Clinical trial NCT03106194: Case Management in HCV Infected PWID
Official title: Case Management in Hepatitis C Virus Infected People Who Inject Drugs in Belgium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse, Intravenous
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: CAD Limburg
First posted: 2017-04-10
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

One of the reasons why PWIDs were excluded from treatment in the past was stigmatization based on greater risk of reinfection. Latest studies show low rates of reinfection among PWID, even with continued injection drug use during and after treatment. The pooled HCV reinfection risk was 2.4 per 100 person years, combined for six studies, across the UK, Australia, the Netherlands and Greece, suggesting that HCV treatment should not be withheld due to concerns about reinfection alone. However, with ongoing risk behaviour, current guidelines recommend monitoring with annual HCV RNA assessments. Furthermore, data from the National Scottish Hepatitis C Clinical Database show that an increasing significant minority of PWID continue to inject post-SVR at an intensity which leads to either hospitalisation or death and increased risk of reinfection. Thus, harm reduction and counselling remain necessary.

With this trial, the investigators want to evaluate a possible approach to reach the different goals defined in the Hepatitis C plan and the future pact. The investigators will study the impact of case management on the outcome of care for HCV infected PWID in Belgium.

Eligibility criteria: Inclusion criteria

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

Exclusion criteria

* 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

Primary outcomes:
measure: Uptake for screening (%)
timeFrame: screening
measure: Uptake for treatment assessment (%)
timeFrame: day 1
measure: Uptake for treatment (%)
timeFrame: day 1
measure: Compliance to therapy (%)
timeFrame: up to three years
measure: Rate of sustained viral response (SVR) (%)
timeFrame: up to three years
measure: Rate of reinfection (%)
timeFrame: up to three years
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Hasselt University
name: Geert Robaeys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Rob Bielen, drs.
role: STUDY_CHAIR
References:
citation: Busschots D, Bielen R, Koc OM, Heyens L, Dercon E, Verrando R, Janssens F, Van den Bergh L, Van Lint P, Bruckers L, Nevens F, Robaeys G. On-site testing and case management to improve hepatitis C care in drug users: a prospective, longitudinal, multicenter study in the DAA era. BMC Public Health. 2021 Aug 20;21(1):1574. doi: 10.1186/s12889-021-11608-9.