title: Serum HBV DNA level at week 12 is superior to viral response at week 24 in predicting long-term treatment outcome of telbivudine for chronic hepatitis B patients.
abstract: BACKGROUND
  Telbivudine, one of the five nucleos(t)ide antiviral drugs, was reported to be superior to lamivudine in a better biochemical, virological, and histological response for treatment-naive patients in the GLOBE trial. The aim of this study was to determine the antiviral potency, viral resistance, and the signifcance of early response for long-term telbivudine treatment.
  
  
  METHODS
  We recruited 161 patients of chronic hepatitis B (CHB) on telbivudine between January 2009 and September 2011 in Macau, China. The serum hepatitis B virus DNA levels, hepatitis B e antigen (HBeAg) seroconversion, alanine aminotransferase (ALT) normalization, and viral resistance were analyzed.
  
  
  RESULTS
  The median age and follow-up duration were 48 years and 16.9 months. All patients were followed up for at least 6 months, while data were collected for 132, 120, 95, and 53 patients at 12, 24, 48, and 96 weeks respectively. The cumulative HBeAg seroconversion rate was 20.8% and only three patients (1.9%) presented with telbivudine low level resistance. The ALT normalization rates were 76.9% at 48 weeks and 77.6% at 96 weeks. Undetectable HBV DNA was achieved by 1.8%, 31.6%, 60%, and 74.1% in HBeAg positive patients and 29.3%, 60.3%, 84%, and 84.6% in HBeAg negative patients at each time point. Week 12 HBV DNA level < 1000 copies/ml (< 200 IU/ml) was a better predictor of viral suppression at 2-year follow-up (P = 0.001, OR = 27.00) than undetectable HBV DNA level at week 24 (P = 0.120, OR = 4.81).
  
  
  CONCLUSIONS
  Two-year telbivudine treatment yielded high rates of viral suppression and ALT normalization. Serum HBV DNA level at week 12 is a superior predictor for long-term viral suppression.
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Beijing 100730, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Lü
authors.forename: Hai-Hong
authors.initials: HH
authors.lastname: Yang
authors.forename: Yun-Ming
authors.initials: YM
authors.lastname: Fan
authors.forename: Takming
authors.initials: T
authors.lastname: Li
authors.forename: Li-Fan
authors.initials: LF
authors.lastname: Zhang
authors.forename: Chongseong
authors.initials: C
authors.lastname: Mui
authors.forename: Hong-Wei
authors.initials: HW
authors.lastname: Fan
authors.forename: Bao-Tong
authors.initials: BT
authors.lastname: Zhou
authors.forename: Zheng-Yin
authors.initials: ZY
authors.lastname: Liu
authors.forename: Hou
authors.initials: H
authors.lastname: Ng
authors.forename: Xiao-Qing
authors.initials: XQ
authors.lastname: Liu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood*; D024882:Drug Resistance, Viral; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D000077712:Telbivudine; D000410:Alanine Transaminase; D013936:Thymidine