Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC)-NCT01514890
Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC)-NCT01514890
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DOI：
10.1016/j.jhep.2013.04.035
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发表时间：
2013-09-01
影响因子：
25.7
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
背景和目标：在III期临床试验中，三联疗法（聚乙二醇干扰素/利巴韦林与博赛泼韦或特拉匹韦）的安全性似乎在HCV治疗后出现的腹泻和非腹泻患者中相似，但很少包括腹泻。我们报告了在法国抢先体验Programme.Methods：674例基因型1患者，前瞻性纳入，接受了48周的三联疗法的一个队列中的16周的安全性和疗效分析。结果：严重不良事件发生率高（40.0%），死亡和严重并发症（严重感染或肝功能失代偿）发生率高（6.4%），贫血管理困难（促红细胞生成素和输血使用率分别为50.7%和12.1%）。贫血的独立预测因子= 65岁（OR 3.04，95% CI 1.54-6.02，p = 0.0014），血红蛋白水平（
Background & Aims: In phase III trials, the safety profile of triple therapy (pegylated interferon/ribavirin with boceprevir or telaprevir) seems to be similar in HCV treatment-experienced cirrhotic and non-cirrhotic patients, but few cirrhotics were included. We report the week 16 safety and efficacy analysis in a cohort of compensated cirrhotics treated in the French Early Access Programme.Methods: 674 genotype 1 patients, prospectively included, received 48 weeks of triple therapy. The analysis is restricted to 497 patients reaching week 16.Results: A high incidence of serious adverse events (40.0%), and of death and severe complications (severe infection or hepatic decompensation) (6.4%), and a difficult management of anaemia (erythropoietin and transfusion use in 50.7% and 12.1%) were observed. Independent predictors of anaemia = 65 years (OR 3.04, 95% CI 1.54-6.02, p = 0.0014), haemoglobin level (