title: Exploratory study on telaprevir given every 8 h at 500 mg or 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients.
abstract: OBJECTIVE
  The aims of this study are to assess the antiviral effects, safety and telaprevir (TVR) pharmacokinetics in two cohorts given TVR every 8 h (q8h) at doses of 500 mg and 750 mg with peginterferon-α-2b and ribavirin in chronic hepatitis C patients.
  
  
  METHODS
  Twenty chronic hepatitis C (HCV) patients with genotype 1b in high viral loads were randomly assigned to two TVR-based regimens of 750 mg q8h (group A) and 500 mg q8h (group B) in combination with peginterferon-α-2b and ribavirin for 12 weeks.
  
  
  RESULTS
  Although the difference was not statistically significant other than trough concentration (Ctrough ) at week 4, the parameters of maximum concentration (Cmax ), the area under the concentration time curve (AUC0-∞ ) and Ctrough tended to be higher in group A than those in group B. The antiviral effects were similar in the two groups (sustained virological response rates [SVR], 40% in group A, 50% in group B). The discontinuation rates by anemia were 30% in group A and 20% in group B. Serum creatinine concentrations were lower in group B than those in group A.
  
  
  CONCLUSIONS
  Although the exposure to TVR tended to be lower in 500 mg q8h than that in 750 mg q8h, the SVR rates in both groups were similar. The result suggests that the 500 mg q8h dose may be one option for treatment. In addition, the present findings indicate that the development of adverse events which increase with a TVR-based regimen, specifically anemia and creatinine, could be avoided by dose adjustment of TVR.
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Fumitaka
authors.initials: F
authors.lastname: Suzuki
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Hitomi
authors.initials: H
authors.lastname: Sezaki
authors.forename: Norio
authors.initials: N
authors.lastname: Akuta
authors.forename: Yuya
authors.initials: Y
authors.lastname: Seko
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Kawamura
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Hosaka
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Saito
authors.forename: Yasuji
authors.initials: Y
authors.lastname: Arase
authors.forename: Kenji
authors.initials: K
authors.lastname: Ikeda
authors.forename: Rie
authors.initials: R
authors.lastname: Mineta
authors.forename: Sachiyo
authors.initials: S
authors.lastname: Watahiki
authors.forename: Mariko
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Nakayasu
authors.forename: Hidetaka
authors.initials: H
authors.lastname: Tsuda
authors.forename: Keiji
authors.initials: K
authors.lastname: Aoki
authors.forename: Ichimaro
authors.initials: I
authors.lastname: Yamada
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kumada