Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs (TOPIC)
Hepatitis C, Liver Inflammation, Liver Cirrhoses
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring people who inject drugs, injecting related infectious diseases
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be eligible to participate in this study.
- 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
Participants must meet the following additional inclusion criteria to be treated in this study.
- 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:
Participants who meet any of the exclusion criteria are not to be enrolled in this study.
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
Actively intoxicated.
Participants that meet any of the additional exclusion criteria are not to be treated in this study.
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
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.
Sites / Locations
- Prince of Wales Hospital
- St Vincent's Hospital SydneyRecruiting
- Blacktown Mt Druitt Hospital
- Westmead Hospital
- Royal Adelaide Hospital
- The Alfred Hospital
- St Vincent's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort A: 8 weeks G/P standard therapy
Cohort B: 4 weeks SOF/G/P shortened 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).
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).