We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
The prospective randomized study on telaprevir at 1500 or 2250 mg with pegylated interferon plus ribavirin in Japanese patients with HCV genotype 1.
- Authors
Oze, Tsugiko; Hiramatsu, Naoki; Yakushijin, Takayuki; Yamada, Ryoko; Harada, Naoki; Morishita, Naoki; Yamada, Akira; Oshita, Masahide; Kaneko, Akira; Suzuki, Kunio; Inui, Yoshiaki; Tamura, Shinji; Yoshihara, Harumasa; Imai, Yasuharu; Miyagi, Takuya; Yoshida, Yuichi; Tatsumi, Tomohide; Kasahara, Akinori; Hayashi, Norio; Takehara, Tetsuo
- 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 log IU/ml in the TVR-2250 group and 6.70 ± 0.62, 1.02 ± 0.62, 0.13 ± 0.41 log 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).
- Subjects
HEPATITIS C treatment; RIBAVIRIN; TELAPREVIR; JAPANESE people; INTERFERONS; GENOTYPES; LONGITUDINAL method; RANDOMIZED controlled trials; THERAPEUTICS; DISEASES
- Publication
Journal of Gastroenterology, 2015, Vol 50, Issue 3, p313
- ISSN
0944-1174
- Publication type
Article
- DOI
10.1007/s00535-014-0965-8