Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (Telaprevir or Boceprevir), Pegylated Interferon (PEG-IFN) and Ribavirin (RBV) Included in the French Early Access Program for the Use of Protease Inhibitors in Genotype 1 Patients Who Failed to Eradicate HCV With a Previous Standard PEG-IFN and RBV Combination.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 675
- 试验地点
- 1
- 主要终点
- Rate of sustained virological response (SVR) defined by an undetectable RNA by real-time PCR.
研究概览
简要总结
The purpose fo the study is to evaluate the efficacy defined by the sustained virological response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and telaprevir or boceprevir in the French Early Access Program for the use of protease inhibitors or after the approval of these drugs through the the marketing authorization.
详细描述
Methodology: Multicentric French national cohort with prospective collection of data and constitution of biobank, in HCV genotype 1 patients with compensated cirrhosis who failed to eradicate HCV with the combination PEG-IFN and RBV, treated with protease inhibitor (telaprevir or boceprevir), PEG-IFN and RBV, included in the French Early Access Program for the use of protease inhibitors or after approval of these drugs through the the marketing authorization.
Primary objective: Evaluate the efficacy defined by the sustained virological response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and telaprevir or boceprevir in the French Early Access Program for the use of protease inhibitors or after the approval of these drugs.
Estimated enrollment: 900 patients treated in the French Early Access Program for the use of protease inhibitors and after the marketing authorization approval.
Treatments:
- with telaprevir: triple combination with PEG-IFN alfa-2a, 180 µg/week, ribavirin 1000 to 1200 mg/d according the body weight and telaprevir 750 mg/8h, for 12 weeks followed by PEG-IFN and RBV for 36 weeks for a total duration of treatment of 48 weeks.
- or with boceprevir: triple combination with PEG-IFN alfa-2b, 1,5 µg/kg/week, RBV 800 to 1400 mg/d according the body weight and boceprevir 800 mg/8h. The treatment will begin after a lead in phase of PEG-IFN and RBV for 4 weeks, followed by a triple combination (PEG-IFN, RBV and boceprevir)during 44 weeks for a total duration of treatment of 48 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who need the criteria of French Early Access Program for boceprevir and telaprevir or after the marketing authorization approval:
- •patients aged of 18 years or more with chronic hepatitis C
- •relapsers or partial-responders or null-responders to treatment with PEG'IFN α2a or 2b associated or not with RBV
- •chronic infection with genotype 1 HCV
- •fibrosis Metavir score of 4 (cirrhosis)
- •without decompensated liver disease
- •naïve of direct anti-viral treatment
- •without HIV or HBV co-infection
- •signature of participation to the cohort
排除标准
- 未提供
结局指标
主要结局
Rate of sustained virological response (SVR) defined by an undetectable RNA by real-time PCR.
时间窗: 6 months after discontinuation of therapy (at week 72)
次要结局
- early viral kinetic(at the D0, W1, W2 and W4)
- Virological response during and after the treatment with determination of HCV RNA levels as prevised by the French Early Access Program for the use of protease inhibitors and after the approval.(at D0, W4, W8, W12, W24, W48 and 12 (W60) and 24 (W72) weeks after the discontinuation of treatment)
- Rate of premature discontinuation of protease inhibitor, RBV and/or PEG-IFN(in may 2014 (3 month after study completion date))
- occurrence of resistant mutants in partial responders (detectable RNA) or after the occurrence of virological breakthrough and long term evolution of these mutations (on serum bank)(in may 2014 (3 month after study completion date))
- Evolution of quality of life scores(in may 2014 (3 month after study completion date))
- Evaluation of therapeutic observance with auto-questionnaires(in may 2014 (3 month after study completion date))
- Rate of adaptation of dosage of protease inhibitors, RBV and/or PEG-IFN(in may 2014 (3 month after study completion date))