Glecaprevir / Pibrentasvir

Applies to adults, adolescents aged 12 years and older, or children weighing at least 45 kg. Treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Treatment durations (compensated liver disease, with or without cirrhosis): treatment-naive GT 1, 2, 3, 4, 5, 6 — 8 weeks with or without cirrhosis. Patients who failed prior peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin: GT 1, 2, 4-6 — 8 weeks (no cirrhosis) or 12 weeks (cirrhosis); GT 3 — 16 weeks. Liver or kidney transplant recipients with or without cirrhosis: 12 weeks; 16 weeks should be considered in genotype 3-infected, treatment-experienced patients. HIV-1 co-infection: follow the same duration tables. Not recommended for re-treatment of patients with prior exposure to NS3/4A- and/or NS5A inhibitors. Missed dose: the prescribed dose can be taken within 18 hours of the usual time; if more than 18 hours have passed, skip it and resume the usual schedule — do not double dose. If vomiting occurs within 3 hours of dosing, take an additional dose; if more than 3 hours after dosing, no additional dose is needed. Hepatic impairment: no adjustment in mild impairment (Child-Pugh A); not recommended in moderate impairment (Child-Pugh B); contraindicated in severe impairment (Child-Pugh C). Elderly: no dose adjustment required. Paediatric: safety and efficacy in children under 3 years or under 12 kg not established. A coated granules formulation is intended for children aged 3 to less than 12 years weighing 12 kg to less than 45 kg — refer to the SPC for the coated granules for body-weight-based dosing. Tablets and coated granules are NOT interchangeable and a full course must use the same formulation. Screen all patients for HBV before initiating (risk of HBV reactivation). Monitor glucose closely in diabetic patients, particularly in the first 3 months.