title: [Comparison of lamivudine or interferon monotherapy and sequential therapy in chronic hepatitis B: a random controlled trial].
abstract: OBJECTIVE
  To compare the efficacy and safety of lamivudine or interferon monotherapy and sequential therapy in HBeAg positive chronic hepatitis B patients.
  
  
  METHODS
  A total of 225 patients with HBeAg positive chronic hepatitis B were randomized into 3 groups: sequential group (group A, 83 patients), lamivudine group (group B, 89 patients) and interferon group (group C, 53 patients). Group A was administrated with lamivudine 100 mg/d for 32 week, and 5 million units of interferon alpha 2b injected subcutaneously every other day lasting for 24 week were added since week 25. Group B was administrated with lamivudine 100 mg/d for 48 week. Group B was injected with 5 million units of interferon alpha 2b subcutaneously every other day for 24 week. All subjects were followed up for 24 week. Serum HBV DNAs were measured quantitatively by PCR. HBV mutations were analyzed by PCR-RFLP.
  
  
  RESULTS
  For groups A, B and C, baseline HBV DNAs were 7.8±1.0, 7.9±1.1 and 8.0±0.9 log10 copies/mL, respectively, P>0.05. Baseline ALTs were 167.5 (99.0, 267.8), 134.0 (101.0,275.0) and 131.0 (99.0, 192.8)U/L, respectively, P>0.05. At the end of the treatment, HBV DNA decrease rates for groups A, B and C were 78.2%, 87.8% and 78.4% (P>0.05), respectively. At the end of the follow-up, HBV DNA decrease rates for groups A, B and C were 54.4%, 63.6% and 66.7% (P>0.05), respectively. At the end of the treatment, group B (83.5%, P<0.05) achieved the highest response rate and group C achieved the lowest (39.6%, P<0.05). At the end of the follow-up, the response rates for groups A, B and C were 36.2%, 54.4% and 42.1% (P>0.05), respectively. YMDD motif mutation rate in group A was lower than that of group B (10.5% vs 26.9%, P<0.05) at the end of the treatment.
  
  
  CONCLUSIONS
  Sequential therapy decreased hepatitis B virus mutation. But no efficacy advantages were found in sequential therapy than in lamivudine or interferon monotherapy.
authors.affiliation: Department of Infectious Diseases, Peking University First Hospital, Beijing 100034, China.
authors.forename: Jing-hang
authors.initials: JH
authors.lastname: Xu
authors.forename: Yan-yan
authors.initials: YY
authors.lastname: Yu
authors.forename: Chong-wen
authors.initials: CW
authors.lastname: Si
authors.forename: Xin-yue
authors.initials: XY
authors.lastname: Chen
authors.forename: Zhong-hou
authors.initials: ZH
authors.lastname: Han
authors.forename: Yong
authors.initials: Y
authors.lastname: Chen
authors.forename: Wen-jin
authors.initials: WJ
authors.lastname: Zhang
authors.forename: Dao-zhen
authors.initials: DZ
authors.lastname: Xu
authors.forename: Yu-ping
authors.initials: YP
authors.lastname: Chen
authors.forename: Min
authors.initials: M
authors.lastname: Yu
authors.forename: Hong-li
authors.initials: HL
authors.lastname: Xi
authors.forename: Xue-ying
authors.initials: XY
authors.lastname: Li
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D019259:Lamivudine