title: [The degree of HBV suppression with 24 week telbivudine- or lamivudine-treatment in hepatitis B patients predicts the efficacy of the treatment at week 52].
abstract: OBJECTIVE
  To investigate the possibilities of an association between the degrees of HBV suppression with nucleoside treatments at week 24 and week 52 in hepatitis B patients and to find a useful predictor for treatment efficacy.
  
  
  METHODS
  In this phase III, double-blind, multicenter trial, we compared the efficacy of telbivudine treatment with lamivudine treatment in 332 Chinese compensated chronic hepatitis B patients. The patients were randomly assigned to a daily 600 mg telbivudine treatment group or daily 100 mg lamivudine group for 24 weeks. They were then categorized into 4 groups according to their serum HBV DNA levels (copies/ml) at week 24: a PCR-undetectable group (< 300 copies/ml); a QL- < 10(3) copies/ml group; a 10(3)-<10(4) copies/ml group; and a > or = 10(4) copies/ml group. The treatments were continued as they previously had been for another 28 weeks and the patients serum HBV DNA levels were examined again.
  
  
  RESULTS
  At week 52, mean reductions of serum HBV DNA were significantly greater in the telbivudine-treated patients than in the lamivudine-treated group (6.2 log10 vs 5.4 log10, t = 3.6, P < 0.01). Viral resistance was twice as common in lamivudine-treated patients compared to those receiving telbivudine. Telbivudine was well-tolerated with an adverse event profile similar to that of lamivudine. The lower the HBV DNA level achieved at week 24, the higher HBV DNA non-detectable by PCR. ALT normalization and HBeAg seroconversion achieved at week 52, and viral resistance at week 48 decreased parallel to the degree of HBV DNA inhibition.
  
  
  CONCLUSIONS
  HBV DNA PCR-undetectable at week 24 in nucleoside-treated hepatitis B patients suggests a better efficacy at week 52 and lower viral resistance at week 48. The degree of suppression of HBV at week 24 may be used as a predictor of 1-year outcome.
authors.affiliation: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China. jiamd@263.net
authors.forename: Ji-dong
authors.initials: JD
authors.lastname: Jia
authors.forename: Jin-lin
authors.initials: JL
authors.lastname: Hou
authors.forename: You-kuan
authors.initials: YK
authors.lastname: Yin
authors.forename: Dao-zhen
authors.initials: DZ
authors.lastname: Xu
authors.forename: De-ming
authors.initials: DM
authors.lastname: Tan
authors.forename: Jun-qi
authors.initials: JQ
authors.lastname: Niu
authors.forename: Xia-qiu
authors.initials: XQ
authors.lastname: Zhou
authors.forename: Yu-ming
authors.initials: YM
authors.lastname: Wang
authors.forename: Li-min
authors.initials: LM
authors.lastname: Zhu
authors.forename: Yong-wen
authors.initials: YW
authors.lastname: He
authors.forename: Hong
authors.initials: H
authors.lastname: Ren
authors.forename: Mo-bin
authors.initials: MB
authors.lastname: Wan
authors.forename: Cheng-wei
authors.initials: CW
authors.lastname: Chen
authors.forename: Shan-ming
authors.initials: SM
authors.lastname: Wu
authors.forename: Ya-gang
authors.initials: YG
authors.lastname: Chen
authors.forename: Jia-zhang
authors.initials: JZ
authors.lastname: Xu
authors.forename: Qin-huan
authors.initials: QH
authors.lastname: Wang
authors.forename: Lai
authors.initials: L
authors.lastname: Wei
authors.forename: Hong
authors.initials: H
authors.lastname: Ma
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009705:Nucleosides / Q000627:therapeutic use*; D011744:Pyrimidinones / Q000627:therapeutic use*; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D009705:Nucleosides; D011744:Pyrimidinones; D000077712:Telbivudine; D019259:Lamivudine; D013936:Thymidine