Cheng-Yuan Peng1, Tsung-Cheng Hsieh2, Tsai-Yuan Hsieh3, Kuo-Chih Tseng4, Chih-Lin Lin5, Tung-Hung Su6, Tai-Chung Tseng7, Hans Hsienhong Lin7, Chia-Chi Wang8, Jia-Horng Kao9. 1. School of Medicine, China Medical University, Taichung, Taiwan; Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan. 2. Institute of Medical Science, Tzu Chi University, Hualien, Taiwan. 3. Department of Gastroenterology, Tri-Service General Hospital, Taipei, Taiwan. 4. Department of Hepatology, Buddhist Tzu Chi General Hospital, Da-Lin Branch, Hualien, Taiwan; School of Medicine, Tzu Chi University, Hualien, Taiwan. 5. Department of Gastroenterology, Taipei City Hospital, Ren-Ai Branch, Taipei, Taiwan. 6. Graduate Institute of Clinical Medicine and Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan. 7. School of Medicine, Tzu Chi University, Hualien, Taiwan; Department of Hepatology, Buddhist Tzu Chi General Hospital, Taipei Branch, New Taipei City, Taiwan. 8. School of Medicine, Tzu Chi University, Hualien, Taiwan; Department of Hepatology, Buddhist Tzu Chi General Hospital, Taipei Branch, New Taipei City, Taiwan. Electronic address: uld888@yahoo.com.tw. 9. Graduate Institute of Clinical Medicine and Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan. Electronic address: kaojh@ntu.edu.tw.
Abstract
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-naïve 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 (27-1622) U/L and 7.7 (3.8-13.2) log10 IU/mL, respectively. The median treatment duration was 31.7 (24.3-69.6) months. The rate of HBeAg loss at 2 years was 30.9%. By univariate analysis, on-treatment complete virological response at Month 6 was associated with HBeAg loss at 2 years (p = 0.019). After adjustment for age, sex, cirrhosis, baseline ALT, and HBV-DNA levels, this factor remained significant in multivariate analysis (odds ratio: 4.35; 95% confidence interval: 1.24-15.24, p = 0.021). CONCLUSION: On-treatment complete virological response at Month 6 is a favorable factor predictive 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 therapy in HBeAg-positive CHB patients.
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-naïve 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 (27-1622) U/L and 7.7 (3.8-13.2) log10 IU/mL, respectively. The median treatment duration was 31.7 (24.3-69.6) months. The rate of HBeAg loss at 2 years was 30.9%. By univariate analysis, on-treatment complete virological response at Month 6 was associated with HBeAg loss at 2 years (p = 0.019). After adjustment for age, sex, cirrhosis, baseline ALT, and HBV-DNA levels, this factor remained significant in multivariate analysis (odds ratio: 4.35; 95% confidence interval: 1.24-15.24, p = 0.021). CONCLUSION: On-treatment complete virological response at Month 6 is a favorable factor predictive 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 therapy in HBeAg-positive CHB patients.