FDA Approves Pan-Genotypic Treatment for HCV
Mavyret will be available as 100mg/40mg fixed-dose tablets in a 4-week (monthly) or 8-week carton.
AbbVie announced that the Food and Drug Administration (FDA) has approved Mavyret (glecaprevir and pibrentasvir) for the treatment of adults with chronic hepatitis C virus (HCV) infection across all genotypes 1–6 without cirrhosis or with compensated cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. In addition, Mavyret is approved for patients with HCV genotype 1 infection who have been previously treated with a regimen containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.
"The clinical trial program for Mavyret resulted in high cure rates across a range of patient populations, from those who have never been treated and who do not have cirrhosis, all the way to patients with compensated cirrhosis," said Fred Poordad, MD, vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. "This approval helps achieve physicians' goals of delivering effective options for a broad range of patients."
Mavyret is a once-daily, ribavirin-free treatment that combines glecaprevir, an HCV NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor. Both direct-acting antivirals (DAAs) work by targeting and inhibiting proteins required for HCV replication.
The FDA approval was based on data from nine studies that evaluated approximately 2300 patients across all HCV genotypes 1–6 and special patient populations. The data showed 92–100% of patients treated with Mavyret for 8, 12, or 16 weeks had no virus detected in the blood 12 weeks after completing treatment, suggesting cure of infection. Headache, fatigue, and nausea were the most commonly reported adverse events.
Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. “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,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
The FDA previously granted Mavyret Breakthrough Therapy designation as well as Priority Review.
Mavyret will be available as 100mg/40mg fixed-dose tablets in a 4-week (monthly) or 8-week carton. Each carton contains 7 daily dose wallets.
AbbVie receives US FDA approval of MAVYRET™ (glecaprevir/pibrentasvir) for the treatment of chronic hepatitis C in all major genotypes (GT 1-6) in as short as 8 weeks [press release]. North Chicago, Illinois: AbbVie. Published August 8, 2017. Accessed August 7, 2017.