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

Kirby Institute

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Drug: Pegylated interferon alfa 2b

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01364090

VHCRP1007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Standard Treatment Duration (24 weeks)

Active Comparator group

Description:

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).

Treatment:

Drug: Ribavirin

Drug: Pegylated interferon alfa 2b

Shortened Treatment Duration (12 Weeks)

Experimental group

Description:

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).

Treatment:

Drug: Ribavirin

Drug: Pegylated interferon alfa 2b