Five years trial of entecavir for chronic hepatitis B patients failed with lamivudine therapy in the Chongqing area.
- Author:
Hong LI
1
;
Zhi-yi WANG
;
Da-zhi ZHANG
;
Xiao-feng SHI
;
Zhi ZHOU
;
Hong REN
Author Information
- Publication Type:Journal Article
- MeSH: Adult; 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 Surface Antigens; analysis; Hepatitis B e Antigens; analysis; Hepatitis B, Chronic; drug therapy; virology; Humans; Lamivudine; administration & dosage; therapeutic use; Male; Time Factors; Treatment Outcome; Virus Replication; drug effects; Young Adult
- From: Chinese Journal of Hepatology 2009;17(5):338-341
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo evaluate the efficacy and safety of five-year trail of entecavir for chronic hepatitis B patients failed with lamivudine therapy in the Chongqing area.
METHODS32 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.
RESULTSThe 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.
CONCLUSIONEntecavir is effective and safe for the chronic hepatitis B patients failed with lamivudine therapy.