HCV drug approved as 8-week regimen
The combination drug is indicated to treat all treatment-naive adults and some children who have chronic hepatitis C virus (HCV) genotypes 1 through 6 infection, either without cirrhosis or with compensated cirrhosis.
The FDA has approved the first eight-week regimen for patients with chronic hepatitis C virus (HCV) genotypes 1 through 6 infection and compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.
Glecaprevir and pibrentasvir (Mavyret) tablets are now approved as an eight-week treatment for treatment-naive adults and children ages 12 years and older or weighing at least 99 pounds with chronic HCV infection, without cirrhosis or with compensated cirrhosis, the FDA announced on Sept. 26. The treatment is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C), those with any history of liver decompensation, and those taking the drugs atazanavir and rifampin.
Across clinical trials of the regimen for durations of eight, 12, and 16 weeks, sustained virologic response at 12 weeks after treatment ranged from 91% to 100%. The most common adverse reactions are headache and fatigue.