PMID- 17313873
OWN - NLM
STAT- MEDLINE
DCOM- 20070622
LR  - 20141120
IS  - 0578-1426 (Print)
IS  - 0578-1426 (Linking)
VI  - 45
IP  - 11
DP  - 2006 Nov
TI  - [A double-blind, double-dummy, randomized, controlled study of entecavir versus 
      lamivudine for treatment of chronic hepatitis B].
PG  - 891-5
AB  - 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.
FAU - Yao, Guang-bi
AU  - Yao GB
AD  - Clinical Immunology Research Center, Shanghai Jing An Qu Central Hospital, 
      Shanghai 200040, China. yaogb@yahoo.com.cn
FAU - Zhu, Mei
AU  - Zhu M
FAU - Wang, Yu-ming
AU  - Wang YM
FAU - Xu, Dao-zhen
AU  - Xu DZ
FAU - Tan, De-ming
AU  - Tan DM
FAU - Chen, Cheng-wei
AU  - Chen CW
FAU - Hou, Jin-lin
AU  - Hou JL
LA  - chi
PT  - English Abstract
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - China
TA  - Zhonghua Nei Ke Za Zhi
JT  - Zhonghua nei ke za zhi
JID - 16210490R
RN  - 0 (Antiviral Agents)
RN  - 2T8Q726O95 (Lamivudine)
RN  - 5968Y6H45M (entecavir)
RN  - 5Z93L87A1R (Guanine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antiviral Agents/*therapeutic use
MH  - Double-Blind Method
MH  - Follow-Up Studies
MH  - Guanine/*analogs & derivatives/therapeutic use
MH  - Hepatitis B, Chronic/*drug therapy/virology
MH  - Humans
MH  - Lamivudine/*therapeutic use
MH  - Viral Load
EDAT- 2007/02/23 09:00
MHDA- 2007/06/23 09:00
CRDT- 2007/02/23 09:00
PHST- 2007/02/23 09:00 [pubmed]
PHST- 2007/06/23 09:00 [medline]
PHST- 2007/02/23 09:00 [entrez]
PST - ppublish
SO  - Zhonghua Nei Ke Za Zhi. 2006 Nov;45(11):891-5.