Clinical trial
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs
Name
VHCRP1902
Description
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.
Trial arms
Trial start
2021-02-12
Estimated PCD
2025-02-12
Trial end
2025-02-12
Status
Recruiting
Treatment
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
Arms:
Cohort A: 8 weeks G/P standard therapy, Cohort B: 4 weeks SOF/G/P shortened therapy
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
Arms:
Cohort B: 4 weeks SOF/G/P shortened therapy
Size
60
Primary endpoint
SVR12 outcomes for all total patient population
12 weeks post completion of commenced treatment
Eligibility criteria
Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be eligible to participate in this study.
1. Have voluntarily signed the informed consent form.
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
Participants must meet the following additional inclusion criteria to be treated in this study.
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:
Participants who meet any of the exclusion criteria are not to be enrolled in this study.
1. Inability or unwillingness to provide informed consent or abide by the requirements of the study
2. Actively intoxicated.
Participants that meet any of the additional exclusion criteria are not to be treated in this study.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-03-06
1 organization
2 products
3 indications
Organization
Kirby InstituteProduct
Glecaprevir + PibrentasvirIndication
Hepatitis CIndication
HepatitisIndication
Cirrhosis