Medication Monitor

Generic Name (Trade Name—Company)
October 2, 2019


FDA approves first 8-week treatment for all HCV genotypes in patients with compensated cirrhosis

FDA expanded the approval of glecaprevir/pibrentasvir tablets for 8-week treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection and compensated cirrhosis and have not been previously treated for HCV.

Glecaprevir/pibrentasvir is now the first 8-week treatment approved for all treatment-naive adult and certain pediatric patients with HCV genotypes 1–6 both without cirrhosis and with compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.

The most common adverse reactions in patients taking glecaprevir/pibrentasvir are headache and fatigue. The agent is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C) or in those with any history of liver decompensation. It is also contraindicated in patients taking the drugs atazanavir and rifampin.