.; Sagnelli, E.; Fasano, M.; Di Marco, V.; Boninsegna, S.; Farci, P.; Fargion, S.; Giuberti, T.; Iannacone, C.; Regep, L.; Massetto, B.; Facchetti, F.; Colombo, M.; Andreone, P.; Riili, A.; Scuteri, A.; Cursaro, C.; Andriulli, A.; Niro, G. A.; Angarano, G.; Santantonio, T. A.; Palattella, M. S.; Brunetto, M.; Colombatto, P.; Coco, B.; Ciccorossi, P.; Oliveri, F.; Sacco, R.; Bruno, S.; Bollani, S.; Chiesa, A.; Carosi, G.; Baiguera, C.; Rossi, S.; Zaltron, S.; Puoti, M.; Colombo, M.; Cozzolongo, R.; Giannuzzi, V.; Craxi, A.; Calvaruso, V.; Venezia, G.; Lanza, A. G.; Di Perri, G.; Cariti, G.; Mollaretti, O.; De Blasi, T.; Kulmiye, C.; Rostagno, R.; Lai, M. E.; Serra, G.; Chessa, L.; Balestrieri, C.; Cauli, C.; Bertelli, C.; Fatta, E.; Fattovich, G.; Pasino, M.; Zanni, S.; Olivari, N.; Zagni, I.; Ferrari, C.; Schivazappa, S.; Laccabue, D.; Penna, A.; Gaeta, G.; Stanzione, M.; Stornaiuolo, G.; Martines, D.; Raimondo, G.; Caccamo, G.; Squadrito, G.; Isgro, G.; Rizzetto, M.; Lagget, M.; Carenzi, S.; Ruggiero, G.; Marrone, A.; Messina, V.; Di Caprio, D. U.; Selva, V.; Toniutto, P.. - In: GUT. - ISSN 0017-5749. - 62:2(2013), pp. 290-298. [10.1136/gutjnl-2011-301430]
Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B
Andreone P.;Raimondo G.;Ruggiero G.;
2013
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 mg PegIFN for 48 weeks (group A, n=51), 180 μg PegIFN for 48 weeks followed by 135 mg 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.
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