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FDA Approves Two-Drug Combo Mavyret for HCV in Adolescents

The US Food and Drug Administration (FDA) approved glecaprevir and pibrentasvir (Mavyret, AbbVie) tablets for the treatment of all six hepatitis C virus (HCV) genotypes in children ages 12 to 17 years.

The FDA approved the drug combination for adults with all six genotypes of hepatitis C on Aug. 3, 2017.

“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,” Jeffrey Murray, MD, deputy director of the Division of Antiviral Products in the FDA‘s Center for Drug Evaluation and Research, said in a news release. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”

The approval follows consideration of data from clinical trials that included 47 patients with genotype 1, 2, 3, or 4 HCV infection who had mild cirrhosis or no cirrhosis.

All patients (100%) who received the drug combination for 8 or 16 weeks had undetectable virus in the blood 12 weeks after completing treatment, “suggesting that patients’ infection had been cured,” according to the news release.

In children with cirrhosis, history of a kidney and/or liver transplant, or infection with genotype 5 or 6 HCV, previous studies of the drug combination’s safety and efficacy in adults support its use in children. Adverse reactions observed in children are consistent with those seen in adults.

Decisions about treatment duration are made on the basis of treatment history, HCV genotype, and cirrhosis status. The most frequent adverse reactions in those taking glecaprevir and pibrentasvir were headache and fatigue. Glecaprevir and pibrentasvir is not recommended in those who have moderate cirrhosis and it is contraindicated in those with severe cirrhosis. The drug combination is contraindicated in those who take the medications atazanavir and rifampin.

There have been reports of hepatitis B virus (HBV) reactivation in adult patients co-infected with HCV and HBV who were receiving or had finished treatment with HCV direct-acting antivirals, and who were not undergoing HBV antiviral therapy.

“HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Mavyret,” according to the news release.

The US Centers for Disease Control and Prevention estimates 2.7 million to 3.9 million individuals in the United States have chronic HCV. Children born to mothers with HCV infection have an increased risk for contracting it. CDC estimates that 23,000 to 46,000 children in the United States currently are infected with HCV.

The dosing information for glecaprevir and pibrentasvir will now include instructions for its use in adults or children ages 12 years and older, or who weigh at least 99 pounds, infected with genotypes 1, 2, 3, 4, 5, or 6 either with no cirrhosis or with compensated cirrhosis.

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