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Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs

RECRUITING

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.

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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.

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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: 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

  • Inability or unwillingness to provide informed consent or abide by the requirements of the study
  • Actively intoxicated.
  • 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
  • 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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2021-02-12

    Primary completion: 2025-02-12

    Study completion finish: 2025-02-12

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial 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
    Image related to Hepatitis C
    • Condition: Hepatitis C, Liver Inflammation and more

    • DRUG: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet and other drugs

    • Randwick, New South Wales, Australia and more

    • Sponsor: Kirby Institute

    Find a site

    Closest Location:

    Prince of Wales Hospital

    Research sites nearby

    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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    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/ArmIntervention/Treatment
    EXPERIMENTAL: 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).
    DRUG: 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
    EXPERIMENTAL: 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).
    DRUG: 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

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    SVR12 outcomes for all total patient populationTo 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

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    References

    Clinical Trials Gov: Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs

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