A one-year trial of entecavir treatment in patients with HBeAg-positive chronic hepatitis B.
OBJECTIVE
To evaluate the efficacy and safety of entecavir (ETV) in hepatitis Be antigen (HBeAg)-positive chronic hepatitis B (CHB) patients who had not received a nucleoside analogue and who had failed in lamivudine (LVD) therapy.


METHODS
Sixty-one patients were divided into three groups. Forty-two patients who had not received a nucleoside analogue were randomized into two groups: group A (n = 21) received LVD 100 mg/d and group B (n = 21) received ETV 0.5 mg/d. The remaing 19 patients treated with LVD (n = 19), who switched to ETV 1.0 mg/d served as group C. All patients were treated for 48 wk. HBV DNA levels were measured with polimerase-chain-reaction (PCR) analysis. Liver function tests, HBV serology and safety assessments were also conducted.


RESULTS
Significantly more patients in group B (52.1% and 71.4%) had undetectable HBV DNA levels than in groups A (35.8% and 38%; P < 0.0001) and C (10.6% and 21.1%, P < 0.0001) at wk 24 and 48, respectively. At wk 48, ALT levels were normalized in more patients in group B (85.7%) than in groups A (76.2%) and C (74%).


CONCLUSIONS
ETV had a significantly higher response rate than LVD in patients with HBeAg-positive CHB who had not previously received a nucleoside analogue; ETV can effectively inhibit the replication of HBV DNA and normalize the levels of ALT in refractory CHB patients treated with LVD; and ETV is safe in clinical application.
Ren
Fen-Yu
FY
Department of Gastroenterology and Hepatology, Yanbian University Hospital, Yanji 133000, Jilin Province, China. fenyu65@yahoo.com.cn
Piao
Dong-Ming
DM
Piao
Xi-Xu
XX
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004279:DNA, Viral; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D005260:Female; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics / Q000502:physiology; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D014779:Virus Replication / Q000187:drug effects
D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D019259:Lamivudine; C413685:entecavir; D006147:Guanine
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