Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
NCT ID: NCT03981211
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2021-02-12
2025-02-12
Brief Summary
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Detailed Description
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60 participants will be enrolled from participating hospital inpatient services. They will be evaluated for eligibility by the use of rapid point-of-care (POC) confirmation of viraemia in people who inject drugs (PWID) hospitalised for IRID. The period of hospitalisation for management of IRID, particularly when prolonged, may represent an ideal opportunity to engage HCV-infected PWID and a potential important strategy for broader HCV elimination.
Eligible patients will be enrolled into one of two treatment cohorts A and B.
A) 30 patients will immediately commence treatment whilst an inpatient of G/P (glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (standard duration therapy).
Following the successful completion of Cohort A, eligible patients will be enrolled into Cohort B.
B) 30 patients will immediately commence treatment whilst an inpatient of 4 weeks of SOF/G/P (sofosbuvir/glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (short duration therapy).
Any patient with recurrent viraemia during follow-up will be genotyped +/- sequenced to exclude re-infection. If relapse is confirmed the patient will be offered re-treatment with standard of care (SOC) salvage therapy based on results of resistance testing.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort A: 8 weeks G/P standard therapy
8 weeks treatment of a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (standard duration therapy).
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
8 weeks of 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily or 4 weeks of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily
Cohort B: 4 weeks SOF/G/P shortened therapy
4 weeks treatment of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (shortened duration therapy).
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
8 weeks of 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily or 4 weeks of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily
Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily
Interventions
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Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
8 weeks of 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily or 4 weeks of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily
Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily
Eligibility Criteria
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Inclusion Criteria
2. 18 years of age or older.
3. Injected drugs within the last 6 months
4. Hospitalised with an IRID with an anticipated inpatient stay of \> 1 week
5. HCV RNA positive
6. Compensated liver disease
7. Documented non-cirrhotic at enrolment with a qualifying liver FibroScan ≤ 9.5 kpA
8. If co-infection with HIV is documented, the subject must meet the following criteria:
1. ART naïve with CD4 T cell count \>500 cells/mm3; OR
2. On a stable ART regimen (containing only permissible ART) for \>4 weeks prior to screening visit, with CD4 T cell count ≥200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
Exclusion Criteria
2. Actively intoxicated.
3. History of any of the following:
b. Clinical hepatic compensation (i.e. ascites, encephalopathy or variceal haemorrhage) c. Solid organ transplant d. History of severe, life-threatening or other significant sensitivity to study drugs (glecaprevir/pibrentasvir/sofosbuvir) or any excipients of the study drugs
4. Creatinine clearance (CLcr) \< 30 mL/min at screening (Cohort B only)
5. Pregnant or nursing female
6. Decompensated liver disease
7. Use of prohibited concomitant medications
8. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent \> 10 mg/day for \>2 weeks)
9. Prior treatment failure with an NS5A based DAA regimen
Patients without an IRID but who fulfill all other criteria and are admitted with an expected duration of stay \> 1 week may also be included at discretion of study team.
18 Years
ALL
No
Sponsors
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Kirby Institute
OTHER_GOV
Responsible Party
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Locations
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Prince of Wales Hospital
Randwick, New South Wales, Australia
St Vincent's Hospital Sydney
Sydney, New South Wales, Australia
Blacktown Mt Druitt Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VHCRP1902
Identifier Type: -
Identifier Source: org_study_id
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