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.
Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B / P. Lampertico, M. Viganò, G.G. Di Costanzo, E. Sagnelli, M. Fasano, V. Di Marco, S. Boninsegna, P. Farci, S. Fargion, T. Giuberti, C. Iannacone, L. Regep, B. Massetto, F. Facchetti, M. Colombo. - In: GUT. - ISSN 0017-5749. - 62:2(2013 Feb), pp. 290-298.
|Titolo:||Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B|
LAMPERTICO, PIETRO (Primo)
FACCHETTI, FLORIANA (Penultimo)
COLOMBO, MASSIMO GIUSEPPE (Corresponding)
|Parole Chiave:||E-antigen; sustained response; interferon-alpha; lamivudine; epidemiology; retreatment; entecavir; trial|
|Settore Scientifico Disciplinare:||Settore MED/09 - Medicina Interna|
|Data di pubblicazione:||feb-2013|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1136/gutjnl-2011-301430|
|Appare nelle tipologie:||01 - Articolo su periodico|