Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Sustained virological response
研究概览
简要总结
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years
详细描述
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years
Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo
The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f
The secondary aims are to:
- Evaluate adherence to DAA treatment (Work Package 1)
- Identify factors associated with SVR and adherence (Work Package 1)
- Characterize reinfection using next generation sequencing (Work Package 2)
- Identify factors associated with reinfection (Work Package 2)
- Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2)
- Identify factors associated with changes in risk behaviours (Work Package 2)
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
- •HCV RNA positive Attending the low-threshold HCV clinic in Oslo
排除标准
- 未提供
结局指标
主要结局
Sustained virological response
时间窗: 12 weeks
HCV RNA undetectable 12 weeks post treatment
Reinfection
时间窗: 2 years
HCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12
次要结局
未报告次要终点
研究者
Olav Dalgard
Professor
University Hospital, Akershus