HCV Reinfection After DAA Therapy in PWID in Belgium

Study Overview
=================
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.

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

Conditions
-----------------
Hepatitis C Virus Infection, Response to Therapy of, Drug Use

Intervention / Treatment
-----------------
* Other: Blood sampling
* Other: questionaires


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCV reinfection after DAA therapy in PWID<br>Hepatitis C virus reinfection after directly acting antiviral treatment in persons who inject drugs. DAA therapy is an inclusion criteria, not an intervention. | Other: Blood sampling<br>* Blood sampling<br>Other: questionaires<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire to Identify risk factors associated with HCV reinfection |  | day 1 | 
| questionaire to Identify risk factors associated with HCV reinfection |  | up to 2 years |