The combination oral hepatitis C virus (HCV) NS3/4A protease inhibitor and HCV NS5A inhibitor Mavyret (glecaprevir-pibrentasvir), used to treat patients with HCV genotypes 1, 2, 3, 4, 5, or 6 and compensated cirrhosis, is now approved for a treatment duration of eight weeks in treatment-naive adults and pediatric patients over the age of 12 and weighing at least 99 pounds. Previously, the standard treatment duration for patients with HCV and compensated cirrhosis was 12 weeks or more. Like other HCV drugs, Mavyret is considered to cure HCV, as the virus becomes undetectable in nearly all patients who complete treatment.
The Food and Drug Administration (FDA) has revised the product's labeling based on preliminary data from the EXPEDITION-8 trial, which found the drug was effective in eight weeks. Decreasing the treatment time is important, because Mavyret and other HCV drugs are expensive-ranging in price from $25,200 to $94,500 for the full regimen (see Table 1).
Mavyret's manufacturer, Abb-Vie, offers discounted pricing for patients with insurance. The cost is variable depending on the type of insurance. Eligible patients who have private insurance, for example, may pay only $5 per month (see http://www.mavyret.com/copay-savings-card). Costs are higher-ranging from $8 to $2,542 per month-for patients with government insurance (Medicaid, Medicare Part D, Veterans Administration, or Department of Defense). For more information, see http://www.mavyret.com/cost or call (877) 628-9738. Patients without insurance or who cannot afford Mavyret may qualify for free or reduced cost if they meet the manufacturer's requirements-see http://www.abbvie.com/myAbbVieAssist or call (800) 222-6885 to learn more.
To read the FDA News Release about the eight-week treatment duration for Mavyret, see http://www.fda.gov/news-events/press-announcements/fda-approves-treatment-adults.