HCV Reinfection After DAA Therapy in PWID in Belgium

Not Applicable

• Conditions: Hepatitis C Virus Infection, Response to Therapy of; Drug Use
• Interventions: Other: Blood sampling; Other: questionaires

• Registration Number: NCT04251572
• Lead Sponsor: Hasselt University

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.

Study Timeline

• Study First Submitted: 2018-05-30
• Study Start: 2019-07-01
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-02-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCV reinfection after DAA therapy in PWID	Blood sampling	Hepatitis C virus reinfection after directly acting antiviral treatment in persons who inject drugs. DAA therapy is an inclusion criteria, not an intervention.
HCV reinfection after DAA therapy in PWID	questionaires	Hepatitis C virus reinfection after directly acting antiviral treatment in persons who inject drugs. DAA therapy is an inclusion criteria, not an intervention.

Primary Outcome Measures

Name	Time	Method
Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy	up to two years	Number of reinfections with hepatitis C per 100 persons

Secondary Outcome Measures

Name	Time	Method
questionaire to Identify risk factors associated with HCV reinfection	up to 2 years
questionnaire to Identify risk factors associated with HCV reinfection	day 1

Trial Locations

Locations (10)

Free Clinic Antwerp; 🇧🇪 Antwerp, Belgium

ZNA Stuivenberg; 🇧🇪 Antwerp, Belgium

AZ Vesalius; 🇧🇪 Tongeren, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

CHU Saint-Pierre; 🇧🇪 Bruxelles, 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