The FDA has approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all 6 genotypes of hepatitis C in children 12 to 17 years.
The US Food and Drug Administration (FDA) has announced the approval of AbbVie Inc.'s Mavyret (glecaprevir and pibrentasvir) for the treatment of all 6 genotypes of hepatitis C virus (HCV) in pediatric patients aged 12 to 17 years. The tablets were approved to treat adults 18 years and older in 2017.
HCV, which consists of liver inflammation, can lead to reduced liver function and liver failure. The overall risk of HCV is elevated for children who are born to mothers who have HCV and current estimates indicate that 23,000 to 46,000 children in the United States have HCV.
According to dosing information that was released with the announcement of the approval, the agent should be administered to adult or pediatric patients 12 years and older, or weighing at least 99 pounds, who are infected with any of 6 identified HCV genotypes either without cirrhosis or with compensated cirrhosis.
“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, MD, MPH., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research in making the announcement. “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 safety and efficacy of Mavyret was evaluated amongst pediatric patients in clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection who did not have cirrhosis or had mild cirrhosis. The studies found that 100% of patients who received Mavyret for 8 or 16 weeks had no detectable virus in the blood 12 weeks following completion of treatment, suggesting a cure of infection.
"In pediatric patients with either cirrhosis, history of a kidney and/or liver transplant, or genotype 5 or 6 HCV infection, the safety and efficacy of Mavyret are supported by previous studies observed in glecaprevir and pibrentasvir in adults," the FDA's press release says, noting that adverse reactions in the pediatric trials were consistent with those observed in clinical studies in adults. The most common adverse reactions were head ache and fatigue.
The exact duration of treatment with Mavyret will vary based on treatment history, viral genotype and cirrhosis status. The agent is not recommended for use in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and patients taking atazanavir and rifampin.
Additionally, the FDA notes, "hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Mavyret."