The prospective randomized study on telaprevir at 1500 or 2250 mg with pegylated interferon plus ribavirin in Japanese patients with HCV genotype 1.
The prospective randomized study on telaprevir at 1500 or 2250 mg with pegylated interferon plus ribavirin in Japanese patients with HCV genotype 1.
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在日本 HCV 基因型 1 患者中进行了 1500 或 2250 mg 特拉匹韦联合聚乙二醇干扰素加利巴韦林的前瞻性随机研究。
DOI：
10.1007/s00535-014-0965-8
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发表时间：
2015
期刊：
影响因子：
--
通讯作者：
Yoshida Y et al.
中科院分区：
文献类型：
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作者：
Oze T;Hiramatsu N;Yoshida Y et al.
背景特拉匹韦（telaprevir，TVR）、聚乙二醇干扰素和利巴韦林三联疗法可提高慢性丙型肝炎（CH-C）患者的抗病毒疗效。然而，TVR引起的严重不良反应是重要的解决方案。在这项前瞻性、随机、多中心、开放标签研究中，对减少TVR给药的抗病毒疗效和安全性进行了检查。（TVR-2250）或1500 mg结果治疗开始、2周和4周时HCVRNA平均值分别为6.69 ± 0.70，1.05 ± 0.74，TVR-2250组为0.22 ± 0.48 log 10 IU/ml，TVR-1500组为6.70 ± 0.62、1.02 ± 0.62、0.13 ± 0.41 log 10 IU/ml。两组的SVR率均为85%（分别为35/41和34/40）。两组均无患者发生病毒突破。至于不良反应，TVR-2250组的皮疹超过中度和重度贫血，血红蛋白<8.5 g/dl，高于TVR-1500组（分别为p= 0.046，p < 0.001）。TVR-2250组的血清肌酐水平升高和估计肾小球滤过率降低高于TVR-1500组。（1500 mg/天）与较高剂量的TVR相比，可导致相似的SVR率和较低的治疗相关不良反应（2250 mg/天）三联疗法（UMIN：000007313，000007330）。
BackgroundTriple 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.MethodsA 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.ResultsThe mean HCV RNA at start, 2 and 4 weeks of treatment were 6.69 ± 0.70, 1.05 ± 0.74, 0.22 ± 0.48 log10IU/ml in the TVR-2250 group and 6.70 ± 0.62, 1.02 ± 0.62, 0.13 ± 0.41 log10IU/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.ConclusionsThe 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).