Results of 3 years of continuous entecavir treatment in nucleos(t)ide-naive chronic hepatitis B patients.
- Author:
Guang-bi YAO
1
;
Hong REN
;
Dao-zhen XU
;
Xia-qiu ZHOU
;
Ji-dong JIA
;
Yu-ming WANG
;
Cheng-wei CHEN
Author Information
- Publication Type:Journal Article
- MeSH: Adolescent; Adult; Aged; Alanine Transaminase; blood; Antiviral Agents; administration & dosage; therapeutic use; DNA, Viral; blood; Double-Blind Method; Drug Resistance, Viral; Female; Guanine; administration & dosage; analogs & derivatives; therapeutic use; Hepatitis B e Antigens; blood; Hepatitis B, Chronic; blood; drug therapy; virology; Humans; Lamivudine; administration & dosage; therapeutic use; Male; Middle Aged; Time Factors; Treatment Outcome; Viral Load; Young Adult
- From: Chinese Journal of Hepatology 2009;17(12):881-886
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo evaluate the virological, serological and biochemical outcomes of 3 years of entecavir (ETV) treatment in nucleoside-naive chronic hepatitis B patients.
METHODSThis study was divided into two stages: Patients receiving either ETV 0.5 mg/d (n = 258) or lamivudine (LAM) 100 mg/d (n = 261) entered the initial 96-week randomized, double blind, controlled efficacy study. Patients not achieving a consolidated response (HBV DNA less than 0.7 MEq/ml, ALT less than 1.25 times*ULN, and if HBeAg-positive at baseline, loss of HBeAg for >or= 24 weeks), or those experienced viral breakthrough or relapse, entered a 48-week entecavir rollover study.
RESULTS96 weeks after the treatment, 79% of ETV treated and 46% of LAM treated patients had HBV DNA less than 300 copies/ml (P < 0.0001), 96% of ETV treated and 92% of LAM treated patients had normalized ALT (P = 0.06). 21% of ETV treated and 23% of LAM treated patients achieved HBeAg seroconversion. Among the 160 patients received continuous ETV for 144 weeks, 89% had undetectable serum HBV DNA, 86% showed ALT normalization, and 27% achieved HBeAg seroconversion. ETV resistance was rare: only 3 patients showed ETV resistance 96 weeks after the treatment, and additional 2 patients developed ETV resistance during the following 48 weeks, genotyping indicated the ETV resistance was caused by gene mutation. Adverse event rates in ETV-treated patients were similar to those in LAM-treated patients, but fewer ALT flares were observed in ETV-treated patients.
CONCLUSIONSThis study demonstrates that ETV treatment results in long-term HBV suppression and ALT normalization in Chinese CHB patients, and is associated with low rate of drug resistance.