Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria. JAILFREE-C
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Sustained Virological Response
研究概览
简要总结
The objectives of this study are:
- To perform a systematic screening and evaluation of the prevalence of infection by hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) in the prison population.
- To perform an adequate characterization of patients and the characteristics of HCV infection in this population.
- To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen.
- To evaluate the impact of a strategy of systematic HCV treatment on the rates of persistent infection, reinfection and super-infection in a prison population, in the short, medium and long term.
详细描述
Background:
Infections caused by hepatitis B, C and HIV viruses represent a serious health problem. The inmate population represents a reservoir with high prevalence of these kind of infections. The completion of a secondary prevention through early detection of infections in early stages, and tertiary prevention by treatment of diagnosed cases, constitutes one of the pillars of the approach to these diseases. This strategy is even more valuable in the inmate population because it can help eliminate a source of spread of these diseases in addition to relieving the burden of disease in this population. In this regard, one of the mandates of the recently adopted National Strategy Plan for the Hepatitis C in Spain emphasizes these strategies.
Finally, a program of this nature is intended as a pilot experience that could be extended to other prison communities at national and European level.
Endpoints
-
- To estimate the prevalence of HBV, HCV and HIV in the inmate population of El Dueso.
-
- To perform a systematic treatment of the inmate population against HCV infection. The treatment will be directed to both, the prevalent population and the new prisoners who enter the prison. The other detected infections will be also treated accordingly.
-
- To carry out a descriptive evaluation of the efficacy and safety of an interferon-free regimen against the HCV infection in this population. This regimen will be mainly based on Sofosbuvir and ledipasvir (± RBV) according to the current clinical practice adopted in the National Strategy Plan for the Hepatitis C.
-
- To evaluate the rates of persistent infection, reinfection and super-infection as defined.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epidemiology study: All inmates at the El Dueso Penitentiary Centre including new admissions within the study period.
- •Interventional study: All HCV infected patients with detectable viral load (HCV RNA)
- •Informed consent signature
排除标准
- •Not informed consent signature.
- •Pregnant or breastfeeding women
- •Hypersensitivity or any temporary or permanent absolute contraindication to either drug that should be prescribed according to clinical and virological characteristics of the patient.
研究组 & 干预措施
Active treatment
All HCV chronic infected patients will be treated with oral anti-HCV regimens containing sofosbuvir, ledipasvir (associated or not to ribavirin) according to clinical practice as indicated into the current guidelines (1)
(1)European Association for Study of Liver (EASL). EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. PubMed PMID: 25911336.
干预措施: sofosbuvir (Drug)
Active treatment
All HCV chronic infected patients will be treated with oral anti-HCV regimens containing sofosbuvir, ledipasvir (associated or not to ribavirin) according to clinical practice as indicated into the current guidelines (1)
(1)European Association for Study of Liver (EASL). EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. PubMed PMID: 25911336.
干预措施: ledipasvir (Drug)
结局指标
主要结局
Percentage of Participants with Sustained Virological Response
时间窗: 12 weeks after the end of treatment
Percentage of Participants with Sustained Virological Response (undetectable viral load) at this point
Prevalence of chronic hepatitis C
时间窗: 12 months after the beginning of the study.
Percentage of viremic hepatitis C patients with respect to the whole inmate population
次要结局
- HCV seroprevalence(baseline)
- Percentage of Participants with Sustained Virological Response(4 weeks after the end of treatment)
- HIV seroprevalence(baseline)
- Chronic HCV infection prevalence(baseline)
- Adverse events(24 weeks after the start of treatment)
- HBV seroprevalence(baseline)