HCV Reinfection After DAA Therapy in PWID in Belgium

Drug Use Clinical Trial

— REINF_HCV  

Official title:

Hepatitis C Reinfection After Successful Directly Acting Antiviral Treatment: A Belgian Interventional Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04251572
• Other study ID #: 18/0012U
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2021
• Source: Hasselt University
• Contact: Geert Robaeys, prof. dr.
• Phone: +32 89 32 15 60
• Email: geert.robaeys[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Use
• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection, Response to Therapy of

Intervention

Other:
• Blood sampling
Blood sampling
• questionaires
Included participants will complete a baseline questionnaire at end of treatment (EOT) and a follow-up questionnaire throughout the follow-up period (Table 1). The questionnaires collect information on socio-demographics (age, gender, ethnicity, employment status, education level, housing status, incarceration, medical history and OST), injecting drug use (drugs injected, injection frequency and sharing of needle/syringe, cookers, cotton/filter or water). Details on the received DAA regime including mode of administration (direct observed therapy, pill box, etc.) and self-reported data on treatment adherence will also be recorded.

Locations

Country	Name	City	State
Belgium	Free Clinic Antwerp	Antwerp
Belgium	ZNA Stuivenberg	Antwerp
Belgium	CHU Saint-Pierre	Bruxelles
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	AZ Maria-Middelares	Gent
Belgium	CAD Limburg	Hasselt
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	CHC Saint-Josephe, Liège	Liège
Belgium	Sint-Trudo Ziekenhuis	Sint-Truiden
Belgium	AZ Vesalius	Tongeren

Sponsors (11)

Lead Sponsor	Collaborator
Hasselt University	Algemeen Ziekenhuis Maria Middelares, Algemeen Ziekenhuis Vesalius, CAD Limburg, Centre Hospitalier Universitaire Saint Pierre, Clinique Saint Joseph, Liège, Free Clinic Antwerp, Jessa Hospital, Sint-Trudo, Ziekenhuis Netwerk Antwerpen (ZNA), Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy	Number of reinfections with hepatitis C per 100 persons	up to two years
Secondary	questionnaire to Identify risk factors associated with HCV reinfection		day 1
Secondary	questionaire to Identify risk factors associated with HCV reinfection		up to 2 years