[A double-blind, double-dummy, randomized, controlled study of entecavir versus lamivudine for treatment of chronic hepatitis B].
OBJECTIVE
This study was to evaluate the antiviral efficacy and safety in nucleoside naive Chinese patients with chronic hepatitis B (CHB) treated with entecavir (ETV) or lamivadine (LVD).


METHODS
The trial was a randomized, double-blind, double-dummy and control design. 519 nucleoside naive CHB patients were treated with daily dose of ETV 0.5 mg (258 patients) or LVD 100 mg (261 patients) for at least 52 weeks. The primary endpoint was a composite endpoint of HBV DNA < 0.7 MEq/ml by bDNA assay and ALT < 1.25 x ULN at week 48. HBV DNA levels were also measured by the Roche Cobas Amplicor(TM) PCR assay at weeks 12, 24, 36 and 48. Clinical and laboratory adverse events were recorded every 4 weeks.


RESULTS
Baseline characteristics were well balanced between treatment groups. The primary end point were achieved in 90% of ETV treated patients versus 69% of LVD treated patients (P < 0.0001). The mean HBV DNA level decreased 5.9 lg copies/ml (by PCR assay) from baseline in ETV group versus 4.3 lg copies/ml in LVD group (P < 0.0001). The serum HBV DNA become undetectable (< 300 copies/ml by PCR) in 76% of ETV group versus 43% of LVD group (P < 0.0001). The normalization of ALT were 90% in ETV group versus 78% in LVD group (P = 0.0003). The difference of HBeAg seroconversion rates between this 2 groups (15% vs 18%) at week 48 was no statistically significant. The overall incidence of adverse events (AEs) was comparable: 60% of ETV patients and 56% of LVD patients reported AEs; and 3% of ETV patients and 5% of LVD patients reported serious AEs.


CONCLUSIONS
ETV achieves better virologic and biochemical improvements in nucleoside-naive patients with CHB while the safety profile is comparable to LVD.
Yao
Guang-bi
GB
Clinical Immunology Research Center, Shanghai Jing An Qu Central Hospital, Shanghai 200040, China. yaogb@yahoo.com.cn
Zhu
Mei
M
Wang
Yu-ming
YM
Xu
Dao-zhen
DZ
Tan
De-ming
DM
Chen
Cheng-wei
CW
Hou
Jin-lin
JL
D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D019562:Viral Load
D000998:Antiviral Agents; D019259:Lamivudine; C413685:entecavir; D006147:Guanine