A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3

Phase 4

Completed

Brief Summary: This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.

Detailed Description: The study will evaluate the feasibility, safety and effectiveness of shortened treatment for hepatitis C genotypes 2/3 in current injection drug users or receiving opiate substitution therapy. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have non-quantifiable (\<15 IU/ml detected and \<15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 and 24 weeks in those that have quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4.

Recruitment & Eligibility

Inclusion Criteria

18 years of age
chronic HCV infection
HCV genotype 2/3 infection
active injection drug use (within 24 weeks prior to consent) or currently receiving opiate substitution therapy
compensated liver disease
negative pregnancy test (within 24 hours of first dose of study medication)
effective contraception for the duration of the study
written informed consent

Exclusion Criteria

previous interferon or ribavirin therapy
investigation drug use in the 6 weeks prior to first dose of study medication
infection with HCV genotypes other than 2/3
HIV infection
HBV infection
ongoing severe psychiatric disease
frequent drug use that is judged by the treating physician to compromise treatment safety
standard clinical and medical exclusions for treatment with pegylated interferon alfa 2b and ribavirin

Arm && Interventions

Group	Intervention	Description
Shortened Treatment Duration (12 Weeks)	Pegylated interferon alfa 2b	Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).
Standard Treatment Duration (24 weeks)	Pegylated interferon alfa 2b	Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).
Standard Treatment Duration (24 weeks)	Ribavirin	Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).
Shortened Treatment Duration (12 Weeks)	Ribavirin	Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).

Primary Outcome Measures

Name	Time	Method
Treatment Efficacy	36 weeks	The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (\<15 IU/ml detected and \<15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.

Secondary Outcome Measures

Name	Time	Method
Treatment Adherence	48 weeks	Evaluate the adherence (\>80 of PEG-IFN, \>80% of RBV, \>80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
Treatment Response (ETR & SVR24)	48 weeks	Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.
Behavioral and Quality of Life	48 weeks	Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.

Locations (17): Nottingham University Hospitals NHS Trust
🇬🇧
Nottingham, United Kingdom
East London Foundation NHS Trust
🇬🇧
London, United Kingdom
Hunter Pharmacotherapy
🇦🇺
Newcastle, New South Wales, Australia
Nepean Hospital
🇦🇺
Penrith, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
St Vincent's Hospital
🇦🇺
Sydney, New South Wales, Australia
Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
ZNA Stuivenberg / MSOC Free Clinic
🇧🇪
Antwerp, Belgium
Ziekenhuis Oost Limburg / MSOC Limburg
🇧🇪
Genk, Belgium
Vancouver ID Research and Care Centre Society
🇨🇦
Vancouver, British Columbia, Canada
Praxiszentrum Im Tal (PIT)
🇩🇪
Munich, Germany
Koda Bern/Poliklinik fur Infektiologe
🇨🇭
Bern, Switzerland
East Toronto Hepatitis C Program
🇨🇦
Toronto, Ontario, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
🇨🇦
Montreal, Quebec, Canada
Oslo/Akershus University hospitals
🇳🇴
Oslo, Lorenskog, Norway
Basel Zentrum fur Suchtmedizin
🇨🇭
Basel, Switzerland
ARUD, Poliklinik Zokl 1
🇨🇭
Zurich, Switzerland