New Care Pathways to Achieve HCV Elimination in the Community: Real-world Outcomes From HCV Infected Patients Treated in Addiction Centers in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 30
- 主要终点
- Percentage of participants with and without Hepatitis C Virus (HCV) treatment prescribed at end of the inclusion visit.
研究概览
简要总结
Hepatitis C Virus is liver disease and is a leading cause of death and morbidity with around 71 million people affected worldwide. Widespread availability of highly effective direct-acting antivirals (DAAs) have dramatically changed the treatment landscape of HCV with a cure rate of over 95%. In May 2019, French Health Authorities expanded prescription abilities to all physicians treating adult treatment-naive patients with HCV without cirrhosis of the liver. This study will assess the treatment uptake and barriers to treatment by non-HCV specialist in France in community-based addiction centers. Beyond these evaluations, data on health resource utilization in addiction centers, level of knowledge of both patients and providers on HCV infection and treatment, care cascade, effectiveness and safety of Glecaprevir/Pibrentasvir among patients treated in addiction centers and evolution of addiction behavior after treatment are of specific interest.
Glecaprevir/Pibrentasvir is a drug approved to treat HCV. About 400 Adult participants with a confirmed positive HCV ribonucleic acid (RNA) test will be enrolled in the study at approximately 30 addiction centers in France.
All participants will attend an inclusion visit. Participants who are not prescribed Glecaprevir/Pibrentasvir at the inclusion visit will have no further follow-up in the study. Participants who are prescribed Glecaprevir/Pibrentasvir will take three tablets once daily. The duration of the study is approximately 12 months.
All study visits will occur during routine clinical practice but there may be a higher burden for participants prescribed Glecaprevir/Pibrentasvir. These participants will be asked to complete questionnaires after each visit.
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
- •Followed in an addiction center.
- •Confirmed positive for HCV ribonucleic acid (RNA).
排除标准
- 未提供
结局指标
主要结局
Percentage of participants with and without Hepatitis C Virus (HCV) treatment prescribed at end of the inclusion visit.
时间窗: Inclusion visit (Week 0)
Percentage of participants with and without HCV treatment prescribed at end of the inclusion visit. Criteria for treatment choice and reasons for treatment refusal will be described.
次要结局
- Number of participants with HCV Antibodies (HCV Ab)(Inclusion visit (Week 0))
- Time from HCV RNA to end of treatment(Approximately 12 months)
- Level of HCV infection knowledge(Inclusion visit (Week 0))
- Determinants associated with initiation of HCV treatment(Inclusion visit (Week 0))
- Number of participants achieving sustained viral response at 12 weeks (SVR12)(Approximately 12 months)
- Health Care Resources and Utilization(Inclusion visit (Week 0))
- Percentage of cured participants willing to share their experience with other substance abuse patients.(Approximately 12 months)
- Data and disease characteristics from patients with and without HCV treatment(Inclusion visit (Week 0))
- Number of participants who completed treatment(Approximately 12 months)
- Number of people in charge of patient follow-up(Approximately 12 months)
- Number of participants with HCV RNA(Inclusion visit (Week 0))
- Time from HCV Ab to HCV RNA(Inclusion visit (Week 0))
- Percentage of participants achieving SVR12(Approximately 12 months)
- Time to SVR12(Approximately 12 months)
- Percentage of participants with treatment adherence(Approximately 12 months)
- Patient Reported Quality of Life(Approximately 12 months)
- Number of participants with addictive behaviors(Approximately 12 months)