Strategic Treatment Reduction in Very Early Liver Disease With 4 Weeks Sofosbuvir Plus Glecepravir-pibrentasvir (STRIVE-4)
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Participants must meet all inclusion criteria to be eligible to participate in this study:
- Have voluntarily signed the informed consent form.
- 18 years of age or older.
- Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
- Quantifiable HCV RNA at screening.
- HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
Liver fibrosis stage F0-F2, defined by at least one of the following:
- Liver stiffness measurement <9.5 kPa by transient elastography (FibroScan®)
- AST to platelet ratio index (APRI) <0.5
- Liver biopsy
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 - see protocol section 6.3) for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
- Negative pregnancy test at screening and baseline (females of childbearing potential only).
- All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.
Exclusion Criteria:
Participants who meet any of the exclusion criteria are not to be enrolled in this study.
History of any of the following:
- Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
- Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
- Solid organ transplant.
- History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
Any of the following lab parameters at screening:
- ALT > 10 x ULN
- AST > 10 x ULN
- Direct bilirubin > ULN
- Platelets < 150,000/μL (cells/mm3)
- Creatinine clearance (CLcr) < 50 mL/min
- Albumin < LLN
- INR > 1.5 ULN
- Pregnant or breastfeeding female.
- HBV infection (HBsAg positive).
- Use of prohibited concomitant medications as described in protocol section 6.3.
- Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks).
- Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug.
- Any investigational drug ≤6 weeks prior to the first dose of study drug.
- Ongoing severe psychiatric disease as judged by the treating physician.
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Sites / Locations
- St Vincent's HospitalRecruiting
- Blacktown Mt Druitt HospitalRecruiting
- Royal Adelaide HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Sof plus G/P
Four weeks of sofosbuvir (400mg) plus glecaprevir-pibrentasvir (300mg/120mg) will be administered, followed by immediate retreatment of virological relapse with glecepravir/pibrentasvir (300mg/120mg) for 12 weeks, in treatment-naïve participants with chronic HCV infection and early liver disease (F0-F2).