title: Partial virological response to entecavir in treatment-naive patients with chronic hepatitis B.
abstract: BACKGROUND
  The proposed definition of a partial virological response (PVR) to nucleos(t)ide analogue therapy in the 2009 European Association for the Study of the Liver (EASL) guidelines is based on limited evidence, especially in terms of the cutoff HBV DNA level and the time point at which to judge it. This study assessed optimal PVR criteria for predicting virological response (VR) at week 96 in treatment-naive patients with chronic hepatitis B (CHB) receiving entecavir (ETV).
  
  
  METHODS
  A total of 175 patients (126 men, 49 women) who completed 96 weeks of first-line ETV therapy were prospectively recruited. For predicting VR at week 96, the area under the receiver operating characteristic curve (AUC) was used to find the optimal time point and the Youden index was used to calculate the optimal cutoff HBV DNA level.
  
  
  RESULTS
  After 96 weeks of ETV therapy, 139 (79.4%) patients achieved VR. The AUC at week 48 was significantly better than that at week 24 for predicting VR at week 96 (P=0.023). The optimal cutoff HBV DNA level at week 48 was 35 IU/ml. Forty-one (23.4%) patients met this PVR criteria of ETV (HBV DNA level >35 IU/ml at week 48).
  
  
  CONCLUSIONS
  An HBV DNA level >35 IU/ml at week 48 is the optimal PVR criteria for predicting non-VR at week 96 in treatment-naive patients with CHB who are receiving ETV. This study supports the proposed EASL PVR for ETV based on scientific evidence.
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Young Eun
authors.initials: YE
authors.lastname: Chon
authors.forename: Seung Up
authors.initials: SU
authors.lastname: Kim
authors.forename: Chun Kyon
authors.initials: CK
authors.lastname: Lee
authors.forename: Jeong
authors.initials: J
authors.lastname: Heo
authors.forename: Ja Kyung
authors.initials: JK
authors.lastname: Kim
authors.forename: Ki Tae
authors.initials: KT
authors.lastname: Yoon
authors.forename: Mong
authors.initials: M
authors.lastname: Cho
authors.forename: Kwan Sik
authors.initials: KS
authors.lastname: Lee
authors.forename: Dong Hwan
authors.initials: DH
authors.lastname: Kim
authors.forename: Eun Hee
authors.initials: EH
authors.lastname: Choi
authors.forename: Jun Yong
authors.initials: JY
authors.lastname: Park
authors.forename: Do Young
authors.initials: DY
authors.lastname: Kim
authors.forename: Chae Yoon
authors.initials: CY
authors.lastname: Chon
authors.forename: Kwang-Hyub
authors.initials: KH
authors.lastname: Han
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Ahn
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood*; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006515:Hepatitis B virus / Q000187:drug effects* / Q000235:genetics / Q000502:physiology; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; C413685:entecavir; D006147:Guanine