对先前治疗反应各据特点的的丙型肝炎患者应用特拉普韦（第一代蛋白酶抑制剂）再治疗
背景：该实验是对应用长效干扰素和利巴韦林治疗后未达到SVR的患者应用特拉普韦（第一代蛋白酶抑制剂）进行再治疗。本研究旨在评估特拉普韦联合长效干扰素、利巴韦林对三个II期临床试验中未能实现SVR的患者治疗的安全性、有效性。方法：来自三个II期临床试验的合格患者可以加入这项开放的、非随机研究，这些患者他们或者为标准治疗后无应答，或者为48周治疗后复发。最初的协议是一个24周的方案：先为12周特拉普韦联合长效干扰素、利巴韦林治疗，接下来的12周为长效干扰素、利巴韦林治疗。在研究过程中协议被修改为将早先治疗无应答的患者的长效干扰素、利巴韦林治疗疗程延长至48周。对其他在4周和12周丙肝病毒测不出的患者获得24周的治疗。那些4周、12周能检测到病毒的患者总共接受了48周的治疗，总体的SVR率为59%。结果：特拉普韦联合长效干扰素、利巴韦林治疗12周SVR率：先前治疗无应答的患者为37% (19/51)，先前治疗部分应答患者为55% (16/29)，先前病毒突破患者为75% (6/8)，先前治疗后复发患者为97% (28/29)。总体复发率为16% (13/83).不良事件与特拉普韦从前的实验相似，有9%的患者因不良反应终止实验，大部分是由于皮疹和贫血。结论：本研究表明对于长效干扰素联合利巴韦林治疗无应答或是复发的患者，应用特拉普韦为基础的方案治疗是疗效的。
吉林大学第一医院肝胆胰内科 姜翠 摘译
Retreatment with telaprevir combination therapy in hepatitis C patients with well-characterized prior treatment response
Background：Retreatment with peginterferon alpha and ribavirin (PR) offers a limited chance of sustained virologic response (SVR) in patients who did not achieve SVR with prior PR treatment. his study evaluated the safety and efficacy of telaprevir-based treatment in combination with PR in well-characterized patients who did not achieve SVR in the control arms of three Phase II clinical trials.
Methods：Patients eligible to enroll in this open-label nonrandomized study either met on-treatment criteria for nonresponse or relapsed after 48 weeks of treatment in the control arm of the three Phase II PROVE studies. The initial protocol was a 24-week regimen: 12 weeks of telaprevir and PR followed by an additional 12 weeks of PR. During the study the protocol was amended to extend PR to 48 weeks for patients with previous null response. All other patients with undetectable hepatitis C virus (HCV) RNA at weeks 4 and 12 received 24 weeks of therapy. Those with detectable HCV RNA at weeks 4 or 12 received a total of 48 weeks of therapy. The overall SVR rate was 59% (69/117).
Results：SVR rates with T12PR were 37% (19/51) in prior null responders, 55% (16/29) in prior partial responders, 75% (6/8) in prior breakthroughs, and 97% (28/29) in prior relapsers. The overall relapse rate was 16% (13/83). Adverse events were similar to those in previous trials with telaprevir, with 9% of patients discontinuing due to an adverse event (most commonly rash and anemia).
Conclusion:This study demonstrated the benefit of retreatment with a telaprevir-based regimen for patients with well-characterized nonresponse (null and partial) or relapse to a prior course of PR treatment.
