title: The prospective randomized study on telaprevir at 1500 or 2250 mg with pegylated interferon plus ribavirin in Japanese patients with HCV genotype 1.
abstract: BACKGROUND
  Triple therapy with telaprevir (TVR), pegylated interferon and ribavirin has improved antiviral efficacy in patients with chronic hepatitis C (CH-C). However, the severe adverse effects caused by TVR are important to resolve. In this prospective, randomized, multicenter, open-label study, the antiviral efficacy and safety in the reduced administration of TVR were examined.
  
  
  METHODS
  A total of 81 CH-C Japanese patients with HCV genotype 1 were randomized into two regimens of TVR 2250 mg (TVR-2250) or 1500 mg (TVR-1500) and treated with triple therapy for 24 weeks.
  
  
  RESULTS
  The mean HCV RNA at start, 2 and 4 weeks of treatment were 6.69 ± 0.70, 1.05 ± 0.74, 0.22 ± 0.48 log10 IU/ml in the TVR-2250 group and 6.70 ± 0.62, 1.02 ± 0.62, 0.13 ± 0.41 log10 IU/ml in the TVR-1500 group. The SVR rates were 85% in both groups (35/41 and 34/40, respectively). There were no patients with viral breakthrough in either group. As for adverse effects, rash more than moderate and severe anemia with <8.5 g/dl of hemoglobin were higher in the TVR-2250 group than in the TVR-1500 group (p = 0.046, p < 0.001, respectively). The increase in serum creatinine levels and decrease in estimated glomerular filtration rates were higher in the TVR-2250 group than in the TVR-1500 group.
  
  
  CONCLUSIONS
  The lower dose of TVR (1500 mg/day) can result in similar SVR rates and lower treatment-related adverse effects compared to the higher dose of TVR (2250 mg/day) in triple therapy (UMIN: 000007313, 000007330).
authors.affiliation: Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan, t-oze@gh.med.osaka-u.ac.jp.
authors.forename: Tsugiko
authors.initials: T
authors.lastname: Oze
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiramatsu
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yakushijin
authors.forename: Ryoko
authors.initials: R
authors.lastname: Yamada
authors.forename: Naoki
authors.initials: N
authors.lastname: Harada
authors.forename: Naoki
authors.initials: N
authors.lastname: Morishita
authors.forename: Akira
authors.initials: A
authors.lastname: Yamada
authors.forename: Masahide
authors.initials: M
authors.lastname: Oshita
authors.forename: Akira
authors.initials: A
authors.lastname: Kaneko
authors.forename: Kunio
authors.initials: K
authors.lastname: Suzuki
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Inui
authors.forename: Shinji
authors.initials: S
authors.lastname: Tamura
authors.forename: Harumasa
authors.initials: H
authors.lastname: Yoshihara
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Imai
authors.forename: Takuya
authors.initials: T
authors.lastname: Miyagi
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Yoshida
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tatsumi
authors.forename: Akinori
authors.initials: A
authors.lastname: Kasahara
authors.forename: Norio
authors.initials: N
authors.lastname: Hayashi
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Takehara
mesh_terms: D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D003875:Drug Eruptions / Q000209:etiology; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009842:Oligopeptides; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C417083:peginterferon alfa-2b