Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 主要终点
- Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir 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 was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real world conditions in Ireland in a clinical practice patient population.
详细描述
This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Ireland. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post- treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1, 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
- •Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial
排除标准
- 未提供
研究组 & 干预措施
Participants with HCV genotype 1
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
干预措施: Ombitasvir/paritaprevir/ritonavir (Drug)
Participants with HCV genotype 1
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
干预措施: Dasabuvir (Drug)
Participants with HCV genotype 1
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
时间窗: 12 weeks after the last actual dose of study drug
SVR12 was defined as 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: * evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN * an HCV RNA value ≥50 IU/mL at the last measurement post-baseline * HCV RNA \<50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure
次要结局
- Percentage of Participants With On-treatment Virologic Failure(Up to 24 weeks)
- Percentage of Participants With Relapse(From the end of treatment through the end of study (maximum of 48 weeks post-treatment))
- Percentage of Participants With Virologic Response at End of Treatment (EOT)(Up to 24 weeks)
- Percentage of Participants With Viral Breakthrough(Up to 24 weeks)
- Percentage of Participants Meeting Relapse Criteria(Up to 12 weeks after the last actual dose of study drug)
- Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria(Up to 24 weeks)
- 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(12 weeks after the last actual dose of study drug)