In study ETV-056, which included Chinese patients who previously failed lamivudine (Epivir-HBV) therapy, treatment with 48 weeks of entecavir (Baraclude) resulted in 27% of participants achieving HBV DNA < 300 copies/mL.

Thereafter, 138 entecavir-treated patients from study ETV-056 enrolled in a rollover study, ETV-050. At the 43rd annual meeting of the European Association for the Study of the Liver (EASL) last month in Milan, researchers presented efficacy and safety results from a cohort of patients from ETV-056and ETV-050 who received at least 36 weeks of continuous therapy with entecavir.

The ETV-056 continuous entecavir cohort included 128 patients. Analysis of this cohort allowed evaluation of safety and virological, serological, and biochemical (ALT) outcomes and after 3 years of continuous treatment with 1 mg entecavir in patients with available samples at week 144.

Results

• Efficacy parameters for patients who completed 3 years of therapy are presented in the table below.

• The safety profile of entecavir was consistent with previously reported experience.

The investigators concluded, "In this cohort of Chinese patients who previously failed lamivudine therapy, continuous treatment with 3 years of entecavir resulted in 55% achieving undetectable HBV DNA and 65% achieving ALT normalization."

Clinical Immunology Research Center, Shanghai Jing An Central Hospital, Shanghai, China;Beijing Ditan Hospital, Beijing, China; No.2 Hospital Affiliated to Chongqing Medical University, Chongqing, China; Ruijin Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China; Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China; Southwest Hospital Affiliated to the 3rd Military Medical University, Chongqing, China; Shanghai Liver Disease Research Center of Nanjing Military Area, 85th Hospital of PLA, China; Bristol-Myers Squibb Company Research and Development, Belgium and Wallingford, CT.

5/06/08

Reference
GB Yao, DZ Xu, H Ren, and others. Three years of continuous entecavir treatment in Chinese patients who had previously failed lamivudine: results from studies entecavir-056 and -050. 43rd Annual Meeting of the European Association for the Study of the Liver (EASL 2008). Milan, Italy. April 23-27, 2008.