Sezaki Hitomi, Suzuki Fumitaka, Hosaka Tetsuya, Akuta Norio, Fukushima Taito, Hara Tasuku, Kawamura Yusuke, Kobayashi Masahiro, Suzuki Yoshiyuki, Saitoh Satoshi, Arase Yasuji, Ikeda Kenji, Kumada Hiromitsu
Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
Hepatol Res. 2014 Oct;44(10):E163-71. doi: 10.1111/hepr.12268. Epub 2014 Jan 8.
To compare the early virological effectiveness, sustained virological response and safety of telaprevir 1500 mg/day with telaprevir 2250 mg/day, when combined in triple therapy with pegylated interferon and ribavirin in Japanese patients with high viral loads of genotype 1 hepatitis C virus.
The telaprevir 2250 mg/day and 1500 mg/day groups each contained 60 patients matched by age, sex and history of previous interferon-based treatment. Serum levels of genotype 1 hepatitis C virus RNA, hemoglobin levels, drug adherence and drug discontinuation rates were monitored during and after triple therapy.
Patients receiving telaprevir 1500 mg/day had significantly lower telaprevir adherence and lower initial ribavirin dose but similar or superior pegylated interferon and ribavirin adherence and a lower rate of telaprevir discontinuation than did those receiving telaprevir 2250 mg/day. The early virological responses and sustained virological response rates were similar in both groups. Hemoglobin levels decreased to a greater extent in patients treated with telaprevir 2250 mg/day.
Compared to triple therapy including telaprevir 2250 mg/day, that including telaprevir at a reduced dose of 1500 mg/day was associated with lower rates of anemia and similar antiviral efficacy. Such a regimen may meaningfully improve sustained virological response rates, especially among female and elderly Japanese patients.
在日本高病毒载量的1型丙型肝炎病毒患者中,比较每日1500毫克替拉瑞韦与每日2250毫克替拉瑞韦在与聚乙二醇干扰素和利巴韦林三联疗法联合使用时的早期病毒学疗效、持续病毒学应答及安全性。
每日2250毫克替拉瑞韦组和每日1500毫克替拉瑞韦组各有60例患者,根据年龄、性别和既往基于干扰素治疗的病史进行匹配。在三联疗法期间及之后监测1型丙型肝炎病毒RNA的血清水平、血红蛋白水平、药物依从性及药物停药率。
接受每日1500毫克替拉瑞韦治疗的患者,其替拉瑞韦依从性显著较低,初始利巴韦林剂量也较低,但聚乙二醇干扰素和利巴韦林依从性相似或更佳,且替拉瑞韦停药率低于接受每日2250毫克替拉瑞韦治疗的患者。两组的早期病毒学应答和持续病毒学应答率相似。接受每日2250毫克替拉瑞韦治疗的患者血红蛋白水平下降幅度更大。
与包含每日2250毫克替拉瑞韦的三联疗法相比,包含每日1500毫克替拉瑞韦的三联疗法导致贫血发生率更低,抗病毒疗效相似。这样的治疗方案可能会显著提高持续病毒学应答率,尤其是在日本女性和老年患者中。