ORIGINAL ARTICLE
HBV-DNA level at 6 months of entecavir treatment predicts HBeAg loss in HBeAg-positive chronic hepatitis B patients
Cheng-Yuan Penga,b, Tsung-Cheng Hsiehc, Tsai-Yuan Hsieh d, Kuo-Chih Tsenge,f, Chih-Lin Ling, Tung-Hung Suh, Tai-Chung Tsengf,i, Hans Hsienhong Linf,i, Chia-Chi Wangf,i,**, Jia-Horng Kaoh,*
a School of Medicine, China Medical University, Taichung, Taiwan
b Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
c Institute of Medical Science, Tzu Chi University, Hualien, Taiwan
d Department of Gastroenterology, Tri-Service General Hospital, Taipei, Taiwan
e Department of Hepatology, Buddhist Tzu Chi General Hospital, Da-Lin Branch, Hualien, Taiwan
f School of Medicine, Tzu Chi University, Hualien, Taiwan
g Department of Gastroenterology, Taipei City Hospital, Ren-Ai Branch, Taipei, Taiwan
h Graduate Institute of Clinical Medicine and Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
i Department of Hepatology, Buddhist Tzu Chi General Hospital, Taipei Branch, New Taipei City, Taiwan
Received 1 June 2013; received in revised form 29 October 2013; accepted 31 October 2013
KEYWORDS chronic hepatitis B; complete virological response; entecavir; hepatitis B e antigen; HBeAg loss
Background/Purpose: To evaluate whether on-treatment HBV-DNA level could predict the treatment response to entecavir in hepatitis B e antigen (HBe)-positive chronic hepatitis B (CHB) patients.
Methods: A total of 68 treatment-naı ¨ve HBeAg-positive patients (75% male, mean age at 46.6 - 11.9 years) receiving at least 2 years of entecavir therapy were enrolled. The primary therapeutic endpoint was HBeAg loss. On-treatment complete virological response was defined as serum HBV-DNA < 63 IU/mL.
Results: The median baseline alanine aminotransferase (ALT) and HBV-DNA levels were 199.5 (27e1622) U/L and 7.7 (3.8e13.2) log10IU/mL, respectively. The median treatment duration was 31.7 (24.3e69.6) months. The rate of HBeAg loss at 2 years was 30.9%. By univariate anal- ysis, on-treatment complete virological response at Month 6 was associated with HBeAg loss at 2 years (p Z 0.019). After adjustment for age, gender, cirrhosis, baseline ALT, and HBV-DNA levels, this factor remained significant in multivariate analysis (odds ratio: 4.35; 95% confi- dence interval: 1.24e15.24, p Z 0.021). Conclusion: On-treatment complete virological response at Month 6 is a favorable factor pre- dictive of HBeAg loss at 2 years of entecavir therapy. Therefore, measurement of serum HBV- DNA level at 6 months of entecavir therapy is optimal to predict HBeAg loss at 2 years of ther- apy in HBeAg-positive CHB patients. Copyright ª 2013, Elsevier Taiwan LLC & Formosan Medical Association. All rights reserved. 作者: StephenW 时间: 2014-2-6 20:56