Hepatitis CPhase 4SToP-CNCT02064049
Surveillance and Treatment of Prisoners With Hepatitis C
A Phase 4 study testing Sofosbuvir/velpatasvir in people with Hepatitis C, run by Kirby Institute at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir/velpatasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,692 participants
- Where
- 4 sitesAustralia
- Study dates
- Oct 2014to Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1) Prisoners of a security classification which makes clinic attendance for study visits logistically difficult 5.2 Treatment Intervention Inclusion criteria
- 18 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.
Show all 50Show fewer
- 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.
- Suitable ARV include:
- Nucleos(t)ide reverse transcriptase inhibitors: Tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), emtricitabine (FTC)Non-nucleoside reverse transcriptase inhibitors: Rilpivirine
- Protease inhibitors: Atazanavir, darunavir, lopinavir, ritonavir
- Integrase inhibitors: Dolutegravir, raltegravir, elvitegravir/cobicistat
- Contraindicated ARV include:
- Efavirenz (50% reduction in velpatasvir exposure)
- Didanosine
- Zidovudine
- Tipranavir Other ARV agents may be permissible at the time of study commencement pending further drug-drug interaction studies; please discuss with the Medical Monitor.
- Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <6 months prior to the first dose of study drug.
- Any investigational drug <6 weeks prior to the first dose of study drug.
- History or other evidence of clinical hepatic decompensation (i.e. ascites, encephalopathy or oesophageal variceal haemorrhage)
- Solid organ transplant
- Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the prisoner treatment, assessment or compliance with the protocol; prisoners currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
- History of any of the following:
- Malignancy within 5 years prior to screening, with exception of specific cancers that may have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are also excluded.
- Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- Any of the following lab parameters at screening:
- ALT > 10 x ULN
- AST > 10 x ULN
- Direct bilirubin > 1.5 x ULN
- Platelets < 50,000/uL
- Creatinine clearance < 60 mL/min
- Haemoglobin < 11 g/dL for females ; < 12 g/dL for males
- Albumin < 30g/L
- INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
- Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day)
- Known hypersensitivity to VEL, SOF or formulation excipients.
- Use of prohibited concomitant medications as described in section 6.2
- Pregnant or nursing female
- Ongoing severe psychiatric disease as judged by the treating physician.
- Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
- Any other criteria that is judged by the treating physician to potentially compromise treatment safety.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Goulburn Correctional Centre
Goulburn, New South Wales, 2580
Lithgow Correctional Centre
Lithgow, New South Wales, 2790
Dillwynia Correctional Centre
Windsor, New South Wales, 2756
Outer Metropolitan Multipurpose Correctional Centre
Windsor, New South Wales, 2756
About this study
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
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.
Read the 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
- Being tested
- Sofosbuvir/velpatasvir
- Keywords
- Hepatitis C virus, People who inject drugs, Drug users, Direct acting antiviral (DAA), Infectious diseases, Prisoners
- Medical subject headings
- Hepatitis C, Drug Misuse, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir/velpatasvirDrug
Also called Epslusa
The treatment phase will commence in year 2. This is 12 weeks of the pangenotypic sofosbuvir/velpatasvir 400/100mg, coformulated into one tablet daily.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Sofosbuvir/velpatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis C virus (HCV) incidence
Incidence of HCV infection over a two year period in a network of four participating correctional centres.
Measured: 2 years
Secondary outcomes (9)
Hepatitis C virus prevalence
Change in prevalence of HCV infection over a two year period in a network of four participating correctional centres.
Measured: 2 years
SVR12
The proportion of patients with undetectable HCV RNA at 12 weeks following the end of treatment (SVR12)
Measured: 24 weeks
ETR
The proportion of patients with an end of treatment response (ETR)
Measured: 12 weeks
Rapid Virological Response (RVR)
The proportion of patients with undetectable HCV RNA at 4 weeks following the initiation of treatment (RVR)
Measured: 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
Measured: 12 weeks
Number of patients with adverse events
Safety and tolerability of the treatment regimen
Measured: 16 weeks
Treatment uptake
The rate of HCV treatment uptake among eligible inmates and reasons for non-uptake
Measured: 2 years
On-treatment change in illicit drug use
Changes in illicit drug use behaviours during treatment
Measured: 24 weeks
HCV reinfection rate
The rate of HCV reinfection following treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gregory Dore, MBBS,PhD, Principal investigator, Kirby Institute, University of New South Wales; St Vincent's Hospital Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064049
- Sponsor's protocol ID
- VHCRP1302
- Acronym
- SToP-C
- Status last verified
- Dec 2019
- First submitted
- 12 Feb 2014
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38344130Carson 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.
PubMed 35362522Hajarizadeh 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.
PubMed 33965006
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02064049
- Acronym / sponsor ID
- SToP-C / VHCRP1302
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C virus, People who inject drugs, Drug users, Direct acting antiviral (DAA), Infectious diseases, Prisoners
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,692 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C treatment | Experimental | Drug: Sofosbuvir/velpatasvirAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (50 listed)
- 1) Prisoners of a security classification which makes clinic attendance for study visits logistically difficult 5.2 Treatment Intervention Inclusion criteria
- 18 years of age or older.
- Voluntarily signed the (treatment phase) informed consent form.
- Detectable HCV RNA in plasma.
- HCV genotypes 1-6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir/velpatasvirAlso: EpslusaThe treatment phase will commence in year 2. This is 12 weeks of the pangenotypic sofosbuvir/velpatasvir 400/100mg, coformulated into one tablet daily. | Drug | Hepatitis C treatment |
Primary outcome
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.
9 secondary outcomes
Hepatitis C virus prevalence
Time frame: 2 years
SVR12
Time frame: 24 weeks
ETR
Time frame: 12 weeks
Rapid Virological Response (RVR)
Time frame: 4 weeks
Treatment adherence
Time frame: 12 weeks
Number of patients with adverse events
Time frame: 16 weeks
Treatment uptake
Time frame: 2 years
On-treatment change in illicit drug use
Time frame: 24 weeks
HCV reinfection rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Derived from this study: PubMed 38344130Shih 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.
- Derived from this study: PubMed 35362522Carson 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.
- Derived from this study: PubMed 33965006Hajarizadeh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Dore, MBBS,PhD principal investigator
Kirby Institute, University of New South Wales; St Vincent's Hospital Sydney
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir/velpatasvir in people with Hepatitis C, run by Kirby Institute at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatitis C virus (HCV) incidence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064049, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.