[Efficacy of adefovir dipivoxil was not related to genotypes B and C of hepatitis B virus: a randomized, double-blind, multicenter clinical study].

OBJECTIVE

To determine the relationship between the response to adefovir dipivoxil (ADV) treatment in patients with HBV genotypes B and C of HBeAg positive chronic hepatitis B.

METHODS

This clinical trial was a randomized, double-blind, placebo-controlled, multicenter study. A total of 226 eligible patients with HBeAg positive chronic hepatitis B were randomized (in a ratio of 2:1) receiving ADV 10 mg/d for 48 weeks (ADV+ADV group) or placebo for 24 weeks followed by ADV 10 mg/d for 24 weeks (PLB+ADV group). The primary efficacy was virologic response. The genotypes of HBV were determined by PCR-restricted fragment length polymorphism (RFLP) method using serum samples before therapy. rtN236T and rtA181V mutations were confirmed by sequencing.

RESULTS

In this study, HBV genotype C was 66.7%, genotype B was 25.2%. Genotype B was more common in Guangzhou. Patients with genotype B were much younger than those with the genotype C. Patients with genotype B previously received less anti-HBV therapy. There were no significant difference in virological response (including mean reduction in HBV DNA level from baseline, serum HBV DNA load after treatment and HBV DNA undetectable rate) and serological response (the rate of HBeAg loss and HBeAg seroconversion) between patients infected with genotypes B and C in both treatment arms.

CONCLUSION

There were no significant difference in virological and serological response to ADV therapy between patients infected with HBV genotype B and C.