The purpose of the study is to assess how feasible it is to treat and prevent the transmission of Hepatitis C in the prison setting to achieve substantial reductions in the incidence and prevalence of Hepatitis C. It is hypothesised that a rapid scale-up of Hepatitis C Virus (HCV) treatment with interferon-free Direct Acting Anti-virals (DAAs) in prison inmates will achieve a \>50% reduction in the incidence of HCV infection over a two year period in the prison setting.
The study will be conducted initially in two maximum security prisons located in New South Wales, Australia and comprises four phases: Phase 1, Surveillance of HCV Incidence and Prevalence and Liver Disease Burden: The HCV incidence and prevalence phase is a prospective longitudinal cohort. HCV incidence and prevalence and liver disease burden will be monitored through regular six-monthly cross-sectional surveys of participants for 3.5 years. Phase 2, Modelling: The data from year 1 of the surveillance of HCV incidence and prevalence phase will be used to model the number of participants required to be treated to demonstrate a 50% reduction in incidence. Phase 3, Treatment Intervention: The treatment intervention will only be conducted in one of the maximum security prisons (Treatment Prison). The second prison will continue to care for HCV infected inmates as per standard of care (Control Prison). The intervention component of this study will consist of a phase IV open-label study of interferon-free DAAs for the treatment of HCV infection. The treatment phase will commence in year 2 and will be two years in duration. The exact drug combination and regimen to be used in the treatment intervention will be determined in year 1 once phase II and III data of sofosbuvir and ledipasvir and other potential interferon-free DAA regimens are published. The exact number of participants required to demonstrate a 50% reduction in incidence will be determined during the modelling phase. Phase 4, Cost-effectiveness: During the treatment intervention phase participants will be required to complete a survey to obtain estimates of health outcomes (EQ-5D survey) at regular intervals. This data will be used by the health economist to determine the cost effectiveness of treatment as prevention in the prison setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3,692
The treatment phase will commence in year 2. This is 12 weeks of the pangenotypic sofosbuvir/velpatasvir 400/100mg, coformulated into one tablet daily.
Goulburn Correctional Centre
Goulburn, New South Wales, Australia
Lithgow Correctional Centre
Lithgow, New South Wales, Australia
Dillwynia Correctional Centre
Windsor, New South Wales, Australia
Outer Metropolitan Multipurpose Correctional Centre
Windsor, New South Wales, Australia
Hepatitis C virus (HCV) incidence
Incidence of HCV infection over a two year period in a network of four participating correctional centres.
Time frame: 2 years
Hepatitis C virus prevalence
Change in prevalence of HCV infection over a two year period in a network of four participating correctional centres.
Time frame: 2 years
SVR12
The proportion of patients with undetectable HCV RNA at 12 weeks following the end of treatment (SVR12)
Time frame: 24 weeks
ETR
The proportion of patients with an end of treatment response (ETR)
Time frame: 12 weeks
Rapid Virological Response (RVR)
The proportion of patients with undetectable HCV RNA at 4 weeks following the initiation of treatment (RVR)
Time frame: 4 weeks
Treatment adherence
The proportion adherent to therapy (both on-treatment adherence and treatment discontinuation) and the association between adherence and response to treatment
Time frame: 12 weeks
Number of patients with adverse events
Safety and tolerability of the treatment regimen
Time frame: 16 weeks
Treatment uptake
The rate of HCV treatment uptake among eligible inmates and reasons for non-uptake
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Time frame: 2 years
On-treatment change in illicit drug use
Changes in illicit drug use behaviours during treatment
Time frame: 24 weeks
HCV reinfection rate
The rate of HCV reinfection following treatment
Time frame: 2 years