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FDA expands Mavyret approval for adults, children with any HCV genotype

The FDA has expanded the approval of Mavyret for a treatment duration of 8 weeks to include treatment-naive adults and children aged 12 years and older with chronic hepatitis C genotype 1 through 6 and compensated cirrhosis.

The label expansion of Mavyret (glecaprevir/pibrentasvir, AbbVie) was based on data from the phase 3b EXPEDITION-8 study that included patients with any of the six HCV genotypes. Twelve weeks after treatment, 98% of the 343 enrolled patients achieved sustained virologic response.

“This approval provides a treatment duration of 8 weeks for both pediatric and adult patients with compensated cirrhosis regardless of HCV genotype,” Jeffrey Murray, MD, deputy director of the division of antiviral products in the FDA’s Center for Drug Evaluation and Research, said in the FDA brief. “[Glecaprevir/pibrentasvir] is a combination of direct-acting antiviral drugs that reduce the amount of HCV in the body to undetectable levels by preventing the virus from multiplying, and in most cases, curing HCV infection.”

Additional data from the EXPEDITION-8 study showed that the most common adverse events were fatigue (8%), pruritus (7%) and headache (6%).

“While over 100,000 patients have been prescribed [glecaprevir/pibrentasvir] for chronic HCV in the U.S., there are still a significant number of patients that need options,” Janet Hammond, MD, PhD, vice president of the general medicine and virology therapeutic area at AbbVie, said in a press release. “This approval provides more HCV patients an option to treat their disease in as little as 8 weeks.”

Reference: www.fda.gov; www.abbvie.com