Journal of Gastroenterology

, Volume 50, Issue 3, pp 313–322

The prospective randomized study on telaprevir at 1500 or 2250 mg with pegylated interferon plus ribavirin in Japanese patients with HCV genotype 1

  • Tsugiko Oze
  • Naoki Hiramatsu
  • Takayuki Yakushijin
  • Ryoko Yamada
  • Naoki Harada
  • Naoki Morishita
  • Akira Yamada
  • Masahide Oshita
  • Akira Kaneko
  • Kunio Suzuki
  • Yoshiaki Inui
  • Shinji Tamura
  • Harumasa Yoshihara
  • Yasuharu Imai
  • Takuya Miyagi
  • Yuichi Yoshida
  • Tomohide Tatsumi
  • Akinori Kasahara
  • Norio Hayashi
  • Tetsuo Takehara
Original Article—Liver, Pancreas, and Biliary Tract

DOI: 10.1007/s00535-014-0965-8

Cite this article as:
Oze, T., Hiramatsu, N., Yakushijin, T. et al. J Gastroenterol (2015) 50: 313. doi:10.1007/s00535-014-0965-8

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).

Keywords

Chronic hepatitis C Telaprevir Pegylated interferon plus ribavirin Dose reduction 

Abbreviations

HCV

Hepatitis C virus

IFN

Interferon

Peg-IFN

Pegylated interferon

RBV

Ribavirin

PI

Protease inhibitor

TVR

Telaprevir

SVR

Sustained virologic response

EOT

End of treatment

HCC

Hepatocellular carcinoma

CH-C

Chronic hepatitis C

Hb

Hemoglobin

WBC

White blood cell

RVR

Rapid virologic response

c-EVR

Complete early virologic response

ETR

End of treatment response

SMV

Simeprevir

Supplementary material

535_2014_965_MOESM1_ESM.docx (14 kb)
Supplementary material 1 (DOCX 14 kb)

Copyright information

© Springer Japan 2014

Authors and Affiliations

  • Tsugiko Oze
    • 1
  • Naoki Hiramatsu
    • 1
  • Takayuki Yakushijin
    • 1
  • Ryoko Yamada
    • 1
  • Naoki Harada
    • 1
  • Naoki Morishita
    • 1
  • Akira Yamada
    • 2
  • Masahide Oshita
    • 3
  • Akira Kaneko
    • 4
  • Kunio Suzuki
    • 5
  • Yoshiaki Inui
    • 6
  • Shinji Tamura
    • 7
  • Harumasa Yoshihara
    • 8
  • Yasuharu Imai
    • 9
  • Takuya Miyagi
    • 1
  • Yuichi Yoshida
    • 1
  • Tomohide Tatsumi
    • 1
  • Akinori Kasahara
    • 10
  • Norio Hayashi
    • 11
  • Tetsuo Takehara
    • 1
  1. 1.Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineSuitaJapan
  2. 2.Sumitomo HospitalOsakaJapan
  3. 3.Osaka Police HospitalOsakaJapan
  4. 4.NTT West Osaka HospitalOsakaJapan
  5. 5.Saiseikai Senri HospitalSuitaJapan
  6. 6.Hyogo Prefectural Nishinomiya HospitalNishinomiyaJapan
  7. 7.Minoh City HospitalMinohJapan
  8. 8.Osaka Rosai HospitalSakaiJapan
  9. 9.Ikeda Municipal HospitalIkedaJapan
  10. 10.Department of General MedicineOsaka University HospitalSuitaJapan
  11. 11.Kansai Rosai HospitalAmagasakiJapan

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