Drug Abuse, Intravenous, Hepatitis C
Conditions
Keywords
Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
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.
Interventions
DRUGSofosbuvir/ledispasvir fixed dose combination (SOF + LDP)
SOF + LDV tablets contain 400mg of SOF and 90mg of LDV.
Sponsors
St Vincent's Hospital Melbourne
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
SECONDARY PARTICIPANTS INCLUSION AND
Exclusion criteria
Study INCLUSION criteria for primary participants are as follows: * Current PWID (i.e., injected any drug at least once during the previous six months); * Evidence of chronic HCV infection (detectable plasma HCV RNA viral load above 1000 IU/ml on two occasions ≥ 6 months apart) * Willing and able to provide written informed consent. Subjects must have the following laboratory parameters at screening: * ALT \<10 times the upper limit of normal (ULN) * AST \<10 times ULN * Haemoglobin ≥12g/dL for males, ≥11g/dL for female subjects * INR ≤1.5 times ULN unless is stable on an anticoagulant regimen affecting INR * Albumin ≥3g/dL * Direct bilirubin ≤1.5 times ULN * Creatinine clearance (CLcr) ≥60mL/min, as calculated by the Cockcroft-Gault Equation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 the level of transient liver elastography readings (measured using Fibroscan®) among treated participants versus non-treated participants | Up to 84 weeks |
Countries
Australia
Contacts
Primary ContactDr Joseph Doyle
Backup ContactDr Brendan Quinn
Outcome results
None listed