Treatment as Prevention for Hepatitis C in Iceland. A Nationwide Campaign for Reducing Disease Burden Using Combination Antiviral Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of transmission of HCV in Iceland
研究概览
简要总结
The main aim of this study is to test in the Icelandic population the hypothesis that a nationwide treatment program which offers effective treatment to all known cases of Hepatitis C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a reduction in incidence and disease burden associated with chronic HCV infection.
详细描述
In Iceland, a nationwide effort is planned where all patients with HCV infection will be offered treatment using direct acting antiviral agents. The aim of the initiative, besides offering cure to patients, is to substantially reduce domestic transmission of HCV and thereby lower the incidence. Ultimately, with these intense efforts the long-term complications of chronic HCV infection could potentially be nearly eliminated. In Iceland, there is mandatory reporting of all new cases of hepatitis C to the State Epidemiologist.
In the study, short term and long term outcomes of this initiative will be investigated. In an initial treatment phase which will last for up to three years, all patients diagnosed with hepatitis C in Iceland will be offered treatment with direct acting antiviral agents. Virological response rate and compliance will be monitored. Long term, the incidence of HCV infection acquired in Iceland will be monitored for up to 15 years, and the incidence rates of cirrhosis and hepatocellular carcinoma due to HCV will be monitored for up to 15 years.
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 positive subjects 18 years and older, living in Iceland and covered by the Icelandic Health Insurance.
排除标准
- •Age under 18 years
- •Inability to sign informed consent.
结局指标
主要结局
Incidence of transmission of HCV in Iceland
时间窗: Measured annually for up to 15 years
次要结局
- Incidence of cirrhosis and hepatocellular carcinoma in Iceland(Measured annually for up to 15 years)
- Reinfection rate as measured by new infections diagnosed in patients who were previously treated and achieved SVR(Measured for up to 36 months)
- Sustained virological response rate (SVR) to treatment with antiviral agents as measured by negative HCV RNA 12 weeks post treatment(Measured for up to 36 months)