A Pilot Study to Assess the Feasibility of Hepatitis C Virus (HCV) Treatment as Prevention With Interferon-free Direct Acting Antivirals (DAAs) in the Prison Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,692
- 试验地点
- 4
- 主要终点
- Hepatitis C virus (HCV) incidence
研究概览
简要总结
The purpose of the study is to assess how feasible it is to treat and prevent the transmission of Hepatitis C in the prison setting to achieve substantial reductions in the incidence and prevalence of Hepatitis C.
It is hypothesised that a rapid scale-up of Hepatitis C Virus (HCV) treatment with interferon-free Direct Acting Anti-virals (DAAs) in prison inmates will achieve a >50% reduction in the incidence of HCV infection over a two year period in the prison setting.
详细描述
The study will be conducted initially in two maximum security prisons located in New South Wales, Australia and comprises four phases:
Phase 1, Surveillance of HCV Incidence and Prevalence and Liver Disease Burden:
The HCV incidence and prevalence phase is a prospective longitudinal cohort. HCV incidence and prevalence and liver disease burden will be monitored through regular six-monthly cross-sectional surveys of participants for 3.5 years.
Phase 2, Modelling:
The data from year 1 of the surveillance of HCV incidence and prevalence phase will be used to model the number of participants required to be treated to demonstrate a 50% reduction in incidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hepatitis C treatment
All prisoners (in participating correctional centres) with hepatitis c, as identified during the hepatitis C surveillance phase of the study will be offered treatment for hepatitis C. The treatment course is sofosbuvir/velpatasvir 400/100mg for 12 weeks (1 tablet once daily).
干预措施: Sofosbuvir/velpatasvir (Drug)
结局指标
主要结局
Hepatitis C virus (HCV) incidence
时间窗: 2 years
Incidence of HCV infection over a two year period in a network of four participating correctional centres.
次要结局
- ETR(12 weeks)
- HCV reinfection rate(2 years)
- Hepatitis C virus prevalence(2 years)
- SVR12(24 weeks)
- Rapid Virological Response (RVR)(4 weeks)
- Treatment adherence(12 weeks)
- Number of patients with adverse events(16 weeks)
- Treatment uptake(2 years)
- On-treatment change in illicit drug use(24 weeks)