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Comparison of entecavir monotherapy and de novo lamivudine and adefovir combination therapy in HBeAg-positive chronic hepatitis B with high viral load: 48-week result.

Authors
  • Cai, Shaohang1, 2
  • Yu, Tao1
  • Jiang, Yegui3
  • Zhang, Yonghong4
  • Lv, Fangfang5
  • Peng, Jie6
  • 1 Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, China.
  • 2 First Affiliated Hospital of Xiamen University, Xiamen, Fujian Province, China.
  • 3 Southwest Hospital, Third Military Medical University, Chongqing, China.
  • 4 Second Xiangya Hospital, Central South University, Changsha, Hunan Province, China.
  • 5 Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang Province, China.
  • 6 Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, China. [email protected]
Type
Published Article
Journal
Clinical and experimental medicine
Publication Date
August 2016
Volume
16
Issue
3
Pages
429–436
Identifiers
DOI: 10.1007/s10238-015-0373-2
PMID: 26164128
Source
Medline
Keywords
License
Unknown

Abstract

This study compared virologic response to entecavir monotherapy and de novo lamivudine plus adefovir (LAM + ADV) combination therapy in patients with chronic hepatitis B (CHB) with high viral load (HVL). Hepatitis B e antigen (HBeAg)-positive patients [hepatitis B virus (HBV) DNA levels >1 × 10(7) copies/ml] were assigned to LAM + ADV or entecavir treatment. The primary efficacy endpoint measure of the multicenter prospective cohort study was proportion of patients with CHB with virologic response, defined as HBV DNA <300 copies/ml at week 48. During treatment, 39.1 % (18/46) of patients in the LAM + ADV group and 48.1 % (25/52) of those in the entecavir group achieved virologic response in week 48 (P = 0.37). A baseline alanine aminotransferase (ALT) level ≥5 × ULN (upper limit of normal) or baseline serum HBV DNA level <8 log10 IU/ml could predict virologic response at week 48 (P = 0.025). The mean reduction in HBV DNA was comparable (P = 0.45); no significant difference was found in the proportion of ALT normalization (P = 0.46) or HBeAg seroconversion (P = 0.88). Two cases of genotypic resistance were found (rtM204 V + rtL180 M and rtA181T/V) in the LAM + ADV group, with a resistance rate of 4.3 %; there was no genotypic resistance in the entecavir group (P = 0.13). De novo LAM + ADV combination therapy is as effective as entecavir monotherapy in HBeAg-positive patients with CHB with HVL. Moreover, genotypic resistance was only found in the LAM + ADV group at week 48. Baseline ALT levels ≥5 ULN or baseline serum HBV DNA levels <8 log10 IU/ml were favorable predictors of virologic response in CHB with HVL.

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