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BASELINE HBsAg LEVEL PREDICT HBsAg LOSS IN CHRONIC HEPATITIS B PATIENTS TREATED WITH A COMBINATION OF PEGINTERFERON ALFA-2A AND ADEFOVIR: AN INTERIM ANALYSIS
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EASL April 23 2009 Copenhagen Denmark
Reported by Jules Levin
B.
Takkenberg1, H. Zaaijer2, C. Weegink1, V. Terpstra3, M. Dijkgraaf4, P. Jansen1, H. Janssen5, M. Beld6, H. Reesink1
1AMC Liver Center; Department of Gastroenterology and Hepatology, 2Laboratory of Clinical Virology, Department of Medical Microbiology, 3Department of Pathology, 4Department of Clinical Epidemiology and Biostatistics, Academic Medical Center; University of Amsterdam, Amsterdam, 5Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, 6Royal Tropical Institute, KIT Biomedical Research, Amsterdam, The Netherlands
Results: 55 CHB patients (25 HBeAg positive and 30 HBeAg negative) had completed 48 weeks of treatment, and 45 patients reached end of follow-up (20 HBeAg positive and 25 HBeAg negative). In 11 patients (5 HBeAg positive and 6 HBeAg negative) HBsAg loss was observed (Table 1). In one patient, HBsAg re-appeared during long-term follow-up period. HBsAg clearance was 18% and 22%, 24 and 72 weeks after end of treatment. HBsAg loss was 6/15 (40%) observed in genotype A and 4/30 (13%) genotype non-A (p=0.10). In the 10 patients who had HBsAg loss at end of follow-up, median log HBsAg levels (U/L) at baseline was 2.23 U/L (iqr 2.10-2.47 U/L), and was significantly lower than observed in patients who did not achieve HBsAg loss (2.42 U/L, iqr 2.40-2.50; p=0.029). In HBeAg positive as well as in HBeAg negative CHB patients, baseline HBV DNA levels did not vary between patients who lost HBsAg and patients that did not lose HBsAg (p=0.57 and p=0.24). If baseline log HBsAg in patients was lower than 2.25 U/L, a positive predictive value (PPV) of 75% (95% CI 62%-88%) for achieving HBsAg loss was calculated.
Conclusion: This interim analysis showed that in CHB patients combination therapy with Peg-IFN and ADF for 48 weeks induced a high rate of HBsAg loss (18-22%). Baseline HBsAg levels ≤ 2.25 log U/L predicted HBsAg clearance (PPV 75%).
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