Abstract
Introduction: We previously demonstrated that 48 weeks of ADV therapy resulted in a significant median 73% reduction of serum HBsAg (Werle, Gastroenterology 2004). Changes in HBsAg were significantly and positively correlated with changes in intrahepatic cccDNA, total intrahepatocellular HBV DNA and serum HBV DNA. The number of HBcAg positive hepatocytes remained stable. Aim: To determine the reduction of serum HBsAg titer from baseline to end-of- treatment in CH-B patients undergoing antiviral combination therapy. Methods: 21/26 patients with HBeAg positive and negative CH-B completed a 48-week course of treatment with ADV and PegIFN in a single center pilot study as of September 2004. HBsAg was quantified in patient sera by ELISA using the Monolisa® AgHBs Ultra Kit (Biorad, France) with purified HBsAg as the standard (Hytest, Finland). Intrahepatic ccc- and HBV DNA was quantified as described earlier. Results: At baseline, median serum HBsAg titer was 257µg/ml. After 48 weeks of combination therapy median serum HBsAg titer decreased to 136µg/ml, a 47% reduction. cccDNA decreased from median 6 copies/hepatocyte to 0.2 copies/hepatocyte (–1.46log). Total intrahepatocellular HBV DNA was reduced by –2.1log10, serum HBV DNA decreased by–4.7log10. Changes in HBsAg were positively correlated with changes in total intracellular HBV DNA and serum HBV DNA. Conclusions: 48 weeks of combination therapy with PegIFN and ADV results in an approx. 50% decrease in serum HBsAg in chronic hepatitis B patients. Earlier studies suggested the decline in HBsAg titer during antiviral therapy with a nucleotide analogue due to the reduced reservoir of transcriptionally active cccDNA rather than to the loss of infected hepatocytes. Further analysis of this non-cytolytical mechanism for the clearance of HBV-infection is currently under way.
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