HCV Reinfection After DAA Therapy in PWID in Belgium (REINF_HCV)

Hasselt University

Status: Unknown

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

Treatments: Other: Blood sampling; Other: questionaires

Study type: Interventional

Funder types: Other

Identifiers

NCT04251572

18/0012U

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

HCV reinfection after DAA therapy in PWID

Experimental group

Description:

Hepatitis C virus reinfection after directly acting antiviral treatment in persons who inject drugs. DAA therapy is an inclusion criteria, not an intervention.

Treatment:

Other: Blood sampling

Other: questionaires