FDA Approves Mavyret For All Pediatric Hepatitis C Genotypes

APRIL 30, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has approved glecaprevir/pibrentasvir tablets (Mavyret) to treat all 6 hepatitis C virus (HCV) genotypes in children aged 12-17 years old.

The approval expands Mavyret’s indication to pediatric patients following the approval for adult patients in 2017.

The efficacy and safety of glecaprevir/pibrentasvir in pediatric patients was evaluated in clinical trials involving 47 patients with genotype 1, 2, 3, or 4 HCV without cirrhosis or with mild cirrhosis. All (100%) of pediatric patients who received the therapy for either 8 or 16 weeks had no detected virus in their blood samples post-12 weeks, indicating cured infection.

In treated pediatric patients with cirrhosis, a history of kidney and/or liver transplant, or genotype 5/6 HCV, investigators evidenced the efficacy and safety of glecaprevir/pibrentasvir through previous adult clinical trials. Observed adverse reactions were consistent with those reported in adult trials.

At the time of its adult patient indication in August 2017, the NS3/4A protease-NS5A inhibitor from AbbVie combination therapy was touted for its shortened, daily regimen of 8 weeks. Now, its indication for pediatric patients means most of the estimated 2.7-3.9 million Americans with chronic HCV—including the 23,000-46,000 infected children—have a therapy option that could result in them being cured.

“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 a statement.

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