Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
This study will evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID (injecting related infectious diseases) and commencing inpatient DAA treatment within public hospital services.
Study details:
This study will be conducted as a Phase IV, multicentre, sequential cohort trial. 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Have voluntarily signed the informed consent form.
- 18 years of age or older.
- Injected drugs within the last 6 months
- Hospitalised with an IRID with an anticipated inpatient stay of > 1 week
- HCV RNA positive
- Compensated liver disease
- Documented non-cirrhotic at enrolment with a qualifying liver FibroScan ≤ 9.5 kpA
- If co-infection with HIV is documented, the subject must meet the following criteria: ART naïve with CD4 T cell count >500 cells/mm3; OR 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
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Actively intoxicated.
- History of any of the following: Clinical hepatic compensation (i.e. ascites, encephalopathy or variceal haemorrhage), Solid organ transplant, History of severe, life-threatening or other significant sensitivity to study drugs (glecaprevir/pibrentasvir/sofosbuvir) or any excipients of the study drugs
- Creatinine clearance (CLcr) < 30 mL/min at screening (Cohort B only)
- Pregnant or nursing female
- Decompensated liver disease
- Use of prohibited concomitant medications
- Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks)
- Prior treatment failure with an NS5A based DAA regimen
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT03981211
Intervention or treatment
DRUG: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
DRUG: Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
Conditions
- Hepatitis C
- Liver Inflammation
- Liver Cirrhoses
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Prince of Wales Hospital
Select from list below to view details:
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
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Who is running the clinical trial?
Kirby Institute
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Cohort A: 8 weeks G/P standard therapy
| Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet |
EXPERIMENTAL: Cohort B: 4 weeks SOF/G/P shortened therapy
| Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet, Drug: Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| SVR12 outcomes for all total patient population | To evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID and commencing inpatient DAA treatment within public hospital services. | 12 weeks post completion of commenced treatment |
Secondary Outcome
References
Clinical Trials Gov: Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject DrugsOther trials to consider
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