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临床试验/NCT03106194
NCT03106194已完成不适用

Case Management in Hepatitis C Virus Infected People Who Inject Drugs in Belgium

Hasselt University2 个研究点 分布在 1 个国家目标入组 441 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
441
试验地点
2
主要终点
Rate of sustained viral response (SVR) (%)

研究概览

简要总结

To study the impact of case management on the outcome of the care of chronic hepatitis C in people who inject drugs (PWID). By creating the function of case manager, the investigators will target all the barriers to care of the HCV care continuum. Partial objectives are to measure the impact of case management on the uptake for screening, the uptake and outcome of treatment, and the rate of reinfection.

详细描述

Hepatitis C virus infection (HCV) is nowadays one of the leading causes of chronic liver disease, with prevalence of liver cirrhosis still increasing. The hepatitis C virus (HCV) is primarily transmitted through blood-to-blood contact. In the Western world, overall prevalence of HCV antibodies is low. In Belgium, prevalence of HCV in the general population is estimated around 1% by expert opinion. However, in high-risk populations prevalence of HCV increases. Data for HCV antibody prevalence in Belgium show rates of 60-80% in people who inject drugs (PWID). Populations at increased risk of HCV infection include:

  • PWID
  • recipients of infected blood products or invasive procedures in health-care facilities with inadequate infection control practices (western world: before 1992)
  • children born to mothers infected with HCV
  • people with sexual partners who are HCV-infected
  • people with HIV infection
  • prisoners or previously incarcerated persons
  • people who have used intranasal drugs
  • people who have had tattoos or piercings

Based on international guidelines, the Belgian Association for the Study of the Liver (BASL) recommends targeted screening for these populations to assess HCV prevalence. This is not yet executed in Belgium, despite the severe health and economic burden accompanied with chronic hepatitis C virus infection (CHC). In response to this lacuna in the Belgium health care, the "Hepatitis C Plan (2014-2019)" was developed. This action plan aims to improve the following goals:

  • Uptake for screening in high-risk populations
  • Creation of a national systematic screening procedure
  • Development of an HCV expertise network to improve care and linkage-to-care Furthermore, in April of 2015 the federal government of Belgium distributed a pact with the pharmaceutical industry, called "The Future Pact". This pact between industry and government focuses on accessibility to care, specifically for high-risk groups. Goals are to create a national registry for therapy and develop patient support programs, next to the expansion of reimbursement of therapy for HCV infection in fibrosis stadium II. However, despite the international guidelines and despite the strategic aims in the Hepatitis C plan and the Future Pact, no specific actions are described, and screening is not systematically executed in high-risk groups in Belgium.

The importance of this screening cannot be underestimated as HCV is now curable, with success rates of 60-100% according to other associated factors (e.g. use of direct acting antivirals (DAAs), severity of liver disease, HCV genotype, resistance). Furthermore, different studies state that treatment of patients with CHC in an early stage has the potential to be cost-effective, as hospitalization costs after development of liver disease far exceed the cost of antiviral therapy. Nonetheless, treatment uptake also remains low.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

入选标准

  • ≥ 18 years of age
  • History of injection drug use with substitution program
  • Written informed consent obtained

排除标准

  • Possible acute HCV infection within the previous 6 months defined by one of the following: acute hepatitis symptoms, ALT ≥ 10x ULN, negative or unknown HCV antibody status

结局指标

主要结局

Rate of sustained viral response (SVR) (%)

时间窗: up to three years

percentage of patients who clear the hepatitis C virus in relation to total patients treated

Uptake for screening (%)

时间窗: screening

percentage of clients screened in relation to number of clients in follow-up at CAD

Uptake for treatment assessment (%)

时间窗: day 1

percentage of HCV positive clients who attented a hepatology consultation in relation of total of HCV positive clients

Uptake for treatment (%)

时间窗: day 1

percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment

Rate of reinfection (%)

时间窗: up to three years

percentage of patients who get reinfected with HCV in relation to total cured patients

Compliance to therapy (%)

时间窗: up to three years

percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment

次要结局

未报告次要终点

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Geert Robaeys

prof. dr.

Hasselt University

研究点 (2)

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