A Phase IIIb, Open-label, Multicentre, International Randomised Controlled Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir (300mg)/Pibrentasvir (120mg) in Chronic HCV Treatment naïve Patients Without Cirrhosis
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified. Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification. Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks. One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).
• 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.
• HCV RNA plasma ≥ 10,000 IU/ml at screening.
• HCV genotype 1-6.
• HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
• Stage F0-3, based on: hepatic elastography \<12.5 kPa on Fibroscan® or APRI \<1.0.
• 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 3.2) 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.