A Phase IV Open-label Multicentre International Pilot Study of 4-week Treatment With Sofosbuvir (400 mg) Plus Glecaprevir/Pibrentasvir (300mg/120mg) in Chronic HCV Treatment naïve Patients With Early Liver Disease
This study aims to evaluate the efficacy, safety and feasibility of four weeks of sofosbuvir plus glecaprevir-pibrentasvir, followed by immediate retreatment of virological relapse with glecepravir-pibrentasvir for 12 weeks, in treatment-naïve participants with chronic HCV infection and early liver disease (F0-F2).
• \- 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.