Results of 3 years of continuous entecavir treatment in nucleos(t)ide-naive chronic hepatitis B patients

• Published in: Zhonghua gan zang bing za zhi Vol. 17; no. 12; p. 881
• Main Authors: Yao, Guang-bi, Ren, Hong, Xu, Dao-zhen, Zhou, Xia-qiu, Jia, Ji-dong, Wang, Yu-ming, Chen, Cheng-wei
• Format: Journal Article
• Language: Chinese
• Published: China 01.12.2009
• Subjects: Adolescent; Adult; Aged; Alanine Transaminase - blood; Antiviral Agents - administration & dosage; Antiviral Agents - therapeutic use; DNA, Viral - blood; Double-Blind Method; Drug Resistance, Viral; Female; Guanine - administration & dosage; Guanine - analogs & derivatives; Guanine - therapeutic use; Hepatitis B e Antigens - blood; Hepatitis B, Chronic - blood; Hepatitis B, Chronic - drug therapy; Hepatitis B, Chronic - virology; Humans; Lamivudine - administration & dosage; Lamivudine - therapeutic use; Male; Middle Aged; Time Factors; Treatment Outcome; Viral Load; Young Adult
• ISSN: 1007-3418

To evaluate the virological, serological and biochemical outcomes of 3 years of entecavir (ETV) treatment in nucleoside-naive chronic hepatitis B patients. This 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. 96 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 HB