Hepatitis C Virus Infection, Response to Therapy of, Drug Use
Conditions
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.
Interventions
OTHERBlood sampling
Blood sampling
OTHERquestionaires
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
Ziekenhuis Oost-Limburg
Jessa Hospital
Algemeen Ziekenhuis Vesalius
CAD Limburg
Sint-Trudo
Free Clinic Antwerp
Ziekenhuis Netwerk Antwerpen (ZNA)
Clinique Saint Joseph, Liège
Centre Hospitalier Universitaire Saint Pierre
Algemeen Ziekenhuis Maria Middelares
Hasselt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
Belgium
Contacts
Primary ContactGeert Robaeys, prof. dr.
Backup ContactRob Bielen, dr.
Outcome results
None listed