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First Pediatric Treatment Approved for All Genotypes of Hepatitis C

This week, the United States Food and Drug Administration (U.S. FDA) approved the use of Mavyret in kids 12 to 17 years-old. This decision will make Mavyret the first medication approved for the treatment of all six genotypes of hepatitis C in pediatric patients. Mavyret is a combination medication that includes glecaprevir and pibrentasvir. It is made by AbbVie Inc. In 2017, Mavyret was approved for use in adults, but is now deemed safe and effective for kids.

How do kids get hepatitis C?

Children are at risk for hepatitis C in the same way adults are, however, children can be born with hepatitis C if their mother had the virus at the time of their birth. The FDA estimates that as many as 23,000-46,000 kids in the U.S. may have hepatitis C. Being able to treat all forms of hepatitis C in kids may help reduce this number.

Who can be treated with Mavyret now?

Children with one of the six genotypes of hepatitis C who are 12 to 17 years-old, or who weigh at least 99 pounds, are eligible for treatment with Mavyret. Kids being treated with Mavyret must also have no cirrhosis or compensated cirrhosis when they start the medication. Children with moderate or severe cirrhosis should not be treated with Mavyret at this time.

How do we know Mavyret is safe for kids?

Clinical trials were used to determine if Mavyret was effective and safe for use in pediatric patients. Of the 47 kids with hepatitis C studied, 100% had no detectable virus in their blood 12 weeks after treatment. This means that every child was cured after eight or sixteen weeks of treatment with Mavyret. The kids included in the study had genotype 1, 2, 3, or 4 virus and had mild cirrhosis or no cirrhosis. Other clinical studies were used to determine that Mavyret was safe for use in kids with a history of kidney or liver transplant, or who had genotype 5 or 6 hepatitis C.

What are the side effects or concerns of Mavyret for kids?

The side effects of taking Mavyret as a child were found to be similar to those in adults. The most common side effects experienced were fatigue and headache. The length of treatment with Mavyret is determined on a case by case basis, and depends on cirrhosis status, genotype, and past treatment history.

People who are taking medications like rifampin and atazanavir should not take Mavyret. If you are unsure whether or not you are taking a medication that should not be used alongside Mavyret, ask your doctor or healthcare provider. It’s also important to talk with your provider if you have ever been diagnosed with hepatitis B virus. Your doctor may test you for hepatitis B before starting treatment, since reactivation of hepatitis B may happen while taking Mavyret or other direct-acting antiviral medications.1

  1. FDA Approves First Treatment for All Genotypes of Hepatitis C in Pediatric Patients. U.S. FDA. Published April 30, 2019. Accessed April 30, 2019.