Changes to the Mavyret Product Label for Pediatrics

The FDA has approved Mavyret (glecaprevir and pibrentasvir) oral pellets (100mg/40mg) for the treatment of pediatric patients 3 to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. The approval is based on a phase 2/3, open-label study to investigate the pharmacokinetics, safety and efficacy of Mavyret in HCV infected children 3 to less than 12 years of age.

Below is a summary of the major changes to the product labeling.

• Revised the minimum patient age from 12 to 3 years of age

• Removed the minimum patient body weight requirement

• Revised dosage recommendations for pediatric patients 3 years of age and older

• The oral pellets should be taken together, with food, once daily. In addition, the oral pellets for the total daily dose should be sprinkled on a small amount of soft food with a low water content that will stick to a spoon and should be swallowed without chewing (e.g., peanut butter, chocolate hazelnut spread, cream cheese, thick jam, or Greek yogurt).

• Liquids or foods that would drip or slide off the spoon are not recommended as the drug may dissolve quickly and become less effective.

• The entire mixture of food and oral pellets should be swallowed within 15 minutes of preparation; the oral pellets should not be crushed or chewed.