Eradicate Hepatitis C Virus: a treatment to prevent hepatitis C in active drug users

Not Applicable

Completed

• Conditions: Hepatitis C infection in active intravenous drug users; Infections and Infestations; Hepatitis C

• Registration Number: ISRCTN27564683
• Lead Sponsor: niversity of Dundee (UK)

Brief Summary

2019 results in https://pubmed.ncbi.nlm.nih.gov/30422370/ (added 27/08/2020)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-22
• Study Completion: 2017-02-28
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 94

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.