Hepatitis C infection in active intravenous drug users Infections and Infestations Hepatitis C
Conditions
Interventions
The major challenge here is to access younger infected drug users and persuade them to engage with treatment for HCV. Most of them do not regard their drug use as a problem and have no motivation to c
with those positive seeking enrolment in opiate substitution programs and those negative accessing the exchange for clean works much more frequently. Within this group a number of young infected indiv
Sponsors
University of Dundee (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female (age limit 18-70) 2. Chronic HCV positive infection 3. Genotype & PCR confirmed in addition to complying with all screening requirements 4. If female, must have negative urine test results for pregnancy during initial screening period (for trial inclusion) & immediately prior to commencing study and agree to consider / commence adequate contraceptive cover (depot injection/ implanon rod) 5. Current illicit IV drug use established through drug screening (oral swab / urine) 6. Sign and date informed consent, agreeing to study and monitoring criteria
Exclusion criteria
Exclusion criteria: 1. Aggressive or violent behaviour 2. Inability to provide informed consent 3. Features of decompensated liver failure 4. Evidence of primary hepatocellular carcinoma 5. Pregnancy, breast feeding, or pre-menopausal female not using effective contraception 6. Patients with contraindications to use of interferon or ribavirin as congestive cardiac failure or known hypersensitivity to either product 7. Previous treatment with Peginterferon alpha or Ribavirin or Telaprevir 8. Participation in a drug study within the previous 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify and treat with HCV antivirals 100 new HCV positive individuals over a 5 year period, who are active drug users using the needle exchange and other services and to determine the Sustained Viral Response rate in those patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the demographic and patient response information between those refusing testing, those testing positive for HCV but declining treatment and those entering therapy. 2. To perform a health economic evaluation against standard care pathways 3. Measuring Quality of Life before, during and after therapy. 4. Determining the level of reinfection rates in the treated population over 5 years. 5. To collect marginal costs 6. To determine the rate of Adverse events in the treatment cohort compared to a matched group of standard pathway of care patients 7. Concomitant medication and drug use interactions will be assessed by questionnaire and urine toxicology screening 8. To assess the benefit of contingency management, low threshold methadone, peer/family support and mobile phone virtual support on adherence in terms of Sustained Viral Response compared to standard care pathway. 9. Patient assessment of relative importance of the adherence interventions, by focus group and qualitative interviews. 10. To determine the impact of this level of treatment over 5, 7 and 10 years on the population prevalence of HCV by comparing annual measurement of HCV chronic infection prevalence in drug users in routine dried blood spot testing in needle exchanges and as determined by the NESI project data. 11. Impact of HCV therapy on drug use will be assessed by record linkage to drug rehabilitation programs, comparing HCV treated patients to HCV negative controls from the testing program. | — |
Countries
United Kingdom
Outcome results
None listed