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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

  • Cai, Shaohang1, 2
  • Yu, Tao1
  • Jiang, Yegui3
  • Zhang, Yonghong4
  • Lv, Fangfang5
  • Peng, Jie1
  • 1 Southern Medical University, Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Guangzhou, Guangdong Province, 510515, China , Guangzhou (China)
  • 2 First Affiliated Hospital of Xiamen University, Xiamen, Fujian Province, China , Xiamen (China)
  • 3 Third Military Medical University, Southwest Hospital, Chongqing, China , Chongqing (China)
  • 4 Central South University, Second Xiangya Hospital, Changsha, Hunan Province, China , Changsha (China)
  • 5 Zhejiang University, Sir Run Run Shaw Hospital, Hangzhou, Zhejiang Province, China , Hangzhou (China)
Published Article
Clinical and Experimental Medicine
Springer International Publishing
Publication Date
Jul 12, 2015
DOI: 10.1007/s10238-015-0373-2
Springer Nature


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 × 107 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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