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

Kirby Institute93 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C, Chronic

Interventions

Pegylated interferon alfa 2bDRUG

Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

RibavirinDRUG

Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Hunter Pharmacotherapy

Newcastle, New South Wales, Australia

Nepean Hospital

Penrith, New South Wales, Australia

Outcomes

Primary Outcomes

Treatment Efficacy

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.

Time frame: 36 weeks

Secondary Outcomes

Treatment Adherence

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.

Time frame: 48 weeks

Treatment Response (ETR & SVR24)

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.

Time frame: 48 weeks

Behavioral and Quality of Life

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.

Data from ClinicalTrials.gov

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