Efficacy of entecavir in chronic hepatitis B patients with persistently normal alanine aminotransferase: Randomized, double-blind, placebo-controlled study

Kuo Chih Tseng, Chi Yi Chen, Hung Wen Tsai, Ting Tsung Chang, Wan Long Chuang, Ping I. Hsu, Wen Chun Liu, Pin Nan Cheng

研究成果: Article

6 引文 (Scopus)

摘要

Background: It is still inconclusive whether chronic hepatitis B (CHB) patients with persistently normal alanine aminotransferase (PNALT) should receive nucleoside/nucleotide analogues. This study is to evaluate the efficacy of entecavir in improving liver histology in CHB patients with PNALT. Methods: In this prospective randomized, double-blind, placebo-controlled study, 380 CHB patients with PNALT were screened, 82 patients received biopsy and 43 patients met the HBV DNA and histology criteria and were randomly assigned to either an entecavir or placebo group for 52 weeks, with 22 and 21 in each group, respectively. The primary objective was to evaluate histological improvement. The secondary objective is to evaluate virological efficacy. Results: A total of eight (38.1%) patients in the entecavir group and eight (44.4%) in the placebo group (P=0.752) showed histological improvement. The decrease in total Knodell scores (±SD) was 1.3 ±1.9 in the entecavir group and 1.5 ±2.2 in the placebo group (P=0.803). The subjects with undetectable HBV DNA at week 52 were 16/21 (76.2%) in the entecavir group and 0/18 (0%) in the placebo group (P<0.001). The mean HBV DNA reduction from baseline to week 52 was 4.73 ±0.83 in the entecavir and 0.25 ±0.81 in the placebo group (P<0.001). Conclusions: CHB patients with PNALT receiving entecavir therapy for one year achieved virological efficacy, but not histological benefit.

原文English
頁(從 - 到)755-764
頁數10
期刊Antiviral Therapy
19
發行號8
DOIs
出版狀態Published - 2014

指紋

Chronic Hepatitis B
Alanine Transaminase
Placebos
DNA
Histology
entecavir
Nucleosides
Nucleotides
Biopsy
Liver

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

引用此文

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title = "Efficacy of entecavir in chronic hepatitis B patients with persistently normal alanine aminotransferase: Randomized, double-blind, placebo-controlled study",
abstract = "Background: It is still inconclusive whether chronic hepatitis B (CHB) patients with persistently normal alanine aminotransferase (PNALT) should receive nucleoside/nucleotide analogues. This study is to evaluate the efficacy of entecavir in improving liver histology in CHB patients with PNALT. Methods: In this prospective randomized, double-blind, placebo-controlled study, 380 CHB patients with PNALT were screened, 82 patients received biopsy and 43 patients met the HBV DNA and histology criteria and were randomly assigned to either an entecavir or placebo group for 52 weeks, with 22 and 21 in each group, respectively. The primary objective was to evaluate histological improvement. The secondary objective is to evaluate virological efficacy. Results: A total of eight (38.1{\%}) patients in the entecavir group and eight (44.4{\%}) in the placebo group (P=0.752) showed histological improvement. The decrease in total Knodell scores (±SD) was 1.3 ±1.9 in the entecavir group and 1.5 ±2.2 in the placebo group (P=0.803). The subjects with undetectable HBV DNA at week 52 were 16/21 (76.2{\%}) in the entecavir group and 0/18 (0{\%}) in the placebo group (P<0.001). The mean HBV DNA reduction from baseline to week 52 was 4.73 ±0.83 in the entecavir and 0.25 ±0.81 in the placebo group (P<0.001). Conclusions: CHB patients with PNALT receiving entecavir therapy for one year achieved virological efficacy, but not histological benefit.",
author = "Tseng, {Kuo Chih} and Chen, {Chi Yi} and Tsai, {Hung Wen} and Chang, {Ting Tsung} and Chuang, {Wan Long} and Hsu, {Ping I.} and Liu, {Wen Chun} and Cheng, {Pin Nan}",
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TY - JOUR

T1 - Efficacy of entecavir in chronic hepatitis B patients with persistently normal alanine aminotransferase

T2 - Randomized, double-blind, placebo-controlled study

AU - Tseng, Kuo Chih

AU - Chen, Chi Yi

AU - Tsai, Hung Wen

AU - Chang, Ting Tsung

AU - Chuang, Wan Long

AU - Hsu, Ping I.

AU - Liu, Wen Chun

AU - Cheng, Pin Nan

PY - 2014

Y1 - 2014

N2 - Background: It is still inconclusive whether chronic hepatitis B (CHB) patients with persistently normal alanine aminotransferase (PNALT) should receive nucleoside/nucleotide analogues. This study is to evaluate the efficacy of entecavir in improving liver histology in CHB patients with PNALT. Methods: In this prospective randomized, double-blind, placebo-controlled study, 380 CHB patients with PNALT were screened, 82 patients received biopsy and 43 patients met the HBV DNA and histology criteria and were randomly assigned to either an entecavir or placebo group for 52 weeks, with 22 and 21 in each group, respectively. The primary objective was to evaluate histological improvement. The secondary objective is to evaluate virological efficacy. Results: A total of eight (38.1%) patients in the entecavir group and eight (44.4%) in the placebo group (P=0.752) showed histological improvement. The decrease in total Knodell scores (±SD) was 1.3 ±1.9 in the entecavir group and 1.5 ±2.2 in the placebo group (P=0.803). The subjects with undetectable HBV DNA at week 52 were 16/21 (76.2%) in the entecavir group and 0/18 (0%) in the placebo group (P<0.001). The mean HBV DNA reduction from baseline to week 52 was 4.73 ±0.83 in the entecavir and 0.25 ±0.81 in the placebo group (P<0.001). Conclusions: CHB patients with PNALT receiving entecavir therapy for one year achieved virological efficacy, but not histological benefit.

AB - Background: It is still inconclusive whether chronic hepatitis B (CHB) patients with persistently normal alanine aminotransferase (PNALT) should receive nucleoside/nucleotide analogues. This study is to evaluate the efficacy of entecavir in improving liver histology in CHB patients with PNALT. Methods: In this prospective randomized, double-blind, placebo-controlled study, 380 CHB patients with PNALT were screened, 82 patients received biopsy and 43 patients met the HBV DNA and histology criteria and were randomly assigned to either an entecavir or placebo group for 52 weeks, with 22 and 21 in each group, respectively. The primary objective was to evaluate histological improvement. The secondary objective is to evaluate virological efficacy. Results: A total of eight (38.1%) patients in the entecavir group and eight (44.4%) in the placebo group (P=0.752) showed histological improvement. The decrease in total Knodell scores (±SD) was 1.3 ±1.9 in the entecavir group and 1.5 ±2.2 in the placebo group (P=0.803). The subjects with undetectable HBV DNA at week 52 were 16/21 (76.2%) in the entecavir group and 0/18 (0%) in the placebo group (P<0.001). The mean HBV DNA reduction from baseline to week 52 was 4.73 ±0.83 in the entecavir and 0.25 ±0.81 in the placebo group (P<0.001). Conclusions: CHB patients with PNALT receiving entecavir therapy for one year achieved virological efficacy, but not histological benefit.

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DO - 10.3851/IMP2754

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