Serum levels of surface large envelope proteins: prognostic markers for hepatitis B e antigen-negative patients with adefovir dipivoxil treatment.

BACKGROUND: The present investigation was undertaken to evaluate the prognostic role of pretreatment serum hepatitis B virus (HBV) surface large envelope protein (LHBs) levels in the curative effects after 48-week adefovir dipivoxil (ADV) treatment. METHODS: A total of 128 patients received ADV once daily for 48 weeks. Serum levels of LHBs were detected by ELISA. Real-time quantitative PCR was used to analyse HBV genotype and HBV DNA copies in serum. Receiver operating characteristic (ROC) curve analysis was performed to assess the optimal cutoff value of pretreatment LHBs for predicting the curative effects of ADV treatment. RESULTS: After ADV treatment for 48 weeks, viral response and partial response were 31.4% (16/51) and 29.4% (15/51), respectively, in patients from the hepatitis B e antigen (HBeAg)-positive group; viral response and partial response were 39.7% (27/68) and 39.7% (27/68), respectively, in patients from the HBeAg-negative group. HBeAg-negative patients with high serum levels of LHBs had low response rates to antiviral therapy. ROC curve analysis showed that HBeAg-negative patients with serum LHBs levels > or =3.889 microg/ml at baseline predicted non-response to antiviral therapy. The sensitivity was 42.5% and specificity was 92.86%. Among a total of 19 patients with high serum levels of LHBs (> or =3.889 microg/ml) at baseline, only 2 (11%) patients responded to antiviral therapy. There was no correlation observed between HBV genotype and effects of ADV treatment. CONCLUSIONS: HBeAg-negative patients with high serum levels of LHBs (> or =3.889 microg/ml) at baseline should not be recommended to receive ADV treatment.