The first eight-week medication cycle for chronic hepatitis C virus (HCV) recently earned approval from the U.S. Food and Drug Administration in the form of Mavyret (glecaprevir and pibrentasvir), shortening treatment duration by one-third.
Previously, the course of therapy lasted for 12 weeks minimum. Mavyret is indicated for all HCV genotypes in adults lacking cirrhosis and without prior treatment. At least six genotypes, or strains, are known; identification can facilitate better treatment outcomes.
“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” Dr. Edward Cox, who directs the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, said.
The FDA awarded the approval to AbbVie Inc., with the application designated under both the categories of priority review and breakthrough therapy. Treatment length varies based on individual history and genotype. Approximately three-quarters of U.S. residents with HCV have Genotype 1; between one-fifth and one-fourth have Genotypes 2 or 3; and the rest (a minority) have Genotypes 4, 5 or 6.