HCV Reinfection After DAA Therapy in PWID in Belgium

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.

Conditions

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

Interventions

OTHER

Blood sampling

Blood sampling

OTHER

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.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg

  collaborator OTHER

• Jessa Hospital

  collaborator OTHER

• Algemeen Ziekenhuis Vesalius

  collaborator OTHER

• CAD Limburg

  collaborator UNKNOWN

• Sint-Trudo

  collaborator UNKNOWN

• Free Clinic Antwerp

  collaborator UNKNOWN

• Ziekenhuis Netwerk Antwerpen (ZNA)

  collaborator OTHER

• Clinique Saint Joseph, Liège

  collaborator OTHER

• Centre Hospitalier Universitaire Saint Pierre

  collaborator OTHER

• Algemeen Ziekenhuis Maria Middelares

  collaborator OTHER

• Hasselt University

  lead OTHER

Principal Investigators

• Geert Robaeys, prof. dr. · Hasselt University

• Rob Bielen, dr. · Hasselt University

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2022-02-28

Completion

2022-02-28

Countries

• Belgium

Study Locations