FDA approves Mavyret for all genotypes of hepatitis C
The FDA has approved Mavyret (glecaprevir and pibrentasvir), from AbbVie, tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret was previously approved to treat HCV in adults in 2017.
The safety and efficacy of Mavyret in pediatric patients was evaluated during clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 100 percent of patients who received Mavyret for eight or 16 weeks had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients' infection had been cured. In pediatric patients with 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 adverse reactions observed were consistent with those observed in clinical studies of Mavyret in adults.
Treatment duration with Mavyret differs depending on treatment history, viral genotype and cirrhosis status. The most common adverse reactions in patients taking Mavyret were headache and fatigue. Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.
Comment: Maviret is a once-daily regimen that combines two distinct antiviral agents - the NS3/4A protease inhibitor glecaprevir (300mg) and NS5A inhibitor pibrentasvir (120mg) - dosed once-daily as three oral tablets and shown in trials to cure the virus in just eight weeks. Regulators are allowing its use to treat patients without cirrhosis and who are new to treatment, who comprise the majority of the 71 million people living with chronic hepatitis C virus (HCV) infection globally, as well as those with specific treatment challenges, including those with compensated cirrhosis or severe chronic kidney disease.
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