NCT02064049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,692

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

5.1 years

First QC Date

February 12, 2014

Last Update Submit

December 5, 2019

Conditions

Hepatitis C

Keywords

Hepatitis C virusPeople who inject drugsDrug usersDirect acting antiviral (DAA)Infectious diseasesPrisoners

Outcome Measures

Primary Outcomes (1)

  • Hepatitis C virus (HCV) incidence

    Incidence of HCV infection over a two year period in a network of four participating correctional centres.

    2 years

Secondary Outcomes (9)

  • Hepatitis C virus prevalence

    2 years

  • SVR12

    24 weeks

  • ETR

    12 weeks

  • Rapid Virological Response (RVR)

    4 weeks

  • Treatment adherence

    12 weeks

  • +4 more secondary outcomes

Study Arms (1)

Hepatitis C treatment

EXPERIMENTAL

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).

Drug: Sofosbuvir/velpatasvir

Interventions

Sofosbuvir/velpatasvirDRUG

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

Also known as: Epslusa
Hepatitis C treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Voluntarily signed the (surveillance phase) informed consent form.
  • Adequate English and mental health status to provide written informed consent and comply with study procedures

You may not qualify if:

  • years of age or older.
  • Voluntarily signed the (treatment phase) informed consent form.
  • Detectable HCV RNA in plasma.
  • HCV genotypes 1-6
  • Anticipated incarceration duration \>12 weeks following the planned commencement of therapy.
  • Compensated liver disease where the following criteria must be met:
  • INR\< 1.8
  • Albumin \>30 g/L
  • Bilirubin \<35umol/L
  • Prisoners with Fibroscan \> 12KPa or AFP \>50 ng/mL must have an abdominal ultrasound or CT scan without evidence of hepatocellular carcinoma within 2 months prior to screening.
  • Negative pregnancy test at baseline (females of childbearing potential only).
  • \[For prisoners released during treatment or follow-up\] If engaging in sexual intercourse which may potentially result in pregnancy, all fertile males must be using effective contraception during treatment and during the 90 days after treatment end, and all fertile females must be using effective contraception during treatment and during the 30 days after treatment end
  • If co-infection with HIV is documented, the subject must meet the following criteria:
  • Antiretroviral (ARV) untreated for \>8 weeks preceding screening visit with CD4 T cell count \>500 cells/mm3 OR
  • On a stable ARV regimen for \>8 weeks prior to screening visit, with CD4 T cell count \>200 cells/mm3 and an undetectable plasma HIV RNA level.
  • +34 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Goulburn Correctional Centre

Goulburn, New South Wales, 2580, Australia

Location

Lithgow Correctional Centre

Lithgow, New South Wales, 2790, Australia

Location

Dillwynia Correctional Centre

Windsor, New South Wales, 2756, Australia

Location

Outer Metropolitan Multipurpose Correctional Centre

Windsor, New South Wales, 2756, Australia

Location

Related Publications (3)

  • Shih STF, Stone J, Martin NK, Hajarizadeh B, Cunningham EB, Kwon JA, McGrath C, Grant L, Grebely J, Dore GJ, Lloyd AR, Vickerman P, Chambers GM. Scale-up of Direct-Acting Antiviral Treatment in Prisons Is Both Cost-effective and Key to Hepatitis C Virus Elimination. Open Forum Infect Dis. 2023 Dec 18;11(2):ofad637. doi: 10.1093/ofid/ofad637. eCollection 2024 Feb.

    PMID: 38344130DERIVED

  • Carson JM, Dore GJ, Lloyd AR, Grebely J, Byrne M, Cunningham E, Amin J, Vickerman P, Martin NK, Treloar C, Martinello M, Matthews GV, Hajarizadeh B; Surveillance and Treatment of Prisoners With Hepatitis C (SToP-C) Study Group. Hepatitis C Virus Reinfection Following Direct-Acting Antiviral Treatment in the Prison Setting: The SToP-C Study. Clin Infect Dis. 2022 Nov 14;75(10):1809-1819. doi: 10.1093/cid/ciac246.

    PMID: 35362522DERIVED

  • Hajarizadeh B, Grebely J, Byrne M, Marks P, Amin J, McManus H, Butler T, Cunningham EB, Vickerman P, Martin NK, McHutchison JG, Brainard DM, Treloar C, Chambers GM, Grant L, Mcgrath C, Lloyd AR, Dore GJ; SToP-C study group. Evaluation of hepatitis C treatment-as-prevention within Australian prisons (SToP-C): a prospective cohort study. Lancet Gastroenterol Hepatol. 2021 Jul;6(7):533-546. doi: 10.1016/S2468-1253(21)00077-7. Epub 2021 May 7.

    PMID: 33965006DERIVED

MeSH Terms

Conditions

Hepatitis CDrug MisuseCommunicable Diseases

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gregory Dore, MBBS,PhD

    Kirby Institute, University of New South Wales; St Vincent's Hospital Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 17, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

December 9, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(4)