Validation of a stopping rule at week 12 using HBsAg and HBV DNA for HBeAg-negative patients treated with peginterferon alfa-2a

Vincent Rijckborst, Bettina Hansen, P Ferenci, MR Brunetto, F Tabak, Y Cakaloglu, AG Lanza, V Messina, C Iannacone, B Massetto, L Regep, M Colombo, HLA Janssen, P Lampertico

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Abstract

Background & Aims: It was recently demonstrated that none of the hepatitis B e antigen (HBeAg)-negative patients without any serum hepatitis B surface antigen (HBsAg) decline and with <2 log hepatitis B virus (HBV) DNA decline at week 12 of a 48-week peginterferon alfa-2a (PEG-IFN) treatment course achieved a sustained response (SR). We aimed at validating this stopping rule in two independent trials. Methods: HBeAg-negative patients receiving 48 or 96 weeks of PEG-IFN in the phase III registration trial (N = 85) and PegBeLiver study (N = 75) were stratified according to the presence of any HBsAg decline and/or >= 2 log HBV DNA decline at week 12. SR was defined as HBV DNA <2000 IU/ml and normal alanine aminotransferase 24 weeks after treatment. Results: The original PARC trial included 102 patients (genotype A/D/other: 14/81/7), 25 (25%) had an SR. The validation dataset consisted of 160 patients (genotype A/B/C/D/other: 10/18/34/91/7), 57(36%) achieved an SR. The stopping rule performed well across the two studies (p = 0.001) and its negative predictive value [NPV] was 95% in the validation dataset harbouring genotypes A-D. Its performance was best for genotype D. Moreover, among the 34 patients treated for 96 weeks, none of the 7 (21 Conclusions: We confirmed in two independent studies that the combination of HBsAg and HBV DNA levels at week 12 identifies HBeAg-negative patients with a very low chance of SR to either 48 or 96 weeks of PEG-IFN therapy. (C) 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Original languageUndefined/Unknown
Pages (from-to)1006-1011
Number of pages6
JournalJournal of Hepatology
Volume56
Issue number5
DOIs
Publication statusPublished - 2012

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  • EMC MM-04-20-02-A

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