[Five years trial of entecavir for chronic hepatitis B patients failed with lamivudine therapy in the Chongqing area].
OBJECTIVE
To evaluate the efficacy and safety of five-year trail of entecavir for chronic hepatitis B patients failed with lamivudine therapy in the Chongqing area.


METHODS
32 patients failed with lamivudine therapy were enrolled in this study. In the double-blind phase, patients were randomly divided into entecavir 1.0 mg/d group (n = 28) and placebo group(n = 4) for 12 weeks. In the open-lable phase, patients received ETV 1.0 mg/d for 240 weeks. HBV DNA level, liver function, HBV serology were observed.


RESULTS
The mean reduction in HBV DNA level at week 12 was 4.05 log10 copies/ml in ETV group, and 0.08 log10 copies/ml in placebo group (P less than 0.05). The mean of HBV DNA level after 240 weeks of ETV treatment was decreased to 2.58 log10 copies/ml. The proportion of patients with HBV DNA less than 3 log10 copies/ml was 0, 6.25%, 15.6% , 50%, and 57.14% at 0, 8, 24, 96 and 240 weeks respectivfely. There were 2 patients with HBsAg seroconversion and 4 patients with HBeAg seroconversion at the end of the study. The ALT level returned to normal at week 12 and remained normal throughout the following 240 weeks. One patient had a severe adverse event during the trail.


CONCLUSIONS
Entecavir is effective and safe for the chronic hepatitis B patients failed with lamivudine therapy.
LI
Hong
H
Department of Infectious Diseases, Second Affiliated Hospital, Chongqing Medical University, Chongqing 400010, China.
WANG
Zhi-yi
ZY
ZHANG
Da-zhi
DZ
SHI
Xiao-feng
XF
ZHOU
Zhi
Z
REN
Hong
H
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D004311:Double-Blind Method; D024882:Drug Resistance, Viral; D005260:Female; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006513:Hepatitis B e Antigens / Q000032:analysis; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D013997:Time Factors; D016896:Treatment Outcome; D014779:Virus Replication / Q000187:drug effects; D055815:Young Adult
D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D019259:Lamivudine; C413685:entecavir; D006147:Guanine; D000410:Alanine Transaminase