Mavyret tablets were approved last week by the Food and Drug Administration for the treatment of all six genotypes of hepatitis C virus (HCV) in teenagers.
There are approximately 23,000-46,000 children in the U.S. with HCV, which can be caught from infected mothers. HCV causes liver damage and failure.
“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” said Jeffrey Murray, deputy director of the division of antiviral products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”
Those 12 and older who weigh at least 99 pounds are able to take the approved Mavyret. In studies, participants with genotypes 1-4 took Mavyret for eight or sixteen weeks and 100 percent saw no virus in their blood 12 weeks after finishing treatment. Those with genotype 5 or 6, the safety and efficacy of Mavyret were supported by previous studies in adults.
Mavyret is not recommended for patients with moderate cirrhosis and is contraindicated for patients with severe cirrhosis. The most common side effect were headache and fatigue.
