FDA Approves Mavyret for all HCV Genotypes in Children
The FDA approved Mavyret to treat all six genotypes of hepatitis C in pediatric patients aged 12 years to 17 years, according to a press release from the organization.
“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,” Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”
The new dosing information provided for Mavyret (glecaprevir/pibrentasvir, AbbVie) includes approved treatment of HCV in adults or pediatric patients aged 12 years or older or those who weigh at least 99 pounds.
Researchers evaluated the safety and efficacy of glecaprevir/pibrentasvir in pediatric patients during clinical trials of 47 patients with genotype 1, 2, 3 or 4 without cirrhosis or with mild cirrhosis. Results showed 100% sustained virologic response in patients treated for 8 weeks or 16 weeks. Other previous studies supported the safety and efficacy of pediatric patients with cirrhosis, history of kidney or liver transplantation, or genotype 5 or 6.
Adverse reactions were consistent with those observed in clinical trials of glecaprevir/pibrentasvir in adults.
The FDA advised that health care professionals should screen all patients for evidence of current or prior hepatitis B infection before starting treatment with glecaprevir/pibrentasvir due to reports of HBV reactivation in coinfection adults.