HCV Reinfection After DAA Therapy in PWID in Belgium

Hasselt University100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Hepatitis C Virus Infection, Response to Therapy of Drug Use

Interventions

Blood samplingOTHER

Blood sampling

questionairesOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Free Clinic Antwerp

Antwerp, Belgium

RECRUITING

ZNA Stuivenberg

Antwerp, Belgium

RECRUITING

CHU Saint-Pierre

Brussels, Belgium

Outcomes

Primary Outcomes

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

Time frame: up to two years

Secondary Outcomes

questionnaire to Identify risk factors associated with HCV reinfection

Time frame: day 1

questionaire to Identify risk factors associated with HCV reinfection

Time frame: up to 2 years

Central Contacts

Geert Robaeys, prof. dr.

CONTACT

+32 89 32 15 60 geert.robaeys@zol.be

Rob Bielen, dr.

CONTACT

+32 89 32 15 60 rob.bielen@zol.be

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.