Effectiveness of Telaprevir or Boceprevir in Treatment-Experienced Patients With HCV Genotype 1 Infection and Cirrhosis
Effectiveness of Telaprevir or Boceprevir in Treatment-Experienced Patients With HCV Genotype 1 Infection and Cirrhosis
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DOI：
10.1053/j.gastro.2014.03.051
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发表时间：
2014-07-01
期刊：
影响因子：
29.4
通讯作者：
Bronowicki, Jean-Pierre
中科院分区：
文献类型：
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作者：
Hezode, Christophe;Fontaine, Helene;Bronowicki, Jean-Pierre
背景与目的：我们研究了蛋白酶抑制剂聚乙二醇干扰素和利巴韦林治疗丙型肝炎病毒（HCV）基因型感染和肝硬化患者的有效性。方法：在丙型病毒性肝硬化的蛋白酶抑制剂的同情使用研究中，511例HCV基因型感染和代偿性肝硬化患者对先前的集乙二醇干扰素和利巴韦林治疗无反应（44.3%为复发或病毒突破患者，44.8%为部分应答者，8.0%为无效应答者）给予泰拉韦（n = 299）或波昔普韦（n = 212） 48周。我们评估了治疗后12周持续病毒反应的患者百分比和安全性。这项观察性研究不允许对两种方案进行直接比较。结果：在给予telaprevir的患者中，74.2%的复发者、40.0%的部分缓解者和19.4%的无缓解者达到了SVR12。在给予boceprevir的患者中，53.9%的复发者、38.3%的部分缓解者和零缓解者均未达到SVR12。在多变量分析中，与SVR12相关的因素包括先前对治疗反应的反应、无引入期、HCV亚型1b （vs 1a）和基线血小板计数大于100,000/mm(3)。49.9%的病例发生严重不良事件，包括肝脏失代偿、10.4%的严重感染和2.2%的死亡。在多变量分析中，基线血清白蛋白水平低于35 g/L和基线血小板计数100,000/mm(3)或更少预示着严重的副作用或死亡。结论：在现实生活中，接受过治疗的HCV基因1型感染和肝硬化患者中，相对较高的比例对聚乙二醇干扰素和利巴韦林联合泰拉韦或博昔韦有反应。然而，副作用经常发生，而且往往很严重。白蛋白和血小板计数的基线水平可用于指导治疗决策。ClinicalTrials.gov编号：NCT01514890。
BACKGROUND & AIMS: We investigated the effectiveness of the protease inhibitors peginterferon and ribavirin in treatment-experienced patients with hepatitis C virus (HCV) genotype 1 infection and cirrhosis. METHODS: In the Compassionate Use of Protease Inhibitors in Viral C Cirrhosis study, 511 patients with HCV genotype 1 infection and compensated cirrhosis who did not respond to a prior course of peginterferon and ribavirin (44.3% relapsers or patients with viral breakthrough, 44.8% partial responders, and 8.0% null responders) were given either telaprevir (n = 299) or boceprevir (n = 212) for 48 weeks. We assessed percentages of patients with sustained viral responses 12 weeks after therapy and safety. This observational study did not allow for direct comparison of the 2 regimens. RESULTS: Among patients given telaprevir, 74.2% of relapsers, 40.0% of partial responders, and 19.4% of null responders achieved SVR12. Among those given boceprevir, 53.9% of relapsers, 38.3% of partial responders, and none of the null responders achieved SVR12. In multivariate analysis, factors associated with SVR12 included prior response to treatment response, no lead-in phase, HCV subtype 1b (vs 1a), and baseline platelet count greater than 100,000/mm(3). Severe adverse events occurred in 49.9% of cases, including liver decompensation, severe infections in 10.4%, and death in 2.2%. In multivariate analysis, baseline serum albumin level less than 35 g/L and baseline platelet counts of 100,000/mm(3) or less predicted severe side effects or death. CONCLUSIONS: Relatively high percentages of real-life, treatment-experienced patients with HCV genotype 1 infection and cirrhosis respond to the combination of peginterferon and ribavirin with telaprevir or boceprevir. However, side effects are frequent and often severe. Baseline levels of albumin and platelet counts can be used to guide treatment decisions. ClinicalTrials.gov number: NCT01514890.