Surveillance and Treatment of Prisoners With Hepatitis C

Phase 4

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Sofosbuvir/velpatasvir

• Registration Number: NCT02064049
• Lead Sponsor: Kirby Institute

Brief 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.

Study Timeline

• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-10
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3692

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepatitis C treatment	Sofosbuvir/velpatasvir	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).

Primary Outcome Measures

Name	Time	Method
Hepatitis C virus (HCV) incidence	2 years	Incidence of HCV infection over a two year period in a network of four participating correctional centres.

Secondary Outcome Measures

Name	Time	Method
ETR	12 weeks	The proportion of patients with an end of treatment response (ETR)
HCV reinfection rate	2 years	The rate of HCV reinfection following treatment
Hepatitis C virus prevalence	2 years	Change in prevalence of HCV infection over a two year period in a network of four participating correctional centres.
SVR12	24 weeks	The proportion of patients with undetectable HCV RNA at 12 weeks following the end of treatment (SVR12)
Rapid Virological Response (RVR)	4 weeks	The proportion of patients with undetectable HCV RNA at 4 weeks following the initiation of treatment (RVR)
Treatment adherence	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	16 weeks	Safety and tolerability of the treatment regimen
Treatment uptake	2 years	The rate of HCV treatment uptake among eligible inmates and reasons for non-uptake
On-treatment change in illicit drug use	24 weeks	Changes in illicit drug use behaviours during treatment

Trial Locations

Locations (4)

Goulburn Correctional Centre; 🇦🇺 Goulburn, New South Wales, Australia

Dillwynia Correctional Centre; 🇦🇺 Windsor, New South Wales, Australia

Outer Metropolitan Multipurpose Correctional Centre; 🇦🇺 Windsor, New South Wales, Australia

Lithgow Correctional Centre; 🇦🇺 Lithgow, New South Wales, Australia