NCT02064049

Surveillance and Treatment of Prisoners With Hepatitis C

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,692 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Sofosbuvir/velpatasvir	The treatment phase will commence in year 2. This is 12 weeks of the pangenotypic sofosbuvir/velpatasvir 400/100mg, coformulated into one tablet daily.

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2014-02-17
• Last updated: 2019-12-09

Locations

4 sites across 1 country: Australia