HCV Reinfection After DAA Therapy in PWID in Belgium

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Hasselt University
Updated on 19 February 2024
hepatitis

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.

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.

Details
Condition Drug abuse, Hepatitis C Virus Infection, Response to Therapy of
Age 18-100 years
Treatment blood sampling, questionaires
Clinical Study IdentifierNCT04251572
SponsorHasselt University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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