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TITLE: Predictors of Serum HBsAg Decline in Chronic Hepatitis B Patients Undergoing Entecavir Therapy
AUTHORS (FIRST NAME, LAST NAME): Hsueh-Chou Lai1, 2, Cheng-Yuan Peng1, 4, Wen-Pang Su1, Chia-Hsin Lin1, Po-Heng Chuang1, Jon-Ta Kao1, 4, Sheng-Hung Chen1, 3
Institutional Author(s):
INSTITUTIONS (ALL): 1. Division of Hepato-gastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
2. School of Chinese Medicine and Graduate Institute of Clinical Medical Science, China Medical University , Taichung, Taiwan.
3. Graduate Institute of Clinical Medical Science, China Medical University , Taichung, Taiwan.
4. School of Medicine , China Medical University , Taichung, Taiwan.
ABSTRACT BODY: Background: The decline in quantitative serum hepatitis B surface antigen (qHBsAg) level and its predictors in chronic hepatitis B (CHB) patients undergoing long-term entecavir (ETV) therapy remain unclear. Patients and Methods: Three hundred and sixty-one treatment-naïve (321 compensated and 40 acutely decompensated) CHB patients had been treated with ETV for at least 1 year. Serum HBsAg and HBV DNA levels were measured with the Abbott Architect HBsAg QT assay and the Cobas Amplicor HBV Monitor Test throughout treatment, respectively. Results: The baseline features were: median age: 49 years, 75.3% men, 37.9% HBeAg-positive (N=137), 59.2% genotype B infection, median ALT: 87 IU/L, HBV DNA: 6.56 log10copies/mL, and qHBsAg: 3.3 log10IU/mL. Among them, 249, 186 and 94 patients had received ETV therapy for ≧3, 4 and 5 years, respectively (mean duration: 46.5±14.6 months (M)). At 3 and 12M of therapy, 25.6% (HBeAg-positive: 38.4% vs -negative: 17.7%) and 30.8% (HBeAg-positive:40.8% vs -negative: 24.9%) of patients had qHBsAg decline from baseline of ≧50%, respectively. For HBeAg-positive patients, there were significant declines in qHBsAg level between baseline and 3M, 12 and 24M (P=0.0281), and 36 and 48M (P=0.0116). For HBeAg-negative patients, there were significant declines in qHBsAg level between baseline and 3M, 6 and 12M,12 and 24M, 24 and 36M, and 36 and 48M (all P<0.05). Patients were categorized in three subgroups according to the pattern of qHBsAg decline from baseline:≧50% at 3M, ≧50% at 12M, and <50% at 12M. For HBeAg-positive patients, the subgroup with qHBsAg decline from baseline of ≧50% at 3M of therapy had significantly lower qHBsAg levels than the other two subgroups up to 3 years of treatment. Multivariate logistic regression analyses identified genotype B (OR=2.572, P=0.0460), ALT ≧120 IU/L (OR=9.295, P<0.0001) and baseline qHBsAg ≧5000 IU/mL (OR=3.795, P=0.0045) as predictors of qHBsAg decline from baseline of ≧50% at 3M of therapy. For HBeAg-negative patients, the qHBsAg levels between the subgroups with qHBsAg decline from baseline of ≧50% at 3 or 12M of therapy were similar but was significantly lower than the subgroup with qHBsAg decline from baseline of <50% at 12M of therapy. Multivariate logistic regression analyses identified ALT ≧120 IU/L (OR=8.255, P<0.0001) and baseline qHBsAg ≧5000 log10 IU/mL (OR=6.311, P<0.0001) as predictors of qHBsAg decline from baseline of ≧50% at 12M of therapy. Conclusion: Higher baseline serum qHBsAg and ALT levels are predictors of qHBsAg decline from baseline of ≧50% for both HBeAg-positive and -negative patients undergoing ETV therapy.
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