Journal
JOURNAL OF HEPATOLOGY
Volume 56, Issue 5, Pages 1006-1011Publisher
ELSEVIER
DOI: 10.1016/j.jhep.2011.12.007
Keywords
HBV therapy; Immunomodulator; Nucleos(t)ide analogues; Peginterferon; Quantitative HBsAg; HBV genotype
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Funding
- Bristol Myers Squibb
- Gilead Sciences
- Novartis
- Roche
- Merck
- Innogenetics
- Foundation for Liver and Gastrointestinal Research (SLO) Rotterdam, the Netherlands
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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%) without HBsAg decline and with <2 log HBV DNA decline at week 12 achieved an SR (NPV 100%). 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.
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