Non-Interventional, Prospective Cohort Study of the Effectiveness, Safety and Utilization of Two Approved Pegylated Interferon-Based Direct Acting Antiviral Triple Therapies in the Management of Genotype 1 Chronic Hepatitis C in Routine Clinical Practice in the USA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 672
- 试验地点
- 66
- 主要终点
- Time to Premature Treatment Discontinuation Due to Any Reason
研究概览
简要总结
This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and US labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult patients, >/= 18 years of age
- •Chronic hepatitis C, genotype 1
- •Receiving pegylated interferon-based direct acting antiviral therapy (pegylated interferon and ribavirin plus either telaprevir or boceprivir) in accordance with local standard of care and US labeling
排除标准
- •Contraindications per US labels
结局指标
主要结局
Time to Premature Treatment Discontinuation Due to Any Reason
时间窗: Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)
Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason - first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.
Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period
时间窗: 12 weeks or later post-completion of the treatment period
SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period
次要结局
- Predictors of Sustained Virologic Response by Week(Weeks 2, 4, 6, 8, and 12)
- Number of Participants With SVR by Subgroups (Demographic and Baseline Factors)(Week 12)
- Number of Participants With Virologic Response (VR)(Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period)
- Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication(From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48))
- Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above(Weeks 2, 4, 8, and 12)
- Compliance of Study Treatment(Weeks 4, 8, 12, and 24)
- Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label(Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy))
- Number of Participants With Any AEs and Serious Adverse Events (SAEs)(Up to 12 weeks post-treatment)
- Change From Baseline in Work Loss And Productivity Outcomes (WPAI)(Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment)
- Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder(Up to Week 48)
- Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment(Up to Week 48)
- Time to Premature Treatment Discontinuation Due to Lack of Efficacy(Up to Week 48)
- Number of Participants With Safety-related Dose Reductions(Up to 48 weeks)
- Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs)(Up to 48 weeks)
- Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication(From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48))
- Time to Premature Treatment Discontinuation Due to Intolerance(Up to Week 48)
- Treatment Duration, as Measure of Extent of Exposure to Study Medication(From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48))
- Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label(Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48))