Glecaprevir with 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 duration (compensated liver disease, with or without cirrhosis) - treatment-naive, genotypes 1-6: 8 weeks with or without cirrhosis. Prior failure on peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin: genotypes 1, 2, 4-6 - 8 weeks without cirrhosis, 12 weeks with cirrhosis; genotype 3 - 16 weeks with or without cirrhosis. Liver or kidney transplant recipients: 12 weeks (with or without cirrhosis); consider 16 weeks in genotype 3 treatment-experienced patients. HIV-1 co-infection: follow the same durations (see SPC section 4.5 for HIV antivirals). Not recommended for re-treatment of patients with prior exposure to NS3/4A- and/or NS5A inhibitors. Missed dose: may be taken within 18 hours of the usual time; if more than 18 hours have passed, skip it and take the next dose as usual - do not double dose. If vomiting occurs within 3 hours of dosing, take an additional dose; beyond 3 hours, no additional dose is needed. Elderly: no dose adjustment. Hepatic impairment: no adjustment in Child-Pugh A; not recommended in Child-Pugh B; contraindicated in Child-Pugh C. Screen all patients for HBV before starting (risk of hepatitis B reactivation). Diabetic patients may experience improved glucose control with symptomatic hypoglycaemia - monitor closely, particularly in the first 3 months. Paediatric: safety and efficacy in children under 3 years or under 12 kg not established; the coated granules formulation is intended for children aged 3 to under 12 years weighing 12 kg to under 45 kg and is dosed by body weight per its own SPC - the tablets and the coated granules are NOT interchangeable and a full course must use the same formulation. Verify against a children's formulary.