FDA Approves New Option For Hep C and Compensated Cirrhosis

The FDA has expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an 8-week duration for the treatment of adults and children aged 12 years and older or weighing at least 99 pounds with chronic hepatitis C virus genotypes 1, 2, 3, 4, 5, or 6 infection and compensated cirrhosis who are treatment-naïve.

Standard treatment length for patients with compensated cirrhosis was previous 12 weeks or more.

The safety and efficacy of Mavyret was examined in clinical trials that evaluated more than 2500 patients with hepatitis C virus infection. The participants received the treatment for durations of 8, 12, or 16 weeks. Overall, the sustained virologic response at 12 weeks was 91% to 100% across the trials.

The most common adverse reactions were headache and fatigue.

—Michael Potts

Reference:

FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks [press release]. https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-adults-and-children-all-genotypes-hepatitis-c-and-compensated-cirrhosis.