Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C - An Observational Study in Greece
The interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions.
This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real-world conditions in Greece in a clinical practice patient population.
研究概览
详细说明
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
- If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
- Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
- Participant must not have participated or intended to participate in a concurrent interventional therapeutic trial
Exclusion Criteria:
- None
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
具有 HCV 基因型 1 或 4 的参与者
Ombitasvir/paritaprevir/ritonavir(两片 12.5 mg/75 mg/50 mg 复合片剂,每日一次); ± dasabuvir(片剂;250 mg,每天两次); ± 基于体重的利巴韦林(片剂;1000 或 1200 毫克,每天两次)长达 24 周
|
药片
其他名称:
药片
Co-formulated tablet
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
大体时间:12 weeks after the last actual dose of study drug
|
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:
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12 weeks after the last actual dose of study drug
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
符合过早研究药物停药标准的参与者百分比
大体时间:最后一次实际服用研究药物后 12 周
|
过早停用研究药物定义为过早停用研究药物且没有治疗病毒学失败的参与者。
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最后一次实际服用研究药物后 12 周
|
Percentage of Participants With Virologic Response at End of Treatment (EoT)
大体时间:Up to 24 weeks
|
Virologic response was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.
|
Up to 24 weeks
|
Percentage of Participants With Relapse
大体时间:Up to 24 weeks
|
Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.
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Up to 24 weeks
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Percentage of Participants With Viral Breakthrough
大体时间:Up to 24 weeks
|
Viral breakthrough was defined as at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.
|
Up to 24 weeks
|
Percentage of Participants With On-treatment Virologic Failure
大体时间:12 weeks after the last actual dose of study drug
|
On-treatment virologic failure was defined as breakthrough (at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).
|
12 weeks after the last actual dose of study drug
|
Percentage of Participants Meeting Relapse Criteria
大体时间:12 weeks after the last actual dose of study drug
|
Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.
|
12 weeks after the last actual dose of study drug
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Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
大体时间:12 weeks after the last actual dose of study drug
|
The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response was documented.
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12 weeks after the last actual dose of study drug
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合作者和调查者
赞助
调查人员
- 学习椅:Georgios Mitas, MS、AbbVie Pharmaceuticals S.A. (Greece)
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- P15-842
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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