Last week, the United States Food & Drug Administration (FDA) expanded the use of the drug Mavyret. Now, an eight-week course of the drug is approved for anyone with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 and compensated cirrhosis, ages 12 and older, who weigh at least 99 pounds, and who have not tried other treatments.1Compensated cirrhosis means the liver is scarred but still able to function.
This makes Mavyret the first eight-week medication approved for the treatment of all six genotypes of hepatitis C in people who also have compensated cirrhosis. Mavyret is a combination drug that includes glecaprevir and pibrentasvir.
Mavyret is made by AbbVie Inc. It first hit the market in 2017 when it was approved only for adults. Earlier approvals had made a 12-week course of treatment available to tweens and teens who had no signs of cirrhosis.
Who can be treated with Mavyret now?
Tweens, teens, and adults with one of the six genotypes of hepatitis C who are at least 12 years old, and who weigh at least 99 pounds, are eligible for an eight-week treatment with Mavyret. Those taking Mavyret should be “treatment naïve” meaning the person has not tried any other hepatitis C treatments. Mavyret is taken once daily in three tablets with food.2
Earlier approvals required that children could have no cirrhosis or compensated cirrhosis when using the drug. This new approval cuts treatment time to eight weeks (earlier treatments for those with compensated cirrhosis required 12 weeks or longer).
The FDA’s expanded approval rests on the results of 2,500 people with HCV gentotypes 1-6 found that sustained virologic response (SVR) rates at 12 weeks after treatment ranged from 91 percent to 100 percent. Shorter treatment times generally result in better outcomes, so expanding access to an eight-week treatment option may make a cure accessible to more people.
What are the side effects of Mavyret?
The most common side effects of taking Mavyret were headache and fatigue. People with moderate or severe cirrhosis should not be treated with Mavyret at this time. Those who are taking the drugs atazanavir or rifampin should not take Mavyret.1-2
If you are not sure whether or not you are taking a medication that should not be used with Mavyret, ask your healthcare provider. It is also important to talk with your doctor if you have ever been diagnosed with hepatitis B virus. Your doctor may test you for hepatitis B before starting treatment, since Mavyret and other direct-acting antiviral medications sometimes reactivate hepatitis B.
U.S. Food & Drug Administration. FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-adults-and-children-all-genotypes-hepatitis-c-and-compensated-cirrhosis. Published 9/26/19. Accessed 9/30/19.
Cision PRNewswire. AbbVie Receives FDA Approval of MAVYRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes. Available at: https://www.prnewswire.com/news-releases/abbvie-receives-fda-approval-of-mavyret-glecaprevirpibrentasvir-to-shorten-treatment-duration-to-eight-weeks-for-treatment-naive-patients-with-chronic-hepatitis-c-and-compensated-cirrhosis-across-all-genotypes-300926647.html. Published 9/26/19. Accessed 9/30/19.