The TAP Study: Treating People Who Inject Drugs in Community-Based Settings Using a Social Network Approach

Phase 3

• Conditions: Hepatitis C; Drug Abuse, Intravenous
• Interventions: Drug: Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)

• Registration Number: NCT02363517
• Lead Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Brief Summary

This study will investigate the feasibility of treating people who inject drugs (PWID) with hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy combination of sofosbuvir plus ledipasvir. It will also measure the effectiveness of using a social network-based approach to reduce HCV incidence among PWID.

Detailed Description

This study will investigate the feasibility of treating people who inject drugs (PWID) with hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy combination of sofosbuvir plus ledipasvir (SOF + LDP). It will also measure the effectiveness of using a social network-based approach ("bring your friends") to reduce HCV incidence among PWID. Participants will initially be sourced from the Burnet Institute's existing SuperMIX cohort (N= 757). This cohort comprises PWID followed for between two and six years (median=1057 days), of whom 299 have chronic HCV infection. The HCV genotype distribution in the SuperMIX cohort is: HCV-1 (55%); HCV-3 (40%) and HCV-6 (\<5%).

Participants will be randomly allocated to three groups:

Group 1: Primary (n=40) and secondary (n=100) participants will receive supportive care only.

Group 2: Primary participants (n=40) will be treated with SOF + LDP for 12 weeks. Secondary participants (n=100) will receive supportive care only.

Group 3: Primary (n=40) and secondary participants with chronic HCV infection (n=50%\*100) will be treated with SOF + LDP for 12 weeks. Participants in Group C who have evidence of HCV re-infection will be offered re-treatment with SOF + LDP for 12 weeks.

Treatment participants will have a clinical review, questionnaire and blood sample collected at baseline, weeks 4, 8 and 12 (end-of-treatment), and at weeks 12 (SVR12), 24 (SVR24), 36, 48, 60 and 72 post-treatment. Non-treatment participants will have a clinical review, questionnaire and blood sample collected at baseline and weeks 12, 24, 36, 48, 60, 72 and 84.

Study Timeline

• Study First Submitted: 2014-12-21
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-16
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-08
• Last Update Posted: 2018-04-10
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)	Primary participants (n=40) will be treated with 'Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP) for 12 weeks. Secondary participants (n=100) will receive supportive care only. Participants with HCV not allocated to treatment arms will receive deferred treatment at the end of the follow-up period.
Group C	Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)	Primary (n=40) and secondary participants with chronic HCV infection (approx. n=50%\*100) will be treated with 'Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP) for 12 weeks. Participants in Group C who have evidence of HCV re-infection will be offered re-treatment with SOF + LDP for 12 weeks.

Primary Outcome Measures

Name	Time	Method
The effectiveness of treating PWID using a "bring your friends" strategy on rates of HCV primary infection and reinfection, as measured by HCV incidence rates among participants	Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84
The efficacy of treating PWID with HCV using 12 weeks of oral therapy via a community-based, nurse-led treatment model, as measured by SVR rates	Change in sustained viral response rates at weeks 12 and 24 post-treatment. Participant retention rate at weeks 4, 8 and 12 (end of treatment).
The effectiveness of treating PWID on rates of HCV primary infection and reinfection among their social networks, as measured by HCV incidence rates among primary and secondary participants	Changes in rates of HCV primary infection and reinfection at weeks 12, 24, 36, 48, 60, 72 and 84	Hypothesis: Offering HCV treatment to PWID will lead to a lower incidence of transmission of HCV from primary participants to their injecting partners, compared to not treating any PWID.
The feasibility of treating PWID with HCV using 12 weeks of oral therapy via a community-based, nurse-led treatment model, as measured by SVR rates and participant retention	Change in participant retention rates at weeks 4, 8 and 12 (end of treatment)

Secondary Outcome Measures

Name	Time	Method
Changes to Quality of Life (QoL) among treated participants versus non-treated participants, as measured by self-reported responses to validated QoL scales	Weeks 12, 24, 36, 48, 60, 72 and 84
Changes in the level of transient liver elastography readings (measured using Fibroscan®) among treated participants versus non-treated participants	Up to 84 weeks
The prevalence of HCV resistance associated variants among treated participants who do not achieve SVR12	At 12 weeks post-treatment (SVR12) and weeks 24 (SVR24), 36, 48, 60 and 72 post-treatment
Changes in levels of injecting risk behaviours among participants following HCV treatment, as measured by self-reported frequency of risky injecting behaviours among participants	Weeks 12, 24, 36, 48, 60, 72 and 84

Trial Locations

Locations (1)

Burnet Institute; 🇦🇺 Melbourne, Victoria, Australia