title: Defining virologic relapse in chronic hepatitis B.
abstract: OBJECTIVE
  Different definitions of virologic relapse (VR) are being used. One way of defining VR is "reappearance of HBV DNA in the serum," while another definition is an "increase in HBV DNA level greater than 1 log in two determinations at least 4 weeks apart." The aim of this study was to see the effectiveness of these two definitions
  
  
  METHODS
  Forty-five HBeAg-positive chronic hepatitis B patients with a virologic response [negative PCR (<12 IU/ml)] who had discontinued therapy were analyzed retrospectively for VR, HBeAg reversion and biochemical flare.
  
  
  RESULTS
  HBV DNA reappeared in the serum (≥12 IU/ml) of all 45 patients (100%). An increase in HBV DNA level greater than 1 log in two determinations at least 4 weeks apart was identified in 20 of 25 patients (80%). Biochemical flare and HBeAg reversion were observed in 18 (40%) and 14 (31%) patients, respectively. Peak off-therapy HBV DNA level was significantly associated with biochemical flare (r=0.758, P<0.001) and HBeAg reversion (r=0.645, P<0.001). Two patients with high initial off-therapy HBV DNA levels (≥4.0 log(10) IU/ml) were reassessed at 4 weeks, and both experienced a biochemical flare and HBeAg reversion. Two patients had an increase in HBV DNA level greater than 1 log at a very low level (1 log to 2 or 3 log), but did not experience biochemical flare or HBeAg reversion during follow-up.
  
  
  CONCLUSIONS
  Reappearance of HBV DNA was universal when sensitive HBV DNA assay was used. Waiting 4 weeks to confirm VR may be harmful for patients with a high HBV DNA level, and was ineffective to indicate re-therapy for patients with increase in HBV DNA at a very low level. There is a need for improved and standardized definitions of VR.
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul, 135-710, Korea.
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Kim
authors.forename: Dong Hyun
authors.initials: DH
authors.lastname: Sinn
authors.forename: Won Kyoung
authors.initials: WK
authors.lastname: Yun
authors.forename: Hyun Chin
authors.initials: HC
authors.lastname: Cho
authors.forename: Yun Young
authors.initials: YY
authors.lastname: Lee
authors.forename: Geum-Youn
authors.initials: GY
authors.lastname: Gwak
authors.forename: Moon Seok
authors.initials: MS
authors.lastname: Choi
authors.forename: Joon Hyeok
authors.initials: JH
authors.lastname: Lee
authors.forename: Kwang Cheol
authors.initials: KC
authors.lastname: Koh
authors.forename: Byung Chul
authors.initials: BC
authors.lastname: Yoo
authors.forename: Seung Woon
authors.initials: SW
authors.lastname: Paik
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects / Q000302:isolation & purification*; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use*; D012008:Recurrence; D012189:Retrospective Studies; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; D019259:Lamivudine; C053001:adefovir; D000225:Adenine