Surveillance and Treatment of Prisoners With Hepatitis C (SToP-C)
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|ClinicalTrials.gov Identifier: NCT02064049|
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : December 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Sofosbuvir/velpatasvir||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||3692 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess the Feasibility of Hepatitis C Virus (HCV) Treatment as Prevention With Interferon-free Direct Acting Antivirals (DAAs) in the Prison Setting|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||November 2019|
|Actual Study Completion Date :||November 2019|
Experimental: Hepatitis C treatment
All prisoners (in participating correctional centres) with hepatitis c, as identified during the hepatitis C surveillance phase of the study will be offered treatment for hepatitis C. The treatment course is sofosbuvir/velpatasvir 400/100mg for 12 weeks (1 tablet once daily).
The treatment phase will commence in year 2. This is 12 weeks of the pangenotypic sofosbuvir/velpatasvir 400/100mg, coformulated into one tablet daily.
Other Name: Epslusa
- Hepatitis C virus (HCV) incidence [ Time Frame: 2 years ]Incidence of HCV infection over a two year period in a network of four participating correctional centres.
- Hepatitis C virus prevalence [ Time Frame: 2 years ]Change in prevalence of HCV infection over a two year period in a network of four participating correctional centres.
- SVR12 [ Time Frame: 24 weeks ]The proportion of patients with undetectable HCV RNA at 12 weeks following the end of treatment (SVR12)
- ETR [ Time Frame: 12 weeks ]The proportion of patients with an end of treatment response (ETR)
- Rapid Virological Response (RVR) [ Time Frame: 4 weeks ]The proportion of patients with undetectable HCV RNA at 4 weeks following the initiation of treatment (RVR)
- Treatment adherence [ Time Frame: 12 weeks ]The proportion adherent to therapy (both on-treatment adherence and treatment discontinuation) and the association between adherence and response to treatment
- Number of patients with adverse events [ Time Frame: 16 weeks ]Safety and tolerability of the treatment regimen
- Treatment uptake [ Time Frame: 2 years ]The rate of HCV treatment uptake among eligible inmates and reasons for non-uptake
- On-treatment change in illicit drug use [ Time Frame: 24 weeks ]Changes in illicit drug use behaviours during treatment
- HCV reinfection rate [ Time Frame: 2 years ]The rate of HCV reinfection following treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064049
|Australia, New South Wales|
|Goulburn Correctional Centre|
|Goulburn, New South Wales, Australia, 2580|
|Lithgow Correctional Centre|
|Lithgow, New South Wales, Australia, 2790|
|Dillwynia Correctional Centre|
|Windsor, New South Wales, Australia, 2756|
|Outer Metropolitan Multipurpose Correctional Centre|
|Windsor, New South Wales, Australia, 2756|
|Principal Investigator:||Gregory Dore, MBBS,PhD||Kirby Institute, University of New South Wales; St Vincent's Hospital Sydney|