The US Food and Drug Administration today approved Mavyret tablets (glecaprevir and pibrentasvir) to treat all six hepatitis C virus (HCV) genotypes in children between 12 and 17 years of age. approved for the treatment of HCV in adults in 2017.
"Direct-acting antivirals reduce the amount of HCV in the body by preventing virus proliferation, and in most cases cure HCV infection," said Jeffrey Murray, MD, MPH, Deputy Director of Antiviral Products in the Czech Republic. FDA Center for Drug Evaluation and Research. "Today's approval is another treatment option for HCV children and adolescents, but for the first time in all HCV genotypes."
With today's approval, dosing information for Mavyret is provided for the treatment of adults or pediatric patients 12 years of age or older or at least 99 pounds infected with any of the six identified HCV genotypes either without cirrhosis or with compensated cirrhosis.
The safety and efficacy of Mavyret in pediatric patients were evaluated in clinical trials with 47 patients with HCV infection by genotype 1, 2, 3 or 4 without cirrhosis or mild cirrhosis. The results of the studies showed that 100% of patients who received Mavyret for eight or 16 weeks had no virus in their blood 12 weeks after stopping treatment, suggesting a cure for patients' infection. In pediatric cirrhosis patients, a history of kidney and / or liver transplantation or HCV genotype 5 or 6 infection, the safety and efficacy of Mavyret are supported by previous studies observed in glecaprevir and pibrentasvir in adults. The adverse reactions observed were consistent with those observed in clinical trials with Mavyret in adults.
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The duration of treatment with Mavyret varies depending on the history of treatment, the genotype of the virus and the condition of cirrhosis. The most common side effects in patients taking Mavyret were headache and fatigue. Mavyret is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking atazanavir and rifampin.
Hepatitis B virus reactivation (HBV) has been reported in HCV / HBV co-infected adult patients who have undergone or undergone HCV treatment with directly acting antiviral agents and who have not been treated with HBV antivirals. Reactivating HBV in patients treated with directly acting antiviral agents may lead to severe liver problems or death in some patients. Prior to initiating Mavyret treatment, healthcare professionals should examine all patients for the presence of current or previous HBV infection before starting Mavyret therapy.
HCV is a viral disease that causes liver inflammation, which can lead to decreased liver function or liver failure. According to the US Centers for Disease Control and Prevention, 2.7 to 3.9 million people in the US are estimated to suffer from chronic HCV and children born to HCV positive mothers are at risk of HCV infection. It is estimated that there are 23,000 to 46,000 children with HCV infection in the US.
FDA grants Mavyret approval to AbbVie Inc.