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# FDA Expands Mavyret Indication
- URL: https://www.fdaweb.com/fda-expands-mavyret-indication/
- Published: 2019-09-26T12:00:00.000Z
- Updated: 2026-09-15T01:52:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145108

FDA has approved an expanded indication for AbbVie’s Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for treating adults and children ages 12 and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection and compensated cirrhosis, and are treatment-naïve. An agency [announcement](https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-adults-and-children-all-genotypes-hepatitis-c-and-compensated-cirrhosis?ref=fdaweb.com) says Mavyret is now the first eight-week treatment approved for all treatment-naïve adults and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis. Standard length of treatment for patients with compensated cirrhosis was previously 12 weeks or more, the agency says.

Mavyret’s efficacy and safety were established in clinical trials that cumulatively evaluated more than 2,500 people with HCV genotype 1, 2, 3, 4, 5, or 6 infection who received Mavyret for eight, 12, or 16 weeks. The trial included patients with HIV co-infection, kidney or liver transplant recipients and patients with advanced kidney disease, including those requiring hemodialysis.

The most common adverse reactions in patients taking Mavyret are headache and fatigue. It is contraindicated in patients with moderate or severe liver impairment or in those with any history of liver decompensation. It is also contraindicated in patients taking atazanavir (Bristol-Myers Squibb’s Reyataz) and rifampin (Lupin Pharmaceuticals’ Rifadin).