Consolidation therapy for HBeAg-positive Asian chronic hepatitis B patients receiving lamivudine treatment: a multicentre study.

OBJECTIVES

For hepatitis B e antigen (HBeAg)-positive patients, continuing therapy (consolidation) for 6-12 months before cessation of nucleos(t)ide analogues (NAs) was recommended. This study aimed to investigate whether a longer period of lamivudine consolidation therapy leads to better outcomes and the clinical factors associated with response.

METHODS

Combined response [HBeAg seroconversion and undetectable serum hepatitis B virus (HBV) DNA by PCR assay] 6 months [end of follow-up (EOF)] after cessation of therapy was assessed in 101 HBeAg-positive chronically infected patients who received continued long-term lamivudine treatment and achieved a combined response at the end of treatment.

RESULTS

The rate of combined response at EOF was 40.6%. A lower pretreatment HBV DNA level, a longer duration of consolidation therapy, pretreatment hepatitis B surface antigen titre <1500 IU/mL and a higher proportion of consolidation duration of >18 months were significantly associated with combined response. A lower pretreatment HBV DNA level and a longer duration of consolidation therapy were independent factors associated with combined response at EOF by multivariate logistic regression analyses. The rate of combined response was 71.4%, 39.0% and 25.6% in patients with consolidation duration of >18 months, 12-18 months and <12 months, respectively (P = 0.001). Consolidation therapy for >18 months achieved a significantly higher rate of combined response at EOF in patients achieving combined response within or after 6 months.

CONCLUSIONS

Consolidation therapy for >18 months significantly improved the outcome of lamivudine therapy, particularly for patients who achieved a combined response after 6 months.