Entecavir Treatment for up to 5 Years in Patients with Hepatitis B e Antigen-Positive Chronic Hepatitis B

被引:484
作者
Chang, Ting-Tsung [1 ]
Lai, Ching-Lung [2 ]
Yoon, Seung Kew [3 ]
Lee, Samuel S. [4 ]
Coelho, Henrique Sergio M. [5 ]
Carrilho, Flair Jose [6 ]
Poordad, Fred [7 ]
Halota, Waldemar [8 ]
Horsmans, Yves [9 ]
Tsai, Naoky [10 ]
Zhang, Hui [11 ]
Tenney, Daniel J. [11 ]
Tamez, Ricardo [12 ]
Iloeje, Uchenna [11 ]
机构
[1] Natl Cheng Kung Univ, Coll Med, Tainan 70101, Taiwan
[2] Queen Mary Hosp, Hong Kong, Hong Kong, Peoples R China
[3] Catholic Univ Korea, Kangnam St Mary Hosp, Seoul, South Korea
[4] Univ Calgary, Foothills Prov Gen Hosp, Calgary, AB, Canada
[5] Univ Fed Rio de Janeiro, Hosp Univ Clementino Fraga Filho, Rio De Janeiro, Brazil
[6] Univ Sao Paulo, Sch Med, Dept Gastroenterol, Sao Paulo, Brazil
[7] Cedars Sinai Med Ctr, Dept Hepatol & Liver Transplantat, Los Angeles, CA 90048 USA
[8] Nicholas Copernicus Univ, Dept Infect Dis & Hepatol, Bydgoszcz, Poland
[9] Clin St Luc, Dept Gastroenterol & Hepatol, Brussels, Belgium
[10] Univ Hawaii, Honolulu, HI 96822 USA
[11] Bristol Myers Squibb Co, Res & Dev, Wallingford, CT 06492 USA
[12] Bristol Myers Squibb Co, Res & Dev, Princeton, NJ USA
关键词
TENOFOVIR DISOPROXIL FUMARATE; NUCLEOSIDE-NAIVE PATIENTS; ADEFOVIR DIPIVOXIL; HEPATOCELLULAR-CARCINOMA; PEGINTERFERON ALPHA-2A; RESISTANCE; LAMIVUDINE; RISK; TELBIVUDINE; MANAGEMENT;
D O I
10.1002/hep.23327
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Sustained virologic suppression is a primary goal of therapy for chronic hepatitis B (CHB). In study entecavir (ETV)-022, 48 weeks of entecavir 0.5 mg was superior to lamivudine for virologic suppression for hepatitis B e antigen (HBeAg)-positive CHB. A total of 183 entecavir-treated patients from ETV-022 subsequently enrolled in study ETV-901. We present the results after up to 5 years (240 weeks) of continuous entecavir therapy. The entecavir long-term cohort consists of patients who received >= 1 year of entecavir 0.5 mg in ETV-022 and then entered ETV-901 with a treatment gap <= 35 days. In ETV-901 the entecavir dose was 1.0 mg daily. For patients with samples available at Year 5, proportions with hepatitis B virus (HBV) DNA <300 copies/mL, normal alanine aminotransferase (ALT) levels, HBeAg loss, and HBeAg seroconversion were determined. In all, 146 patients met criteria for inclusion in the entecavir long-term cohort. At Year 5, 94% (88/94) had HBV DNA <300 copies/mL and 80% (78/98) had normal ALT levels. In addition to patients who achieved serologic responses during study ETV-022, 23% (33/141) achieved HBeAg seroconversion and 1.4% (2/145) lost hepatitis B surface antigen (HBsAg) during study ETV-901. Through 5 years, entecavir resistance emerged in one patient. The safety profile of entecavir was consistent with previous reports. Conclusion: Extended therapy with entecavir through 5 years maintained or increased rates of HBV DNA suppression and ALT normalization. Additional patients also achieved HBeAg loss and seroconversion. Entecavir provides sustained viral suppression with minimal resistance during long-term treatment of HBeAg-positive CHB. (HEPATOLOGY 2010;51:422-430.)
引用
收藏
页码:422 / 430
页数:9
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