Clinical trial NCT04251572: HCV Reinfection After DAA Therapy in PWID in Belgium
Official title: Hepatitis C Reinfection After Successful Directly Acting Antiviral Treatment: A Belgian Interventional Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C Virus Infection, Response to Therapy of
Drug Use
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: Jessa Hospital
name: Algemeen Ziekenhuis Vesalius
name: CAD Limburg
name: Sint-Trudo
name: Free Clinic Antwerp
name: Ziekenhuis Netwerk Antwerpen (ZNA)
name: Clinique Saint Joseph, Liège
name: Centre Hospitalier Universitaire Saint Pierre
name: Algemeen Ziekenhuis Maria Middelares
First posted: 2020-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to calculate the incidence of HCV reinfection after successful DAA treatment among people who have recently injected drugs. The secondary aim is to identify factors associated with reinfection in this population.

Individuals with active injecting drug abuse with a chronic HCV infection who have achieved end of treatment response (ETR; defined as non-detectable HCV RNA at end of treatment) to any interferon-free DAA combination will be included in this multicenter interventional study.

Detailed description: This protocol is an adapted version of the protocol 'Hepatitis C reinfection after successful directly acting antiviral treatment: A North-Atlantic multicenter interventional study'. The investigators will plan this study so that the data are similar to this protocol and results can be compared within this alliance of hepatologists with special interest in care for substance users.

Study schedule: Data collection will be performed according to the study schedule shown in Table 1. Following assessment for SVR12, participants will be followed for 2 years at 6 months' intervals at the discretion of each study site.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age 18 years or older
* Injecting drug use within 6 months before start of treatment
* Achieved an ETR following at least eight weeks of DAA treatment
* Completed DAA treatment no more than 6 months prior to inclusion
* Blood sample drawn within 6 months pre-treatment stored at -70° C

Exclusion Criteria:

* Patients not fulfilling the inclusion criteria.

Primary outcomes:
measure: Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy
timeFrame: up to two years
Secondary outcomes:
measure: questionnaire to Identify risk factors associated with HCV reinfection
timeFrame: day 1
measure: questionaire to Identify risk factors associated with HCV reinfection
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Free Clinic Antwerp
city: Antwerp
country: Belgium
facility: ZNA Stuivenberg
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: AZ Maria-Middelares
city: Hasselt
country: Belgium
facility: CAD Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Liège
country: Belgium
facility: CHC Saint-Josephe, Liège
city: Sint-Truiden
country: Belgium
facility: Sint-Trudo Ziekenhuis
city: Tongeren
country: Belgium
facility: AZ Vesalius
Study officials:
affiliation: Hasselt University
name: Geert Robaeys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Rob Bielen, dr.
role: STUDY_CHAIR
References:
citation: Busschots D, Bielen R, Koc OM, Heyens L, Verrando R, de Galocsy C, Van Steenkiste C, Nevens F, Midgard H, Dalgard O, Robaeys G. Hepatitis C reinfection in former and active injecting drug users in Belgium. Harm Reduct J. 2021 Oct 12;18(1):102. doi: 10.1186/s12954-021-00552-x.