title: Importance of virological response in the early stage of telaprevir-based triple therapy for hepatitis C.
abstract: OBJECTIVE
  To investigate the efficacy of virological response (VR) to telaprevir (TVR)-based triple therapy in predicting treatment outcome of hepatitis C.
  
  
  METHODS
  This prospective, multicenter study consisted of 253 Japanese patients infected with hepatitis C virus (HCV) genotype 1b. All received 12 wk of TVR in combination with 24 wk of pegylated-interferon-α (IFN-α) and ribavirin. Serum HCV RNA was tested at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. VR was defined as undetectable serum HCV RNA. Sustained virological response (SVR) was VR at 24 wk after the end of treatment and was regarded as a successful outcome.
  
  
  RESULTS
  Of 253 patients, 207 (81.8%) achieved SVR. The positive predictive value of VR for SVR was 100% at week 2, after which it gradually decreased, and was over 85% to week 12. The negative predictive value (NPV) gradually increased, reaching 100% at week 12. The upslope of the NPV showed a large increase from week 4 (40.6%) to week 6 (82.4%). There was a moderate concordance between the SVR and VR at week 6 (kappa coefficient = 0.44), although other VRs had poor concordance to SVR. Multiple logistic regression analysis extracted VR at week 6 (P < 0.0001, OR = 63.8) as an independent factor contributing to SVR. In addition, the interleukin-28B single nucleotide polymorphism and response to previous pegylated-IFN-α and ribavirin therapy were identified as independent factors for SVR.
  
  
  CONCLUSIONS
  VR at week 6, but not at week 4, is an efficient predictor of both SVR and non-SVR to TVR-based triple therapy.
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hiramine
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Norihiro
authors.initials: N
authors.lastname: Furusyo
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Eiichi
authors.initials: E
authors.lastname: Ogawa
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Nakamuta
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Kajiwara
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Nomura
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Kazufumi
authors.initials: K
authors.lastname: Dohmen
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Takahashi
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Takeaki
authors.initials: T
authors.lastname: Satoh
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Azuma
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Kawano
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Toshimasa
authors.initials: T
authors.lastname: Koyanagi
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kotoh
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Shimoda
authors.affiliation: Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Hayashi
keywords: Chronic hepatitis C; Direct-acting antiviral agent; Early virological response; Rapid virological response; Response-guided treatment