Abstract

BACKGROUND: The aim of this study was to compare the effect of combination lamivudine (LAM) and adefovir dipivoxil (ADV) versus entecavir (ETV) monotherapy for naïve HBeAg-positive chronic hepatitis B (CHB) patients.

MATERIAL AND METHODS: Fifty enrolled patients with CHB were evenly divided into 2 groups: a group treated with of lamivudine (LAM) (100 mg/day) plus adefovir (ADV) (10 mg/day) combination, and a group treated with entecavir (ETV) (0.5 mg/day). Serum levels of ALT, AST, creatinine, bilirubin, HBsAg, HBeAg and HBV viral load, and genotypic resistance were analyzed at 0, 12, 24, 52, and 104 weeks. HBV DNA levels were determined by real-time PCR and HBsAg and HBeAg by chemiluminescence. Serum levels of ALT, AST, creatinine, and bilirubin were measured by an automatic biochemical analyzer. Data analysis was performed with SPSS 12.0 software.

RESULTS: There were no significant differences in the virological response (VR) rates between LAM+ADV and ETV cohorts at 24, 52, and 104 weeks (P>0.05). The HBeAg seroconversion rates were 28% and 20%, and the biochemical response (BR) rates were 88% and 84% at week 104 in the LAM+ADV and ETV groups, respectively. The rates of undetectable HBV DNA, HBeAg seroconversion, and ALT normalization rates were similar in both cohorts. No virological breakthrough or serious adverse effects were noted for any patient during the study period.

CONCLUSIONS: Both LAM + ADV combination therapy and ETV monotherapy were effective and safe in the treatment of ­naïve HBeAg-positive CHB patients. However, further studies are needed to obtain long-term results.

Keywords: Adult, Adenine - therapeutic use, Alanine Transaminase - blood, Analysis of Variance, Aspartate Aminotransferases - blood, Bilirubin - metabolism, Drug Combinations, Enzyme-Linked Immunosorbent Assay, Guanine - therapeutic use, Hepatitis B Surface Antigens - blood, Hepatitis B e Antigens - blood, Hepatitis B virus - drug effects, Hepatitis B, Chronic - drug therapy, Lamivudine - therapeutic use, Organophosphonates - therapeutic use, Pilot Projects